Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROCASE Decision-Aid
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring PSA screening, Decision aids
Eligibility 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
Sites / Locations
- Broadway Family Medicine Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants (Males, age 50-75 yrs)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Will be determined through a questionnaire administered to patients.
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Will be determined through a questionnaire administered to patients.
Full Information
NCT ID
NCT01484665
First Posted
November 29, 2011
Last Updated
August 21, 2014
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01484665
Brief Title
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
Official Title
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
PSA screening, Decision aids
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants (Males, age 50-75 yrs)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PROCASE Decision-Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Provider Satisfaction with Implementation of the Shared Decision Making Process
Description
Will be determined through a combination of surveys and responses to questions derived during focus groups.
Time Frame
At 3-5 Months
Title
Provider Satisfaction with Implementation of the Shared Decision Making Process
Description
Will be determined through a combination of surveys and responses to questions derived during focus groups.
Time Frame
At 8-10 Months
Secondary Outcome Measure Information:
Title
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Description
Will be determined through a questionnaire administered to patients.
Time Frame
At 8-10 Months
Title
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Description
Will be determined through a questionnaire administered to patients.
Time Frame
At 3-5 Months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Warlick, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Broadway Family Medicine Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
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