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Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02512276
Recruitment Status : Completed
First Posted : July 30, 2015
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Diabetes Hypertension Behavioral: Telepharmacist intervention Not Applicable

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.

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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

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


  2. 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.


  3. Healthcare Utilization - ER Visits [ Time Frame: 12 months ]
    Number of patients with at least 1 ER visit.

  4. Healthcare Utilization - Office Visits [ Time Frame: 12 months ]
    Number of patients with at least 1 office visit.

  5. Healthcare Utilization - Hospitalizations [ Time Frame: 12 months ]
    Number of patients with at least 1 hospitalization.



Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Harvard Vanguard Medical Associates
Newton, Massachusetts, United States, 02466
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard Vanguard Medical Associates
Investigators
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Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital:
Medication Non-adherence
Hyperlipidemia
Diabetes
Hypertension
Additional relevant MeSH terms:
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Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases