HyperlipidemiaADH-WizardNCT03748420

Medication Adherence Clinical Decision Support

A study testing Adherence Intervention in people with Hyperlipidemia and Hypertension, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hyperlipidemia, Hypertension, Diabetes
What is being tested?: Adherence Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,421 participants
Where: 1 siteUnited States
Study dates: 19 Aug 2020to 31 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

One or more of the following clinical criteria:
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).
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).
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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthPartners Care System
Bloomington, Minnesota, 55425

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Hyperlipidemia, Hypertension, Diabetes, Medication Nonadherence
Being tested: Adherence Intervention
Keywords: Decision Support Systems, Clinical, Cardiovascular Diseases, Cardiovascular Risk Factor, Medication Non-adherence
Medical subject headings: Hyperlipidemias, Hypertension, Diabetes Mellitus, Medication Adherence, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adherence InterventionOther
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.

Study groups in NCT03748420
Study group	Role	What they receive
Usual Care	No intervention	Patients in the usual care arm receive the basic cardiovascular related clinical decision support which is considered standard of care at the organization.
Adherence Intervention	Experimental	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. Receives: Other: Adherence Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after an index visit

Secondary outcomes (1)

Clinic-based Medical Care Costs
Change in annual clinic-based medical care costs, defined from the health system perspective.
Measured: 12 months after an index visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202031 Jan 2023

First posted20 Nov 2018
Study start19 Aug 2020
Primary completion25 Oct 2022
Study completion31 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HyperlipidemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5,421 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03748420
Sponsor's protocol ID: A16-691
Other IDs: 1R01HL136937-01A1
Acronym: ADH-Wizard
Status last verified: Aug 2023
First submitted: 14 Nov 2018
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39786775
Sperl-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.
PubMed 37956792

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Team-Based and Technology-Driven Adherence Intervention to Improve Chronic Disease Outcomes
ClinicalTrials.gov ID: NCT03748420
Acronym / sponsor ID: ADH-Wizard / A16-691
Conditions: Hyperlipidemia, Hypertension, Diabetes, Medication Nonadherence
Keywords: Decision Support Systems, Clinical, Cardiovascular Diseases, Cardiovascular Risk Factor, Medication Non-adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,421 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 19 Aug 2020 (actual)
Primary completion: 25 Oct 2022 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 20 Nov 2018 (actual)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients are randomly allocated 1:1 through a computer-generated program to either control or intervention.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–Patients in the usual care arm receive the basic cardiovascular related clinical decision support which is considered standard of care at the organization.
Adherence Intervention	Experimental	Other: Adherence InterventionPatients 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

One or more of the following clinical criteria:
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).
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).
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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adherence InterventionThe 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.	Other	Adherence Intervention

Primary outcome

Blood Pressure Medication Adherence
Time frame: 12 months after an index visit
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.
Non-Insulin Glycemic Medication Adherence
Time frame: 12 months after an index visit
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.
Statin Medication Adherence
Time frame: 12 months after an index visit
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.
Mean Change in Systolic Blood Pressure
Time frame: 12 months after an index visit
Mean change in systolic blood pressure (SBP) from index to the last SBP value within 12 months after the index visit.
Mean Change in A1c
Time frame: 12 months after an index visit
Mean change in A1c (glycated hemoglobin) value from the index visit to the last lab test within 12 months after the index visit.

1 secondary outcome

Clinic-based Medical Care Costs
Time frame: 12 months after an index visit

Results and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	2,676	2,421
Adherence Intervention	2,745	2,486

Primary outcome: Blood Pressure Medication Adherence

Time frame: 12 months after an index visit. Count of participants. Unit: Participants

Measure	Usual Care n = 843	Adherence Intervention n = 887
Value	396	470

Usual Care vs Adherence Intervention: Odds Ratio (OR): 1.29 (95% CI 1.06 to 1.56), p = 0.0103, Regression, Logistic

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

Primary outcome: Non-Insulin Glycemic Medication Adherence

Time frame: 12 months after an index visit. Count of participants. Unit: Participants

Measure	Usual Care n = 596	Adherence Intervention n = 628
Value	279	296

Usual Care vs Adherence Intervention: Odds Ratio (OR): 1.03 (95% CI 0.82 to 1.30), p = 0.7967, Regression, Logistic

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

Primary outcome: Statin Medication Adherence

Time frame: 12 months after an index visit. Count of participants. Unit: Participants

Measure	Usual Care n = 1039	Adherence Intervention n = 1063
Value	529	586

Usual Care vs Adherence Intervention: Odds Ratio (OR): 1.18 (95% CI 0.99 to 1.41), p = 0.0589, Regression, Logistic

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

Primary outcome: Mean Change in Systolic Blood Pressure

Time frame: 12 months after an index visit. Mean (95% Confidence Interval). Unit: mm Hg

Measure	Usual Care n = 723	Adherence Intervention n = 772
Value	-15.2 (-16.7 to -13.6)	-13.8 (-15.3 to -12.3)

Usual Care vs Adherence Intervention: Mean Difference (Net): 1.4 (95% CI -0.8 to 3.5), p = 0.21, Mixed Models Analysis

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety monitoring started at a patients index date and continued for an average of 11.6 months after index date.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	557 of 2,808 (19.8%)	127 of 2,808 (4.5%)	24 of 2,808
Adherence Intervention	559 of 2,879 (19.4%)	127 of 2,879 (4.4%)	28 of 2,879

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39786775O'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.
Derived from this study: PubMed 37956792Sperl-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.
Individual participant dataSharing planned: No

Related trials for Hyperlipidemia

Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
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A Study to Evaluate COR-1004 in Adult Volunteers.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick J O'Connor, MD principal investigator

HealthPartners Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Adherence Intervention in people with Hyperlipidemia and Hypertension, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure Medication Adherence (time frame: 12 months after an index visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03748420, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.