Trial results for a study on expanding access to home-based palliative care for patients with COPD, Cancer, and Congestive Heart Failure were posted on 2025-09-22. The trial was terminated early after enrolling only 35 participants, significantly fewer than its planned target of 1,155.
Background
Palliative care aims to improve the quality of life for patients and their families facing serious illnesses. Integrating home-based palliative care within primary care clinics is an approach designed to enhance patient and caregiver outcomes, particularly for those with conditions like cancer, congestive heart failure, and chronic obstructive pulmonary disease. This study sought to test the effectiveness of such an integrated model.
Trial design
This study, designated as Phase NA, was planned as a randomized controlled trial. It aimed to enroll 1,155 seriously ill patients and approximately 884 family caregivers. However, the trial was terminated early, with only 35 participants enrolled. The conditions investigated included Cancer, Congestive Heart Failure, and Chronic Obstructive Pulmonary Disease. Patients were to be randomized to one of two study groups: Home-based Palliative Care (HBPC) or Enhanced Usual Care (EUC).
Key results
Despite early termination and low enrollment, results were posted for several measurements:
- Edmonton Symptom Assessment Survey for Patients:
- Home-based Palliative Care - Patients: Mean score of 35.2 (Standard Deviation 12.5) on a scale.
- Enhanced Usual Care - Patients: Mean score of 28.1 (Standard Deviation 10.6) on a scale.
- Hospital Anxiety and Depression Scale (HADS) for Patients:
- Home-based Palliative Care - Patients: Mean score of 15.9 (Standard Deviation 6.9) on a scale.
- Enhanced Usual Care - Patients: Mean score of 14.4 (Standard Deviation 2.9) on a scale.
- Patient Health Questionnaire-9 (PHQ-9) for Patients:
- Home-based Palliative Care - Patients: Mean score of 10.8 (Standard Deviation 5.4) on a scale.
- Enhanced Usual Care - Patients: Mean score of 8.7 (Standard Deviation 4.5) on a scale.
- Rating of Being at Peace Among Patients:
- Home-based Palliative Care - Patients: Mean score of 4.0 (Standard Deviation 1.2) on a scale.
- Enhanced Usual Care - Patients: Mean score of 3.2 (Standard Deviation 0.8) on a scale.
- Hearth Hope Index for Patients:
- Home-based Palliative Care - Patients: Mean score of 37.7 (Standard Deviation 2.8) on a scale.
- Enhanced Usual Care - Patients: Mean score of 37.3 (Standard Deviation 3.6) on a scale.
- Consultation Care Measure (CCM) for Patients:
- Home-based Palliative Care - Patients: Mean score of 43.9 (Standard Deviation 10.8) on a scale.
- Enhanced Usual Care - Patients: Mean score of 56.7 (Standard Deviation 13.0) on a scale.
What this means
The early termination of this trial and the significantly low enrollment of only 35 participants, compared to the target of 1,155, severely limit the ability to draw definitive conclusions or generalize these findings. While some differences in mean scores were observed between the home-based palliative care and enhanced usual care groups across various patient-reported outcomes, the small sample size means these observations are not statistically robust. Therefore, these results cannot reliably inform clinical practice regarding the effectiveness of integrating home-based palliative care in primary care for patients with COPD, cancer, or congestive heart failure.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03128060, titled "Expanding Access to Home-Based Palliative Care", were posted on 2025-09-22 on clinicaltrials.gov.