CYCLE Vanguard: Flow Sheet for Protocol Schedule of Forms + Procedures. Binder Title and Cover Pages. Required Materials Study Schema RC flowsheet

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1 Binder Title and Cover Pages Required Materials Study Schema flowsheet 1

2 1. Screening a. Screen patient for eligibility. ASAP after ICU admission (within 4 days of mechanical ventilation and 7 days of ICU admission) b. Complete Electronic Screening Bi-weekly Log and send to Aileen Costigan (acostiga@stjosham.on.ca) and Alex Molloy (amolloy@stjosham.on.ca). c. Add completed screening logs ASAP after completion to the regulatory binder. d. Complete Form 1 Screening All eligible and eligible nonrandomized entered into study database Screening Log Screening Log Manual Electronic Screening Log (Excel file) Overall Screening Data (PowerPoint contact Methods Centre for current version) Form 1 Screening 2

3 2. Consent a. Review Informed Consent form with patient and/or substitute decision maker (SDM) in person or by telephone. ASAP after patient is screened as eligible Informed Consent Form (English) Informed Consent Form (French) Telephone Script b. Collect baseline data for page 3.3 of Form 3 Baseline from SDM. ASAP after informed consent is received Form 3 Baseline (focus on page 3.3) CRF Operations Manual (section 12) c. Complete Consent Discussion Form then file with the patient s consent form. After consent is received Consent Discussion Form 3

4 3. Randomization a. Randomize patient to intervention group using randomize.net. b. Contact PT to inform them of randomization assignment. c. If patient is randomized to cycling + routine PT, select a RT300 ID. ASAP after consent is received ASAP after patient is randomized ASAP after patient is randomized to cycling + routine PT treatment arm * Form 2 - Randomization randomize.net info * * Pre-generated RT300 ID and RT300 PIN (see Therapist Material s Master Binder List tab) CRF Operations Manual (section 12) d. If patient is randomized to cycling + routine PT, revise RT300 PIN to the patient s birth month and last two digits of year (mmyy). Copy the RT300 ID and revised PIN onto first Form 5C - PT Therapy: Cycling. e. Post the following materials in the following locations: - Chart stickers in patient chart - Bedside handouts outside patient room f. Complete Clinical Note for Patient s Chart and place in patient s chart. g. Complete remaining Baseline data collection. Note: All information may not be available immediately. Flag to complete later. After RT300 ID is selected for patient After consent is received After consent is received After patient is randomized or ICU PT (TBD by site) * Pre-generated RTI IDs and PINs Patient s date of birth Form 5C PT Therapy: Cycling (see Section 4 Daily ICU Responsibility) CYCLE chart stickers CYCLE bedside handouts Clinical Note for Patient s Chart Form 3 Baseline focus on pages 3.1 and 3.2 CRF Operations Manual (section 12) Therapist Materials Binder SOP APACHE II (PROSPECT and CCCTG) APACHE II scoring worksheet SOP APACHE III Admitting Diagnoses h. Update paper Master Patient List. After patient is randomized i. Assemble patient data folder. After patient is randomized * CYCLE Master Patient List (see Therapist Material s Master Binder List tab) Determined by site Sample patient data folder 4

5 4. Daily ICU Responsibilities a. Track the location and status of all enrolled patients. Daily * Patient Tracking Sheet b. Track the forms that are Daily * CRF Checklist completed for each patient. c. Collect Daily Data. Daily (7 days/week) * Form 4 - Daily Data Form 4A - Daily Data While On Ward if patient is readmitted to ICU within 72 hours of discharge and eligible to receive research intervention, use for days patient was outside ICU d. PT Therapy Weekdays in ICU up to ICU PT - PT Therapy Worksheet 28 days, excluding - Form 5R - PT Therapy: Routine PT statutory holidays. - Form 5C - PT Therapy: Cycling e. Daily cognitive screening for PT ICU awakening assessment during PT therapy session. Weekdays in ICU up to 28 days, excluding statutory holidays. PT Therapy Worksheet Form 5R - PT Therapy: Routine PT Form 5C - PT Therapy: Cycling RT300 ID, revised PIN Form 15 Variability Sub-Study (SJH and Ottawa only) ICU PT PT Therapy Worksheet CRF Operations Manual (section 12) EN common types nutritional info EN, MP Calculation Templates PT Therapy Worksheet + Form 5R/5C PT Therapy Operations Manual Therapist Materials Binder f. Report safety events If safety event(s) occur during a cycling or routine PT session. ICU PT Form 6 Safety Events CRF Operations Manual (section 12) 5

6 5. ICU Awakening a. PT Strength and Function Assessment (Form 7) b. ICU PT notifies when ICU Awakening: Strength and Function Assessment is complete. ASAP within 72 hours after patient scores 3/5 during cognitive screening; PT believes the patient ready for assessment ASAP after ICU Awakening: Strength and Function Assessment is completed ICU PT Form 7 ICU Awakening: Strength and Function ICU PT Outcome Measures Binder c. Intensive Care Psychological Assessment Tool (IPAT Form 8) After ICU Awakening: Strength and Function Assessment complete; patient not delirious Form 8 ICU Awakening: Intensive Care Psychological Assessment Tool (IPAT) IPAT Administration Guidelines Introduction to IPAT PowerPoint Presentation 6

7 6. ICU Discharge a. PT Strength and Function Assessment (ICU Discharge Ax Form 9) Within 72 hours of ICU discharge ICU PT Form 9 ICU Discharge: Strength and Function Outcomes Measures Binder b. Assessment (ICU Discharge Form 10) c. Complete page 14.1 of Form 14 Final Status and Outcomes Assessments. ASAP within 72 hours of ICU discharge After patient has been discharged from the ICU for >72 hours Form 10 ICU Discharge: Research Coordinator Assessment Form 14 Final Status and Outcomes Assessments CRF Operations Manual (section 12) CRF Operations Manual (section 12) 7

8 7. Pre-hospital Discharge a. Follow patient for readmission to ICU and / or plans for hospital discharge Regularly, until patient discharged from hospital Patient Tracking Sheet (see Section 4 Daily ICU Responsibilities) b. PT Post-ICU Discharge (Form 13) c. PT Strength and Function Assessment (3-Days Post-ICU Ax Form 9A) All days patient receives PT post-icu or poststudy day 28. Ward PT (ICU PT if patient post-study day 28 in ICU) Blinded PT Form 13 PT Post-ICU Discharge Form 9A 3 Days Post-ICU Discharge: Strength and Function CRF Operations Manual (section 12) Outcome Measures Binder d. Contact blinded PT for outcomes assessment Projected hospital discharge <72 hours e. PT Strength and Function Assessment (Hospital Discharge Ax Form 11) Within 72 hours before hospital discharge Blinded PT Form 11 Hospital Discharge: Strength and Function Outcome Measures Binder f. Assessment (Form 12) Within 72 hours before hospital discharge Form 12 Research Coordinator Hospital Discharge Assessment CRF Operations Manual (section 12) 8

9 8. Hospital Discharge, Death, or Withdrawal a. Complete page 14.2 of Form 14 Final Status and Outcome Assessments. Update patient tracking sheet. ASAP after patient has left the study due to hospital discharge, death, or withdrawal. Form 14 Final Status and Outcome Assessments (page 14.2; see Section 6 ICU Discharge) Patient Tracking Sheet (see Section 4 Daily ICU Responsibilities) CRF Operations Manual (section 12) 9

10 9. Background Articles See Outcome Measures Binder See Therapist Materials Binder Please visit for all CYCLE background articles 10

11 10. FAQ s Please visit for most up-to-date FAQ document 11

12 11. Case Report Forms Please visit for most up-to-date FAQ document 12

13 12. Case Report Form (Operations) Manual Please visit for most up-to-date documents 13