Clinical trial NCT02929017: Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
Official title: Integrating Palliative Care for Patients With Idiopathic Pulmonary Fibrosis and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Fibrosis
IPF
Caregivers
Pulmonary
Palliative
end of life
Idiopathic
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-10-10
Enrollment: 140
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stress
timeFrame: 3 years
Secondary outcomes:
measure: Disease Preparedness
timeFrame: 3 years
measure: Knowledge
timeFrame: 3 years
measure: Advance Care Planning
timeFrame: 3 years
measure: Quality of Dying and Death
timeFrame: 3 years
measure: Symptom Burden
timeFrame: 3 years
measure: Health Related Quality of Life in IPF
timeFrame: 3 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
state: Pennsylvania
Study officials:
affiliation: Dorothy P. and Richard P. Simmons Center for ILD
name: Kathleen O Lindell, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.