Dissemination of Prostate Cancer Screening to PCP's in African American Communities

Prostate Cancer Clinical Trial

Official title:

Dissemination of Prostate Cancer Screening to Primary Care Physicians in African American Communities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00629330
• Other study ID #: AAAA6313
• Secondary ID: PC020492
• Status: Terminated
• Phase: Phase 4
• First received: February 26, 2008
• Last updated: October 12, 2015
• Start date: January 2004
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aims of this project are to adapt and extend the use of academic detailing to the dissemination of prostate cancer (CaP) screening findings to primary care physicians practicing in African American communities. The objectives of this study are:

1. To test the hypothesis that a community physician-based educational intervention (multi-component academic detailing, including an interactive, digitized, web-based program for informed decision-making about prostate cancer, and patient education materials designed for low literacy patients) will increase physician knowledge, positive attitudes/beliefs toward screening and screening options, and prostate cancer screening (using the digital rectal exam, and the serum prostate specific antigen test) at baseline, 6-, and 12-months post- randomization, compared to the rate observed in a service- as-usual control.

1A. To demonstrate the feasibility of disseminating the American Cancer Society guidelines for prostate cancer screening among primary care practitioners using multi-component academic detailing.

2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of PC screening guidelines to different physician subgroups.

The long term goal of this project is to increase prostate cancer screening among African American communities, thus decreasing cancer-related morbidity and mortality.

Description:

We will conduct a two-arm trial, recruiting, obtaining consent, then assigning 200 physicians' offices at random to one of two arms: intervention (multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients) or to a service-as-usual control arm. We will query 200 physicians about their PC knowledge, attitudes/beliefs toward screening and screening options, and PSA testing at baseline, 6, and 12months post-randomization, compared to the rate observed in a service-as-usual control. Physician counseling in cancer control will be verified by a chart review at baseline and at 12months post-randomization (N=750). The instruments will assess prostate cancer knowledge, attitudes and beliefs toward screening, and uptake of the PSA. The nested design uses the physician's office as the unit of randomization, and the office as the unit of analysis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: November 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Charts of male patients age 45 -75, (using the average age of death in this population) with at least one visit to the primary care provider over the last two years will be reviewed.

Exclusion Criteria:

Exclusion criteria will include:

• Diagnosis of cancer other than non-melanotic skin cancer.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Academic Detailing
Multi-component academic detailing including an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	United States Department of Defense

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA and DRE		12-month followup	No
Secondary	Counseling on PSA testing		12-month followup	No