Background Health systems need evidence about how best to deliver home-based palliative care (HBPC) to meet the growing needs of seriously ill patients. We hypothesised that a tech-supported model that aimed to promote timely inter-professional team coordination using video consultation with a remote physician while a nurse is in the patient’s home would be non-inferior compared with a standard model that includes routine home visits by nurses and physicians.
Methods We conducted a pragmatic, cluster randomised non-inferiority trial across 14 sites (HomePal Study). Registered nurses (n=111) were randomised to the two models so that approximately half of the patients with any serious illness admitted to HBPC and their caregivers were enrolled in each study arm. Process measures (video and home visits and satisfaction) were tracked. The primary outcomes for patients and caregivers were symptom burden and caregiving preparedness at 1–2 months.
Results The study was stopped early after 12 months of enrolment (patients=3533; caregivers=463) due to a combination of low video visit uptake (31%), limited substitution of video for home visits, and the health system’s decision to expand telehealth use in response to changes in telehealth payment policies, the latter of which was incompatible with the randomised design. Implementation barriers included persistent workforce shortages and inadequate systems that contributed to scheduling and coordination challenges and unreliable technology and connectivity.
Conclusions We encountered multiple challenges to feasibility, relevance and value of conducting large, multiyear pragmatic randomised trials with seriously ill patients in the real-world settings where care delivery, regulatory and payment policies are constantly shifting.
- home care
- supportive care
- symptoms and symptom management
- service evaluation
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Contributors HN and RAM had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: HN, RAM. Acquisition, analysis, or interpretation of data: All authors. Drafting of the manuscript: HN, CM. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: ES and ECH. Study supervision: HN and RAM.
Funding This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (PLC-1609-36108). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study was approved by the KPSC (#11633) and KPNW (#834) Institutional Review Boards.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. Requester will be responsible for expenses associated with efforts to deidentify the data set.
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