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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Healthy Men Age 50 Who Are Considering PSA Screening

Intervention / Treatment
-----------------
* Behavioral: DESI for home viewing
* Behavioral: DESI for viewing at Shared Medical Appointment
* Behavioral: Option of SMA and DESI or DESI only


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mail DVD<br> | Behavioral: DESI for home viewing<br>* 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.<br>|
| Experimental: Invite to SMA to view and discuss DESI<br> | Behavioral: DESI for viewing at Shared Medical Appointment<br>* 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.<br>|
| Experimental: SMA and DVD<br> | Behavioral: Option of SMA and DESI or DESI only<br>* 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.<br>|
| No Intervention: Encouraged to talk to physician<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA test vs. No PSA test | We will determine whether a DESI viewing had an impact on testing. | 12 month follow-up | 
| Healthcare utilization and costs | All prostate specific health care utilization and cost will be estimate for each group. | 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DESI viewing | Did the patient view the decision support intervention or not? | 4 months after mailings | 
| Decision specific knowledge | Patient's knowledge will be assessed with a validated 10-item measure. | 4 months after mailings | 
| Discussion with provider | Patients will be asked if they discussed prostate cancer screening with a healthcare provider. | 4 months after mailings | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Decision support intervention (DESI), Shared medical appointments (SMA), Comparative effectiveness research (CER)