Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1

Healthy Men Age 50 Who Are Considering PSA Screening Clinical Trial

Official title:

Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241656
• Other study ID #: 10-1317
• Secondary ID: 1R18AE000023-01
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: June 21, 2013
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

In this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (DESI) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design.

We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.

Description:

We will use a randomized experimental design to compare the effects of 3 different strategies to implement a prostate cancer screening decision support intervention (DESI) with a control condition in primary care in 2 clinical systems - PAMF (Palo Alto Medical Foundation) and UNC. The primary outcomes of interest are men's screening decisions and their subsequent healthcare utilization. Secondary outcomes include the likelihood that they review the DESI and their decision-specific knowledge. The 3 strategies selected by the PAMF and UNC health systems are: (1) mailing men a DESI in DVD; (2) inviting men to participate in a shared (group) medical appointment (SMA) to watch and discuss the DESI with a healthcare provider and other men; and (3) providing men options by inviting them to a SMA while also providing them a DESI in DVD which they can use individually if they are unable or choose not to attend a SMA. The 3 groups will be compared to a control condition that does not receive a DESI but will be encouraged to discuss prostate cancer screening with their physician. Because of its significantly larger patient population, the PAMF site will also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday, when they first become guideline eligible to consider prostate cancer screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2521
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 50 or older

• do not have a prostate diagnosis

• have not had a PSA test in the past 10 months

• have not seen their primary care physicians in the last 3 months

Exclusion Criteria:

• Women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Men Age 50 Who Are Considering PSA Screening

Intervention

Behavioral:
• DESI for home viewing
Decision support intervention is a 31 minute DVD mailed to the patients in all of the experimental groups. The program explains the function and location of the prostate and the nature of prostate cancer, including its associated mortality. Next, the program describes the different tests that are used to detect prostate cancer including the digital rectal exam, prostate specific antigen (PSA) test and prostate biopsy.
• DESI for viewing at Shared Medical Appointment
Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
• Option of SMA and DESI or DESI only
Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID), Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA test vs. No PSA test	We will determine whether a DESI viewing had an impact on testing.	12 month follow-up	No
Primary	Healthcare utilization and costs	All prostate specific health care utilization and cost will be estimate for each group.	12 month follow-up	No
Secondary	DESI viewing	Did the patient view the decision support intervention or not?	4 months after mailings	No
Secondary	Decision specific knowledge	Patient's knowledge will be assessed with a validated 10-item measure.	4 months after mailings	No
Secondary	Discussion with provider	Patients will be asked if they discussed prostate cancer screening with a healthcare provider.	4 months after mailings	No