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Medication Adherence Clinical Decision Support

A Team-Based and Technology-Driven Adherence Intervention to Improve Chronic Disease Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03748420
Acronym
ADH-Wizard
Enrollment
5421
Registered
2018-11-20
Start date
2020-08-19
Completion date
2023-01-31
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperlipidemia, Hypertension, Medication Nonadherence

Keywords

Decision Support Systems, Clinical, Cardiovascular Diseases, Cardiovascular Risk Factor, Medication Non-adherence

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.

Detailed description

Patients are randomly allocated 1:1 through a computer-generated program to either control or intervention. Control: All control patients will continue to receive the basic Electronic Medical Record (EMR)-linked Clinical Decision Support (CDS) tool for cardiovascular (CV) risk factor management. This CDS includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. The basic CDS does not include any information on medication adherence. Patients will receive basic CDS plus usual care. Intervention: For intervention patients, the basic CDS system for CV risk-factor control is enhanced to support a team-based care model that identifies risk of non-adherence, computes adherence information and incorporates it in the CDS, creates a registry to direct proactive pharmacist outreach, and coordinates action plans. To do this, the CDS Web service will combine EMR-identified medications with Epic Medication Adherence score (e-PDC) data. Algorithms will identify poor adherence using e-PDC scores available within the Epic EMR at patient encounters. When medication adherence issues are identified, alert messages will appear on the CDS tools for patients and providers. Patients with index visits will be followed-up for 6 months as they continue to receive CDS at subsequent encounters. At 6 months, patient e-PDC as well as clinical outcomes will be reevaluated. Patients with persistent adherence issues identified are added to a registry that is used by the pharmacists to conduct outreach. Pharmacist outreach will be conducted primarily by phone, but in-person arrangements are also an option. Pharmacists conducting outreach will identify themselves to patients as part of the care team working with the primary care provider (PCP). Examples of specific action plans that may be recommended includes education, recommending lower cost alternative medications or combination medications, addressing side effects, using pill boxes, modifying pill-taking schedules and/or using reminder systems, or referrals to medication therapy management (MTM) services or health educators. Pharmacists will be guided by a script template for the phone outreach that walks them through the IMB intervention and data collection. The pharmacists involved will have full read/write access to the EMR in full compliance with HIPAA regulations. They can make medication changes through established care protocols and/or communicate with the prescriber through secure messaging or phone consultation. The date of the pharmacist outreach and actions that result from the IMB intervention will be documented in the EMR and incorporated into subsequent CDS tools and registries to reflect the new patient state.

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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 \<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): 1. 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 2. Age \>21 and LDL \>190 mg/dL 3. 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 4. 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: 1. Patients enrolled in hospice, 2. Patients with active cancer or undergoing chemotherapy 3. Patients with pregnancy in the last year 4. Patients without HealthPartners insurance coverage for at least 11 of the 12 months before the index visit will be excluded from cost analysis. 5. For Statin cohort, ≥1 LDL result \<100 mg/dl within 2 years

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure Medication Adherence12 months after an index visitNumber 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.
Non-Insulin Glycemic Medication Adherence12 months after an index visitNumber 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.
Statin Medication Adherence12 months after an index visitNumber 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.
Mean Change in Systolic Blood Pressure12 months after an index visitMean change in systolic blood pressure (SBP) from index to the last SBP value within 12 months after the index visit.
Mean Change in A1c12 months after an index visitMean change in A1c (glycated hemoglobin) value from the index visit to the last lab test within 12 months after the index visit.

Secondary

MeasureTime frameDescription
Clinic-based Medical Care Costs12 months after an index visitChange in annual clinic-based medical care costs, defined from the health system perspective.

Countries

United States

Participant flow

Recruitment details

Participants were identified as eligible using an automated algorithm designed to display the adherence enhanced decision support at the point of care at a primary care clinic visit. The first visit where a participant met eligibility criteria (and prior to applying exclusion criteria) was considered their index visit. There was no direct contact between study participants and the study team. The study was granted a waiver of informed consent from HealthPartners IRB.

Pre-assignment details

Patients were randomly allocated 1:1 through a computer generated program to either control or intervention. The number Completed reflects the number of participants included in the final analysis after exclusions were applied.

Participants by arm

ArmCount
Usual Care
Patients in the usual care arm received the basic clinical decision support that is considered the standard of care at HealthPartners. Patients in this study group were accrued over 6 months and followed for 12 months at which point they were assessed for improved medication adherence and clinical outcomes.
2,676
Adherence Intervention
Patients 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.
2,745
Total5,421

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath2428
Overall StudyLost to Follow-up231230
Overall StudyNo 12 month medication adherence data available01

Baseline characteristics

CharacteristicUsual CareAdherence InterventionTotal
Age, Continuous57.5 years
STANDARD_DEVIATION 10.6
57.2 years
STANDARD_DEVIATION 10.9
57.4 years
STANDARD_DEVIATION 10.7
Ethnicity (NIH/OMB)
Hispanic or Latino
114 Participants116 Participants230 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2045 Participants2119 Participants4164 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
517 Participants510 Participants1027 Participants
Presence of cardiovascular disease (CVD)323 Participants353 Participants676 Participants
Race (NIH/OMB)
American Indian or Alaska Native
10 Participants16 Participants26 Participants
Race (NIH/OMB)
Asian
207 Participants189 Participants396 Participants
Race (NIH/OMB)
Black or African American
700 Participants688 Participants1388 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants6 Participants9 Participants
Race (NIH/OMB)
Unknown or Not Reported
197 Participants216 Participants413 Participants
Race (NIH/OMB)
White
1559 Participants1630 Participants3189 Participants
Region of Enrollment
United States
2676 participants2745 participants5421 participants
Sex: Female, Male
Female
1196 Participants1235 Participants2431 Participants
Sex: Female, Male
Male
1480 Participants1510 Participants2990 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
24 / 2,80828 / 2,879
other
Total, other adverse events
127 / 2,808127 / 2,879
serious
Total, serious adverse events
557 / 2,808559 / 2,879

Outcome results

Primary

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.

Time frame: 12 months after an index visit

Population: Participants that were not at evidence-based goals for blood pressure (BP) and had PDC less than 80% with moderate to high confidence.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareBlood Pressure Medication Adherence396 Participants
Adherence InterventionBlood Pressure Medication Adherence470 Participants
p-value: 0.010395% CI: [1.06, 1.56]Regression, Logistic
Primary

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.

Time frame: 12 months after an index visit

Population: Participants that were not at evidence-based goals for hemoglobin A1c and had PDC less than 80% with moderate to high confidence.

ArmMeasureValue (MEAN)
Usual CareMean Change in A1c-1.1 percentage of glycated hemoglobin
Adherence InterventionMean Change in A1c-1.2 percentage of glycated hemoglobin
p-value: 0.295% CI: [-0.4, 0.1]Mixed Models Analysis
Primary

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.

Time frame: 12 months after an index visit

Population: Not at evidence-based clinical goals for SBP and had proportion of days covered (PDC) greater than or equal to 80%.

ArmMeasureValue (MEAN)
Usual CareMean Change in Systolic Blood Pressure-15.2 mm Hg
Adherence InterventionMean Change in Systolic Blood Pressure-13.8 mm Hg
p-value: 0.2195% CI: [-0.8, 3.5]Mixed Models Analysis
Primary

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.

Time frame: 12 months after an index visit

Population: Participants that were not at evidence-based goals for glucose (A1c) and had PDC less than 80% with moderate to high confidence.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareNon-Insulin Glycemic Medication Adherence279 Participants
Adherence InterventionNon-Insulin Glycemic Medication Adherence296 Participants
p-value: 0.796795% CI: [0.82, 1.3]Regression, Logistic
Primary

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.

Time frame: 12 months after an index visit

Population: Participants that had PDC less than 80% with moderate to high confidence.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareStatin Medication Adherence529 Participants
Adherence InterventionStatin Medication Adherence586 Participants
p-value: 0.058995% CI: [0.99, 1.41]Regression, Logistic
Secondary

Clinic-based Medical Care Costs

Change in annual clinic-based medical care costs, defined from the health system perspective.

Time frame: 12 months after an index visit

Population: All enrolled participants that were not at evidence-based goals for blood pressure (BP) or glucose and had proportion of days covered (PDC) less than 80% with moderate to high confidence for blood pressure, glucose, or statin medications.

ArmMeasureValue (MEAN)Dispersion
Usual CareClinic-based Medical Care Costs1210.15 US dollarsStandard Error 40.59
Adherence InterventionClinic-based Medical Care Costs1202.68 US dollarsStandard Error 44.13
p-value: 0.90195% CI: [-124.99, 110.04]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026