search
Back to results

Medication Adherence Clinical Decision Support (ADH Wizard)

Primary Purpose

Hyperlipidemia, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence-enhanced clinical decision support
ReachOut Adherence intervention
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hyperlipidemia focused on measuring Decision Support Systems, Clinical, Cardiovascular Diseases, Cardiovascular Risk Factor, Medication Non-adherence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • One or more of the following clinical criteria:

A. In the 12 months prior to the index visit, most recent 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

Sites / Locations

  • HealthPartners Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

ReachOut Adherence intervention

Arm Description

Basic clinical decision support alone

Adherence-enhanced clinical decision support plus pharmacist-based adherence outreach

Outcomes

Primary Outcome Measures

Change in blood pressure medication adherence
Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all blood pressure medications
Change in blood pressure control
Mean change in systolic blood pressure (SBP) from the last BP within the 12 months prior to the index visit, to the last BP value within 12 months after the index visit.
Change in non-insulin glycemic medication adherence
Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all non-insulin glycemic medications
Change in glycemic control
Change in A1C (glycated hemoglobin) value from the last lab test within the 12 months prior to the index visit, to the last lab test within 12 months after the index visit.
Change in statin medication adherence
Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all statin medications

Secondary Outcome Measures

Cost of the intervention
Intervention costs and incremental medical care costs attributable to the intervention, defined from the health system perspective.

Full Information

First Posted
November 14, 2018
Last Updated
April 26, 2023
Sponsor
HealthPartners Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03748420
Brief Title
Medication Adherence Clinical Decision Support
Acronym
ADH Wizard
Official Title
A Team-Based and Technology-Driven Adherence Intervention to Improve Chronic Disease Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Hypertension, Diabetes, Medication Nonadherence
Keywords
Decision Support Systems, Clinical, Cardiovascular Diseases, Cardiovascular Risk Factor, Medication Non-adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4907 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Basic clinical decision support alone
Arm Title
ReachOut Adherence intervention
Arm Type
Experimental
Arm Description
Adherence-enhanced clinical decision support plus pharmacist-based adherence outreach
Intervention Type
Other
Intervention Name(s)
Adherence-enhanced clinical decision support
Intervention Description
Clinical decision support system integrating electronic medication data with claims data on prescription fills
Intervention Type
Behavioral
Intervention Name(s)
ReachOut Adherence intervention
Intervention Description
The pharmacist outreach intervention is based on the theoretically grounded and evidence-based Information-Motivation-Behavioral framework endorsed by the World Health Organization to improve adherence
Primary Outcome Measure Information:
Title
Change in blood pressure medication adherence
Description
Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all blood pressure medications
Time Frame
12 months after an index visit
Title
Change in blood pressure control
Description
Mean change in systolic blood pressure (SBP) from the last BP within the 12 months prior to the index visit, to the last BP value within 12 months after the index visit.
Time Frame
12 months after an index visit
Title
Change in non-insulin glycemic medication adherence
Description
Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all non-insulin glycemic medications
Time Frame
12 months after an index visit
Title
Change in glycemic control
Description
Change in A1C (glycated hemoglobin) value from the last lab test within the 12 months prior to the index visit, to the last lab test within 12 months after the index visit.
Time Frame
12 months after an index visit
Title
Change in statin medication adherence
Description
Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all statin medications
Time Frame
12 months after an index visit
Secondary Outcome Measure Information:
Title
Cost of the intervention
Description
Intervention costs and incremental medical care costs attributable to the intervention, defined from the health system perspective.
Time Frame
12 months after an index visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: One or more of the following clinical criteria: A. In the 12 months prior to the index visit, most recent 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J O'Connor, MD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Care System
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Medication Adherence Clinical Decision Support

We'll reach out to this number within 24 hrs