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Medication Adherence Clinical Decision Support (Wizard)

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ClinicalTrials.gov Identifier: NCT03748420
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
The study team will implement and evaluate a team-based, informatics-driven intervention that integrates primary care clinical decision support with active outreach from pharmacists. The intervention will proactively (1) identify and address nonadherence for adults with chronic diseases; (2) improve management of previously uncontrolled blood pressure, blood sugar, and lipid disorders; (3) increase patient involvement in medication decision making; and (4) develop informatics systems that integrate retail pharmacists within the primary care team.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Hypertension Diabetes Medication Nonadherence Other: Adherence-enhanced clinical decision support Behavioral: ReachOut Adherence intervention Not Applicable

Detailed Description:

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

Control: All control clinics will continue to use 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: In intervention clinics, 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 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). The Information-Motivation-Behavior Change (IMB) model described in detail in Section 2.2 will be the framework for assessing and addressing adherence. 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) pharmacists 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Team-Based and Technology-Driven Adherence Intervention to Improve Chronic Disease Outcomes
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Basic clinical decision support alone
Experimental: ReachOut Adherence intervention
Adherence-enhanced clinical decision support plus pharmacist-based adherence outreach
Other: Adherence-enhanced clinical decision support
Clinical decision support system integrating electronic medication data with claims data on prescription fills

Behavioral: ReachOut Adherence intervention
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 Measures :
  1. Change in blood pressure medication adherence [ Time Frame: 12 months after an index visit ]
    Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all blood pressure medications

  2. Change in blood pressure control [ Time Frame: 12 months after an index visit ]
    Number of patients who achieve a reduction in systolic blood pressure

  3. Change in non-insulin glycemic medication adherence [ Time Frame: 12 months after an index visit ]
    Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all non-insulin glycemic medications

  4. Change in glycemic control [ Time Frame: 12 months after an index visit ]
    Number of patients who achieve a reduction in amount of glycated hemoglobin (A1C) values

  5. Change in statin medication adherence [ Time Frame: 12 months after an index visit ]
    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 :
  1. Cost of the intervention [ Time Frame: 12 months after an index visit ]
    Intervention costs and incremental medical care costs attributable to the intervention, defined from the health system perspective.

  2. Long-term Health Impact [ Time Frame: Simulated 10, 20 and 30-years post intervention ]
    We will estimate the long-term health impact as predicted by the HealthPartners Institute ModelHealthTM: Cardiovascular Disease microsimulation model.

  3. Long-term cost-effectiveness [ Time Frame: Simulated 10, 20 and 30-years post intervention ]
    We will estimate the cost-effectiveness of the intervention as predicted by the HealthPartners Institute ModelHealthTM: Cardiovascular Disease microsimulation model.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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):

  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 <70 mg/dl within 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748420


Contacts
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Contact: Lilian N Chumba 952-967-5279 Lilian.N.Chumba@HealthPartners.Com

Locations
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United States, Minnesota
HealthPartners Care System Recruiting
Bloomington, Minnesota, United States, 55425
Contact: JoAnn Sperl-Hillen, MD    952-967-5009    joann.m.sperlhillen@healthpartners.com   
Contact: Lilian Chumba, MD    9529675279    lilian.n.chumba@healthpartners.com   
Sub-Investigator: Pamala Pawloski, PharmD         
Sub-Investigator: Caitlin Frail, PharmD         
Sub-Investigator: Patrick O'Connor, MD         
Sub-Investigator: Jeffrey Anderson, ScD         
Sub-Investigator: Steve Dehmer, PhD         
Sponsors and Collaborators
HealthPartners Institute
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: JoAnn M Sperl-Hillen, MD HealthPartners Institute

Publications:
Sperl-Hillen JM, Averbeck B, Palattao K, Amundson J, Rush B, PJ OC. Outpatient EHR-Based Diabetes Clinical Decision Support That Works: Lessons Learned From Implementing Diabetes Wizard. Diabetes Spectrum. 2010;23(3):150-154.
HealthPartners Institute for Education and Research. ModelHealth Microsimulation Models. 2015. https://www.healthpartners.com/hprf/modelhealth/index.html. Accessed March 2, 2017.
Agency for Healthcare Research and Quality. Medical Expenditure Panel Survey. 2001-2010; http://meps.ahrq.gov/mepsweb/. Accessed March 2, 2017.
Kung Yee L, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13-22.

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03748420    
Other Study ID Numbers: A16-691
1R01HL136937-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
Decision Support Systems, Clinical
Cardiovascular Diseases
Cardiovascular Risk Factor
Medication Non-adherence
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases