Clinical Decision Support for Medication Management and Adherence
Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy
2 other identifiers
interventional
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Sep 2009
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 15, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedDecember 11, 2012
December 1, 2012
1.5 years
September 15, 2009
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.
Baseline, 12 months
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (3)
Medication report
EXPERIMENTALMedication reports delivered to providers at the point of care
Med. report plus care manager notices
EXPERIMENTALMedication reports delivered to providers at the point of care and notices sent electronically to care managers
Control
NO INTERVENTIONInterventions
Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient opted-out
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David F Lobach, MD, PhD, MS
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2009
First Posted
September 17, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2012
Last Updated
December 11, 2012
Record last verified: 2012-12