Palliative Care Coaching for Families With Rare Advanced Lung Diseases

NCT03813667 | Completed

• 1 other identifier: 1703528067
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Rare Non-Neoplastic Disorder

Keywords

advanced lung diseases; Palliative Care; Dyspnea; pilot projects; Terminal Care

Outcome Measures

Primary Outcomes (1)

• patient outcomes

  The intervention group R-ALD patients will report lower scores on breathlessness scale compared to control group patients at 3 months. Breathlessness is measured by Self-report shortness of breath scale (1 item, 0-10; 0-no shortness of breath, 10 = shortness of breath as bad as can be) (Gift, Narsavage, 1998

  3 months

Secondary Outcomes (3)

• family caregiver outcomes

  3 months

• patients' decision on EOLPC

  3 months

• Helpfulness of home R-ALD EOLPC intervention

  3 months

Study Arms (2)

Control

NO INTERVENTION

The control patients have standard care given through the WVU hospital and outpatient clinics, prescribed by the patient's pulmonologist and recorded in the medical record

Intervention

EXPERIMENTAL

The FamPALcare intervention group receives all standard care plus 2 weeks of home EOLPC coaching by community nurses experienced in end-of-life palliative care.

Behavioral: Intervention FamPALcare

Interventions

Intervention FamPALcare BEHAVIORAL

The FamPALcare intervention includes all standard care information on R-ALD home care plus 2 weeks of EOLPC coaching by community nurses experienced in EOLPC. The nurse uses the "Conversation Ready" pamphlet to guide discussion of EOL preferences. The nurse will: (1) support the patient and family in making decisions about EOL care options based on their preferences; (2) discuss options for EOL care when the patient's R-ALD symptoms become severe; (3) encourage completion of the advance directive forms at next physician appointment. The nurse will use "teach-back" processes to ensure that FamPALcare discussions are clear.

Also known as: FamPALcare

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 32297352 DERIVED

MeSH Terms

Conditions

Lung Diseases; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ubolrat Piamjariyakul, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care provider and outcome assessor including data collectors will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: January 23, 2019
• Study Start: November 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)