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

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01484665
Collaborator
(none)
72
Enrollment
1
Location
1
Arm
6
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PROCASE Decision-Aid
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Provider Satisfaction with Implementation of the Shared Decision Making Process [At 3-5 Months]

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

  2. Provider Satisfaction with Implementation of the Shared Decision Making Process [At 8-10 Months]

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

Secondary Outcome Measures

  1. Patient Satisfaction with Shared Decision Making and Reach of the Intervention [At 8-10 Months]

    Will be determined through a questionnaire administered to patients.

  2. Patient Satisfaction with Shared Decision Making and Reach of the Intervention [At 3-5 Months]

    Will be determined through a questionnaire administered to patients.

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Broadway Family Medicine Clinic Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Christopher Warlick, M.D., Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT01484665
Other Study ID Numbers:
  • 2011NTLS071
First Posted:
Dec 2, 2011
Last Update Posted:
Aug 22, 2014
Last Verified:
Aug 1, 2014
Keywords provided by University of Minnesota
PSA screening
Decision aids
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 22, 2014