Clinical Decision Support for Medication Management and Adherence

Stroke Clinical Trial

Official title:

Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979225
• Other study ID #: Pro00002524
• Secondary ID: R18HS017072
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: December 10, 2012
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Coronary Artery Disease
• Diabetes Mellitus
• Heart Failure
• Hypertension
• Myocardial Ischemia
• Stroke

Intervention

Other:
• Medication Management report
Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Agency for Healthcare Research and Quality (AHRQ), North Carolina Division of Medical Assistance, North Carolina Office of Rural Health and Community Care, Northern Piedmont Carolina Community Care Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.		Baseline, 12 months	No
Secondary	Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class		Baseline, 12 months	No
Secondary	Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.		Baseline, 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The proportion of email notices that were followed up by a documented care management encounter within 30 days.		12 months	No
Secondary	The proportion of email notices that were followed up by a completed clinic encounter within 60 days.		12 months	No
Secondary	Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient).		12 months	No
Secondary	Provider satisfaction measured using standard usability survey instruments.		12 months	No
Secondary	Outpatient encounter rates.		Baseline, 12 months	No
Secondary	Emergency department encounter rates.		Baseline, 12 months	No
Secondary	Inpatient hospitalization rates.		Baseline, 12 months	No