Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT)

March 5, 2019 updated by: Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

4078

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02466
        • Harvard Vanguard Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
No Intervention: Usual care
Patients randomized to this arm will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Harvard Vanguard Medical Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P001076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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