Clinical trial NCT01484665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: PSA screening
Decision aids
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 72
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Provider Satisfaction with Implementation of the Shared Decision Making Process
timeFrame: At 3-5 Months
measure: Provider Satisfaction with Implementation of the Shared Decision Making Process
timeFrame: At 8-10 Months
Secondary outcomes:
measure: Patient Satisfaction with Shared Decision Making and Reach of the Intervention
timeFrame: At 8-10 Months
measure: Patient Satisfaction with Shared Decision Making and Reach of the Intervention
timeFrame: At 3-5 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Broadway Family Medicine Clinic
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Christopher Warlick, M.D.
role: PRINCIPAL_INVESTIGATOR
References: