Outcomes and instruments
| Measures to be collected in InSPIRe:CF trial | ||||
| Outcome | Instrument | Description | Frequency | |
| Aim 1 (Patients) | QoL (Primary) | FACIT-Pal15 | 46-item measure of generic and serious illness-specific QoL | Baseline, months 3, 6, 9, 12, 15 |
| CF-specific QoL | Cystic Fibrosis Questionnaire-Revised16 | 50-item CF-specific measure of 9 QoL and 3 symptom domains | ||
| Symptom burden | Memorial Symptom Assessment Scale – CF5 | 32 general and CF-specific symptoms, evaluating symptom frequency, severity and distress | ||
| Psychological distress | Hospital Anxiety and Depression Scale (HADS)17 | 14-item measure of depression (7 items) and anxiety (7 items) | ||
| Coping | Brief COPE18 | 28-item measure assessing 14 scales of coping styles and strategies | Baseline, 12 and 15 months | |
| Satisfaction with care | FAMCARE P-1619 | 16-item measure of satisfaction with information-giving, availability of care, and physical care among individuals with serious illness | ||
| Healthcare utilisation | Custom items | Emergency department visits, inpatient hospitalisations, unplanned outpatient visits, vital status (if death, CF-related or not) | ||
| Advance care planning | Patient’s report of ≥1 of the following: living will or durable power of attorney, DNR order, or having discussed end-of-life care wishes20 | |||
| Demographics | Age, race, ethnicity, sex, marital status, education, income, social support, health insurance, religiosity | Baseline | ||
| Aim 2 (Caregivers) | QoL | PROMIS-Global 10 | 10-item measure of health-related quality of life | Baseline, months 3, 6, 9, 12, 15 |
| Psych. distress | HADS17 | See above | ||
| Caregiver burden | Zarit Burden Interview21 | 12-item measure of caregiver burden | ||
| Coping | Brief COPE18 | See above | ||
| Demographics | Custom items | See above | Baseline | |
COPE, Coping Orientation to Problems Experienced; DNR, do not resuscitate; FACIT-Pal, Functional Assessment of Chronic Illness Therapy-Palliative care; FAMCARE, Family Satisfaction with Advanced Cancer Care; InSPIRe:CF, Integrating Specialist Palliative care to Improve care and Reduce suffering:Cystic Fibrosis; PROMIS, Patient-Reported Outcomes Measurement Information System; QoL, quality of life.