Cystic fibrosis in adults Nutritional, Metabolic, Endocrine Cystic fibrosis
Conditions
Interventions
Randomization to either quarterly visits and monthly calls with a palliative care nurse practitioner embedded in the cystic fibrosis (CF) clinic, or usual CF care. The visits will address physical and
Sponsors
Emory University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. English-speaking 2. Age =18 years 3. Palliative needs, as indicated by the following criteria: 3.1. =1 moderate or severe symptom (captured by the Integrated Palliative Outcomes Scale [IPOS]); OR 3.2. Reduced QoL (as captured by the IPOS); OR 3.3. =2 hospitalizations in the preceding year
Exclusion criteria
Exclusion criteria: 1. Post lung transplant 2. Patient does not receive primary CF care from the study site or intends to transfer primary CF care elsewhere over the next year 3. Received outpatient specialty palliative care within the past 12 months 4. Lack of reliable telephone or internet access 5. Active suicidal ideation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient quality of life, measured by FACIT-PAL at baseline and quarterly for 15 months (months 3, 6, 9, 12, 15) 2. Caregiver quality of life, measured by PROMIS Global 10 at baseline and quarterly for 15 months (months 3, 6, 9, 12, 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. CF-specific quality of life measured by Cystic Fibrosis Questionnaire-Revised (collected monthly, primary endpoint 12 months, secondary endpoint 15 months) 2. Symptom burden measured by Memorial Symptom Assessment Scale-CF (collected monthly, primary endpoint 12 months, secondary endpoint 15 months) 3. Psychological distress measured by Hospital Anxiety and Depression Scale (HADS) (collected monthly, primary endpoint 12 months, secondary endpoint 15 months) 4. Coping measured by Brief COPE (collected monthly, primary endpoint 12 months, secondary endpoint 15 months) 5. Satisfaction with care measured by FAMCARE-16 (collected monthly, primary endpoint 12 months, secondary endpoint 15 months) 6. Healthcare utilization measured by emergency department visits, inpatient hospitalization, unplanned outpatient visits, vital status (baseline and 15 months) 7. Advance care planning measured by presence of documentation of discussion of care wishes or signed ACP documents (baseline and 15 months) 8. Caregiver burden measured by Zarit Burden Interview (collected monthly, primary endpoint 12 months, secondary endpoint 15 months) | — |
Countries
Canada, United States of America
Contacts
Public ContactJane Lowers
Outcome results
None listed