Clinical Decision Support for Medication Management and Adherence
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension Diabetes Mellitus Stroke Myocardial Ischemia Heart Failure Asthma |
Other: Medication Management report Other: Care manager email notices |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy |
- Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
- Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
- Rates of adherence to pharmacotherapy rules for a specific IOM priority condition. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
- Rates of adherence to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
- The proportion of email notices that were followed up by a documented care management encounter within 30 days. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- The proportion of email notices that were followed up by a completed clinic encounter within 60 days. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Provider satisfaction measured using standard usability survey instruments. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Outpatient encounter rates. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
- Emergency department encounter rates. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
- Inpatient hospitalization rates. [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 5000 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 Name: Care manager notices
|
| No Intervention: Control |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | David F Lobach, MD, PhD, MS | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00979225 History of Changes |
| Other Study ID Numbers: | Pro00002524, R18 HS017072 |
| Study First Received: | September 15, 2009 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
health information technology clinical decision support medication management medication adherence |
Additional relevant MeSH terms:
|
Asthma Myocardial Ischemia Coronary Artery Disease Diabetes Mellitus Heart Failure Hypertension Ischemia Stroke Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Heart Diseases Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013