Community and Clinician Partnership for Prevention (C2P2)

February 12, 2015 updated by: Duke University
The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tobacco use, poor diet, and lack of physical activity are associated with the leading causes of significant morbidity and mortality, including coronary heart disease, hypertension, cancer, stroke, diabetes, and respiratory dysfunction. One solution to decreasing unhealthy behaviors would be to better integrate primary care providers with community resources, including community and public health organizations that already have the capacity and expertise to deliver effective interventions. This project is a randomized trial to evaluate different practice-level interventions to link practices to community resources to decrease unhealthy behaviors.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27715
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Internal medicine and family practices in Durham and Orange counties, North Carolina

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual Care
Usual care
Other: No intervention
No intervention
Experimental: Active Intervention
Direct referral to community organizations, with support for practices to do so. These include the North Carolina Tobacco Quitline, public health department dietitians, and the YMCA.
Other: Active Intervention
Quality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources
Experimental: Passive Intervention
Provision of information about community organizations to patients as above.
Other: Passive Intervention
Provision of tools to help with referrals to community resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of referrals from the practices to the community resources
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of referrals received by each resource
Time Frame: 6 months
6 months
The proportion of patients with unhealthy behaviors who were referred from the practices to community resources
Time Frame: 6 months
6 months
Practice attitudes and practice regarding referral to community resources
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Alex R Kemper, MD, MPH, MS, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Estimate)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00004061
  • HHSA290200710014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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