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Consumer Engagement to Increase Advance Care Planning

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ClinicalTrials.gov Identifier: NCT02208947
Recruitment Status : Terminated (failure to accure)
First Posted : August 5, 2014
Last Update Posted : June 15, 2017
Sponsor:
Collaborators:
Donaghue Medical Research Foundation
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Amber Barnato, MD, MPH, MS, University of Pittsburgh

Brief Summary:
The specific aims of the project are: 1) to test the effectiveness of consumer-directed financial incentives paired with provider-directed financial incentives, compared to provider-directed financial incentives alone, for increasing advance care planning (ACP) among Medicaid beneficiaries; and 2) to assess perceptions regarding the appropriateness of consumer-directed financial incentives for ACP among study participants. The investigators hypothesize that consumer-directed financial incentives will result in a 15-percentage point absolute increase in the proportion of subjects completing ACP. The investigators do not advance hypotheses about the qualitative component.

Condition or disease Intervention/treatment Phase
Advance Care Planning Behavioral: Consumer financial incentive Behavioral: PREPARE Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Consumer Engagement to Increase Advance Care Planning
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

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.
Behavioral: PREPARE
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).
Behavioral: Consumer financial incentive
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).

Behavioral: PREPARE
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208947


Locations
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United States, California
Partnership HealthPlan-contracting provider groups in Northern California
Fairfield, California, United States, 94534
Sponsors and Collaborators
University of Pittsburgh
Donaghue Medical Research Foundation
Robert Wood Johnson Foundation
Investigators
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Principal Investigator: Amber E Barnato, MD MPH MS University of Pittsburgh

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Responsible Party: Amber Barnato, MD, MPH, MS, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02208947     History of Changes
Other Study ID Numbers: PRO13120230
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by Amber Barnato, MD, MPH, MS, University of Pittsburgh:
advance care planning
decision making
patient engagement
patient education
financial incentives
behavioral economics