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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00115557
Other study ID # 1R21HS014850
Secondary ID
Status Completed
Phase N/A
First received June 23, 2005
Last updated August 11, 2010
Start date October 2004
Est. completion date July 2006

Study information

Verified date September 2007
Source Agency for Healthcare Research and Quality (AHRQ)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The major goal of this project is to determine the effectiveness of a multi-component intervention designed to help primary care practices implement three office system strategies known to increase delivery of immunizations and other preventive services. This two-year study will contribute to our understanding of multi-component translational interventions in primary care, and particularly within practice-based research networks.


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:

1. 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.

2. Document contextual factors and barriers to the adoption of the three strategies and their impact on the intervention.

3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date July 2006
Est. primary completion date May 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 65 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Other:
Practice intervention
Performance feedback, academic detailing, practice facilitation, IT support
Practice intervention 2
Performance feedback only.

Locations

Country Name City State
United States OKPRN Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implementation of one or more of three evidence-based strategies 6 months No
Secondary Rates of delivery of selected preventive services 6 months No
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