Clinical Decision Support for Medication Management and Adherence

Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy

This three-year, grant funded project will be conducted by the Division of Clinical Informatics in the Department of Community and Family Medicine at Duke University Medical Center. The project seeks to improve care quality and safety in an ambulatory care setting through clinical decision support for evidence-based (EB) pharmacotherapy delivered as point-of-care reports to clinic-based practitioners and as population health-based alerts to care managers.

This project will build upon a regional Health Information Exchange (HIE) network created to connect providers serving 37,000 Medicaid beneficiaries from both rural and urban settings in a 5 county region in the Northern Piedmont of North Carolina. This network includes 16 private practices, 3 federally qualified health centers, 5 rural health centers, 3 urgent care facilities, 10 government agencies, 5 hospitals, and 2 cross-disciplinary care management teams.

The proposed information system will be based on an emerging standard for decision support and will utilize routinely available claims and scheduling data in order to serve as a replicable model for broader use of decision support for medication management. Increased availability and use of decision support tools for medication management can be expected to reduce medication errors, improve health care quality at an acceptable cost, and augment disease management for patients and populations.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Failure; Stroke; Hypertension; Diabetes Mellitus; Asthma
• Intervention / Treatment: Other: Medication Management report; Other: Care manager email notices

Detailed Description

The study will be conducted in accordance with the following four specific aims:

Aim 1: Expand the functionality of an existing decision support system in use within a regional HIE network to incorporate EB pharmacotherapy guidelines and to promote medication adherence. Primary care clinicians will receive EB pharmacotherapy suggestions and a patient-specific summary of prescription claims data delivered to the point-of-care via fax. Care managers will receive alerts delivered via email to encourage patients to arrange follow-up clinic appointments because of possible medication non-adherence.

Aim 2: Implement and evaluate the impact of the two interventions on adherence to EB pharmacotherapy recommendations among Medicaid patients with high priority conditions as designated by the Institute of Medicine (IOM) in ambulatory care settings through a three-arm randomized controlled trial.

Aim 3: Compare resource utilization and assess the economic attractiveness (cost-savings or cost-effectiveness) of the interventions to promote medication adherence and EB pharmacotherapy.

Aim 4: Disseminate information regarding the development and impact of the interventions through Web teleconferences, professional meetings, educational lectures, and peer review journals.

• Study Type: Interventional
• Enrollment (Actual): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Carolina Access Medicaid patients continuously enrolled for 10 of 12 months prior to August 2009
• Patients assigned to one of 14 participating primary care clinics within the Northern Piedmont Community Care Network
• At least one of six IOM priority conditions: hypertension, diabetes mellitus, stroke, ischemic heart disease, heart failure, or persistent asthma

Exclusion Criteria:

• Patient opted-out

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Medication report; Medication reports delivered to providers at the point of care	Other: Medication Management report; Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.; Other Names: Medication management reports
Experimental: Med. report plus care manager notices; Medication reports delivered to providers at the point of care and notices sent electronically to care managers	Other: Medication Management report; Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.; Other Names: Medication management reports; Other: Care manager email notices; Community-based care managers receive email notices if the patient has not seen his/her primary care provider in the past 6 months, has low adherence to medications, and has no scheduled appointment.; Other Names: Care manager notices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class	Baseline, 12 months
Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.	Baseline, 12 months
Rates of adherence to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.	Baseline, 6 months
Rates of adherence by drug class to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.	Baseline, 6 months
Rates of adherence by IOM condition to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.	Baseline, 6 months
The proportion of email notices that were followed up by a documented care management encounter within 30 days.	12 months
The proportion of email notices that were followed up by a completed clinic encounter within 60 days.	12 months
Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient).	12 months
Provider satisfaction measured using standard usability survey instruments.	12 months
Outpatient encounter rates.	Baseline, 12 months
Emergency department encounter rates.	Baseline, 12 months
Inpatient hospitalization rates.	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Northern Piedmont Carolina Community Care Partners; North Carolina Division of Medical Assistance; North Carolina Office of Rural Health and Community Care
• Investigators: Principal Investigator: David F Lobach, MD, PhD, MS, Duke University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: September 16, 2009
• First Posted (Estimate): September 17, 2009

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: medication adherence; clinical decision support; health information technology; medication management
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: Pro00002524; R18HS017072 (U.S. AHRQ Grant/Contract)