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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01484665
First received: November 29, 2011
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Other: PROCASE Decision-Aid

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Provider Satisfaction with Implementation of the Shared Decision Making Process [ Time Frame: At 3-5 Months ] [ Designated as safety issue: No ]
    Will be determined through a combination of surveys and responses to questions derived during focus groups.

  • Provider Satisfaction with Implementation of the Shared Decision Making Process [ Time Frame: At 8-10 Months ] [ Designated as safety issue: No ]
    Will be determined through a combination of surveys and responses to questions derived during focus groups.


Secondary Outcome Measures:
  • Patient Satisfaction with Shared Decision Making and Reach of the Intervention [ Time Frame: At 8-10 Months ] [ Designated as safety issue: No ]
    Will be determined through a questionnaire administered to patients.

  • Patient Satisfaction with Shared Decision Making and Reach of the Intervention [ Time Frame: At 3-5 Months ] [ Designated as safety issue: No ]
    Will be determined through a questionnaire administered to patients.


Enrollment: 72
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants (Males, age 50-75 yrs)
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
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.

Detailed Description:

This pilot project will evaluate two approaches to implementing the use of a simple printed PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a significant number of African-Americans. All subjects will complete a survey assessing their knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians will also be briefly queried about their perceptions of the SDM process.

After the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of DA in the clinical setting. Another three month implementation period will follow using the same methods to assess outcomes. Finally we will conduct another round of focus groups to assess the overall impact of the interventions.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484665

Locations
United States, Minnesota
Broadway Family Medicine Clinic
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Christopher Warlick, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01484665     History of Changes
Other Study ID Numbers: 2011NTLS071
Study First Received: November 29, 2011
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
PSA screening
Decision aids

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013