Chronic DiseaseSyNCMedNCT01963156
Synchronization to Improve Non-Adherence to Cardiovascular Medications
A study testing Prescription synchronization in people with Chronic Disease and Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Cardiovascular Disease, Diabetes Mellitus
- What is being tested?
- Prescription synchronization
- 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
- 3,675 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
We will enroll patients 18 years of age and older who within 6 months of study enrollment have filled ≥ 2 medications intended for long-term use (i.e. maintenance medications) by mail order at CVS Caremark. At least 1 of these 2 medications of must be for the treatment of diabetes or cardiovascular disease. In addition, these medications must be delivered on two or more unique delivery dates, there must be at least one refill remaining for all eligible medications and either all or none of their prescriptions must be enrolled in the ReadyFill@Mail program (see Intervention Description for details).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)
The aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications.
- Conditions
- Chronic Disease, Cardiovascular Disease, Diabetes Mellitus
- Being tested
- Prescription synchronization
- Keywords
- Prescription synchronization, Cardiovascular disease, Medication adherence, Randomized controlled trial, Chronic disease, Pharmacy benefit design, Quality improvement
- Medical subject headings
- Chronic Disease, Cardiovascular Diseases, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription synchronizationBehavioural
Each patient's medication that has the greatest quantity of pills on hand after randomization will be defined as the "index "medication and partial supplies will be provided for all other eligible medications in order to synchronize all of a patient's medication. Prescribers will be contacted for a new prescription to ensure all eligible medications are on the same renewal schedule.
Randomization will occur within strata of whether patients are enrolled in the "ReadyFill@Mail" program. Once synchronized, patients who are not enrolled in the ReadyFill@Mail program will initiate their own refills. Patients who are enrolled in the ReadyFill@Mail program will have their refills automatically filled, however patients may disenroll from ReadyFill@Mail at any time, in which case they will initiate their own refills. Patients may disenroll in whole or in part from the program at any point.
| Study group | Role | What they receive |
|---|---|---|
| Prescription synchronization | Experimental | Not described Receives: Behavioral: Prescription synchronization |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims
Measured: 12 months
Secondary outcomes (1)
Full adherence to medications for the treatment of diabetes or cardiovascular disease
Percent of subjects achieving full adherence (defined as a Medication Possession Ratio > 80%) to medications for cardiovascular disease and diabetes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- None (open label)
- Enrolment
- 3,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CVS Caremark
- Responsible party
- Principal investigator, Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
- Investigators
- Niteesh K Choudhry, MD, PhD, Principal investigator, Brigham and Women's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963156
- Sponsor's protocol ID
- Pro00008813
- Acronym
- SyNCMed
- Status last verified
- Jan 2016
- First submitted
- 10 Oct 2013
- Last updated
- 11 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronization to Improve Non-Adherence to Cardiovascular Medications (SyNCMed)
- ClinicalTrials.gov ID
- NCT01963156
- Acronym / sponsor ID
- SyNCMed / Pro00008813
- Conditions
- Chronic Disease, Cardiovascular Disease, Diabetes Mellitus
- Keywords
- Prescription synchronization, Cardiovascular disease, Medication adherence, Randomized controlled trial, Chronic disease, Pharmacy benefit design, Quality improvement
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3,675 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- CVS Caremark
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Oct 2013 (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.
The aim of this study is to evaluate if synchronizing when patients with diabetes and/or coronary artery disease fill their prescriptions improves long-term adherence to these medications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription synchronization | Experimental | Behavioral: Prescription synchronization |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Prescription synchronizationEach patient's medication that has the greatest quantity of pills on hand after randomization will be defined as the "index "medication and partial supplies will be provided for all other eligible medications in order to synchronize all of a patient's medication. Prescribers will be contacted for a new prescription to ensure all eligible medications are on the same renewal schedule. Randomization will occur within strata of whether patients are enrolled in the "ReadyFill@Mail" program. Once synchronized, patients who are not enrolled in the ReadyFill@Mail program will initiate their own refills. Patients who are enrolled in the ReadyFill@Mail program will have their refills automatically filled, however patients may disenroll from ReadyFill@Mail at any time, in which case they will initiate their own refills. Patients may disenroll in whole or in part from the program at any point. | Behavioural | Prescription synchronization |
Primary outcome
Medication adherence
Time frame: 12 months
Average adherence to medications for the treatment of cardiovascular disease and diabetes medications as assessed using administrative pharmacy claims
1 secondary outcome
Full adherence to medications for the treatment of diabetes or cardiovascular disease
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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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.
Niteesh K Choudhry, MD, PhD principal investigator
Brigham and Women's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription synchronization in people with Chronic Disease and Cardiovascular Disease, run by Brigham and Women's Hospital 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?
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: stopped early, as of the sponsor's last update on 11 Jan 2016. 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 was stopped early. Results are not available in the source record.
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?
Medication adherence (time frame: 12 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 11 Jan 2016.