- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115557
Delivery of Preventive Services in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The multi-component translational intervention that we plan to test includes medical record audits with feedback and benchmarking, academic detailing by an opinion leader including information from literature review plus the advice of local exemplars, a practice facilitator, who will work with the practices over a six-month period, and an IT application that provides decision-support, prompts, and reminders to office staff and patients.
The proposed project will be a randomized controlled trial of a multi-component strategy designed to facilitate the incorporation into primary care practices of three office management components known to increase preventive service delivery rates: 1) nurse standing orders; 2) special immunization/ preventive services "clinics;" and 3) recall and reminder systems. Twenty-four practices, all members of a primary care practice-based research network, will be enrolled and randomized to receive the complete intervention or performance feedback with benchmarking only. The primary outcomes will be number of management components implemented. Characteristics of clinicians and practices that are associated with greater or lesser success in implementing the three strategies and barriers encountered will also be examined, and we will measure and compare rates of selected immunizations and preventive services delivered.
The specific aims for this project are to:
- Determine the effectiveness of a multi-component translational intervention on adoption of three strategies known to increase delivery of preventive services: nurse standing orders, a reminder/recall system (preferably PSRS), and special immunization and/or preventive services clinics. The intervention will include: a) performance feedback and benchmarking; b) training of clinicians and office staff in principles of effective preventive services (enhanced academic detailing by a physician opinion leader); c) practice enhancement assistants to facilitate office system changes; and d) an IT application that provides prompts and reminders to office staff, clinicians, and patients.
- Document contextual factors and barriers to the adoption of the three strategies and their impact on the intervention.
- Measure the impact of the intervention on rates of delivery of the following preventive services: DtaP#4, MMR#1, and HepB#3 in 2-3 year olds, and pneumococcal immunization, colorectal cancer screening, and mammography in adults 50 - 75 years of age.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- OKPRN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary care physician
- Member of the Oklahoma Physicians Resource/Research Network
- Computer with internet connection
- More than 30 patients seen per week
- Provides care to 2-3 year-olds and/or 50-75 year olds
Exclusion Criteria:
- Does not provide preventive services
- Inclusion of more than two of the preventive service delivery strategies at baseline
- Involved in another network project
- Unwilling to work with an external practice facilitator
- IRB used by the practice will not allow records audits without individual patient consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Performance feedback, academic detailing, practice facilitation, IT support
|
Performance feedback, academic detailing, practice facilitation, IT support
|
|
Active Comparator: 2
Performance feedback only
|
Performance feedback only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Implementation of one or more of three evidence-based strategies
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rates of delivery of selected preventive services
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: James W Mold, MD, MPH, University of Oklahoma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R21HS014850 (U.S. AHRQ Grant/Contract)
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