NCT03694431: HomePal

Comparative Trial of Home-Based Palliative Care

Terminated NA Last updated 20 February 2020

What this trial tests

NA trial testing Tech-supported HBPC in Cancer in 3,999 participants. Terminated before completion.

Timeline

7 January 2019

Primary endpoint
24 January 2020

24 January 2020

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	3,999
Start date	7 January 2019
Primary completion	24 January 2020
Estimated completion	24 January 2020
Sites	2 locations across United States

Drugs / interventions tested

• Tech-supported HBPC
• Standard HBPC

Conditions studied

• Cancer — all drugs for Cancer →
• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
• Heart Failure — all drugs for Heart Failure →
• Dementia — all drugs for Dementia →

Sponsor

Kaiser Permanente — full company profile →

Who can join

18 and older, any sex, with Cancer or Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: To effectively alleviate suffering and improve quality of life for patients with serious illness and their caregivers, palliative care (PC) services must be offered across multiple settings. Research is needed to determine how best to optimize home-based palliative care (HBPC) services to meet the needs of individuals with high symptom burden and functional limitations.

Aim: The investigators will compare a standard HBPC model that includes routine home visits by a nurse and provider with a more efficient tech-supported HBPC model that promotes timely inter-professional team coordination via synchronous video consultation with the provider while the nurse is in the patient's home. The investigators hypothesize that tech-supported HBPC will be as effective as standard HBPC.

Design: Cluster randomized trial. Registered nurses (n\~130) will be randomly assigned to the tech-supported or standard HBPC model so that half of the patient-caregiver dyads will receive one of the two models.

Setting/Participants: Kaiser Permanente (15 Southern California and Oregon sites). Patients (n=10,000) with any serious illness and a prognosis of 1-2 years and their caregivers (n=4,800)

Methods: Patients and caregivers will receive standard PC services: comprehensive needs assessment and care planning, pain and symptom management, education/skills training, medication management, emotional/spiritual support; care coordination, referral to other services, and 24/7 phone assistance.

Results: Primary patient outcomes: symptom improvement at 1 month and days spent at home in the last six months of life; caregiver outcome: perception of preparedness for caregiving.

Conclusion: Should the more efficient tech-supported HBPC model achieves comparable improvements in outcomes that matter most to patients and caregivers, this would have a lasting impact on PC practice and policy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hospital utilisation in home palliative care: caregiver health, preparedness and burden associations.
   Nguyen HQ, Haupt EC, Duan L, Hou AC, et al · · 2022 · cited 4× · PMID 35078873 · DOI 10.1136/bmjspcare-2021-003455
2. Performance of Patient-Reported Outcome Measures in a Large Pragmatic Trial of Home-Based Palliative Care (HomePal): Methodological and Practical Considerations for Embedded Patient-Centered Design.
   Mularski RA, Mittman B, Haupt E, Wang S, et al · · 2022 · cited 4× · PMID 34735285 · DOI 10.1089/jpm.2021.0164
3. A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine.
   Commiskey P, Armstrong AW, Coker TR, Dorsey ER, et al · · 2021 · cited 3× · PMID 34542417 · DOI 10.2196/29511