Tele-Pharmacy Intervention to Improve Treatment Adherence

NCT02512276 | Completed Results

• 1 other identifier: 2013P001076
• Study Type: interventional
• Target: 4,078
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperlipidemia; Diabetes; Hypertension

Keywords

Medication Non-adherence; Hyperlipidemia; Diabetes; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disease Control - All Eligible Conditions

  12 months

• Disease Control

  12 months

• Healthcare Utilization - ER Visits

  12 months

• Healthcare Utilization - Office Visits

  12 months

• Healthcare Utilization - Hospitalizations

  12 months

Study Arms (2)

Telepharmacist intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Patients randomized to this arm will receive usual care.

Interventions

Telepharmacist intervention BEHAVIORAL

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.

Telepharmacist intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with \<6 months of continuous enrolment in the health plan
• Patients with no available contact information

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Vanguard Medical Associates: collaborator

Study Sites (1)

Harvard Vanguard Medical Associates

Newton, Massachusetts, 02466, United States

Location

Related Publications (1)

• Choudhry NK, Isaac T, Lauffenburger JC, Gopalakrishnan C, Lee M, Vachon A, Iliadis TL, Hollands W, Elman S, Kraft JM, Naseem S, Doheny S, Lee J, Barberio J, Patel L, Khan NF, Gagne JJ, Jackevicius CA, Fischer MA, Solomon DH, Sequist TD. Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1182-1189. doi: 10.1001/jamainternmed.2018.3189.

  PMID: 30083727 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Diabetes Mellitus; Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Niteesh K. Choudhry, MD, PhD
• Organization: Brigham and Women's Hospital

nkchoudhry@bwh.harvard.edu

617-278-0930

Study Officials

• Niteesh K Choudhry, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 30, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-03

Locations

US (1)