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Completed

NCT Number: NCT01484665

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Broadway Family Medicine Clinic

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROCASE Decision-Aid

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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