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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Other: SUPPORT; Other: Currently Available Printed Material

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.
Other: Usual Care; Group will receive usual standard-of-care, and be provided with currently available printed material for information about their illness.	Other: Currently Available Printed Material; Subjects will receive their usual standard of care, including currently available printed patient material.; Other Names: Usual Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Perceived Stress Scale at baseline and completion of study in patients and caregivers	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Preparedness	Survey to measure preparation for disease course at completion of study for patients and caregivers.	3 years
Knowledge	Survey to measure knowledge of IPF at baseline and study completion with patients and caregivers	3 years
Advance Care Planning	Survey to measure completion of advance care plan at study completion with patients	3 years
Quality of Dying and Death	Quality of Dying and Death for caregivers if patient deceased during study	3 years
Symptom Burden	Promis-29 to measure symptom burden in patients at baseline and study completion.	3 years
Health Related Quality of Life in IPF	ATAQ-IPF instrument to measure quality of life in patients at baseline and study completion.	3 years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Kathleen O Lindell, PhD, RN, Dorothy P. and Richard P. Simmons Center for ILD

Publications and helpful links

General Publications

• Lindell KO, Klein SJ, Veatch MS, Gibson KF, Kass DJ, Nouraie M, Rosenzweig MQ. Nurse-Led Palliative Care Clinical Trial Improves Knowledge and Preparedness in Caregivers of Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Nov;18(11):1811-1821. doi: 10.1513/AnnalsATS.202012-1494OC.
• Lindell KO, Nouraie M, Klesen MJ, Klein S, Gibson KF, Kass DJ, Rosenzweig MQ. Randomised clinical trial of an early palliative care intervention (SUPPORT) for patients with idiopathic pulmonary fibrosis (IPF) and their caregivers: protocol and key design considerations. BMJ Open Respir Res. 2018 Feb 19;5(1):e000272. doi: 10.1136/bmjresp-2017-000272. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): June 24, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Fibrosis; Caregivers; Pulmonary; Idiopathic Pulmonary Fibrosis; IPF; Idiopathic; end of life; Palliative
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: PRO16070539; 1K23NR016276-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No