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N/A N=5,421 Randomized Health Services Research

Medication Adherence Clinical Decision Support

Hyperlipidemia · Hypertension · Diabetes · Medication Nonadherence

Enrolled (actual)
5,421
Serious AEs
19.6%
Results posted
Feb 2024
Primary outcome: Primary: Blood Pressure Medication Adherence — 396; 470 Participants — p=0.0103

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Adherence Intervention (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
HealthPartners Institute
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood Pressure Medication Adherence
396; 470 0.0103 sig
PRIMARY
Non-Insulin Glycemic Medication Adherence
279; 296 0.7967
PRIMARY
Statin Medication Adherence
529; 586 0.0589
PRIMARY
Mean Change in Systolic Blood Pressure
-15.2; -13.8 0.21
PRIMARY
Mean Change in A1c
-1.1; -1.2 0.20
SECONDARY
Clinic-based Medical Care Costs
1210.15; 1202.68 0.901

Summary

More than 50% of adults treated for diabetes, hypertension, or lipid disorders have suboptimal medication adherence, a prominent barrier to continued improvement in chronic disease care in the United States. Primary care providers (PCPs) often fail to identify medication nonadherence and/or have insufficient time and training to address underlying reasons for it. In this project, we propose a patient-centered and technology-driven strategy to identify patients with adherence issues and apply a team approach to help them achieve evidence-based personalized goals for glucose, blood pressure, or lipids. This intervention extends the use of a widely available clinical decision support (CDS) infrastructure to support a model of care that, for the first time outside of a fully integrated care environment, will integrate pharmacists within the primary care team. The intervention relies on a continuous health informatics loop to do the following: (a) identify high-risk patients with adherence problems at the point of care by expanding the capability of an electronic medical record (EMR)-linked CDS to identify poor adherence to medications; (b) establish and maintain an auto-populating up-to-date registry of patients identified for proactive pharmacist outreach; (c) implement a pharmacist outreach strategy based on an information-motivation-behavioral (IMB) framework recommended by the World Health Organization (WHO) with demonstrated ability to influence adherence across a variety of clinical applications; and (d) coordinate care and adherence information by incorporating pharmacist assessment and action plans into CDS at subsequent office encounters.

Eligibility Criteria

Inclusion Criteria

  • One or more of the following clinical criteria:

A. In the 12 months prior to the index visit, most recent hemoglobin A1C ≥8% AND have one or more active non-insulin glycemic medications on their electronic health record (EHR) medication list AND a potential adherence issue for one or more of these medications based on the Epic Medication Adherence score (e-PDC 21 with atherosclerotic cardiovascular disease (ASCVD) identified by a cardiovascular disease (CVD) diagnosis on the problem list or two or more International Classification of Diseases (ICD)-10 diagnostic codes in the last 2 years

  • Age >21 and LDL >190 mg/dL
  • Aged 40 to 75 AND diabetes identified by the diagnosis on the problem list or two or more ICD-10 diagnostic codes in the last 2 years
  • Aged 40 to 75 with 10-year CV Risk Score >7.5% based on the ACC/AHA 10-year ASCVD risk equation.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from the study analysis:

  • Patients enrolled in hospice,
  • Patients with active cancer or undergoing chemotherapy
  • Patients with pregnancy in the last year
  • Patients without HealthPartners insurance coverage for at least 11 of the 12 months before the index visit will be excluded from cost analysis.
  • For Statin cohort, ≥1 LDL result <100 mg/dl within 2 years
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03748420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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