Medication Adherence Clinical Decision Support
ADH-Wizard
A Team-Based and Technology-Driven Adherence Intervention to Improve Chronic Disease Outcomes
2 other identifiers
interventional
5,421
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedResults Posted
Study results publicly available
February 26, 2024
CompletedFebruary 26, 2024
August 1, 2023
2.2 years
November 14, 2018
August 22, 2023
February 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Blood Pressure Medication Adherence
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one antihypertensive medication in each currently prescribed blood pressure medication class at 12 months following the index office visit date.
12 months after an index visit
Non-Insulin Glycemic Medication Adherence
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for at least one non-insulin glycemic medication in each currently prescribed glycemic medication class at 12 months following the index office visit date.
12 months after an index visit
Statin Medication Adherence
Number of patients who achieve a proportion of days covered (PDC) greater than or equal to 80% for a statin medication if currently prescribed at 12 months following the index office visit date.
12 months after an index visit
Mean Change in Systolic Blood Pressure
Mean change in systolic blood pressure (SBP) from index to the last SBP value within 12 months after the index visit.
12 months after an index visit
Mean Change in A1c
Mean change in A1c (glycated hemoglobin) value from the index visit to the last lab test within 12 months after the index visit.
12 months after an index visit
Secondary Outcomes (1)
Clinic-based Medical Care Costs
12 months after an index visit
Study Arms (2)
Usual Care
NO INTERVENTIONPatients in the usual care arm receive the basic cardiovascular related clinical decision support which is considered standard of care at the organization.
Adherence Intervention
EXPERIMENTALPatients in the medication adherence enhanced clinical decision support received the enhanced decision support intervention over a 6 month period. Patients were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
Interventions
The adherence enhanced intervention consists of clinical decision support related to cardiovascular risk factors enhanced with external medication adherence information and is delivered at the point of care to the healthcare provider and patient.
Eligibility Criteria
You may qualify if:
- 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 \<80%, moderate or high confidence).
- B. Two consecutive encounters with BP values ≥140/90 mm Hg AND one or more BP medications on their EHR medication list AND a potential adherence issue identified (e-PDC \<80%, moderate/high confidence).
- C. Meet the American College of Cardiology/American Heart Association (ACC/AHA) criteria listed below for moderate or high-intensity statin use AND a statin medication on their EHR medication list AND a potential statin adherence issue identified (e-PDC \<80%, moderate/high confidence):
- Age \>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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HealthPartners Care System
Bloomington, Minnesota, 55425, United States
Related Publications (2)
O'Connor PJ, Haapala JL, Dehmer SP, Chumba LN, Ekstrom HL, Asche SE, Rehrauer DJ, Pankonin MA, Pawloski PA, Raebel M, Sperl-Hillen JM. Clinical Decision Support and Cardiometabolic Medication Adherence: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2453745. doi: 10.1001/jamanetworkopen.2024.53745.
PMID: 39786775DERIVEDSperl-Hillen JM, Haapala JL, Dehmer SP, Chumba LN, Ekstrom HL, Truitt AR, Asche SE, Werner AM, Rehrauer DJ, Pankonin MA, Pawloski PA, O'Connor PJ. Protocol of a patient randomized clinical trial to improve medication adherence in primary care. Contemp Clin Trials. 2024 Jan;136:107385. doi: 10.1016/j.cct.2023.107385. Epub 2023 Nov 11.
PMID: 37956792DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because this study was conducted at a single, relatively high-performing medical group, generalizability of results to other care delivery systems or patient populations is uncertain.
Results Point of Contact
- Title
- Dr. Patrick O'Connor
- Organization
- HealthPartners Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick J O'Connor, MD
HealthPartners Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2018
First Posted
November 20, 2018
Study Start
August 19, 2020
Primary Completion
October 25, 2022
Study Completion
January 31, 2023
Last Updated
February 26, 2024
Results First Posted
February 26, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share