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Original Investigation
September 2018

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

Author Affiliations
  • 1Center for Healthcare Delivery Sciences (C4HDS), Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 3Atrius Health, Newton, Massachusetts
  • 4Western University of Health Sciences, Pomona, California
  • 5Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
  • 6Division of Rheumatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 7Division of General Internal Medicine and Department of Health Care Policy, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2018;178(9):1182-1189. doi:10.1001/jamainternmed.2018.3189
Key Points

Question  Does a remotely delivered multicomponent behaviorally tailored intervention improve adherence to medications for hyperlipidemia, hypertension, and diabetes vs usual care?

Findings  In this cluster randomized clinical trial of 14 primary care practice sites with 4078 adults with poorly controlled disease who were nonadherent to prescribed medications, the intervention improved medication adherence but did not significantly improve disease control.

Meaning  A multicomponent, technologically enabled pharmacist intervention tailored to patients’ adherence barriers and level of health activation improved medication adherence for patients with common, chronic conditions but did not change clinical outcomes.

Abstract

Importance  Approximately half of patients with chronic conditions are nonadherent to prescribed medications, and interventions have been only modestly effective.

Objective  To evaluate the effect of a remotely delivered multicomponent behaviorally tailored intervention on adherence to medications for hyperlipidemia, hypertension, and diabetes.

Design, Setting, and Participants  Two-arm pragmatic cluster randomized controlled trial at a multispecialty group practice including participants 18 to 85 years old with suboptimal hyperlipidemia, hypertension, or diabetes disease control, and who were nonadherent to prescribed medications for these conditions.

Interventions  Usual care or a multicomponent intervention using telephone-delivered behavioral interviewing by trained clinical pharmacists, text messaging, pillboxes, and mailed progress reports. The intervention was tailored to individual barriers and level of activation.

Main Outcomes and Measures  The primary outcome was medication adherence from pharmacy claims data. Secondary outcomes were disease control based on achieved levels of low-density lipoprotein cholesterol, systolic blood pressure, and hemoglobin A1c from electronic health records, and health care resource use from claims data. Outcomes were evaluated using intention-to-treat principles and multiple imputation for missing values.

Results  Fourteen practice sites with 4078 participants had a mean (SD) age of 59.8 (11.6) years; 45.1% were female. Seven sites were each randomized to intervention or usual care. The intervention resulted in a 4.7% (95% CI, 3.0%-6.4%) improvement in adherence vs usual care but no difference in the odds of achieving good disease control for at least 1 (odds ratio [OR], 1.10; 95% CI, 0.94-1.28) or all eligible conditions (OR, 1.05; 95% CI, 0.91-1.22), hospitalization (OR, 1.02; 95% CI, 0.78-1.34), or having a physician office visit (OR, 1.11; 95% CI, 0.91-1.36). However, intervention participants were significantly less likely to have an emergency department visit (OR, 0.62; 95% CI, 0.45-0.85). In as-treated analyses, the intervention was associated with a 10.4% (95% CI, 8.2%-12.5%) increase in adherence, a significant increase in patients achieving disease control for at least 1 eligible condition (OR, 1.24; 95% CI, 1.03-1.50), and nonsignificantly improved disease control for all eligible conditions (OR, 1.18; 95% CI, 0.99-1.41).

Conclusions and Relevance  A remotely delivered multicomponent behaviorally tailored intervention resulted in a statistically significant increase in medication adherence but did not change clinical outcomes. Future work should focus on identifying which groups derive the most clinical benefit from adherence improvement efforts.

Trial Registration  ClinicalTrials.gov identifier: NCT02512276

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