Clinical Decision Support for Medication Management and Adherence

NCT ID: NCT00979225

Last Updated: 2012-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Hypertension; Diabetes Mellitus; Stroke; Myocardial Ischemia; Heart Failure; Asthma

Keywords

health information technology; clinical decision support; medication management; medication adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Medication report

Medication reports delivered to providers at the point of care

Group Type: EXPERIMENTAL

Medication Management report

Intervention Type: OTHER

Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.

Med. report plus care manager notices

Medication reports delivered to providers at the point of care and notices sent electronically to care managers

Group Type: EXPERIMENTAL

Medication Management report

Intervention Type: OTHER

Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.

Care manager email notices

Intervention Type: OTHER

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medication Management report

Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Medication management reports; Care manager notices

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Northern Piedmont Carolina Community Care Partners

UNKNOWN

Sponsor Role: collaborator

North Carolina Division of Medical Assistance

UNKNOWN

Sponsor Role: collaborator

North Carolina Office of Rural Health and Community Care

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David F Lobach, MD, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

R18HS017072

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

Pro00002524

Identifier Type: -

Identifier Source: org_study_id