Learning Collaborative Vs Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer

Study Overview
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Brief Summary
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This trial studies the delivery of the ENABLE palliative care program for patients with advanced cancer. The study compares two methods for delivering ENABLE: Virtual Learning Collaborative (VLC) and Technical Assistance (TA). The focus of the ENABLE palliative care program is on living well, managing stress, patient communication of their personal values and hopes for care, social support, and symptom management. This study may help practices to incorporate ENABLE palliative care services and improve overall mood and quality of life for patients with advanced cancer.

Detailed Description
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This cluster-randomized controlled study evaluates two strategies to implement the ENABLE (Educate, Nurture, Advise, Before Life Ends) early palliative care (EPC) program, while gathering additional information on the ENABLE clinical program and related outcomes. The primary aim is to gather preliminary data on the effectiveness of VLC or TA on ENABLE program uptake, defined as the proportion of patients that complete a Palliative Care Assessment and at least 4 ENABLE sessions. Secondary aims evaluate the preliminary effectiveness of VLC or TA on patient-level outcomes and the relationship between ENABLE program uptake and patient outcomes. Exploratory aims evaluate the preliminary effectiveness of VLC or TA on overall ENABLE program implementation, as measured by the General Organizational Index (GOI) and the relationship between overall ENABLE program implementation and patient outcomes. To achieve the study aims, at least 16 participating sites will be randomized to the Virtual Learning Collaborative study arm (VLC, n = 8 practices) or the Technical Assistance study arm (TA, n = 8 practices). Participating sites randomized to the VLC will have access to monthly group calls with an ENABLE expert and a quality improvement expert for up to 65 weeks. Participating sites randomized to TA will have access to monthly technical assistance support for their practice for up to 65 weeks. Each practice cluster will have a recruitment goal of 13 patients (target n=208 patients total; 104 patients per arm; allowable range per practice cluster 8-25). To account for practice clusters that may be unable to recruit at least 13 patients, we will include an option to recruit 4 additional practices per study arm. Patients who agree to participate in this study will consent to a clinician-led clinical Palliative Care Assessment and up to 6 semi-structured ENABLE telehealth 20-45 minute sessions, and up to 6 monthly follow-up calls over 26 weeks with an ENABLE Coach. Patients will complete assessments of mood and quality of life at baseline (within 14 days of study enrollment), 12 weeks (±2 weeks) and 24 weeks (±2 weeks).

Official Title
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Implementing Palliative Care: Learning Collaborative vs. Technical Assistance

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Behavioral: Virtual Learning Collaborative
* Behavioral: Technical Assistance


Participation Criteria
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Eligibility Criteria
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PATIENTS Inclusion Criteria: Age ≥ 18 English-speaking Willing to complete palliative care assessment and ENABLE sessions. Diagnosed within the last 90 days with an advanced cancer (defined as a newly diagnosed stage III/IV, recurrence, or progressive solid tumor cancer). * Patients can receive any cancer treatment for their advanced cancer while participating in this study. Expected survival of at least 6 months Have access to telephone that can receive incoming calls. Able to provide informed consent. Exclusion Criteria: - Received previous palliative care services (Concurrent palliative care is allowed). PRACTICE SITES Inclusion Criteria: All participating practice clusters will be asked to identify one (or more) ENABLE Coaches as part of study eligibility to deliver the ENABLE program. Commitment of the ENABLE Coach(es) to be trained to conduct the palliative care assessment (and ENABLE sessions if the practice plans to implement them). Desire to implement ENABLE, including presence of an investigator (e.g., Primary Affiliate PI, oncology physician, CCDR Lead) and/or program administrator/supervisor who are willing to be key contacts. Demonstrated support/buy-in from oncology physicians who are willing to enroll patients. Agreement of practice leadership and other individuals at the practice cluster to support/participate in the study activities If necessary, willingness to participate in a phone interview to determine capacity to implement the ENABLE program. ONCOLOGY PHYSICIAN Inclusion Criteria: Oncology Physician (i.e., medical oncologist or radiation oncologist including trainees) caring for oncology patients. Oncology physicians must work at a participating practice cluster with no plans to leave that practice site or retire at the time of enrollment into the study. ENABLE COACH Inclusion Criteria: A registered nurse or advanced practice provider (including a nurse practitioner or physician assistant), a physician (e.g., medical and radiation oncologists, including oncology trainees), or other professionals (e.g., social workers, chaplains) with appropriate credentials and experience to deliver ENABLE. Individuals with an appropriate clinical license (i.e., a registered nurse, advanced practice provider, or physician, as defined above) may perform the Palliative Care Assessment and any ENABLE sessions and follow-up calls the practice chooses to deliver. Other professionals (e.g., social workers, chaplains) may deliver ENABLE sessions and monthly follow-up calls for which their credentials and experience are appropriate. ENABLE Coaches are required to complete appropriate study training for any content delivered.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Learning Collaborative<br> | Behavioral: Virtual Learning Collaborative<br>* Patients undergo a palliative care assessment, participate in up to 6 ENABLE telehealth sessions with an ENABLE coach (20-45 minutes each), and complete up to 6 monthly follow-up calls over a 26-week period. The practice sites participate in a VLC consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for up to 15 months.<br>* Other names: Behavioral, Psychological, or Informational Intervention;|
| Experimental: Technical Assistance<br> | Behavioral: Technical Assistance<br>* Patients undergo a palliative care assessment, participate in up to 6 ENABLE telehealth sessions with an ENABLE coach (20-45 minutes each), and complete up to 6 monthly follow-up calls over a 26-week period. The practice sites undergo practice-based consultation calls with an ENABLE/TA expert monthly for up to 15 months.<br>* Other names: Behavioral, Psychological, or Informational Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ENABLE Program Uptake | ENABLE program uptake is defined as the proportion of enrolled patients at participating NCORP practices that complete a Palliative Care Assessment and at least 4 ENABLE sessions. To capture ENABLE program uptake, participating practices will use standardized logs to capture individuals offered the program, enrollment, and completion of the essential ENABLE elements (i.e., palliative care assessment, ENABLE telehealth sessions, follow-up calls). | 65 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | Survey to measure patient mood. | Baseline, 12 weeks, 24 weeks | 
| Functional Assessment of Chronic Illness-Palliative Care (FACIT-PAL) | Survey to measure patient quality of life. | Baseline, 12 weeks, 24 weeks |