Clinical Decision Support for Medication Management and Adherence

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00979225

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed), Northern Piedmont Carolina Community Care Partners (Other), North Carolina Division of Medical Assistance (Other), North Carolina Office of Rural Health and Community Care (Other)

5,000

Enrollment

Location

Arms

Duration (Months)

166.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Diabetes Mellitus Stroke Myocardial Ischemia Heart Failure Asthma	Other: Medication Management report Other: Care manager email notices	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: Care manager notices
No Intervention: Control

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

Care manager notices

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period. [Baseline, 12 months]

Secondary Outcome Measures

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]
The proportion of email notices that were followed up by a documented care management encounter within 30 days. [12 months]
The proportion of email notices that were followed up by a completed clinic encounter within 60 days. [12 months]
Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient). [12 months]
Provider satisfaction measured using standard usability survey instruments. [12 months]
Outpatient encounter rates. [Baseline, 12 months]
Emergency department encounter rates. [Baseline, 12 months]
Inpatient hospitalization rates. [Baseline, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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