NCT02208947

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 19, 2014

Last Update Submit

June 13, 2017

Conditions

Keywords

advance care planningdecision makingpatient engagementpatient educationfinancial incentivesbehavioral economics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Use of the PREPARE website

    2 months (+/- 1 month)

Study Arms (2)

PREPARE

ACTIVE COMPARATOR

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 + consumer financial incentive

EXPERIMENTAL

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 incentiveBehavioral: PREPARE

Interventions

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 + consumer financial incentive
PREPAREBEHAVIORAL

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).

PREPAREPREPARE + consumer financial incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Partnership HealthPlan of California Medicaid and/or Medicare provider

You may not qualify if:

  • Prohibition by clinic director
  • 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)
  • Completion of a Partnership HelathPlan of California advance care planning attestation form within the last 12 months;
  • Inability to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Partnership HealthPlan-contracting provider groups in Northern California

Fairfield, California, 94534, United States

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Amber E Barnato, MD MPH MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 19, 2014

First Posted

August 5, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

June 15, 2017

Record last verified: 2017-06

Locations