- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02208947
Consumer Engagement to Increase Advance Care Planning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a parallel cluster randomized controlled single-blind trial of consumer-directed financial incentives paired with provider-directed financial incentives (intervention), compared to provider-directed financial incentives alone (control) on the completion of ACP among Partnership HealthPlan of California (PHC) Medi-Cal patients. PHC is a county-organized health system contracted by the State of California to provide a health care delivery system for 360,000 Medi-Cal beneficiaries in Northern California. PHC has 400 contracted Primary Care Provider (PCP) entities, representing over 2000 individual physicians, working in solo practice, small groups, community health centers, large groups, and integrated health systems. The rationale for using PHC is their commitment to experimenting with strategies to improve ACP, including their current quality improvement program incentive payment to PCPs to discuss and document ACP with patients 65+ and <65 with a serious chronic illness.
The investigators will randomize 40 PCPs to one of two different patient education packets for their patients. Each PCP is eligible for financial incentives for documenting ACP (usual care), regardless of the randomization group.
Each PCP will be responsible for identifying and enrolling 10 eligible subjects during routine clinic visits, for a target enrollment of 400 patient subjects.
The investigators will stratify randomization based on salience of the financial incentive (e.g., accrues directly to non-salaried provider, such as in a private practice, or accrues to the organization of a salaried provider, such as in a Federally Qualified Health Center or multispecialty group).
All enrolled patients will receive access to the patient education tool, Prepare for Your Care (www.prepareforyourcare.org), developed by Dr. Sudore for low-literacy Medi-Cal populations, in their education packets. The intervention group patients will additionally be offered a consumer (patient) financial incentive. the primary outcome of the study is having a conversation with the PCP about ACP. Secondary outcomes include: 1) website use metrics and 2) attitudes about providing financial incentives for ACP (among a purposively sampled subset of participants).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Fairfield, California, United States, 94534
- Partnership HealthPlan-contracting provider groups in Northern California
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PCP Subject Inclusion Criteria:
- Partnership HealthPlan of California Medicaid and/or Medicare provider
PCP Subject Exclusion Criteria:
- Prohibition by clinic director
Patient Subject Inclusion Criteria:
- Partnership HealthPlan of California Medicaid and/or Medicare enrollee;
- Age 65+ or < 65 with a life-limiting illness (including advanced cardiac disease [end-stage congestive heart failure, severe coronary artery disease, cardiomyopathy (LVEF <25%)], advanced chronic obstructive pulmonary disease, amputation due to vascular disease, cancer [metastatic/recurrent], dementia, diabetes mellitus with creatinine clearance under 50, or an amputation, end stage renal disease, generalized debility and decreased functioning, long term resident of skilled nursing facility, stroke [w/at least 50% decreased function]);
- Internet access (computer, tablet, phone)
Patient Subject Exclusion Criteria:
- Completion of a Partnership HelathPlan of California advance care planning attestation form within the last 12 months;
- Inability to read English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PREPARE
Partnership HealthPlan of California (PHC) pays primary care physicians (PCPs) to discuss and document ACP with Medi-Cal beneficiaries aged 65 and older and those younger than 65 with a life-limiting illness (usual care).
The control condition, or "enhanced usual care," adds a packet of educational information about ACP and access to the PREPARE website and verbal encouragement by their PCP delivered during a routine clinic visit to usual care.
|
PREPARE for your care is 5-step on-line ACP process developed specifically for low-literacy Medi-Cal populations.
PREPARE can be navigated as interactive, self-directed modules or "played" like a movie, at a time or a place of the subject's own choosing (e.g., home, work, public library).
|
|
Experimental: PREPARE + consumer financial incentive
The experimental condition adds a consumer-directed financial incentive to enhanced usual care (provider-directed financial incentive and educational packet with information about the PREPARE website).
Specifically, subjects will receive an immediate financial reward upon completing self-directed ACP (e.g., PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).
|
PREPARE for your care is 5-step on-line ACP process developed specifically for low-literacy Medi-Cal populations.
PREPARE can be navigated as interactive, self-directed modules or "played" like a movie, at a time or a place of the subject's own choosing (e.g., home, work, public library).
Immediate financial reward upon completing self-directed ACP (e.g., completing the web-based educational modules on PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Advance care planning conversation with provider
Time Frame: 2 months (+/- 1 month)
|
The primary outcome is the patient discussing their ACP with their provider within 2 months of having received the study advance care planning information packet, measured by the provider submitting an attestation form to Partnership HealthPlan of California to receive their ACP quality incentive payment.
|
2 months (+/- 1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of the PREPARE website
Time Frame: 2 months (+/- 1 month)
|
The process measure is developing a plan using the PREPARE website, measured by tracking website user metrics and receipt of the subject's "action plan and summary" by e-mail.
|
2 months (+/- 1 month)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRO13120230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advance Care Planning
-
Southcentral FoundationUniversity of Colorado, Denver; University of Washington; University of Arkansas and other collaboratorsRecruiting
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingAdvance Care PlanningUnited States
-
Tufts Medical CenterNational Institute of Nursing Research (NINR); University of Hawaii; Queen's...Active, not recruiting
-
University of PittsburghCompletedAdvance Care PlanningUnited States
-
The University of Hong KongNot yet recruitingAdvance Care Planning
-
King's College LondonPrincess Alice HospiceCompleted
-
Duke UniversityCompletedAdvance Care PlanningUnited States
-
Southcentral FoundationUniversity of Colorado, Denver; University of Washington; Washington State University and other collaboratorsCompletedAdvance Care PlanningUnited States
-
Liverpool University Hospitals NHS Foundation TrustUniversity of LiverpoolCompleted
-
Duke UniversityCompletedAdvance Care PlanningUnited States
Clinical Trials on PREPARE
-
University Hospitals, LeicesterDiabetes UKCompletedPrediabetic StateUnited Kingdom
-
University of California, San FranciscoNational Institute on Aging (NIA)CompletedChronic DiseaseUnited States
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteCompletedChronic DiseaseUnited States
-
Ottawa Hospital Research InstituteUnknownSocial Isolation | Comorbidities and Coexisting Conditions
-
Womack Army Medical CenterUnited States Department of Defense; Walter Reed National Military Medical...RecruitingMusculoskeletal InjuriesUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; University of California, IrvineCompletedAdvanced Cancer | Advance Care Planning | Advance DirectivesUnited States
-
University of Massachusetts, AmherstUniversity of GhanaCompletedHealth Literacy | Dietary Diversity | Infant Feeding PracticesGhana
-
VA Office of Research and DevelopmentCompleted
-
Brown UniversityThe Miriam HospitalCompletedOptimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization DesignPreventionUnited States
-
University of California, San FranciscoNational Institute on Aging (NIA); University of Minnesota; University of California... and other collaboratorsRecruiting