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Low intervention uptake, lack of substitution of video for home visits, and study sites' decision to expand telehealth use in response to payment changes
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard HBPC | Active Comparator | Patients and caregivers in standard HBPC will continue to receive usual care from the palliative care team which includes home visits |
|
| Tech-supported HBPC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tech-supported HBPC | Other | Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom severity (total score) using the Edmonton Symptom Assessment Scale (ESAS) | The ESAS is a 10-item survey measuring symptom severity. Scores range from 0-100 with higher scores indicating worse symptoms. | Change from baseline to 1 month |
| Days at home in the last 180 days of life among patients surviving at least 180 days after enrolling in HBPC | Baseline to 12 months | |
| Caregiver preparedness for caregiving using the Preparedness for Caregiving Scale | 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 | Change from baseline to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Days at home between study enrollment and death or study completion (365 days) | Variable, up to 12 months | |
| Patient quality of life measured with the PROMIS-10 survey | The PROMIS-10 is a 10-item survey measuring general health related quality of life. Scores range from 0-100 with higher scores indicating better quality of life |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
- Currently receiving HBPC
Caregiver Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huong Q Nguyen, PhD | Kaiser Permanente | Principal Investigator |
| Richard A Mularski, MD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California | Pasadena | California | 91101 | United States | ||
| Kaiser Permanente Northwest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35078873 | Derived | Nguyen 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. | |
| 34735285 | Derived |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| D003704 | Dementia |
| D058625 | End Stage Liver Disease |
| D007676 | Kidney Failure, Chronic |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Randomization of registered nurses stratified by site (n=15) to either standard or tech-supported HBPC
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| Standard HBPC | Other | Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care |
|
| Change from baseline to 1 and 6 months |
| Patient general distress measured with the distress thermometer | Scores for this single item distress thermometer range from 0-10 with higher scores indicating greater distress | Change from baseline to 1 and 6 months |
| Palliative performance scale will be measured using all data available from routine clinical practice as documented in the electronic medical record (EMR) | The Palliative Performance Scale measures overall functional status. A clinician completes this assessment using a scale of 0-100 with higher scores indicating better functional performance | Baseline and variable time periods due to reliance on available data from the EMR |
| Patient satisfaction-care experience measured by a study-specific survey | This 8-item satisfaction-care experience survey was developed specifically to measure satisfaction and care experience with home-based palliative care. | 1 and 6 months |
| Patient acute and post-acute care utilization | Frequency of hospitalizations, emergency department visits and skilled nursing facility stay | Baseline to 12 months |
| Patient outpatient health care utilization | Frequency of primary and specialty care visits | Baseline to 12 months |
| Patient enrollment in and days on hospice before death | Baseline to 12 months |
| Patient death | Baseline to 12 months |
| Caregiver quality of life measured with the PROMIS-10 | The PROMIS-10 is a 10-item survey measuring general health related quality of life. Scores range from 0-100 with higher scores indicating better quality of life | Change from baseline to 1 and 6 months |
| Caregiver burden measured with the Zarit-12 Caregiver Burden Scale | The Zarit-12 is a 12-item survey measuring caregiver burden. Scores range from 0-48 with higher scores indicating greater caregiver burden | Change from baseline to 1 and 6 months |
| Caregiver acute and post-acute care utilization | Frequency of hospitalizations, emergency department visits and skilled nursing facility stay for caregivers who are members of Kaiser Permanente | Baseline to 12 months |
| Caregiver outpatient health care utilization | Frequency of primary and specialty care visits for caregivers who are members of Kaiser Permanente | Baseline to 12 months |
| HBPC clinician perception of facilitators and barriers to implementation of HBPC services | Study specific survey (under development) | Yearly, up to four years |
| Portland |
| Oregon |
| 97227 |
| United States |
| Mularski 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. |
| 31486724 | Derived | Nguyen 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |