Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial

Abstract

Aim: To pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and to estimate effect-size for the power analysis in a future clinical trial. Design:This study uses a parallel randomized control trial. Families are randomly assigned to the intervention group or the control group in a 1:1 fashion. Methods: The study population includes patients with rare advanced lung diseases and their family caregivers who are involved in patients' home care. The control group receives standard care through their hospital or outpatient clinics. The intervention group receives standard care plus 2-weekly home end-of-life and palliative care coaching by experienced community nurses. Primary outcome is breathlessness measured by shortness of breath scale. Secondary outcomes are: (a) caregivers' anxiety and depression measures; (b) the presence of patient's signed advance directives in the medical record or not; and (c) Helpfulness of intervention measured by selfreport Helpfulness scale. The study was funded in October 2018 and received ethical Institutional Review Board approval in February 2019.Discussion: West Virginia has one of the highest incidence rates of lung disease deaths in the nation. However, there is inadequate home end-of-life and palliative care for this underserved population. This is an initial interventional study of nurseled coaching home-based palliative care for rare advanced lung diseases in rural Appalachia. Developing research collaboration with clinicians is essential for enrolment. Enrolment was successful due to regular meetings with pulmonologists who screened patients per the study inclusion criteria in their specialty clinic and madeThe peer review history for this article is available at https://publo ns.com/publo n/10.1111/jan.14395.

Verifying intervention fidelity procedures for a palliative home care intervention with pilot study results

“…Furthermore, there was an improvement in breathlessness (39%) after completion of FamPALcare intervention ( p < 0.05). This data indicated patients' enactment or use of the skills based on the intervention (Piamjariyakul, Smothers, Petitte, et al, 2020) did improve their symptom management.…”

“…All participants signed informed consent to participate. The University IRB approved the study design (Piamjariyakul, Smothers & Young, et al, 2020).…”

“…As recommended by NIH, a FamPALcare intervention manual was developed to include the fidelity intervention delivery approaches. This FamPALcare Intervention Implementation Manual included detailed procedures to administer FamPALcare intervention (Caplin & Saunders, 2015; Piamjariyakul, Smothers & Young, et al, 2020). These procedures included having the learning objectives written in the intervention delivery manual and used in each session (see Table 1).…”

“…Specifically, in this study, the content used in each discussion session was summarized in handout materials that were written in the recommended 5th grade level for health information. These materials were mailed to participants for discussion during FamPALcare telephone implementations (Piamjariyakul, Smothers & Young, et al, 2020). Furthermore, the nurse interventionist recorded each session's start and finish time to monitor fidelity implementation time while also supporting participant variation in the discussion.…”

“…The purpose of this article is to (1) describe the procedures, strategies, and measures based on the NIH Consortium guidelines ensuring intervention fidelity (Bellg et al, 2004); (2) discuss the research training needed to maintain consistent intervention delivery and for observing and rating implementation fidelity; (3) summarize the fidelity rating scores of 10 pilot study intervention sessions, and (4) report the data collected on participants' understanding (receipt) of and use (enactment) of the intervention information and skills for managing their home palliative health care. The pilot study was a palliative care nursing intervention (FamPALcare) for families managing advanced interstitial lung diseases (ILDs) (Piamjariyakul, Smothers & Young, et al, 2020).…”