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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-23

Study Completion Date

2020-06-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention

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.

Group Type OTHER

SUPPORT

Intervention Type OTHER

Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.

Usual Care

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

Group Type OTHER

Currently Available Printed Material

Intervention Type OTHER

Subjects will receive their usual standard of care, including currently available printed patient material.

Interventions

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SUPPORT

Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.

Intervention Type OTHER

Currently Available Printed Material

Subjects will receive their usual standard of care, including currently available printed patient material.

Intervention Type OTHER

Other Intervention Names

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Usual Standard of Care

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No