Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Other: Currently Available Printed MaterialOther: SUPPORT
- Registration Number
- NCT02929017
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
Patients with Idiopathic Pulmonary Fibrosis (IPF) and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning. The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention.
- Detailed Description
Idiopathic Pulmonary Fibrosis (IPF) is a disease of aging associated with intense medical and financial burden and expected to grow in incidence within the US population. Median survival from diagnosis is 3.8 years, although some patients succumb to a rapid death within 6 months. New therapies have recently become available. While these medications slow the rate of pulmonary deterioration, they have no impact on ultimate survival or quality of life. Although transplantation is an effective surgical therapy, less than 20% of patients ever receive a lung transplant. The remaining 80% have few treatment options and a likely rapidly progressive downhill course. Despite the fatal prognosis, we have found that patients and caregivers often fail to understand the poor prognosis as the disease relentlessly progresses. At the end of life, IPF patients and their caregivers experience stress, symptom burden, poor quality of life, and inadequate preparedness for end-of-life care planning.
The proposed study will measure feasibility, acceptability, and impact of a Supportive Care intervention. Patients with IPF and their caregivers will be randomized to receive this intervention or usual care. The intervention will include information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, digital (tablet) delivered by an interventionist. The usual care group will be provided with routine printed patient education.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 45 years or older
- Primary Diagnosis of with Idiopathic Pulmonary Fibrosis (IPF)
- Has a caregiver, 18 years or older (spouse/partner/child/family member/friend), willing to participate.
- Sees a Simmons Center Physician for usual IPF care.
- less than 45 years
- Not diagnosed with IPF
- Has an unwilling caregiver, or a caregiver under 18.
- Does not see a Simmons Center Physician for usual IPF care.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Currently Available Printed Material Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness. Intervention SUPPORT Group will receive SUPPORT, an intervention that provides information about the disease, self-management strategies, and introduction to advanced care planning in a format with enhanced content available across multiple domains (face-to-face, printed material, and digitally (via use of a tablet) delivered by an interventionist.
- Primary Outcome Measures
Name Time Method Stress 3 years Perceived Stress Scale at baseline and completion of study in patients and caregivers
- Secondary Outcome Measures
Name Time Method Disease Preparedness 3 years Survey to measure preparation for disease course at completion of study for patients and caregivers.
Knowledge 3 years Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers
Advance Care Planning 3 years Survey to measure completion of advance care plan at study completion with patients
Quality of Dying and Death 3 years Quality of Dying and Death for caregivers if patient deceased during study
Symptom Burden 3 years Promis-29 to measure symptom burden in patients at baseline and study completion.
Health Related Quality of Life in IPF 3 years ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.
Trial Locations
- Locations (1)
Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
🇺🇸Pittsburgh, Pennsylvania, United States