HyperlipidemiaSTIC2ITNCT02512276
Tele-Pharmacy Intervention to Improve Treatment Adherence
A study testing Telepharmacist intervention in people with Hyperlipidemia and Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperlipidemia, Diabetes, Hypertension
- What is being tested?
- Telepharmacist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,078 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Filled and poorly adherent (defined as a PDC < 80%) to medication for hyperlipidemia, hypertension, or diabetes
- Suboptimal average adherence to all of the qualifying medications that a patient has filled (defined as combined (average of averages) PDC < 80%)
- For patients with hypertension or diabetes, poor or worsening disease control (according to relevant clinical targets)
Who cannot join
- Patients with <6 months of continuous enrolment in the health plan
- Patients with no available contact information
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Vanguard Medical Associates
Newton, Massachusetts, 02466
About this study
Official title: The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)
The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.
Read the detailed description
Long-term adherence to evidence-based medications remains exceptionally poor. Half of all patients become non-adherent within a year of treatment initiation. Interventions that improve medication adherence may have important clinical benefits across large populations, and may even be cost-saving by reducing rates of costly and morbid clinical outcomes such as myocardial infarction and stroke.
The Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC 2 IT) is a cluster randomized controlled trial (RCT) evaluating whether a novel tele-pharmacist-based intervention improves medication adherence and disease control among individuals with hyperlipidemia, hypertension, and diabetes who are nonadherent to their medications and who have poor or worsening disease control. The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. Potentially eligible patients will be identified using data from paid-prescription claims data and the electronic health record. The study is being conducted at 14 practice sites in a large multi-specialty group practice with approximately 250 primary care physicians. Practice sites will be randomized to intervention or control. In intervention sites, the primary care physicians of potentially eligible patients will be asked whether they would like patients to be enrolled in the intervention.
- Conditions
- Hyperlipidemia, Diabetes, Hypertension
- Being tested
- Telepharmacist intervention
- Keywords
- Medication Non-adherence, Hyperlipidemia, Diabetes, Hypertension
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepharmacist interventionBehavioural
The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.
| Study group | Role | What they receive |
|---|---|---|
| Telepharmacist intervention | Experimental | Patients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control. Receives: Behavioral: Telepharmacist intervention |
| Usual care | No intervention | Patients randomized to this arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study.
Medication adherence is often reported as percentage of days covered.
Measured: 12 months
Secondary outcomes (5)
Disease Control - All Eligible Conditions
Percentage of patients achieving good disease control for all eligible conditions.
Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia).
This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all of their eligible conditions, as opposed to at least 1 for Outcome Measure 3. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment.
Measured: 12 months
Disease Control
Percentage of patients achieving good disease control for at least one eligible condition.
Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia).
This outcome measure disease control was measured as the proportion of patients achieving "good" disease control based on guideline-specified targets for all at least 1 eligible condition, as opposed to all of their eligible conditions for Outcome Measure 2. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment.
Measured: 12 months
Healthcare Utilization - ER Visits
Number of patients with at least 1 ER visit.
Measured: 12 months
Healthcare Utilization - Office Visits
Number of patients with at least 1 office visit.
Measured: 12 months
Healthcare Utilization - Hospitalizations
Number of patients with at least 1 hospitalization.
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 posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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
- 4,078 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512276
- Sponsor's protocol ID
- 2013P001076
- Acronym
- STIC2IT
- Status last verified
- Mar 2019
- First submitted
- 29 Jul 2015
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189.
PubMed 30083727
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)
- ClinicalTrials.gov ID
- NCT02512276
- Acronym / sponsor ID
- STIC2IT / 2013P001076
- Conditions
- Hyperlipidemia, Diabetes, Hypertension
- Keywords
- Medication Non-adherence, Hyperlipidemia, Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,078 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Vanguard Medical Associates
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.
Detailed description
Long-term adherence to evidence-based medications remains exceptionally poor. Half of all patients become non-adherent within a year of treatment initiation. Interventions that improve medication adherence may have important clinical benefits across large populations, and may even be cost-saving by reducing rates of costly and morbid clinical outcomes such as myocardial infarction and stroke.
The Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC 2 IT) is a cluster randomized controlled trial (RCT) evaluating whether a novel tele-pharmacist-based intervention improves medication adherence and disease control among individuals with hyperlipidemia, hypertension, and diabetes who are nonadherent to their medications and who have poor or worsening disease control. The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. Potentially eligible patients will be identified using data from paid-prescription claims data and the electronic health record. The study is being conducted at 14 practice sites in a large multi-specialty group practice with approximately 250 primary care physicians. Practice sites will be randomized to intervention or control. In intervention sites, the primary care physicians of potentially eligible patients will be asked whether they would like patients to be enrolled in the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telepharmacist intervention | Experimental | Behavioral: Telepharmacist interventionPatients diagnosed with diabetes, hypertension, or hyperlipidemia exhibiting sub-optimal adherence to their medications [defined as combined (average of averages) proportion of days covered (PDC) < 80%] who also have poor or worsening disease control. |
| Usual care | No intervention | –Patients randomized to this arm will receive usual care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Filled and poorly adherent (defined as a PDC < 80%) to medication for hyperlipidemia, hypertension, or diabetes
- Suboptimal average adherence to all of the qualifying medications that a patient has filled (defined as combined (average of averages) PDC < 80%)
- For patients with hypertension or diabetes, poor or worsening disease control (according to relevant clinical targets)
Key exclusion criteria (2 listed)
- Patients with <6 months of continuous enrolment in the health plan
- Patients with no available contact information
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 |
|---|---|---|
| Telepharmacist interventionThe intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes. | Behavioural | Telepharmacist intervention |
Primary outcome
Medication Adherence
Time frame: 12 months
Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study. Medication adherence is often reported as percentage of days covered.
5 secondary outcomes
Disease Control - All Eligible Conditions
Time frame: 12 months
Disease Control
Time frame: 12 months
Healthcare Utilization - ER Visits
Time frame: 12 months
Healthcare Utilization - Office Visits
Time frame: 12 months
Healthcare Utilization - Hospitalizations
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30083727Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189.
Related trials for Hyperlipidemia
RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Hyperlipidemia, Hypercholesterolemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepharmacist intervention in people with Hyperlipidemia and Diabetes, 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?
The sponsor lists 3 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 6 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
On the ClinicalTrials.gov record for NCT02512276, which also lists 1 linked publication.
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 6 Jun 2019.