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NEW YORK STATE PSYCHIATRIC INSTITUTE DEPARTMENT OF BIOLOGICAL PSYCHIATRY ECT SERVICE, POLICY AND PROCEDURE MANUAL GOVERNING THE USE OF ELECTROCONVULSIVE THERAPY (ECT) 6 I REVISED: January 22, 2001 ECT Policy and Procedures Manual Page 2 POLICY AND PROCEDURE MANUAL APPROVAL This manual has been revised in accordance with OMH directives and regulations, JCAHO standards, APA Committee on ECT recommendations, and New York State Psychiatric Institute policy. MITCHELL S. NOBLER, M.D. Medical Director, ECT Service, N.Y.S.P.I. HAROLD A. SACKEIM, Ph.D. Chief, Department of Biological Psychiatry, N.Y.S.P.I. MARY BONGIOVI-GARCIA, M.D., PH.D. C President of Medical Staff Organization N.Y.S.P.I. AMY BENNETT-STAUB, R.N., M.P.A. Director of Quality Assurance, N.Y.S.P.I. DAVID HELLERSTEIN, M.D. Clinical Director, N.Y.S.P.I. ANDREW SKODOL, M.D. Deputy Director, N.Y.S.P.T. 'JOHN OLDHAM, M.D. Director, N.Y.S.P.I. DATE DATE DATE DATE DATE DATE DATE ECT Policy and Procedures Manual Page 3 TABLE OF CONTENTS TABLE OF CONTENTS 3 A. INTRODUCTION 5 A.1. POLICIES 6 A-1-I. INDICATIONS FOR TREATMENT 7 a. Major Diagnostic Indications 7 1. Major Depressive Disorder 7 2. Mania 3. Schizophrenia b. Other Diagnostic Indications A.1.11. USE OF ECT IN SPECIAL POPULATIONS 8 a. Children b. Elderly c. Pregnancy A.1.III. CONSENT FOR ECT A.1.IV. ANESTHESIA CARE 10 ............................ 10 ............................ 10 A.2. PROCEDURES A.2.I. REFERRAL AND SCREENING .................................... a. Referral 10 b. Pre-ECT Evaluation 11 A.2.II. ADMINISTRATION OF TREATMENT 12 a. Preparation of Patient ........................... b. Preparation of Treatment Room 1. Equipment 12 2. Medications ............................. c. Treatment Administration ETC 7-11 .................................... . 13 1. Staffing 13 2. ev Ice 13 3. Physiological Monitoring 14 4. Anesthesia Induction 14 5. Self-test Procedure 15 6. ECT Electrode Placement 16 7. Seizure Threshold and Stimulus Dosing 16 8. Seizure Monitoring 18 9. Cardiovascular Monitoring 18 10. Missed Seizures ......................................... 11. Abortive or Inadequate Seizures 12. Prolonged Seizures 19 d. Immediate Post-Treatment ........................................... 19 A.3. RECORD DOCUMENTATION 20 A.4. EQ UIPMENT AND SUPPLIES ............. A.4.1. TREATMENT AREA A.4.11. RECOVERY AREA A.4.111. EQUIPMENT MAINTENANCE AND TESTING 22 a. ECT Devices 22 b. Other Equipment and Devices 22 A.S. PHARMACY A.5.I. MEDICATIONS A.5.II. METHODS OF DRUG CONTROL 24 6 ECT Policy and Procedures Manual Page 4 A.6. INFECTION CONTROL 24 B. OUTPATIENT ECT 24 B.1. . B.2. SCREENING AND ADDITIONAL EXCLUSION CRITERIA 25 B.3. RECORD DOCUMENTATION 26 B.4. TREATMENT ADMINISTRATION 26 C. CONTINUATION/MAINTENANCE ECT 26 D. DOCUMENTATION 27 E. EDUCATION AND TRAINING 28 PRIVILEGING IN ECT 29 F. P G. QUALITY ASSESSMENT AND IMPROVEMENT 29 G.1. QUALITY ASSURANCE 29 G.2. CONTINUING QUALITY IMPROVEMENT 30 APPENDIX A FORMS Form #2: Form. #3: Form #4: Form. #5: Form #5A: Form #6: Form #7: Form #1: Electroconvulsive Therapy Consent Form (Acute Course) Electroconvulsive Therapy Consent Form (Continuation/ Maintenance Treatment) ECT Information Booklet Requisition Form for ECT Pre-ECT Information Sheet Record of Electroconvulsive Therapy and Vital Signs Recording Form Pre-anesthesia evaluation and assessment Anesthesia Record ECT Treatment Settings Form ECT Device Inspection Manual and Calibration Forms Quality Assurance Forms ECT QA Form #1: Department of Nursing ECT Monitoring Form N 0 ECT Policy and Procedures Manual A. INTRODUCTION Page 5 The ECT Service is part of the Department of Biological Psychiatry of the New York State Psychiatric Institute (NYSPI). This Service is presently located on the fifth floor of the new building of NYSPI and occupies a suite of rooms: a waiting room (room no. 5300), a treatment room (room no. 5300BA, telephone no. 543-6204), a recovery room (room no. 5301, telephone no. 543-6204), the head nurse's office (room no. 5300D, telephone no. 5430-007) and a room for a neuropsychology technician (room no. 5300C, telephone no. 5436194. The administrative office of the Service is located on the 4th floor of the Annex (room no. 422, telephone no. 543-5855). The purpose of the Service is to provide clinical care for a selected subgroup of psychiatric patients for whom ECT is indicated.(see Section A.M.), as well as to conduct research and teaching in the area of ECT. The clinical staff of the Service is composed of psychiatrists, anesthesiologists, and registered nurses. All members of the clinical staff are privileged by the New York State Psychiatric Institute. These individuals assume responsibility for screening, evaluating and treating patients referred to the Service. The clinical staff share research and teaching functions with other members of the-Department of Biological Psychiatry. The Medical Director of the e ECT Service is a psychiatrist privileged to perform ECT. The Service Director is nominated by the Chief, Department of Biological Psychiatry and approved by the Clinical Director and Director, New York State Psychiatric Institute. The Director of the ECT Service is responsible for the administration and clinical functioning of the Service, including the supervision of privileged psychiatrists, nurses, and trainees, adherence to policy and procedures, and the implementation and execution of quality assurance programs. Anesthesia care is provided only by Board eligible or Board Certified anesthesiologists privileged through the Department of Anesthesiology at the Columbia Presbyterian Medical Center, and who are nominated to conduct anesthesia for the ECT Service and are privileged by the New York State Psychiatric Institute. The Service makes primary contributions to a long-term research program focusing on ECT. For this purpose, the Service actively seeks external funds to support various research studies. Research studies are conducted in accordance with the established policies and procedures of the NYSPI Insti tutional Review Board (IRB), OMH directives, NIH guidelines and requirements, and JCAHO standards. Research and teaching involving human subjects is conducted only to the extent that it does not jeopardize or interfere with the clinical treatment of the patients. Research applications may require, however, specific modification of the policy and procedures described herein. In particular, research applications will typically require a special consent form that contains specific details about the risks and benefits of the specific research procedures. In this manual, the term, attending physician, refers to the physician with overall responsibility for the clinical management of the patient. For inpatients, this individual is typically the patient's primary physician on the inpatient ward. For outpatients, this individual has medical responsibility for psychiatric care provided on an outpatient ECT Policy and Procedures Manual Page 6 basis, other than the administration of ECT. The term, ECT psychiatrist, refers to a psychiatrist who is a member of the ECT Service and who has privileges to conduct ECT. A-1. POLICIES Electroconvulsive therapy is a special treatment procedure requiring clinical justification and clear documentation of the clinical process. The rationale and clinical indications for using ECT shall be documented in the patient's medical record in accordance with the guidelines detailed in Section A.3. In the treatment of acute episodes of psychiatric illness, ECT is normally administered three times per week Monday, Wednesday and Friday mornings, with the exception of official holidays. For individual patients, reduction in the frequency of treatment or termination of treatment is based on clinical response and the severity of adverse effects. For example, the end of the ECT course may be tapered during the introduction of continuation pharmacotherapy in order to forestall relapse. Alternatively, in patients who develop unacceptable acute cognitive side effects, the frequency of ECT may be decreased. These determinations should be made by the attending physician in consultation with the ECT psychiatrist, as appropriate. The plan for using ECT shall be consistent with the patient's rights to know why this form of treatment is indicated in his/her case, the expected outcome of treatment, and the side effects and risks likely to be associated with this treatment. To this end, prior to initiating treatment, meetings with the patient, and family member(s) when available, shall be conducted in which all relevant issues surrounding this treatment shall be fully explained and discussed. The process of informed consent does not end with the patient and family's agreement to initiate the treatment. Rather, this is a continuous process in which patients are informed of occurrences that may alter the relative risks and benefits of continuing or modifying the treatment, and questions raised by the patient or family are addressed. Under ordinary circumstances, a written informed consent by the patient for the use of ECT and containing the above information shall be obtained and made part of the patient's medical record. The patient shall retain the right to withdraw consent at any time (see Form #1, Appendix A). In addition, patients will be given an information booklet that describes the nature of treatment with ECT (see ECT Information Booklet, Appendix A). Exceptionally, patients suffer from symptomatology severe enough to impair his/ her capacity to be truly informed and/or to truly acknowledge the verbal and written consent process. In such cases, the clinical description of the patient's incapacity to participate knowledgeably in his/her treatment shall be clearly documented in the patient's medical record, and procedures shall be followed in accordance with the guidelines detailed in Section A.1.III. ECT Policv and Procedures Manual Page 7 A.1-1. INDICATIONS FOR TREATMENT a. Major Diagnostic Indications 1. Major Depressive Disorder The use of ECT is mainly reserved for, but is not limited to, cases of Major Depressive Disorder (all subtypes) and Bipolar Disorder, depressed, with one or more of the following characteristics: i. Lack of response or intolerance to adequate pharmacological treatment. ii. Presentation of severe symptomatology (e.g., severe major depression with suicidality, psychotic depression, debilitating psychiatric or medical emergencies, inanition) requiring a prompt antidepressant response. iii. Previous favorable response to ECT, as ascertained by history. iv. Complicating medical conditions (e.g., heart disease, narrow angle glaucoma) that could be worsened by the use of psychotropic medications. V. Adverse reactions to psychotropic medications (e.g., neuroleptic malignant syndrome, delirium, urinary retention) that contraindicate their use. vi. Patient preference. 2. Mania ECT is also indicated for the treatment of mania (all subtypes). Reasons for referral should include one of the following: iii. iv. Ineffectiveness or intolerance of pharmacological treatment strategies. Prior favorable response to ECT. Severe psychopathology requiring prompt intervention, e.g., manic delirium. Complicating medical conditions (e.g., heart disease, narrow angle glaucoma) that could be worsened by the use of psychotropic medications. V. 3. Schizophrenia ECT is also indicated for the treatment of schizophrenia. Reasons for referral should include one of the following: iv. Catatonia. Short-duration of current exacerbation or episode. Prior history of favorable response to ECT. Ineffectiveness of pharmacologic treatment strategies. ECT is also effective in related psychotic disorders, notably schizophreniform psychosis and schizoaffective disorder. ECT may also be useful in the treatment of atypical psychosis, when the clinical features are similar to those of other major diagnostic indications, and in medication- resistant psychotic disorders. In ECT Policy and Procedures Manual Page 8 the conditions listed in this paragraph, restrictive qualifications similar to those listed for cases of Major Depressive Disorder also apply. b. Other Diagnostic Indications Occasionally, ECT may be indicated in the treatment of other conditions where symptomatology is severe or chronic and traditional treatment methods have been unsuccessful. These conditions include, but are not limited to: catatonia secondary to medical conditions, toxic psychosis, obsessive compulsive disorder, Parkinson's disease, intractable seizure disorder, and status epilepticus. For 'major diagnostic indications', the attending physician should document the rationale for treatment with ECT, and a psychiatrist from the ECT service should document concurrence with the need for ECT treatment in the patient's medical chart prior to the first ECT treatment session. For conditions listed under 'other diagnostic indications', there should be, in addition, documented approval by the Clinical Director or designee that ECT is indicated for the patient. A.1.II. USE OF ECT IN SPECIAL POPULATIONS a. Children ECT shall be administered to children or adolescents (under the age of 18) only when all the following conditions have been met: 1. Other viable treatments have not been effective or cannot be safely administered. 2. The anesthesiologist for ECT is experienced in anesthetic procedures for children of this age. 3. For children 12 years of age or under, prior to referral for ECT, concurrence with the recommendation for ECT should be provided by two psychiatrists who are not otherwise involved with the case and who are experienced in the treatment of children, i.e., have completed a psychiatric residency and approved child psychiatry fellowship. The consultants should deliver their opinion only after interviewing the patient, reviewing the clinical record, and discussing the case with the patient's attending physician. 4. For children aged 13 to 17 years, the procedure should be the same as in (3) above, with the exception that documented concurrence need be provided by a single psychiatrist with experience treating adolescents, i.e., an individual who has completed a psychiatric residency and child psychiatry fellowship. In all the situations described in this section, informed consent for treatment shall be obtained from the child's parent(s) or legal guardian. b. Elderly ECT may be helpful in the treatment of the elderly, regardless of age. While there is some increased risk, particularly in those with pre-existing cardiac or cognitive abnormalities, there will be no specific policies to alter the usual procedures for ECT Policy and Procedures Manual Page 9 ECT. Appropriate modifications to decrease risk will be determined on a case-by-case basis by the anesthesiologist and the ECT psychiatrist. c. Pregnancy ECT is safe in all trimesters of pregnancy, and may pose less risk to the fetus than treatment with many psychotropic medications. Obstetric consultation will be obtained prior to ECT in all pregnant patients, and recommendations followed. A.1.III. CONSENT FOR ECT Informed consent should be obtained from the patient except in those situations where the patient lacks the capacity to consent. Informed consent for ECT should be given for a treatment course up to a maximum of 25 ECT treatments. If a patient receives 20 treatments in any modality, the Director of the ECT Service will review the case with the clinical staff and document in the medical record the need for further ECT. If more than 25 ECT treatments need to be given in a single course, then consent should be re-obtained. In addition to the Clinical Director or designee should provide documentation that there is a clinical need for ECT to continue. For continuation/ maintenance ECT, informed consent should be obtained for a maximum of 25 ECT treatments or a time period of six months, whichever is reached sooner. The consent form for continuation/ maintenance ECT is a separate document from that used for consent for an acute course and is tailored to the issues involved in receiving continuation/ maintenance treatment (Form #2). At that stage, if it is deemed that ECT should continue, then informed consent should be re obtained. In those instances where continuation/ maintenance ECT follows a course of acute treatment, the number of treatments will be counted separately (acute and continuation/ maintenance) for these purposes. Except for patients receiving continuation/ maintenance ECT, if at any time there is a gap of 15 days (inclusive) or greater between consecutive ECT treatments, the resumption of ECT will be considered to be the beginning of a new course of ECT and informed consent should be re-obtained. Informed consent for an acute course of ECT, which includes the signing of the formal consent document and the patient's receipt of the ECT Information Booklet (Form # 1), should be obtained prior to the first ECT treatment by the patient's attending physician or designee. During an acute ECT course or continuation/ maintenance treatment, the consentor should be informed of any major alterations in the treatment procedure and any other factors having a major effect on risk/benefit considerations. If there is a switch in the modality of ECT (e.g., from unilateral to bilateral), the clinical indication and risks and benefits should be discussed with the patient, and this should be documented in the medical record. Patients are considered to have the capacity to consent for ECT unless the evidence to the contrary is compelling. The determination of capacity to consent is made by the patient's attending physician or designee. In patients who have the capacity to consent, the informed consent procedures described above should ECT Policy and Procedures Manual Page 10 be followed. Patients who have the capacity to consent, and object to receiving ECT, will not receive the treatment. In patients who are deemed to lack the capacity to consent, the following procedures will be used. Surrogate consent can be obtained only when a need for ECT is documented in the patient's clinical chart by the Clinical Director or designee and the patient does not object to the treatment. In such a case, surrogate consent can be obtained from a spouse, parent, adult child or legal guardian. The surrogate should sign the same informed consent form that the patient would have signed if he/she had the capacity to consent. In such a case, if no first degree relative or legal guardian is available, the Clinical Director or designee can direct that ECT be administered only in the circumstance that the patient does not object to the treatment. The justification for ECT in light of the patient's clinical status, and evidence that the patient does not object to the treatment, should be explicitly documented by the Clinical Director or designee in the patient's chart. If the patient objects to the administration of ECT, then a court order needs to be obtained if it is deemed necessary for ECT to be given over the patient's objection. A.1.IV. ANESTHESIA CARE \1 Prior to the initiation of ECT, the anesthesiologist will conduct a pre-anesthesia evaluation. The anesthesiologist shall review the mandatory pre-ECT physical examination and laboratory data, as well as evaluate the patient's condition immediately prior to the induction of anesthesia before the first ECT, and at subsequent treatment sessions when indicated. The results of these evaluations, including patient's previous drug and anesthetic history, shall be documented in the anesthesia record. The single consent form for either an acute course or continuation/ maintenance ECT (Form # 1) will state that the treatment involves administration of general anesthesia and discuss the anesthetic risks related to the procedure. A.2. PROCEDURES The following is a description of the method used by the Service for screening eligible candidates and for administering ECT. It should be emphasized that the procedure described below is one of several acceptable methods currently in use. This procedure has been selected on the basis of previous experience at NYSPI and is subject to periodic refinement and/or revision whenever the necessity arises. A-2.1. REFERRAL AND SCREENING a. Referral Referrals for ECT are initiated by attending physicians on the basis of clinical judgment. After case review, if the patient is judged to be a suitable candidate for ECT, the attending physician shall fully describe to the patient the nature of treatment, e.g., indications, side effects, possible benefits and risks involved. The attending physician shall contact the ECT nurse or the ECT psychiatrist (telephone contact) to provide preliminary information about the patient (ward ECT Policy and Procedures Manual Page 7 location, sex, age, psychiatric diagnosis, medical diagnosis and complications, if any, and rationale for referral). The ECT psychiatrist will review the patient's case history and current clinical status with the attending physician. The decision regarding the patient's eligibility for treatment is made following the description of indications detailed in Section A.M. Prior to beginning ECT, the attending physician shall have filled out the ECT Requisition Form (Form # 2, Appendix A) and have obtained informed consent. b. Pre-ECT Evaluation The minimum pre-ECT medical work-up includes physical examination, an electrocardiogram (EKG), chest X-ray, serum electrolytes (SMAC-7, preferably SMAC-20), and complete blood count (CBC). The physical examination, EKG and laboratory tests should have been conducted during the preceding month, with the exception of the chest X-ray which should have been done during the preceding 3 months. Chest X-ray and urinalysis may be waived in those cases where ECT is to be performed on an emergency basis or the patient is unable to cooperate with these procedures. Electroencephalogram, CT scan of brain, MRI scan of brain or other procedures will be conducted based on clinical indications for the particular patient. The preECT work-up shall include medical evaluation by an internist. Based on the patient's clinical status, the ECT psychiatrist or the anesthesiologist may require that special procedures, or evaluation by a medical consultant, e.g., cardiologist, be conducted prior to the start of treatment. In patients where there is concern about the status of the patient's dentition and risk of complications during ECT, consultation with a dentist is required (and compliance with the dentist's recommendations) prior to initiation of ECT. For patients above the age of 50 years, routine evaluation by the dentist is recommended. The decision to proceed with ECT is based on a risk/benefit analysis by the ECT psychiatrist, informed by the potential medical risks of the procedure, the steps available to minimize those risks, and the potential benefit of the treatment for the individual patient. Prior to the first treatment, the ECT nurse will provide patient teaching about ECT and document this teaching in the medical record. The ECT psychiatrist will evaluate the patient and write a note in the medical chart, and the anesthesiologist will evaluate the patient and write a pre-operative note in the anesthesia record (Form # 7), to indicate their assessment of the patient's status and their agreement to proceed with ECT. Use of concomitant psychotropic and other medications during the ECT course should be reviewed by the attending physician with the ECT psychiatrist and/or anesthesiologist prior to the first treatment, and on an ongoing basis, as indicated. To alleviate the psychological stress associated with ECT, the attending physician is expected to provide an adequate description of the procedure as the patient is likely to experience it. In addition, the physician shall provide an opportunity for the patient to ask questions and to correct his/her possible misconceptions about treatment. The patient should be given an information sheet (see ECT Information Booklet, Appendix A) that describes the nature of treatment with ECT. The physician shall also inform the family about the treatment procedures and about the confusion and memory changes likely to occur during and ECT Policy and Procedures Manual Page 12 following the treatment course. In addition, the attending physician may obtain videotape material from the ECT Service to aid in educating patients and family members about the treatment. If the patient consents to treatment, he/she shall sign a consent form (see Form No. 1 , Appendix A) which is made part of the patient's record. Details of the consent procedure, and conditions under which the usual consent procedure will be altered, are described in Section A.1.III.. A.2.II. ADMINISTRATION OF TREATMENT a. Preparation of Patient ECT is administered early morning, usually three times a week. Inpatients are escorted to the Service from the ward by a staff member of the inpatient service. All patients should be N.P.O. after midnight of the night prior to the treatment, except for necessary medications, e.g., antihypertensives,that may be given with a small sip of water. The patient should be encouraged to void prior to treatment. The patient's head should be checked for hairpins and jewelry and to assure that hair is clean and dry. Eyeglasses, contact lenses, hearing aids, dentures, and nail polish (over the finger used for pulse oximetry) should be removed, unless otherwise indicated. Gum and other foreign bodies should be removed from the mouth. Vital signs should be recorded. A preECT Information Sheet (see Form No. 3, Appendix A) will be completed by ward staff on the morning of the prescribed ECT session. b. Preparation of Treatment Room 1. Equipment Each morning, prior to treatment, the ECT Nurse shall check: a. ECT device (MECTA SPECTRUM 5000Q, or Thymatron Series IV, if in use) paper supply. b. Oxygen tanks and masks and availability of sufficient medical supplies for the scheduled treatments. c. Suction machine. d. EKG and defibrillator connections. The ECT nurse shall also prepare: (1) for the ECT psychiatrist: acetone, electrode paste, electrode gel, EKG and EEG leads and electrodes, ECT electrodes; (2) for the ECT Anesthesiologist: suction catheters, oxygen masks, air ways, infusion sets, tourniquet, alcohol wipes, tongue blades and tape. 2. Medications The following drugs and solutions shall be available for immediate administration during treatment: ECT Policy and Procedures Manual Page 13 Routine medications for each patient: dextrose 5% in water, 250 ml units; atropine .4 mg/cc; Na methohexital 50 mg/cc; succinylcholine 20 mg/cc; other medications as specifically requested, e.g., curare. b. Additional emergency medications to counteract or provide prophylaxis for possible adverse effects of treatment: lidocaine 25 mg /cc; propanolol I mg/cc; esmolol 10 mg/cc; diazepam 5 mg/cc. A complete list of medications that should be available in the ECT suite is listed in Section A.5. An emergency 'crash' cart will be easily accessible in the treatment room. The anesthesiologist and the ECT psychiatrist will check, prior to treatment administration, the readiness, availability and working conditions of the equipment used in the administration of anesthetic agents and electrical stimuli, respectively. Prior to each treatment, the ECT psychiatrist and nurse should check that treatment orders have been written, and both the ECT psychiatrist and the anesthesiologist should review the medical record since the last ECT treatment. A member of the treatment team should check the patient's mouth for the presence of foreign bodies and loose or false teeth and establish that the patient has taken nothing by mouth (except a sip of water for medication, if necessary) from midnight of the previous evening. The presence of significant problems and their management should be noted in the treatment record. The ECT psychiatrist and/or anesthesiologist may cancel a scheduled treatment if appropriate procedures have not been followed or if they decide that the risk of conducting ECT is unacceptably high. c. Treatment Administration 1. Staffing During treatment, the patient shall be attended by the psychiatrist, the anesthesiologist and a nurse. Technicians may assist in the placement of monitoring electrodes (EKG, EEG, pulse oximetry) and noninvasive blood pressure cuff. Psychiatrists, anesthesiologists, resident and fellow physicians in training, medical students, nursing students, technical and research personnel, supervisory hospital staff, and other clinical staff at the New York State Psychiatric Institute may observe the treatment. For these individuals to observe the treatment, permission obtained from the ECT nurse and the ECT psychiatrist will be sufficient. For all other individuals who wish to observe the treatment, the patient receiving ECT will also be required to give explicit permission for this purpose. 2. ECT Device The devices currently used to administer ECT are a modified MECTA SPECTRUM 5000Q (MECTA Corporation) and a Thymatron Series IV (Somatics Corporation). Two devices are always available in case of the need for backup. These devices pass a constant current (500- 9OOmA), bidirectional, square wave, brief pulse stimulus. Pulse frequency may range from 20 to 120 Hz, pulse width may range from 0.2 to 2.0 ECT Policy and Procedures Manual Page 14 Ins and stimulus duration may range from 0.5 to 9.0 s. The devices assess patient static impedance prior to ECT administration. If interface resistance is too low or too high, possibly resulting in excessive current shunting or reduction of current intensity, the ECT stimulator is disabled by an automatic fail/safe mode. The patient will not be stimulated until static impedance is within acceptable range and/or the cause of the exce ptional impedance reading is identified. EEG is monitored continuously on these devices. The SPECTRUM 5000Q devices used by the Service have been modified by the MECTA Corporation to meet the Service's specifications, allowing greater range and flexibility in determining stimulus electrical dosage. Calibration and maintenance of ECT devices, and the testing of new devices, are described in Section A.4.III.a. 3. Physiological Monitoring EEG, EKG, and ECT electrode placements shall be prepared by the ECT psychiatrist, with the assistance of the ECT nurse or research technician, prior to administration of anesthesia. EEG and ECT electrode sites shall be cleansed with acetone or alcohol, dried with gauze pad, and impedance reduced with a mild abrasive, as appropriate. Disposable electrodes are used to monitor EKG, with electrodes over the precordium. EEG is monitored with disposable pediatric EKG electrodes or with gold cup, silver-silver chloride, or other standard electrodes by means of frontal and mastoid placements. EEG recording are taken from left frontal-left mastoid and right frontal- right mastoid leads. In addition to EEG and EKG monitoring, ST-segment, end-tidal PC02 and peripheral oxygen (02) concentration will be monitored throughout each treatment (pulse oximetry). Heart rate and blood pressure will be recorded immediately before, during, and following the treatment. The ECT nurse will obtain and record vital signs, including noninvasive heart rate and blood pressure readings, which will be monitored by the anesthesiologist. Vital sign measurements will commence prior to the administration of atropine until stabilization in the postictal period, as determined by the anesthesiologist. EKG monitoring will commence prior to the administration of atropine and terminate when the anesthesiologist has determined that cardiac function has stabilized in the postictal period. EEG monitoring will commence approximately 10 s prior to the application of the ECT stimulus and terminate with the ECT psychiatrist's determination during the postictal period that ictal activity has terminated. Pulse oximetry will commence prior to the induction of anesthesia and until the return of spontaneous respiration. External physiological monitoring devices connected to e patient in the treatment room will be electrically isolated and all connected to the same grounded circuit. 4. Anesthesia Induction Anesthesia will be induced by the anesthesiologist according to accepted standards of medical practice. Intravenous access should be established and maintained until the patient is ready to leave the treatment area. Atropine (0.4-0.8 mg IV) is usually given prior to administration of the anesthetic agent. Methohexital sodium (Brevital) will be administered in a dose individualized for each patient, which is typically 0.75 mg/kg body weight and hence usually ranges ECT PoIicy and Procedures Manual Page 15 from 30 to 100 mg. The patient shall be oxygenated by mask by the anesthesiologist following medication injection to maintain adequate oxygenation (10070 02, positive pressure). Oxygenation will continue during the seizure and until the resumption of spontaneous respiration. Airway management is the responsibility of the anesthesiologist. A dosage of anesthetic will be used that will minimize anticonvulsant effects on seizure threshold, produce rapid return of consciousness following seizure induction, but insure that the patient remains unconscious throughout the procedure. In exceptional circumstances, other agents may be used as anesthetics (e.g., etomidate, ketamine, medazolam, propofol, thiopental). Likewise in exceptional circumstances, as medically indicated, other medications may be administered prior to or following seizure induction. Succinylcholine will be injected intravenously as soon as the patient demonstrates response to anesthetic. The initial dose is typically 0.75 mg/kg body weight and hence usually ranges from 30 to 100 mg. The concentration is 20 mg/cc. Succinylcholine will be administered in bolus. To determine that a sufficient state of paralysis has been produced, visual observation for fasciculations and flexibility of the lower jaw shall be examined. A nerve stimulator will also be available for use as indicated. Maximal effect of succinylcholine usually occurs within 60 to 120 seconds after IN. administration. Dosage of atropine, methohexital and succinylcholine may be modified based on the patient's response to the anesthetic induction at earlier treatments. The atropine, methohexital, and succiny1choline will be injected into a stopcock or plastic tubing attached to the catheter previously introduced into the patient's vein by the anesthesiologist. Prior to electrical stimulation, a flexible protective bite-block will be inserted to protect the teeth and other oral structures. In patients with poor dentition, a special mouth guard may be used. Whether a special mouth guard is required will be determined by a dental consultation. The patient's chin will be held during the passage of the electrical stimulus to keep the jaw tight against the bite-block. Adequate contact between the ECT stimulus electrodes and scalp, and between EEG electrodes and scalp, should be assured with appropriate use of acetone; paste and conducting gel. The aim here is to minimize impedance to the passage of the ECT stimulus. Conducting gel should be confined to the area under the stimulus electrodes, and should not spread across the hair or scalp between stimulus electrodes. 5. Self-test Procedure Once it is determined that the patient has achieved an acceptable level of anesthesia and muscle relaxation, administration of ECT will proceed. The MECTA SPECTRUM provides a continuous assessment of static impedance (selftest), which will be examined by the ECT psychiatrist prior to stimulation. In the event that the patient requires restimulation due to a subconvulsive administration or an abortive seizure, the static impedance will be inspected again prior to restimulation. The Thymatron Series IV requires that the ECT psychiatrist depress a static impedance button to obtain a reading. This will be ECT Policy and Procedures Manual Page 26 done prior to administration of any electrical stimulus. With this device, the stimulus will not be administered unless the static impedance reading is less than 3,000 ohms. The acceptable range for the MECTA SPECTRUM to deliver a stimulus is between 100 and 5,000 ohms. However, unless there are exceptional circumstances the treatment should not proceed with this device unless static impedance just prior to stimulus delivery is below 2,000 ohms. 6. ECT Electrode Placement For patients not participating in research protocols, the choice of electrode placement, bilateral or unilateral, will be made on a case-by-case basis. This determination will be made by the ECT psychiatrist in consultation with the attending physician. In major depressive disorder, the relative efficacy of bilateral and right unilateral ECT has been subject to controversy. There is considerable evidence that the cognitive side effects of ECT are generally reduced with right unilateral, compared to bilateral, ECT. However, it is possible that bilateral ECT is a more effective treatment for some patients. In making a case-by-case determination of the advisability of initiating ECT with right unilateral or bilateral electrode placements, the following considerations will be kept in mind. For the majority of patients, right unilateral ECT will be recommended as the initial course of treatment. Bilateral ECT will be recommended as the initial treatment particularly for patients who have failed a course of suprathreshold right unilateral ECT in the index episode. Other instances in which initial use of bilateral ECT will be considered are: diagnostic indications other than major depression, history of positive response to bilateral ECT with tolerable side effects, and patient preference. On the other hand, right unilateral ECT may be recommended for patients in whom there is heightened risk of intensified cognitive side effects. Such patients may include individuals who experienced unacceptable side effects with previous administration of bilateral ECT, patients with pre-existing cognitive or neurological impairment, and patients who indicate a preference to be treated with right unilateral ECT. The choice of electrode placement may be altered during the ECT course based on the extent of clinical improvement and cognitive side effects. The standard bifrontotemporal placement will be used for bilateral ECT and the d'Elia positioning for unilateral ECT. Other than in research applications, there is no foreseen use of left unilateral ECT. 7. Seizure Threshold and Stimulus Dosing The empirical titration procedure, developed at this center, is now in widespread use. This procedure provides the ECT psychiatrist with dose finding information by identifying the minimal electrical intensity necessary to produce an adequate generalized seizure. Empirical titration is almost invariably conducted at the first treatment. The information obtained at this treatment will be used to determine the electrical dose administered in subsequent treatments. The titration procedure involves the application of subconvulsive stimuli with stepwise increases in stimulus intensity. The dosage increments typically range from 25 to 100% for consecutive restimulations. Each restimulation should be preceded by a delay of approximately 20 seconds to take into account the possibility of delayed seizure ECT Policy and Procedures Manual Page 17 onset and residual effects of subconvulsive stimulation. Up to five subconvulsive stimuli may be administered at a single treatment session. Subsequent treatments will be at a fixed dosage above the initial seizure threshold based on research protocol and/or clinical considerations. The use of subconvulsive stimuli in a session will be generally restricted to the first one or two treatment sessions, and the last treatment session, when seizure threshold may be re-determined to assess the degree to which the stimulus dose used in the course remained suprathreshold. According to current practice at the Service, the initial stimulus intensity in a titration schedule produces a charge of 36 mC or less (range 12-36 mC). The initial parameters will be altered in specific individuals based on research protocol and clinical considerations. In addition, since the aim of the treatment is to elicit a modified grand mal seizure, in some cases the usual stepwise increment in stimulus intensity may be altered by utilization of greater stimulus intensity than would normally be the case, to insure that a seizure is elicited. Also, in cases where it is felt that determination of seizure threshold is not essential at the first ECT treatment, stimulus intensity at the first application will be determined by the ECT psychiatrist based on clinical considerations, and titration may be conducted at the second or later treatments. There is a paucity of information regarding the optimal stimulus dose for right unilateral and bilateral ECT. Generally speaking, it appears that the higher the electrical dose relative to the patient's seizure threshold, the greater the-degree of short-term cognitive side effects. However, it also appears that stimulus dose impacts on efficacy. For both right unilateral and bilateral ECT, higher electrical dose may accelerate clinical response. For right unilateral ECT, stimulus dose appears to be critical in determining whether patients respond to ECT. Given these considerations, unless modified by the dictates of research protocols or clinical considerations, patients treated with right unilateral ECT will receive an electrical dose that exceeds their initial threshold by at least 300% (typical range 300- 500% with 500% being the most common dosage increment. For patients treated with bilateral ECT, the typical dose range will be between 50-150% in excess of initial seizure threshold. Failure to show clinical improvement or manifesting particularly slow clinical response, with an acceptable level of cognitive side effects, will be grounds for increasing stimulus dose, or switching from right unilateral to bilateral electrode placements. Stimulus dose may be reduced in patients who have shown clinical benefit, but pronounced cognitive side effects. Alternatively, in such patients, the frequency of ECT sessions may be reduced or patients may be switched from bilateral to right unilateral ECT. Oxygenation is maintained by forced pressure by the anesthesiologist, until resumption of adequate spontaneous respiration. During the seizure, EEG and EKG shall be monitored from the beginning of the procedure. Vital signs shall be monitored regularly by the anesthesiologist. After administration of ECT, the teeth and hypopharynx shall be examined and secretions removed by suction, if necessary. Monitoring of vital signs shall continue until stabilization and return of consciousness. During the wakening period, the patient shall be attended to by the nurse and members of the treatment team until he/she is reoriented. The awakening patient will be systematically and gently reassured until reorientation occurs. ECT Policy and Procedures Manual Page 20 escorted back to the ward by the ward's staff member. Upon return to the ward, the patient shall be given breakfast. The recovery area will be equipped with the equipment necessary to continuously monitor EKG, blood pressure, and pulse oximetry. In addition, the recovery will be equipped to deliver oxygen and suction, if ever needed. Post-ictal agitation is a phenomenon that is self-limited in time, and may last from a few minutes to an hour following seizure elicitation. Postictal agitation occurs in a small proportion of patients. In patients with mild agitation, supportive management with reduction of external stimuli and quiet reassurance should suffice. In more severe cases of postictal agitation, intravenous midazolam in doses ranging from 1 to 5 mg or intravenous diazepam in doses ranging from 2.5 mg to 20 mg is usually sufficient to treat this condition. In rare instances, higher doses of midizolam or diazepam may be required. Alternative approaches include the administration of additional methohexital or droperidol, intravenously by the anesthesiologist. In patients whose agitation results in discontinuation of the intravenous line, intramuscular medications, e.g., lorazepam 0.5 to 2 mg or haloperidol 1 to 5 mg, may need to be used. Strategies to prevent postictal excitement at subsequent treatments shall include the intravenous administration of a higher dose of anesthetic or muscle relaxant prior to seizure elicitation or administration *of diazepam, methohexital, or similar agent immediately following seizure termination. DOCUMENTATION The rationale and clinical indications for using ECT shall be documented in the patient's record in a narrative form. In particular, previous treatment response to somatic therapies and characteristics of the clinical state of the patient must be detailed in a note written and signed by the attending physician. The requisition for ECT (Form No. 2) should be completed. The attending physician's order must be written for each treatment. In those exceptional cases where the authorization for treatment is given by a patient's responsible relative, the NYSPI Clinical Director (or designee), or by a court of competent jurisdiction, the Chief of the clinical service where the patient is hospitalized must document in the patient's record the current mental status, including a clinical summary of the patient's judgment and insight as they pertain to capacity to provide informed consent, the need for ECT, and the expected outcome. Details of these required procedures are described in Section A.1.III. Procedures used during the treatment and recovery periods shall be documented using special forms (see Form Nos. 4-6, Appendix A). The ECT nurse, psychiatrist and anesthesiologist are required to document the patient's physiological response to treatment and the patient's recovery from anesthesia and the procedure. Form #4 is completed by the anesthesiologist and ECT psychiatrist and nurse, Form #5 and #5A by the anesthesiologist, and Form #6 by the ECT psychiatrist. Form Nos. 4, 5, and 5A become part of the medical record, and Form No. 6 is kept by the ECT nurse in the ECT suite. In addition, the ECT psychiatrist is required to document in the ECT Policy and Procedures Manual Page 21 medical record the patient's physiological response to the treatrnent and the patient's recovery from anesthesia and the procedure. On at least a weekly basis, the patient's attending physician is required to document in a progress note in the medical record the clinical and mental status of the patient during the ECT course. Such evaluations are performed preferably on the day following a treatment. This evaluation should include a description of the clinical syndrome or symptoms for which the patient is receiving ECT, e.g., depressive symptomatology, and results of testing of cognition. Cognitive testing should include, at minimum, evaluation of orientation to time, place, and person, and recent memory (e.g., 3 out of 3 objects at 5 minutes). It is also recommended that the patient's remote memory (retrograde amnesia) be evaluated, at least on an informal basis, by inquiring about events in the recent past. In cases where the patient remains disoriented in all spheres and recalls 0 out-of 3 objects at five minutes on the day following an ECT treatment session, the rationale for continuation of ECT should be documented in the chart by the patient's physician. Justification for interruption of treatment should be documented by the patient's physician. A.4. Equipment and Supplies A.4.1. TREATMENT AREA Equipment should be available" to induce a seizure, monitor physiologic response, maintain an airway, deliver positive pressure ventilation, and provide resuscitation in case of cardiovascular or respiratory complications. The following equipment should be available in the treatment area: 1. ECT treatment device that includes facility for EEG monitoring, with one backup device. 2. Electrocardiogram (EKG) monitor with defibrillator. 3. Manual sphygmomanometer or automatic device for monitoring blood pressure. 4. Sphygmomanometer or tourniquet to aid in monitoring motor seizure duration (occluding a limb). 5. Stethoscope. 6. Oxygen delivery system capable of providing positive intermittent 7. pressure oxygen by mask or endotracheal tube. 8. Intubation set. 9. Suction delivery apparatus. 10. Reflex hammer. Stretcher or bed with firm mattress and side rails, and capable of easily elevating both head and feet. 11. Pulse oximeter. 12. CO 2 monitor. 13. Peripheral nerve stimulator. 14. Ophthalmoscope. ECT Policy and Procedures Manual Page 22 Related supplies should also be available: 1. Airways. 2. Alcohol and acetone. 3. Electrode gel and paste. 4. Gauze pads, tape, bandages. 5. IV Solutions: 5% dextrose in water, 250 cc. and 500 cc. bags, normal saline 500 cc. bags. 7. IV Tubing -- 84" 1Y inj. sites. 8. Monitoring electrodes (EEG, EKG) and leads. 9. Mouth guards (soft rubber). 10. Oxygen masks. 11. Oxygen tanks. 12. Recording paper for monitoring use. 13. Stimulus and monitoring cables for ECT device. 14. Suction catheters. A.4.II. RECOVERY AREA The recovery area should have the capacity to deliver intermittent positive pressure oxygen, monitor EKG, pulse oximetry, and vital signs, and provide suction. A.4.III. EQUIPMENT MAINTENANCE AND TESTING a. ECT Devices Before a new ECT device is placed in use or on any occasion in which an ECT device is returned from the manufacturer after servicing, the proper operation and calibration of all output characteristics and the functioning of all controls and features will be ascertained and documented. This inspection will at minimum include the procedures recommended by the device manufacturer in the device Service Manual. In addition, the ECT device's will undergo a similar inspection at least once a year. In cases in which device malfunction is suspected or there is an unusual occurrence that could affect device operation (e.g., slippage, fire), device testing will be conducted prior to next use. The results of these inspections will be documented in the ECT Device Test and Calibration Form (see Form No. 7, Appendix A). Form #7 will be kept by the ECT nurse in the ECT suite. No device will be used unless proper operation and calibration has been documented following an inspection. Maintenance of the ECT devices will be performed as recommended by the device manufacturer. b. Other Equipment and Devices Testing of proper operation and function will be conducted for all new devices used by the Service and will be performed on a regular basis following the procedures and time intervals recommended by the manufacturers. Similarly, equipment will be maintained following manufacturers' recommendations. The proper functioning and operation of the anesthesia delivery system is the ECT Policy and Procedures Manual Page 23 responsibility of the anesthesiologists from CoIumbia-Presbyterian Medical Center who are privileged by the New York State Psychiatric Institute. A.5. PHARMACY A.5.I. MEDICATIONS Medications will be ordered as necessary. The ECT psychiatrist is to order Schedule III, IV, V (e.g., Methohexital, Diazepam, Lorazepam). The following should be available at all times in the ECT treatment area: 1. 2% Lidocaine HCI 20 mg/ml 2. Succinylcholine 20 mg/ml 3. Atropine Sulphate 1/ 15 gr/ ml 4. Curare 3 mg/ml 5. Dantrolene 20 mg 6. Phenytoin 250 mg/mI 7. Ephedrine 50 mg/ml 8. Labetolol 5 mg/ml 9. Propranolol 1 mg/ml 10. Methohexital Sodium 500 mg vial 11. Narcan 0.4 mg/ml 12. Neosynephrine 13. Nitroglycerin tabs 0.4 mg (1 / 15 gr.) 14. Nitropaste 2% 15. Physostigmine 1 mg/ml 16. Diazepam 5 mg/mI 17. Xylocaine 1% and 2% local anesthetic 18. Esmolol 10 mg/ml 19. Droperidol 5 mg/2 ml 20. Diphenhyrdamine 21. Tensilon 22. Midazolam 1 mg/ml 23. Verapamil 5 mg/2 ml 24. Solu-Medrol 20 mg/ml 25. Adenosine 6 mg/2 ml. 26. Ketorolac 30 mg/ml 27. Prochlorperazine 10 mg 2 ml 28. Ondansetron 2 mg / ml 29. Haloperidol 5 mg/ml 30. Lorazepam 2 mg/ml 31. Antacids 32. Non-narcotic analgesics, e.g., aspirin, acetominophen, ibuprofen Additional medications will be ordered if medically indicated, e.g., history of specific allergic reaction may require alternative medication. ECT Policy and Procedures Manual Page 25 scope. The aim of outpatient ECT is to provide symptomatic relief of affective and specific psychotic syndromes and/or to prevent relapse of such manifestations. Outpatient ECT shall not substitute for the comprehensive care needed by the psychiatric patient. B.2. SCREENING AND ADDITIONAL EXCLUSION CRITERIA Referrals are initiated by attending physicians and the ECT team member first contacted shall obtain preliminary information about the patient. The ECT psychiatrist shall review with the attending physician the patient's case history and current clinical psychiatric and medical status. The case review is conducted to assess preliminarily whether the patient is a suitable candidate for outpatient ECT treatment. The exclusion/inclusion criteria for entering outpatient ECT are identical to the ones detailed in Section A.1.I., with the following additional exclusion criteria: 1. Below age 18. 2. Suicidal risk (as assessed by present symptomatology, previous history, and family history). 3. Unwillingness on the part of the patient and his/her family to adhere to the following throughout the treatment regimen: a. The patient shall be escorted to and from the ECT Service by a family member/ friend. b. The responsible family member/ friend shall supervise off site treatment requisites, i.e., NPO after midnight on the scheduled days of treatment, and give a brief report about the patient's behavior in between treatments. c. The responsible family member/ friend shall be told to contact either the ECT psychiatrist or the ECT nurse (both available through the NYSPI Operator) of any significant change in the patient's behavior. d. The patient shall be advised not to engage in activities requiring the handling of hazardous objects or machinery, including driving motor vehicles, at least until the acute course of treatment is terminated (does not apply to continuation/ maintenance ECT). e. The patient shall not leave his/her home unless accompanied by a family member/ friend (does not apply to continuation/ maintenance ECT). The medical screening (complete physical examination and laboratory tests) may be performed by physicians not affiliated with NYSPI. The results of the medical work-up, and the list of all current medications with dosages, shall be clearly documented in the patient's medical record in accordance with the procedural guidelines detailed below. ECT Policy and Procedures Manual Page 26 B.3. RECORD DOCUMENTATION Outpatient ECT is a special treatment procedure requiring clinical justification. Clear record documentation as described for inpatients above, with specific additions as outlined below, is mandated. 1. Rationale and clinical justification for using ECT. 2. Clinical justification for administering treatment on an outpatient basis. 3. Implementation of restrictions that apply to patient's selection, as mandated by the policies and screening procedures detailed above. 4. Psychiatric syndrome and target symptoms to be treated. 5. Name, address and telephone number of the designated physician who agrees, after discussion with the ECT psychiatrist, to retain responsibility for the general psychiatric care of the patient during and after treatment. The above documentation shall be made in a narrative form and included in the psychiatric assessment. Prior to beginning ECT treatment, outpatients will be registered by ECT Nurse. Progress notes of therapeutic response to treatment, the type and number of treatments given, medications administered, pre- and post -treatment vital signs and behaviors shall be entered in the patient's medical record. During the course of outpatient ECT, a progress note should be written by the referring physician at a minimum frequency of once a week. B.4. TREATMENT ADMINISTRATION The procedures previously outlined for inpatients should be followed, with the only modification pertaining to the immediate postictal period. After complete return of consciousness occurs, the patient shall be further observed in the recovery room until he/she is able to walk without assistance. Patients are usually able to walk unassisted 30 minutes to 2 hours after treatment. Upon recovery, discharge from the Service shall be authorized by the ECT Psychiatrist. The patient is then escorted out of the ECT Service by the responsible family member or friend. C. CONTINUATION/MAINTENANCE ECT This form of treatment, in which ECT is administered at a frequency of once a week or less following the acute treatment course, may be conducted with either inpatients or outpatients. The policy and procedures for ECT will be identical as already defined for inpatients and outpatients, respectively. Decisions regarding the onset, continuation and termination of continuation/ maintenance ECT should be made by the referring physician in consultation with the ECT psychiatrist, as appropriate. Physical examination and appropriate laboratory evaluation should be conducted at least every 3 months during the course of continuation/ maintenance ECT. As already noted, the informed consent for continuation/ maintenance ECT shall be for a period of six months or 25 treatments, whichever is reached first, and a separate consent form is used for ECT Policy and Procedures Manual Page 27 continuation/ maintenance treatment. After this limit is reached, informed consent should be re- obtained if ECT is to continue. The informed consent document and procedures will otherwise be identical to those outlined in Section A.1.III. The purpose of continuation/ maintenance ECT is to prevent relapse or recurrence of a condition that has responded to an acute course of ECT. When the intent in use of ECT changes from management of acute episodic symptoms to prevention of relapse/ recurrence, then the additional treatment will be considered continuation/ maintenance ECT and a new consent should be obtained. Typical indications for continuation/ maintenance ECT are a history of relapse/ recurrence while receiving adequate pharmacotherapy, intolerance of medications, and/or a previous history of good response to continuation/ maintenance ECT. The frequency of treatments administered typically will be titrated to patient response. When continuation/ maintenance ECT directly follows use of ECT to treat acute or episodic symptom atology, the interval between treatments will be progressively lengthened until a monthly or other regular interval is established or until pat tients manifest prodromal symptomatology suggestive of incipient relapse. In the latter case, the interval will be shortened to minimize return of psychiatric symptoms. There is no upper limit to the number of treatments that may be administered on a maintenance basis. However, use of maintenance ECT for more than a two-year period is rare. D. DOCUMENTATION Detailed documentation, as listed below, should be completed on the accompanying forms and in the patient's medical record. These forms may be modified based on recommendations of ECT Service members or other medical staff, with approval by hospital staff committees, as appropriate. Prior to beginning a course of ECT, the ECT psychiatrist should make certain that the following documentation is included in the patient's clinical record: 1. reason for ECT referral, including an assessment of anticipated benefits and risks; 2. mental status, including baseline information pertinent to later determinants of therapeutic outcome, orientation and memory function; 3. signed consent document (exceptions as noted under Section A.1.III.); 4. complete pre-ECT evaluation including physical examination, laboratory work-up and consultations, as appropriate; 5. a discussion of any planned alterations in the ECT procedure; 6. a justification for outpatient ECT, if applicable, as described in Section Prior to each ECT treatment, an order for ECT should be written by the patient's attending physician, and the current order sheet should be sent with the patient to the ECT suite. Between ECT treatment sessions, notes by the attending physician or designee should be entered at least weekly in the patient's medical record, and at least once a month in patients undergoing continuation or maintenance ECT. These notes should contain an assessment of both therapeutic and adverse effects, and justification for the continuation of ECT when appropriate. ECT Policy and Procedures Mail Manual Page 28 At the time of each ECT treatment session, the following information should be documented in the patient's medical record: 1. baseline vital signs; 2. anesthetic medications administered, and all medications administered in the treatment and recovery areas; 3. documentation by the anesthesiologist regarding the patient's condition during and following the treatment (part of anesthesia record); 4. a note by the ECT psychiatrist regarding the patient's condition during and following the treatment; 5. vital signs taken following the seizure in the treatment room and recovery area; 6. a note by the recovery nurse concerning the patient's condition at the end of his/her stay in the recovery area (Form #4); 7. stimulus electrode placement, stimulus parameter settings and seizure duration (motor) should be documented, though due to research protocol considerations, including maintaining masking, records of these details are customarily kept in the ECT treatment suite. These details will be made available if there is a need for hospital review of individual treatments for specific patients. Following completion of the ECT course, the attending physician or designee should document in the medical record the patient's overall therapeutic outcome and adverse effects as a result of the ECT, and a plan for post-ECT clinical management. For patients receiving maintenance ECT, a progress note should be written at a minimum frequency of once a month. E. EDUCATION AND TRAINING The Service is part of the New York State Psychiatric Institute and the Department of Psychiatry, College of Physicians and Surgeons of Columbia University. In this capacity, education and training are provided for psychiatric residents and fellows, medical students, nursing students and other medical and mental health professionals. Currently, psychiatric residents are required to fulfill minimum requirements in ECT training during their PGY-1 and PGY-2 years. These minimum requirements are as follows: observe the administration of at least six ECT treatments, assist in the conduct of at least one ECT treatment, and clinically follow at least two patients during their ECT treatment course. Currently, NYSPI is one of three sites where residents can meet these requirements (the others being the inpatient unit at Eye-6 and Creedmoor Psychiatric Center). Policies pertaining to residents and medical students will be determined on an ongoing basis by the Director of the ECT service and the Residency Training Director or designee. Policies pertaining to nursing students who observe ECT will be determined by the ECT nurse with the appropriate institutional nursing authorities. ECT Policy and Procedures Manual Page 29 F. PRIVILEGING IN ECT Each member of the ECT treatment team should be clinically privileged to practice his or her ECT-related duties. The Medical Director of the ECT service shall recommend which psychiatrists should be privileged to conduct ECT. Based on this recommendation, the Medical Staff Credentialing and Privileging Committee reviews and recommends appointment or reappointment to the Medical Staff Executive Committee, which in turn makes the recommendation to the Governing Body of NYSPI. The Governing Body shall determine final approval for privileges to conduct ECT. Privileging will be based on an assessment of the general competency of the psychiatrist and specific experience with and knowledge of ECT treatment. Supervised administration at NYSPI of at least 20 ECT treatments is required for a psychiatrist to be considered for ECT privileges. Maintenance of this privilege will follow hospital medical staff standards, with formal re-review occurring no less frequently Tan once every two years. At any time, the Director of the ECT Service may recommend the suspension or revocation of ECT privileges of an ECT psychiatrist, and the usual procedures outlined in the Medical Staff By Laws will be followed. The Chief of the Department of Biological Psychiatry shall nominate the psychiatrist who serves as Medical Director of the ECT Service, subject to approval by the Director of NYSPI. The Medical Director of the ECT Service must have privileges to conduct ECT, and these privileges will be subject to the same review process described in the preceding paragraph. Anesthesiologists are privileged both by the Department of Anesthesiology, Columbia-Presbyterian Medical Center and the Governing Body of NYSPI following recommendation by the Medical Staff of NYSPI. Nurses are privileged by the Medical Director of the ECT Service and the Nursing Department of NYSPI. All registered nurses on the hospital staff are eligible to function as the ECT nurse in the treatment or recovery areas. The minimum requirement to function as the ECT nurse is participation in one orientation session conducted by a privileged ECT nurse, and assisting in ECT treatment and in monitoring of patients for at least one treatment day (one or more patients), under the supervision of a privileged ECT nurse. G. QUALITY ASSESSMENT AND IMPROVEMENT The ECT service monitors the quality of care given to all patients receiving electroconvulsive therapy. The standard of care is based on the descriptions in IS Policy and Procedures Manual, and standards developed by the ECT service with the Quality Assurance (QA) department at NYSPI on an ongoing basis. G-1. QUALITY ASSURANCE The Department of Nursing will monitor the nursing care given to the patient receiving ECT. Four treatments per month will be monitored by nursing administration personnel for appropriate nursing care as per criteria on New York State Psychiatric ECT Policy and Procedures Manual Page 30 Institute, Department of Nursing Chart Monitor. The patients' charts will be reviewed for appropriate documentation as per criteria on the survey tool (ECT QA Form #1). The ECT service will submit a bi-annual report to quality assurance, listing the results of the ECT/ANESTHESIA data for a six month period. This report will include: the number of patients receiving ECT, the number of treatments administered, any events requiring additional medication, and any unusual events occurring during the course of ECT. The report will describe the corrective action taken, along with follow-up monitoring. This report will be completed in May and November, bi-annually, and the results will be presented at the medical staff meeting. G.2. CONTINUING QUALITY IMPROVEMENT Systematic monitoring of the process of care and of outcome will be conducted by the ECT service in conjunction with the Quality Assurance department at NYSPI. Areas where quality assurance standards have not been met will be identified to correct observed insufficiencies. New areas where quality can be improved will be identified and appropriate procedures/ policies will be developed and implemented by the ECT service with consultation from the Quality Assurance department on an ongoing basis. Periodic discussions between the ECT service and Quality Assurance on at least a biannual basis will be held for these purposes. |
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