Tele-Pharmacy Intervention to Improve Treatment Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)

Conditions
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Hyperlipidemia, Diabetes, Hypertension

Intervention / Treatment
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* Behavioral: Telepharmacist intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telepharmacist intervention<br>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. | Behavioral: Telepharmacist intervention<br>* 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.<br>|
| No Intervention: Usual care<br>Patients randomized to this arm will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 
| Healthcare Utilization - ER Visits | Number of patients with at least 1 ER visit. | 12 months | 
| Healthcare Utilization - Office Visits | Number of patients with at least 1 office visit. | 12 months | 
| Healthcare Utilization - Hospitalizations | Number of patients with at least 1 hospitalization. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Non-adherence, Hyperlipidemia, Diabetes, Hypertension