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Clinical Decision Support for Medication Management and Adherence

Primary Purpose

Hypertension, Diabetes Mellitus, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication Management report
Care manager email notices
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring health information technology, clinical decision support, medication management, medication adherence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

  • Patient opted-out

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Medication report

Med. report plus care manager notices

Control

Arm Description

Medication reports delivered to providers at the point of care

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class
Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.
Rates of adherence to applicable pharmacotherapy rules 6 months after an intervention was first initiated or could have been initiated for the control arm.
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.
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.
The proportion of email notices that were followed up by a documented care management encounter within 30 days.
The proportion of email notices that were followed up by a completed clinic encounter within 60 days.
Resource use and medical costs associated with the interventions and their delivery, as well as direct healthcare costs (inpatient and outpatient).
Provider satisfaction measured using standard usability survey instruments.
Outpatient encounter rates.
Emergency department encounter rates.
Inpatient hospitalization rates.

Full Information

First Posted
September 15, 2009
Last Updated
December 10, 2012
Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance, North Carolina Office of Rural Health and Community Care
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1. Study Identification

Unique Protocol Identification Number
NCT00979225
Brief Title
Clinical Decision Support for Medication Management and Adherence
Official Title
Improving Quality Through Decision Support for Evidence-Based Pharmacotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Northern Piedmont Carolina Community Care Partners, North Carolina Division of Medical Assistance, North Carolina Office of Rural Health and Community Care

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Stroke, Myocardial Ischemia, Heart Failure, Asthma
Keywords
health information technology, clinical decision support, medication management, medication adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication report
Arm Type
Experimental
Arm Description
Medication reports delivered to providers at the point of care
Arm Title
Med. report plus care manager notices
Arm Type
Experimental
Arm Description
Medication reports delivered to providers at the point of care and notices sent electronically to care managers
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Medication Management report
Other Intervention Name(s)
Medication management reports
Intervention Description
Patients receive medication management reports delivered to their clinic-based caregivers for pharmacotherapy clinical decision support at point-of-care.
Intervention Type
Other
Intervention Name(s)
Care manager email notices
Other Intervention Name(s)
Care manager notices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rates of aggregate adherence by study group to all applicable pharmacotherapy rules during the study period.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Rates of adherence to pharmacotherapy rules for a specific therapeutic drug class
Time Frame
Baseline, 12 months
Title
Rates of adherence to pharmacotherapy rules for a specific IOM priority condition.
Time Frame
Baseline, 12 months
Title
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
Title
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
Title
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
Title
The proportion of email notices that were followed up by a documented care management encounter within 30 days.
Time Frame
12 months
Title
The proportion of email notices that were followed up by a completed clinic encounter within 60 days.
Time Frame
12 months
Title
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
Title
Provider satisfaction measured using standard usability survey instruments.
Time Frame
12 months
Title
Outpatient encounter rates.
Time Frame
Baseline, 12 months
Title
Emergency department encounter rates.
Time Frame
Baseline, 12 months
Title
Inpatient hospitalization rates.
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David F Lobach, MD, PhD, MS
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Clinical Decision Support for Medication Management and Adherence

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