Health Care UtilizationNCT02922855
Incentives for Primary Care Use in a Safety Net Setting
A study testing 0 dollars group, 50 dollars group and 25 dollars group in people with Health Care Utilization and Primary Care Physician, run by Virginia Commonwealth University.
Trial summary
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an… Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Health Care Utilization, Primary Care Physician, Uninsured
- What is being tested?
- 0 dollars group, 50 dollars group and 25 dollars group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to 8 Nov 2016
- Phase
- Interventional
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults between ages 21-64 years
- No prior enrollment in VCC for the past 12 months
- English or Spanish speaking, and
- Can be contacted by mail and telephone (preferably) or willing to be interviewed in person.
Who cannot join
- Unable to be contacted by phone/mail
- Cannot provide consent
- No longer located in catchment area
About this study
Official title: Incentives for Primary Care Use: A Randomized Controlled Trial in a Safety Net Setting
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an academic safety-net hospital. The investigators will offer financial incentives to encourage an initial primary care visit within 6 months of enrollment and evaluate whether the primary care visit altered subsequent health seeking behavior and influenced patient satisfaction and other outcomes such as self-reported health status.
Read the detailed description
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an academic safety-net hospital. The investigators will offer financial incentives to encourage an initial primary care visit within 6 months of enrollment and evaluate whether the primary care visit altered subsequent health seeking behavior and influenced patient satisfaction and other outcomes such as self-reported health status.
Incentives should steer patients in their decision to seek primary care, reduce barriers to care, and ultimately improve patient health and reduce utilization and costs through their relationship with a PCP. This study is the first of its kind to incentivize low-income patients. This population has the greatest need for health care and exerts the greatest pressure on the United States' safety net system. Furthermore, the safety net population is the target of policies such as Medicaid eligibility expansions, yet urban safety net patients are largely understudied. These patients are rarely given the opportunity to participate in research, and when they are the subjects of measures to reduce health care utilization, they are the subject of policies using negative incentives such as those that introduce cost sharing for using ED services.1 Alternatively, safety net providers invest in case management systems to reduce utilization. The proposed study is a departure from prior measures to reduce utilization among low-income patients by focusing on patients and using positive incentives. The study borrows from the principles of behavioral economics to motivate patients towards primary care utilization. Once in the primary care system, The investigators will test whether primary care contact reduces more expensive forms (e.g., inpatient, ED) of health care.
The investigators will compare outcomes of patients assigned in the highest incentive group ($50) to patients assigned to the modest incentive group ($25) and to patients assigned to usual care (no incentive, but assignment to a PCP). The investigators will also compare incentive patients ($50, $25) to a contemporaneous group of patients that enroll in the safety net clinic at the same time.
- Conditions
- Health Care Utilization, Primary Care Physician, Uninsured
- Being tested
- 0 dollars group, 50 dollars group, 25 dollars group
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 dollars groupBehavioural
Those assigned to the $0 group will not receive an incentive for visiting their PCP.
50 dollars groupBehavioural
Those assigned to the $50 group will receive $50 if they visit their PCP within 6 months of study enrollment.
25 dollars groupBehavioural
Those assigned to the $25 group will receive $25 if they visit their PCP within 6 months of study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Contemporaneous Control | No intervention | This group is our 'usual care' control group. They were not contacted for an interview and were not offered an incentive to visit their primary care physician. |
| $0 group | Active comparator | This group completed a baseline interview but was not offered any incentive if they visited their primary care physician. Receives: Behavioral: 0 dollars group |
| $25 group | Experimental | This group completed a baseline interview and was offered $25 they visited their primary care physician within 6 months. Receives: Behavioral: 25 dollars group |
| $50 group | Experimental | This group completed a baseline interview and was offered $50 they visited their primary care physician within 6 months. Receives: Behavioral: 50 dollars group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Primary Care Physician visits will be assessed using medical claims record data.
The number of primary care visits to a primary care physician will be collected from medical claims record data.
Measured: This will be assessed in the 6 months following study enrollment.
Secondary outcomes (1)
The time to a Primary Care Physician will be assessed using medical claims record data.
The time to a primary care visits to a primary care physician will be collected from dates available in the medical claims record data.
Measured: This will be assessed in the 6 months following study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startJan 2014
- Primary completion8 Nov 2016
- Study completion8 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Cathy Bradley, Phd, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922855
- Sponsor's protocol ID
- HM20000002
- Other IDs
- 1R01HS022534
- Status last verified
- Jun 2018
- First submitted
- 28 Sep 2016
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives for Primary Care Use: A Randomized Controlled Trial in a Safety Net Setting
- ClinicalTrials.gov ID
- NCT02922855
- Acronym / sponsor ID
- HM20000002
- Conditions
- Health Care Utilization, Primary Care Physician, Uninsured
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jan 2014
- Primary completion
- 8 Nov 2016 (actual)
- Study completion
- 8 Nov 2016 (actual)
- First posted
- 4 Oct 2016 (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.
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an academic safety-net hospital. The investigators will offer financial incentives to encourage an initial primary care visit within 6 months of enrollment and evaluate whether the primary care visit altered subsequent health seeking behavior and influenced patient satisfaction and other outcomes such as self-reported health status.
Detailed description
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an academic safety-net hospital. The investigators will offer financial incentives to encourage an initial primary care visit within 6 months of enrollment and evaluate whether the primary care visit altered subsequent health seeking behavior and influenced patient satisfaction and other outcomes such as self-reported health status.
Incentives should steer patients in their decision to seek primary care, reduce barriers to care, and ultimately improve patient health and reduce utilization and costs through their relationship with a PCP. This study is the first of its kind to incentivize low-income patients. This population has the greatest need for health care and exerts the greatest pressure on the United States' safety net system. Furthermore, the safety net population is the target of policies such as Medicaid eligibility expansions, yet urban safety net patients are largely understudied. These patients are rarely given the opportunity to participate in research, and when they are the subjects of measures to reduce health care utilization, they are the subject of policies using negative incentives such as those that introduce cost sharing for using ED services.1 Alternatively, safety net providers invest in case management systems to reduce utilization. The proposed study is a departure from prior measures to reduce utilization among low-income patients by focusing on patients and using positive incentives. The study borrows from the principles of behavioral economics to motivate patients towards primary care utilization. Once in the primary care system, The investigators will test whether primary care contact reduces more expensive forms (e.g., inpatient, ED) of health care.
The investigators will compare outcomes of patients assigned in the highest incentive group ($50) to patients assigned to the modest incentive group ($25) and to patients assigned to usual care (no incentive, but assignment to a PCP). The investigators will also compare incentive patients ($50, $25) to a contemporaneous group of patients that enroll in the safety net clinic at the same time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Contemporaneous Control | No intervention | –This group is our 'usual care' control group. They were not contacted for an interview and were not offered an incentive to visit their primary care physician. |
| $0 group | Active comparator | Behavioral: 0 dollars groupThis group completed a baseline interview but was not offered any incentive if they visited their primary care physician. |
| $25 group | Experimental | Behavioral: 25 dollars groupThis group completed a baseline interview and was offered $25 they visited their primary care physician within 6 months. |
| $50 group | Experimental | Behavioral: 50 dollars groupThis group completed a baseline interview and was offered $50 they visited their primary care physician within 6 months. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults between ages 21-64 years
- No prior enrollment in VCC for the past 12 months
- English or Spanish speaking, and
- Can be contacted by mail and telephone (preferably) or willing to be interviewed in person.
Key exclusion criteria (3 listed)
- Unable to be contacted by phone/mail
- Cannot provide consent
- No longer located in catchment area
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 |
|---|---|---|
| 0 dollars groupThose assigned to the $0 group will not receive an incentive for visiting their PCP. | Behavioural | $0 group |
| 50 dollars groupThose assigned to the $50 group will receive $50 if they visit their PCP within 6 months of study enrollment. | Behavioural | $50 group |
| 25 dollars groupThose assigned to the $25 group will receive $25 if they visit their PCP within 6 months of study enrollment. | Behavioural | $25 group |
Primary outcome
The number of Primary Care Physician visits will be assessed using medical claims record data.
Time frame: This will be assessed in the 6 months following study enrollment.
The number of primary care visits to a primary care physician will be collected from medical claims record data.
1 secondary outcome
The time to a Primary Care Physician will be assessed using medical claims record data.
Time frame: This will be assessed in the 6 months following study enrollment.
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 12 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Cathy Bradley, Phd principal investigator
PI
Questions about this trial
What is this clinical trial studying?
A study testing 0 dollars group, 50 dollars group and 25 dollars group in people with Health Care Utilization and Primary Care Physician, run by Virginia Commonwealth University.
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 4 inclusion and 3 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The number of Primary Care Physician visits will be assessed using medical claims record data. (time frame: This will be assessed in the 6 months following study enrollment.). 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 12 Jun 2018.