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Table 2 Data collection schedule and measurement instruments for patients, informal caregivers and healthcare professionals

From: A cluster randomized controlled trial on a multifaceted implementation strategy to promote integrated palliative care in COPD: study protocol of the COMPASSION study

  Measurement instrument  
Patient   T0 T3 T6 R
Baseline characteristics Questionnaire on demographic characteristics and case report form on disease severity x    
Quality of life (primary outcome) Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) scale [35] x x x  
Spiritual well-being Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp-12) scale [36] x x x  
Anxiety and depression Hospital Anxiety and Depression Scale (HADS) [37] x x x  
Disease-specific health-related quality of life Clinical COPD Questionnaire (CCQ) x x x  
Satisfaction with care Single item question on satisfaction with provided care, self-rated on a numeric rating scale (NRS) from 0 to 10 x   x  
Unplanned healthcare use Medical record assessment on number of ED visits (without admission), hospital admission (number and number of days), ICU admission (number and number of days), in the 12 months pre-enrollment up to 12 months after enrollment     x
Date and place of death, place of care in last week of life if applicable Medical record assessment (and contact with general practitioner if needed)     x
Dose received Questionnaire on received core elements, based on three validated questionnaires [38,39,40] x   x  
  Medical record assessment on core elements     x
Experiences and acceptability Semi-structured interviews   xa   
Informal caregiver   T0 T3 T6  
Baseline characteristics Questionnaire on demographic characteristics x    
Caregiver burden Caregiver Reaction Assessment (CRA) scale [41] x x x  
Satisfaction with care Single item question on satisfaction with provided care to the patient, self-rated on a NRS from 0 to 10 x   x  
Experiences and acceptability Semi-structured interviews   xa   
Health care professional   iT0 iT3 iT12  
Self-efficacy End-of-life professional caregiver survey (EPCS) [42] x x x  
Role identity Developed five-item question on role identity based on MIDI questionnaire [43] x x x  
Satisfaction with care Single item question on satisfaction with provided palliative care to patients with COPD, self-rated on a 5-point Likert scale x x x  
Dose delivered Self-reported provision of delivered core elements x x x  
Experiences, acceptability and determinants to implementation Semi-structured interviews    x  
  1. T0 patient timeline at baseline; T3 patient timeline at 3 months; T6 patient timeline at 6 months; R retrospectively; iT0 pre-implementation (professional timeline at baseline); iT3 initial implementation (3 months after inclusion of first patient); iT12 = late implementation (12 months after training (intervention regions) or inclusion of first patient (control regions))
  2. a Interviews will be held with a purposeful sample of patients and informal caregivers between 3 and 6 months after inclusion