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.

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.

Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster-randomized pragmatic trial.

BACKGROUND: Approximately half of patients with chronic cardiometabolic conditions are nonadherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may not need adherence assistance. OBJECTIVE: To evaluate the effect of a multicomponent, behaviorally tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. TRIAL DESIGN: The STIC2IT trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multicomponent intervention that uses behavioral interviewing, text messaging, mailed progress reports, and video visits. Targeted patients are those who are nonadherent to glucose-lowering, antihypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients' individual health barriers and their level of health activation. We cluster-randomized 14 practice sites of a large multispecialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients who will be followed up for 12months after randomization. The trial's primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and health care resource utilization. CONCLUSION: This trial will determine whether a technologically enabled, behaviorally targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need.

Improving performance of an accountable care organization on a quality measure assessing ß-blocker use in systolic heart failure.

PURPOSE: The implementation and outcomes are described for a clinical pharmacist-generated initiative to improve the performance of a Medicare Pioneer accountable care organization (ACO) quality measure evaluating the percentage of patients at least 18 years of age with heart failure and a left ventricular ejection fraction (LVEF) of less than 40% who are prescribed with an evidence-based ß-blocker (carvedilol, metoprolol succinate, or bisoprolol). SUMMARY: Atrius Health clinical pharmacists developed several educational documents to facilitate appropriate prescribing of evidence-based therapies in patients with heart failure. After educating clinicians, clinical pharmacists reviewed patient charts to determine eligibility for initiating or switching to evidence-based ß-blocker therapy. Medicare Pioneer ACO patients 18-85 years of age with heart failure and a current or prior LVEF of less than 40% were reviewed. Patients had a current prescription for metoprolol tartrate, atenolol, or no ß-blocker. Patients were considered ineligible if they had a documented contraindication or intolerance to ß-blocker therapy or were clinically unstable. Recommendations to initiate or switch to an appropriate ß-blocker were sent electronically by a clinical pharmacist to an eligible patient's treating physician before a scheduled office visit. In approximately three months, 48 patients underwent chart review by a clinical pharmacist. Performance improved by 8% after the implementation, with 82% of eligible patients achieving the quality measure in 2014-an increase from 74% in 2013. CONCLUSION: The performance on a Medicare Pioneer ACO quality measure evaluating ß-blocker use in systolic heart failure improved in a one-year period after a clinical pharmacist-generated initiative was implemented at Atrius Health practice sites.