Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

NCT01484665 | Completed

• 1 other identifier: 2011NTLS071
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.

Conditions

Prostate Cancer

Keywords

PSA screening; Decision aids

Outcome Measures

Primary Outcomes (2)

• Provider Satisfaction with Implementation of the Shared Decision Making Process

  Will be determined through a combination of surveys and responses to questions derived during focus groups.

  At 3-5 Months

• Provider Satisfaction with Implementation of the Shared Decision Making Process

  Will be determined through a combination of surveys and responses to questions derived during focus groups.

  At 8-10 Months

Secondary Outcomes (2)

• Patient Satisfaction with Shared Decision Making and Reach of the Intervention

  At 8-10 Months

• Patient Satisfaction with Shared Decision Making and Reach of the Intervention

  At 3-5 Months

Study Arms (1)

Participants (Males, age 50-75 yrs)

EXPERIMENTAL

Eligible men will be identified from the administrative database and electronic medical record at the University of Minnesota (EMR) at least 24 hours prior to the clinic visit. They will be asked to complete the PROCASE Decision-Aid.

Other: PROCASE Decision-Aid

Interventions

PROCASE Decision-Aid OTHER

VA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled "The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study.

Participants (Males, age 50-75 yrs)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males ages 50-75
• Able to read and speak English
• Provide written informed consent

You may not qualify if:

• Diagnosis of prostate cancer
• PSA testing within last 12 months
• Previous prostate biopsy
• Voiding problems as reason for clinic visit
• Visit scheduled same day or 'walk-In' patient

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Broadway Family Medicine Clinic

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christopher Warlick, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 2, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

US (1)