Acute Myocardial InfarctionNCT02139202
Heartstrong Pilot Program
A study testing Social Influence, Electronic Pill Bottles and Financial Incentives in people with Acute Myocardial Infarction, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a 6-month pilot study intended to test the effect of financial incentives on improving medication adherence in AMI patients; to test the effect on adherence of removing financial incentives; and to test the effect on the enrollment rate of modifying recruitment procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Social Influence, Electronic Pill Bottles and Financial Incentives
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the University of Pennsylvania Health System who are discharged (or scheduled to be discharged) to their homes with a principal or secondary diagnosis code of International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) 410 (except when the fifth digit was 2) and a length of stay of 1 to 180 days will be considered eligible for the study. Patients must be between 18 and 80 years old and have been discharged to home, 3) Patients are only eligible to enroll in the study for up to 60 days after their hospital discharge for a heart attack.
Who cannot join
- Patients will be excluded if they are less than 18 years old, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia). Patients who have a known allergy or history of side effects to any of the 4 targeted classes of medications will be enrolled but provided GlowCaps only for the remaining medications.
- Patients with insurance coverage of one of the main study partners. (Horizon, Independence Blue Cross, Aetna, Keystone Mercy, and HealthFirst) (Please note, patients who are prescribed the anti-platelet Effient® (prasugrel) will not be given a GlowCap to use for this medication due to specific guidance about pill maintenance. The package insert for Effient® (prasugrel) (http://pi.lilly.com/us/effientppi.pdf) indicates the medication should remain in the original bottle, it should be kept at room temperature between 59°F to 86°F (15°C to 30°C) and the container should be closed tightly with the gray cylinder inside and be protected from moisture. This does not necessarily exclude these patients from participation in the study, they will still be eligible as long as they have been prescribed at least 2 of the remaining 3 medications being observed in this study. Also, those who are taking an anti-platelet other than Effient® (prasugrel) (ie, Plavix) will be given a GlowCap to use to take that medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: HeartStrong Pilot Program - Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients
This is a 6-month pilot study intended to test the effect of financial incentives on improving medication adherence in AMI patients; to test the effect on adherence of removing financial incentives; and to test the effect on the enrollment rate of modifying recruitment procedures.
Read the detailed description
This pilot study is part of a larger study. Our plan for testing the implementation of a new model for care delivery builds on infrastructure that we have developed and tested with NIH Support (RC2 AG036592-01, Asch and Volpp, Multiple PIs). We aim to improve medication adherence in patients following hospital admission for acute myocardial infarction (AMI). Poor adherence to cardioprotective medications leads to worse medical treatment outcomes, higher hospitalization and mortality rates, and increased health care costs among CAD patients.20,21(references listed in full grant submission) Hence, medication adherence among such patients is an important modifiable factor that affects the triple aim of improved health care quality, improved health, and lower cost.
In this Pilot, we want to test an alternate approach to recruiting this patient population in hopes of increasing the enrollment rates to greater than that in the main trial. Our hypothesis is that if enrollment barriers are too high, the participants enrolling in the study already possess a predisposition to medication adherence based on their interest in research participation. By increasing the percentage of patients who enroll, we believe we will enable the research results to be more generalizable including more of the patient population, who may experience medication adherence problems as indicated in lack of willingness to participate in research. By increasing the percentage of patients who enroll, we are attempting to include more patients who may receive benefit of improved adherence offered in this program. In this pilot study we plan to recruit patients from UPHS Health System. Patients who decide to enroll will be placed into an abbreviated, 6-month version of our HeartStrong research program offered in the main intervention. The modification in recruitment procedures we are testing is the inclusion of the GlowCap electronic pill bottles in the recruitment mailings that we send to prospective participants, thus lowering the enrollment barrier by giving patients direct contact with the electronic pill bottles. We will examine the enrollment rate using this method in comparison to the methods used in the main intervention.
We believe including the GlowCaps in the recruitment packet will provide a couple of benefits. First, participants will have the opportunity to see the pill bottles and have a better understanding of the study intervention from the beginning of the recruitment process. Second, our study team will be able to conduct the recruitment, verbal consent and GlowCap set up in the space of a single phone call. While this will make the phone call longer, the logistics of getting patients on the phone at multiple time points is challenging, so the opportunity to encapsulate these efforts in one call are beneficial for both the engagement advisors and the patients.
We are also testing the effect upon adherence rates that removing financial incentives has on patient's medication adherence levels. Participants who choose to enroll in this research program will receive a compound set of approaches including: (1) provision of up to 4 Vitality GlowCaps, a remote monitoring and medication bottle reminder device, for aspirin, beta blockers, statins and, if they received a stent for plavix or similar anti-platelet agents; (2) assignment of an engagement advisor from the study team; (3) enlisting a family member or friend (patient choice) as a support person for medication adherence; (4) engagement incentives that will use lotteries where winning will be dependent on medication adherence; and (5) self-service/customization of the Way to Health platform communication methods. Participants in this program will be offered all of these components; however, they are still able to participate even if they opt not to use any of the list above. At the 3-month point, participants will be told the incentive portion has completed and they are to continue using their electronic pill bottles for 3 more months and they will receive all other components of the study.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Social Influence, Electronic Pill Bottles, Financial Incentives
- Keywords
- Acute, Myocardial, Infarction, AMI
- Medical subject headings
- Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social InfluenceBehavioural
Electronic Pill BottlesBehavioural
Financial IncentivesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Full Program | Other | The intervention will (1) use the GlowCaps, a remote monitoring and reminder pill bottle; (2) be assigned an engagement advisor from the study team; (3) be asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence for the first three months; and (5) will determine their preferences for Way to Health platform communication methods during the study.
The group receiving the program intervention will also have their claims data analyzed for the 1 months post-enrollment. Receives: Behavioral: Social Influence; Behavioral: Electronic Pill Bottles; Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Uptake
Primary outcomes will be recruitment uptake of patients discharged with recent AMI from the UPHS.
Measured: up to 6 months
Enrollment Uptake
Primary outcomes will be the enrollment rate of targeted patients in this study.
Measured: up to 3 months
Secondary outcomes (2)
Success of Process
Secondary outcomes will be success of process outcomes as reported by the study team and reported by the recruited patients.
Measured: up to 6 months
Removing Incentives
The effect of removing financial incentives on the medication adherence rate of participants.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivan Mehta, MD, MBA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139202
- Sponsor's protocol ID
- 819466
- Other IDs
- CMS561871
- Status last verified
- May 2017
- First submitted
- 13 May 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartStrong Pilot Program - Automated Hovering to Improve Medication Adherence Among Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT02139202
- Acronym / sponsor ID
- 819466
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute, Myocardial, Infarction, AMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 May 2014 (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 6-month pilot study intended to test the effect of financial incentives on improving medication adherence in AMI patients; to test the effect on adherence of removing financial incentives; and to test the effect on the enrollment rate of modifying recruitment procedures.
Detailed description
This pilot study is part of a larger study. Our plan for testing the implementation of a new model for care delivery builds on infrastructure that we have developed and tested with NIH Support (RC2 AG036592-01, Asch and Volpp, Multiple PIs). We aim to improve medication adherence in patients following hospital admission for acute myocardial infarction (AMI). Poor adherence to cardioprotective medications leads to worse medical treatment outcomes, higher hospitalization and mortality rates, and increased health care costs among CAD patients.20,21(references listed in full grant submission) Hence, medication adherence among such patients is an important modifiable factor that affects the triple aim of improved health care quality, improved health, and lower cost.
In this Pilot, we want to test an alternate approach to recruiting this patient population in hopes of increasing the enrollment rates to greater than that in the main trial. Our hypothesis is that if enrollment barriers are too high, the participants enrolling in the study already possess a predisposition to medication adherence based on their interest in research participation. By increasing the percentage of patients who enroll, we believe we will enable the research results to be more generalizable including more of the patient population, who may experience medication adherence problems as indicated in lack of willingness to participate in research. By increasing the percentage of patients who enroll, we are attempting to include more patients who may receive benefit of improved adherence offered in this program. In this pilot study we plan to recruit patients from UPHS Health System. Patients who decide to enroll will be placed into an abbreviated, 6-month version of our HeartStrong research program offered in the main intervention. The modification in recruitment procedures we are testing is the inclusion of the GlowCap electronic pill bottles in the recruitment mailings that we send to prospective participants, thus lowering the enrollment barrier by giving patients direct contact with the electronic pill bottles. We will examine the enrollment rate using this method in comparison to the methods used in the main intervention.
We believe including the GlowCaps in the recruitment packet will provide a couple of benefits. First, participants will have the opportunity to see the pill bottles and have a better understanding of the study intervention from the beginning of the recruitment process. Second, our study team will be able to conduct the recruitment, verbal consent and GlowCap set up in the space of a single phone call. While this will make the phone call longer, the logistics of getting patients on the phone at multiple time points is challenging, so the opportunity to encapsulate these efforts in one call are beneficial for both the engagement advisors and the patients.
We are also testing the effect upon adherence rates that removing financial incentives has on patient's medication adherence levels. Participants who choose to enroll in this research program will receive a compound set of approaches including: (1) provision of up to 4 Vitality GlowCaps, a remote monitoring and medication bottle reminder device, for aspirin, beta blockers, statins and, if they received a stent for plavix or similar anti-platelet agents; (2) assignment of an engagement advisor from the study team; (3) enlisting a family member or friend (patient choice) as a support person for medication adherence; (4) engagement incentives that will use lotteries where winning will be dependent on medication adherence; and (5) self-service/customization of the Way to Health platform communication methods. Participants in this program will be offered all of these components; however, they are still able to participate even if they opt not to use any of the list above. At the 3-month point, participants will be told the incentive portion has completed and they are to continue using their electronic pill bottles for 3 more months and they will receive all other components of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Program | Other | Behavioral: Social Influence, Behavioral: Electronic Pill Bottles, Behavioral: Financial IncentivesThe intervention will (1) use the GlowCaps, a remote monitoring and reminder pill bottle; (2) be assigned an engagement advisor from the study team; (3) be asked to provide the study team with names and contact information of up to 3 family members or friends as support partners for medication adherence. The study team will contact these people in order listed until 1 agrees to serve in this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on medication adherence for the first three months; and (5) will determine their preferences for Way to Health platform communication methods during the study. The group receiving the program intervention will also have their claims data analyzed for the 1 months post-enrollment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the University of Pennsylvania Health System who are discharged (or scheduled to be discharged) to their homes with a principal or secondary diagnosis code of International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) 410 (except when the fifth digit was 2) and a length of stay of 1 to 180 days will be considered eligible for the study. Patients must be between 18 and 80 years old and have been discharged to home, 3) Patients are only eligible to enroll in the study for up to 60 days after their hospital discharge for a heart attack.
Key exclusion criteria (2 listed)
- Patients will be excluded if they are less than 18 years old, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia). Patients who have a known allergy or history of side effects to any of the 4 targeted classes of medications will be enrolled but provided GlowCaps only for the remaining medications.
- Patients with insurance coverage of one of the main study partners. (Horizon, Independence Blue Cross, Aetna, Keystone Mercy, and HealthFirst) (Please note, patients who are prescribed the anti-platelet Effient® (prasugrel) will not be given a GlowCap to use for this medication due to specific guidance about pill maintenance. The package insert for Effient® (prasugrel) (http://pi.lilly.com/us/effientppi.pdf) indicates the medication should remain in the original bottle, it should be kept at room temperature between 59°F to 86°F (15°C to 30°C) and the container should be closed tightly with the gray cylinder inside and be protected from moisture. This does not necessarily exclude these patients from participation in the study, they will still be eligible as long as they have been prescribed at least 2 of the remaining 3 medications being observed in this study. Also, those who are taking an anti-platelet other than Effient® (prasugrel) (ie, Plavix) will be given a GlowCap to use to take that medication.
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 |
|---|---|---|
| Social Influence | Behavioural | Full Program |
| Electronic Pill Bottles | Behavioural | Full Program |
| Financial Incentives | Behavioural | Full Program |
Primary outcome
Recruitment Uptake
Time frame: up to 6 months
Primary outcomes will be recruitment uptake of patients discharged with recent AMI from the UPHS.
Enrollment Uptake
Time frame: up to 3 months
Primary outcomes will be the enrollment rate of targeted patients in this study.
2 secondary outcomes
Success of Process
Time frame: up to 6 months
Removing Incentives
Time frame: up to 6 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 3 May 2017.
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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.
Shivan Mehta, MD, MBA principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Influence, Electronic Pill Bottles and Financial Incentives in people with Acute Myocardial Infarction, run by University of Pennsylvania 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 1 inclusion and 2 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 3 May 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.
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?
Recruitment Uptake (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 3 May 2017.