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Table 4 Study outcomes and study measures/instruments

From: The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial

Study outcomes Measure/instrument
Co-primary outcomes  
 ED visit rates at 12 months Health administrative data and AHCR-hybrid
 Change in family caregiver reported sense of mastery at 12 months Pearlin Self-Mastery Scale score
Secondary outcomes  
 Healthcare utilization outcomes  
  Number of hospital admissions and days in hospital over 6 and 12 months Health administrative data and AHCR-hybrid
  Hospital free survival at 6 and 12 months Health administrative data and AHCR-hybrid
  Time to first ED visit and first hospital admission Health administrative data and AHCR-hybrid
  Overall survival at 6 and 12 months Health administrative data and AHCR-hybrid
  Number and type of outpatient specialist visits at 6 and 12 months Health administrative data and AHCR-hybrid
  Number of family physician visits at 6 and 12 months Health administrative data and AHCR-hybrid
  Homecare service use at 6 and 12 months Health administrative data and AHCR-hybrid
 Participant and caregiver outcomes  
  Change in caregiver burden from baseline to 6 and 12 months Zarit Burden Interview
  Change in VAI health-related quality of life (HrQoL) from baseline to 6 and 12 months EQ-5D-5L (adults) and EQ-5DY (children)
  Change in patient reported sense of mastery at 12 months Pearlin Self-Mastery Scale score
  Ventilator use/alarms and signs and symptoms questionnaire VentSS and the S3-NIV questionnaires
 Economic outcomes  
  Cost utility (ICER) of TtLIVE intervention compared to usual care in improving patient utility AHCR-hybrid; provincial datasets (IC/ES); provincial costing sources (OCCI); EQ-5D-5L (adults) and EQ-5DY (children)
 Healthcare provider outcomes  
  Healthcare provider time Care Coordination Measurement Tool
 Process measure outcomes  
  Quality of care coordination Family Experiences of Care Coordination
  Adherence to TtLIVE intervention by VAIs/family caregivers over 12 months and platform usage aTouchAway Metrics
  Adherence to TtLIVE intervention by healthcare providers over 12 months and platform usage aTouchAway Metrics
 Adverse events  
  Adverse events unique to the use of the aTouchAway™ platform and the internet (technical issues due to software (aTouchAway™ platform) or hardware (the iPad/ phone/ computer being used) failure, privacy, and security breach Direct reporting from Aetonix, patient, and caregiver