Clinical trial NCT02208947: Consumer Engagement to Increase Advance Care Planning
Official title: Consumer Engagement to Increase Advance Care Planning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Advance Care Planning
Keywords: advance care planning
decision making
patient engagement
patient education
financial incentives
behavioral economics
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Donaghue Medical Research Foundation
name: Robert Wood Johnson Foundation
First posted: 2014-08-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Eligibility 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

Primary outcomes:
measure: Advance care planning conversation with provider
timeFrame: 2 months (+/- 1 month)
Secondary outcomes:
measure: Use of the PREPARE website
timeFrame: 2 months (+/- 1 month)
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Partnership HealthPlan-contracting provider groups in Northern California
state: California
Study officials:
affiliation: University of Pittsburgh
name: Amber E Barnato, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: