Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers

University of Pittsburgh

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Other: Currently Available Printed Material; Other: SUPPORT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02929017

1K23NR016276-01A1 (U.S. NIH Grant/Contract)

PRO16070539

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Intervention

Other group

Description:

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.

Treatment:

Other: SUPPORT

Usual Care

Other group

Description:

Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness.

Treatment:

Other: Currently Available Printed Material