Advance Care PlanningPhase 2/3NCT02418403
Consumer Engagement to Increase Advance Care Planning: Patient Randomization
A Phase 2/3 study testing Financial incentive and Educational website in people with Advance Care Planning, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a study of the effect of consumer-directed financial incentives on completion of advance care planning among Medi-Cal patients. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Financial incentive and Educational website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Partnership HealthPlan of California enrollee
- Receipt of primary care from one of 3 participating clinics (Ole, Petaluma, West County)
- Age > 65
Who cannot join
- > 75
Trial locations and contacts
1 site in 1 country.
United States1 site
Partnership HealthPlan of California
Fairfield, California, 94534-1675
About this study
Official title: Consumer-directed Financial Incentives to Increase Advance Care Planning Among Medi-Cal Patients
This is a study of the effect of consumer-directed financial incentives on completion of advance care planning among Medi-Cal patients.
Read the detailed description
Older adults receiving primary care from one of three clinics contracting with Partnership HealthPlan of California, a multi-county Medi-Cal managed care plan will be mass randomized to receiving educational materials regarding advance care planning with or without a financial reward for completing advance care planning.
- Conditions
- Advance Care Planning
- Being tested
- Financial incentive, Educational website
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentiveBehavioural
Offer of money designed to overcome barriers to advance care planning.
Educational websiteBehavioural
Research-verson of the "Prepare for your care" website (www.prepareforyourcare.org)
| Study group | Role | What they receive |
|---|---|---|
| PREPARE | Active comparator | Access to "Prepare for Your Care" website and written encouragement to discuss ACP with one's PCP. Receives: Behavioral: Educational website |
| PREPARE+financial incentive | Experimental | Access to "Prepare for Your Care" website and written encouragement to discuss ACP with one's PCP; offer of $50 to complete the website and entry into $1000 lottery for discussing ACP with one's PCP. Receives: Behavioral: Financial incentive; Behavioral: Educational website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Having an advance care planning conversation with one's primary care provider
Primary care providers' documentation of an advance care planning conversation in the chart and/or via a Partnership HealthPlan of California ACP attestation form.
Measured: 3 months
Secondary outcomes (1)
Completion of "Prepare for Your Care" website modules
Logging into the website, completing the modules, and creating an action plan
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Barnato, MD, MPH, MS, University of Pittsburgh
- Investigators
- Amber Barnato, MD MPH MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418403
- Sponsor's protocol ID
- PRO14110340
- Status last verified
- Jun 2017
- First submitted
- 13 Apr 2015
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer-directed Financial Incentives to Increase Advance Care Planning Among Medi-Cal Patients
- ClinicalTrials.gov ID
- NCT02418403
- Acronym / sponsor ID
- PRO14110340
- Conditions
- Advance Care Planning
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the effect of consumer-directed financial incentives on completion of advance care planning among Medi-Cal patients.
Detailed description
Older adults receiving primary care from one of three clinics contracting with Partnership HealthPlan of California, a multi-county Medi-Cal managed care plan will be mass randomized to receiving educational materials regarding advance care planning with or without a financial reward for completing advance care planning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREPARE | Active comparator | Behavioral: Educational websiteAccess to "Prepare for Your Care" website and written encouragement to discuss ACP with one's PCP. |
| PREPARE+financial incentive | Experimental | Behavioral: Financial incentive, Behavioral: Educational websiteAccess to "Prepare for Your Care" website and written encouragement to discuss ACP with one's PCP; offer of $50 to complete the website and entry into $1000 lottery for discussing ACP with one's PCP. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Partnership HealthPlan of California enrollee
- Receipt of primary care from one of 3 participating clinics (Ole, Petaluma, West County)
- Age > 65
Key exclusion criteria (1 listed)
- > 75
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial incentiveOffer of money designed to overcome barriers to advance care planning. | Behavioural | PREPARE+financial incentive |
| Educational websiteResearch-verson of the "Prepare for your care" website (www.prepareforyourcare.org) | Behavioural | PREPARE, PREPARE+financial incentive |
Primary outcome
Having an advance care planning conversation with one's primary care provider
Time frame: 3 months
Primary care providers' documentation of an advance care planning conversation in the chart and/or via a Partnership HealthPlan of California ACP attestation form.
1 secondary outcome
Completion of "Prepare for Your Care" website modules
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
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Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Barnato, MD MPH MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Financial incentive and Educational website in people with Advance Care Planning, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Having an advance care planning conversation with one's primary care provider (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.