Clinical Decision Support for Medication Management and Adherence

Completed

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Medication Management report Other
    Other Names: Medication management reports
    Intervention Desc: Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.
    ARM 1: Kind: Experimental
    Label: Medication report
    Description: Medication reports delivered to providers at the point of care
    ARM 2: Kind: Experimental
    Label: Med. report plus care manager notices
    Description: Medication reports delivered to providers at the point of care and notices sent electronically to care managers
  • Care manager email notices Other
    Other Names: Care manager notices
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Med. report plus care manager notices
    Description: Medication reports delivered to providers at the point of care and notices sent electronically to care managers

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Health Services Research
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period. Baseline, 12 months No
Secondary Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class Baseline, 12 months No
Secondary Rates of adherence to pharmacotherapy rules for a specific IOM priority condition. Baseline, 12 months No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary The proportion of email notices that were followed up by a documented care management encounter within 30 days. 12 months No
Secondary The proportion of email notices that were followed up by a completed clinic encounter within 60 days. 12 months No
Secondary Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient). 12 months No
Secondary Provider satisfaction measured using standard usability survey instruments. 12 months No
Secondary Outpatient encounter rates. Baseline, 12 months No
Secondary Emergency department encounter rates. Baseline, 12 months No
Secondary Inpatient hospitalization rates. Baseline, 12 months No

Sponsors