The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hyperlipidemia
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 4078
- Locations
- 1
- Primary Endpoint
- Medication Adherence
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
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.
Investigators
Niteesh K. Choudhry, MD, PhD
Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School
Brigham and Women's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Healthcare Utilization - Hospitalizations(12 months)
- Disease Control(12 months)
- Healthcare Utilization - ER Visits(12 months)
- Healthcare Utilization - Office Visits(12 months)
- Disease Control - All Eligible Conditions(12 months)