Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy Men Age 50 Who Are Considering PSA Screening |
Behavioral: DESI for home viewing Behavioral: DESI for viewing at Shared Medical Appointment Behavioral: Option of SMA and DESI or DESI only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1 |
- PSA test vs. No PSA test [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]We will determine whether a DESI viewing had an impact on testing.
- Healthcare utilization and costs [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]All prostate specific health care utilization and cost will be estimate for each group.
- DESI viewing [ Time Frame: 4 months after mailings ] [ Designated as safety issue: No ]Did the patient view the decision support intervention or not?
- Decision specific knowledge [ Time Frame: 4 months after mailings ] [ Designated as safety issue: No ]Patient's knowledge will be assessed with a validated 10-item measure.
- Discussion with provider [ Time Frame: 4 months after mailings ] [ Designated as safety issue: No ]Patients will be asked if they discussed prostate cancer screening with a healthcare provider.
| Estimated Enrollment: | 3540 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Mail DVD |
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.
|
| Experimental: Invite to SMA to view and discuss DESI |
Behavioral: 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.
|
| Experimental: SMA and DVD |
Behavioral: 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.
|
| No Intervention: Encouraged to talk to physician |
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.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| Palo Alto Medical Foundation Research Institute | |
| Palo Alto, California, United States, 94301 | |
| United States, North Carolina | |
| University of North Carolina, Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Carmen L Lewis, MD, MPH | University of North Carolina, Chapel Hill |
| Principal Investigator: | Dominick L Frosch, PhD | Palo Alto Medical Foundation |
More Information
No publications provided
| Responsible Party: | Carmen Lewis, MD, MPH, Associate Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01241656 History of Changes |
| Other Study ID Numbers: | 10-1317, 1R18AE000023 - 01 |
| Study First Received: | November 15, 2010 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of North Carolina, Chapel Hill:
|
Prostate cancer Decision support intervention (DESI) Shared medical appointments (SMA) Comparative effectiveness research (CER) |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013