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Completed

NCT Number: NCT00979225

Clinical Decision Support for Medication Management and Adherence

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.

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Key information

Conditions

Hypertension Asthma Behavior Brain Diseases Bronchial Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Heart Diseases Heart Failure Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Medication Adherence Metabolic Diseases Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Respiratory Hypersensitivity Respiratory Tract Diseases Stroke Treatment Adherence and Compliance Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication Management report

Other

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

Care manager email notices

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.

Other names: Care manager notices

Primary outcomes

  1. Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.

    Time frame: Baseline, 12 months

Secondary outcomes

  1. Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class

    Time frame: Baseline, 12 months

  2. Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.

    Time frame: Baseline, 12 months

  3. 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

  4. 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

  5. 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

  6. The proportion of email notices that were followed up by a documented care management encounter within 30 days.

    Time frame: 12 months

  7. The proportion of email notices that were followed up by a completed clinic encounter within 60 days.

    Time frame: 12 months

  8. 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

  9. Provider satisfaction measured using standard usability survey instruments.

    Time frame: 12 months

  10. Outpatient encounter rates.

    Time frame: Baseline, 12 months

  11. Emergency department encounter rates.

    Time frame: Baseline, 12 months

  12. Inpatient hospitalization rates.

    Time frame: Baseline, 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • 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

Registry information

Official study title

Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 17, 2009
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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