WISDOM Working to Improve discuSsions about DefibrillatOr Management 1R01HL102084 Manual of Procedures v4.1 Table of Contents PURPOSE OF THE MANUAL OF PROCEDURES ................................................................. III ABSTRACT ................................................................................................................... III VERSION CONTROL ...................................................................................................... IV ABBREVIATIONS ........................................................................................................... VI I. OVERVIEW .................................................................................................................. 1 STUDY FLOW ................................................................................................................ 1 Basic Study Flow ..................................................................................................... 1 ................................................................................................................................ 2 Inpatient Daily Screening Flow ................................................................................ 3 ................................................................................................................................ 3 Patient Post-Enrollment Flow (picks up from patient enrollment on last flow) ........... 4 Enrollment Flow - Caregiver .................................................................................... 5 Enrollment Flow - Clinician ...................................................................................... 6 Intervention Flow ..................................................................................................... 8 Patient Death Flow .................................................................................................. 9 Post-Mortem ICD Interrogation Flow ...................................................................... 10 ROLES AND RESPONSIBILITIES ..................................................................................... 11 II. ENROLLMENT ......................................................................................................... 13 USE OF DECEPTION IN THE ENROLLMENT PROCESS ...................................................... 13 PROJECTED ENROLLMENT ........................................................................................... 14 ELIGIBILITY CRITERIA .................................................................................................. 15 WDM90 - Eligibility Screening Tool ........................................................................ 18 Abstraction Guide to Seattle Heart Failure Model .................................................. 19 Medication List for the SHFM Model ...................................................................... 25 Watchlist ................................................................................................................ 34 EXCLUSION CRITERIA .................................................................................................. 34 PROCEDURES FOR ENROLLING PATIENTS ..................................................................... 35 WDM08 – Patient Eligibility Confirmation ............................................................... 37 WDM01 – Enrollment/Demographics – Patient ...................................................... 37 WDM03 – Patient Contact Information ................................................................... 38 WDM07 – Patient Report of Comorbidity ............................................................... 38 PROCEDURE FOR ENROLLING CAREGIVERS .................................................................. 41 When Caregiver Present ....................................................................................... 41 When Caregiver Not Present ................................................................................. 42 WDM13 – Caregiver Eligibility Confirmation .......................................................... 43 WDM02 – Enrollment/Demographics – Caregiver .................................................. 43 WDM04 – Caregiver Contact Information .............................................................. 44 SCREEN FAILURES AND REFUSALS ............................................................................... 44 WDM14 – Patient/Caregiver Screen Failure .......................................................... 45 PROCEDURE FOR ENROLLING CLINICIANS ..................................................................... 46 WDM12 – Clinician Demographic Information ....................................................... 47 WDM96 – Clinician Contact Form .......................................................................... 47 WDM MOP v4.1 ii WDM97 – Pretest Survey ...................................................................................... 48 WDM91 – Clinician Enrollment Failure .................................................................. 48 III. DATA COLLECTION ............................................................................................... 49 CHART OF OUTCOMES ................................................................................................. 50 SCHEDULE OF INSTRUMENTS (BASED ON TIMELINE V13) ............................................... 51 INSTRUMENTS ............................................................................................................. 56 WDM51 - Patient Baseline and Follow-Up ............................................................. 56 WDM52 - Caregiver Baseline and Follow-Up ......................................................... 60 WDM53 - Bereaved Caregiver Instrument ............................................................. 60 WDM10 - Baseline Patient Chart Abstraction Form ............................................... 61 WDM09 - Hospital Medical Record Abstraction Form ............................................ 63 WDM11 - Outpatient Medical Record Abstraction Form ......................................... 67 WDM06 - Termination Form .................................................................................. 67 WDM05 - Patient Mortality Form ............................................................................ 68 WINDOWS (TIMEFRAMES) FOR DATA COLLECTION ......................................................... 71 REPORTS, ACCURACY, AND COMMUNICATION ............................................................... 74 Enrollment Reports ................................................................................................ 74 Data Completion Reports ...................................................................................... 74 Accuracy Checking ................................................................................................ 74 Scheduled Communication .................................................................................... 74 IV. INTERVENTION PROCEDURES ............................................................................ 76 OVERVIEW OF THE INTERVENTION ................................................................................ 76 1. Training Session: ........................................................................................... 76 WDM98– Intervention Post-Test ............................................................................ 76 2. Reminders ..................................................................................................... 76 3. Aggregated feedback ..................................................................................... 77 REMINDER TEMPLATE .................................................................................................. 77 REMINDER LOG AND TRACKING TOOL ........................................................................... 78 WDM17 – Reminder Tracking Tool ........................................................................ 78 rd WDM16 – Physician Survey after 3 Reminder. (Intervention Only) ...................... 79 REMINDER PROTOCOL ................................................................................................. 80 Qualitative Interviews – Year 5 .............................................................................. 81 V. FORMS AND DATA COLLECTION INSTRUMENTS ............................................... 82 GUIDE TO FORMS ........................................................................................................ 82 VI. SERIOUS ADVERSE EVENTS ............................................................................... 84 PATIENT SUICIDALITY .................................................................................................. 84 INAPPROPRIATE ICD DEACTIVATION ............................................................................. 85 BREECH OF HIPAA OR PATIENT CONFIDENTIALITY ........................................................ 85 VII. SITE VISITS ........................................................................................................... 86 VIII. CONTACT LIST ..................................................................................................... 87 IX. APPENDIX .............................................................................................................. 88 PRESENTATIONS ......................................................................................................... 88 GRANT BODY .............................................................................................................