Comparative Trial of Home-Based Palliative Care
| Tracking Information | |||
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| First Submitted Date ICMJE | September 27, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | January 2019 | ||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS)[ Time Frame: Change from baseline to 1 month ] The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms. Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC[ Time Frame: Baseline to 12 months ] Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale[ Time Frame: Change from baseline to 1 month ] The Preparedness for Caregiving Scale is a 9-item survey measuring caregivers' perception of their preparedness for caregiving. Scores range from 0-36 with higher scores indicating higher perception of preparedness |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Comparative Trial of Home-Based Palliative Care |
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| Official Title ICMJE | A Non-Inferiority Comparative Effectiveness Trial of Home-Based Palliative Care in Older Adults |
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| Brief Summary | 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. |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC Masking: Interventional Masking Description: Primary Purpose: Supportive Care |
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| Intervention ICMJE |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
14800 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | September 2022 | ||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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 | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
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| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | , | ||
| Study Sponsor ICMJE | Kaiser Permanente | ||
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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