Consumer Engagement to Increase Advance Care Planning

Advance Care Planning Clinical Trial

Official title:

Consumer Engagement to Increase Advance Care Planning

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02208947
• Other study ID #: PRO13120230
• Status: Terminated
• Phase: Phase 3
• First received: June 19, 2014
• Last updated: June 13, 2017
• Start date: April 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Partnership HealthPlan-contracting provider groups in Northern California	Fairfield	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Donaghue Medical Research Foundation, Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advance care planning conversation with provider	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	Use of the PREPARE website	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)