Clinical trial NCT03813667: Palliative Care Coaching for Families With Rare Advanced Lung Diseases
Official title: Palliative Care Coaching for Family Caregivers & Patients With Rare Advanced Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Rare Non-Neoplastic Disorder
Keywords: advanced lung diseases
Palliative Care
Dyspnea
pilot projects
Terminal Care
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregivers.
Primary purpose: SUPPORTIVE_CARE

Brief summary: With one of the highest incidences of lung disease deaths in the nation, there is great need for home end-of-life palliative care in the rural, disadvantaged communities of West Virginia. The aims of this proposed study are to: (1) pilot test the nursing care intervention with patients and family members managing home supportive EOLPC for rare advanced lung disease and (2) collect research data to report in the NIH resubmission and future trials.

Detailed description: Nearly 15 million Americans and greater than 10% of West Virginia (WV) residents live with and eventually die from Rare and Advanced Lung Diseases (R-ALD), including pneumoconiosis (i.e., dust, asbestos), and idiopathic pulmonary fibrosis. Patients with R-ALD experience refractory breathlessness, depression, fatigue, and extreme worry about their family members and cost of health care. With one of the highest incidences of lung disease deaths in the nation, there is great need for home EOLPC in the rural, disadvantaged communities of WV. The proposed EOLPC intervention (FamPALcare) is based on R-ALD experts' input, national EOLPC guidelines, and the PI's published EOLPC studies with breathlessness in end-stage heart failure (HF) patients.

This project is well-aligned with the National Institutes of Health (NIH) priority specific to "Appalachian populations experiencing extreme inequities and poor access to healthcare" and the NIH PAR on palliative care for family caregivers and patients with advanced lung diseases. The PI's NIH application review, which received a positive score, stated that this project will have a high impact on improving palliative care for rural families managing lung disease and the project can be translated to other rural communities. This is an initial study of coaching home-based palliative R-ALD care in rural Appalachia. The NIH review stated using the PI's culturally sensitive approaches for R-ALD was novel for chronic lung disease. Also, addressing both family caregivers' and patients' needs was noted as innovative and increased the potential for future funding, as was the rigorous protocol for observing intervention fidelity.

This study uses a random control group comparison design to test the implementation of the FamPALcare intervention with R-ALD patients and their primary family caregiver. Specific aims are to: (1) pilot test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for R-ALD and (2) collect research data to report in the PI's NIH resubmission and future trials. The control patients receive standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist, and recorded in the medical record. The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in EOLPC. Data will be collected at baseline, month one, and month three from patients and caregivers independently. This pilot study provides testing of our research guides and procedures that will be described to enhance the NIH resubmission and will determine power needed for the future RCT design.

Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with R-ALD, and their primary family caregivers dyad.
* All participants must be alert and oriented.
* Be able to read and write in English.

Exclusion Criteria:

* Patients who have received or are on a waiting list for a lung transplant
* Patients diagnosed with another terminal illness.

Primary outcomes:
measure: patient outcomes
timeFrame: 3 months
Secondary outcomes:
measure: family caregiver outcomes
timeFrame: 3 months
measure: patients' decision on EOLPC
timeFrame: 3 months
measure: Helpfulness of home R-ALD EOLPC intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Ubolrat Piamjariyakul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piamjariyakul U, Smothers A, Young S, Petitte T, Wen S, Morrissey E, Shafique S, Zulfikar R, Sangani R, Smith CE. Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial. J Adv Nurs. 2020 Aug;76(8):2182-2190. doi: 10.1111/jan.14395. Epub 2020 May 2.