Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT)
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| ClinicalTrials.gov Identifier: NCT02512276 |
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Recruitment Status :
Completed
First Posted : July 30, 2015
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperlipidemia Diabetes Hypertension | Behavioral: Telepharmacist intervention | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4078 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT) |
| Study Start Date : | August 2015 |
| Actual Primary Completion Date : | August 2017 |
| Actual Study Completion Date : | October 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Telepharmacist intervention
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.
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Behavioral: Telepharmacist intervention
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. |
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No Intervention: Usual care
Patients randomized to this arm will receive usual care.
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- 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.
- Disease Control - All Eligible Conditions [ Time Frame: 12 months ]
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.
- Disease Control [ Time Frame: 12 months ]
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.
- Healthcare Utilization - ER Visits [ Time Frame: 12 months ]Number of patients with at least 1 ER visit.
- Healthcare Utilization - Office Visits [ Time Frame: 12 months ]Number of patients with at least 1 office visit.
- Healthcare Utilization - Hospitalizations [ Time Frame: 12 months ]Number of patients with at least 1 hospitalization.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients with <6 months of continuous enrolment in the health plan
- Patients with no available contact information
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512276
| United States, Massachusetts | |
| Harvard Vanguard Medical Associates | |
| Newton, Massachusetts, United States, 02466 | |
| Principal Investigator: | Niteesh K Choudhry, MD, PhD | Brigham and Women's Hospital |
Documents provided by Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital:
| Responsible Party: | Niteesh K. Choudhry, MD, PhD, Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT02512276 |
| Other Study ID Numbers: |
2013P001076 |
| First Posted: | July 30, 2015 Key Record Dates |
| Results First Posted: | June 6, 2019 |
| Last Update Posted: | June 6, 2019 |
| Last Verified: | March 2019 |
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Medication Non-adherence Hyperlipidemia Diabetes Hypertension |
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Hypertension Hyperlipidemias Hyperlipoproteinemias Vascular Diseases |
Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |