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

NCT ID: NCT00629330

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2010-11-30

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Multi-component Academic Detailing

Includes an interactive, digitized CDROM, 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.

Group Type: EXPERIMENTAL

Academic Detailing

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Multi-component Academic Detailing

Eligibility Criteria

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

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

United States Army Medical Research and Materiel Command (USAMRMC)

Principal Investigators

Sherri Sheinfeld Gorin, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Other Identifiers

PC020492

Identifier Type: OTHER

Identifier Source: secondary_id

AAAA6313

Identifier Type: -

Identifier Source: org_study_id