Clinical Decision Support for Medication Management and Adherence
- Conditions
- HypertensionDiabetes MellitusMyocardial IschemiaHeart FailureAsthmaStroke
- Interventions
- Other: Medication Management reportOther: Care manager email notices
- Registration Number
- NCT00979225
- Lead Sponsor
- Duke University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
- 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
- Patient opted-out
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medication report Medication Management report Medication reports delivered to providers at the point of care Med. report plus care manager notices Medication Management report Medication reports delivered to providers at the point of care and notices sent electronically to care managers Med. report plus care manager notices Care manager email notices Medication reports delivered to providers at the point of care and notices sent electronically to care managers
- Primary Outcome Measures
Name Time Method Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period. Baseline, 12 months
- Secondary Outcome Measures
Name Time Method Provider satisfaction measured using standard usability survey instruments. 12 months Rates of adherence to pharmacotherapy rules for a specific IOM priority condition. Baseline, 12 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 Outpatient encounter rates. Baseline, 12 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 Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient). 12 months Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class Baseline, 12 months The proportion of email notices that were followed up by a completed clinic encounter within 60 days. 12 months The proportion of email notices that were followed up by a documented care management encounter within 30 days. 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 Emergency department encounter rates. Baseline, 12 months Inpatient hospitalization rates. Baseline, 12 months
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States