Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
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|ClinicalTrials.gov Identifier: NCT01484665|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : August 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: PROCASE Decision-Aid||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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.
- Provider Satisfaction with Implementation of the Shared Decision Making Process [ Time Frame: At 3-5 Months ]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 ]Will be determined through a combination of surveys and responses to questions derived during focus groups.
- Patient Satisfaction with Shared Decision Making and Reach of the Intervention [ Time Frame: At 8-10 Months ]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 ]Will be determined through a questionnaire administered to patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484665
|United States, Minnesota|
|Broadway Family Medicine Clinic|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Christopher Warlick, M.D.||Masonic Cancer Center, University of Minnesota|