Clinical trial · Interventional
Comparative Trial of Home-Based Palliative Care
A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| End Stage Liver Disease | — | UNRESOLVED | — |
| End Stage Renal Disease | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Neuromuscular Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard HBPC | Other | — | UNRESOLVED |
| Tech-supported HBPC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard HBPC
- description
- Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits
- interventionNames
- Other: Standard HBPC
- type
- EXPERIMENTAL
- label
- Tech-supported HBPC
- description
- Patients and caregivers in tech-supported HBPC will receive synchronous video visits with a provider (physician or nurse practitioner) while the nurse is in the patient's home. Home visits by the palliative care team will be determined based on patients/caregivers' needs.
- interventionNames
- Other: Tech-supported HBPC
Primary outcomes (3)
- measure
- Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Patient Inclusion Criteria: * Serious illness with 12-24 month life expectancy * Homebound * Need for skilled nursing care (only at KP Southern California) * English or Spanish speakers Patient Exclusion Criteria: \- Currently receiving HBPC Caregiver Inclusion Criteria: * Non-professional family, friend or other caregiver * English or Spanish speakers
References
Publications (3)
- DERIVEDNguyen HQ, Haupt EC, Duan L, Hou AC, Wang SE, Mariano JD, Lee JA, McMullen C. Hospital utilisation in home palliative care: caregiver health, preparedness and burden associations. BMJ Support Palliat Care. 2022 Jan 25:bmjspcare-2021-003455. doi: 10.1136/bmjspcare-2021-003455. Online ahead of print. PMID 35078873
- DERIVEDMularski RA, Mittman B, Haupt E, Wang S, Scholle S, McMullen C, Henry M, Shen E, Nguyen HQ; HomePal Research Group. 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. J Palliat Med. 2022 Apr;25(4):620-627. doi: 10.1089/jpm.2021.0164. Epub 2021 Nov 3. PMID 34735285
- DERIVEDNguyen HQ, Mularski RA, Edwards PE, Lynn J, Machado MT, McBurnie MA, McMullen C, Mittman BS, Reinke LR, Shen E, Wang SE, Werch HS; HomePal Research Group. Protocol for a Noninferiority Comparative Effectiveness Trial of Home-Based Palliative Care (HomePal). J Palliat Med. 2019 Sep;22(S1):20-33. doi: 10.1089/jpm.2019.0116. PMID 31486724