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Clinical Decision Support for Medication Management and Adherence

This study has been completed.
Sponsor:
Collaborators:
Northern Piedmont Carolina Community Care Partners
North Carolina Division of Medical Assistance
North Carolina Office of Rural Health and Community Care
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00979225
First received: September 15, 2009
Last updated: December 10, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979225

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Northern Piedmont Carolina Community Care Partners
North Carolina Division of Medical Assistance
North Carolina Office of Rural Health and Community Care
Investigators
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:
Coronary Artery Disease
Diabetes Mellitus
Heart Failure
Hypertension
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014