Table 1

Outcomes and instruments

Measures to be collected in InSPIRe:CF trial
Aim 1 (Patients)QoL (Primary)FACIT-Pal1546-item measure of generic and serious illness-specific QoLBaseline, months 3, 6, 9, 12, 15
CF-specific QoLCystic Fibrosis Questionnaire-Revised1650-item CF-specific measure of 9 QoL and 3 symptom domains
Symptom burdenMemorial Symptom Assessment Scale – CF532 general and CF-specific symptoms, evaluating symptom frequency, severity and distress
Psychological distressHospital Anxiety and Depression Scale (HADS)1714-item measure of depression (7 items) and anxiety (7 items)
CopingBrief COPE1828-item measure assessing 14 scales of coping styles and strategiesBaseline, 12 and 15 months
Satisfaction with careFAMCARE P-161916-item measure of satisfaction with information-giving, availability of care, and physical care among individuals with serious illness
Healthcare utilisationCustom itemsEmergency department visits, inpatient hospitalisations, unplanned outpatient visits, vital status (if death, CF-related or not)
Advance care planningPatient’s report of ≥1 of the following: living will or durable power of attorney, DNR order, or having discussed end-of-life care wishes20
DemographicsAge, race, ethnicity, sex, marital status, education, income, social support, health insurance, religiosityBaseline
Aim 2 (Caregivers)QoLPROMIS-Global 1010-item measure of health-related quality of lifeBaseline, months 3, 6, 9, 12, 15
Psych. distressHADS17See above
Caregiver burdenZarit Burden Interview2112-item measure of caregiver burden
CopingBrief COPE18See above
DemographicsCustom itemsSee aboveBaseline
  • 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.