Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R18AE000023-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Palo Alto Medical Foundation | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mail DVD | Experimental |
| |
| Invite to SMA to view and discuss DESI | Experimental |
| |
| SMA and DVD | Experimental |
| |
| Encouraged to talk to physician | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DESI for home viewing | Behavioral | 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carmen L Lewis, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Ming Tai-Seale, Ph.D, MPH | Palo Alto Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation Research Institute | Palo Alto | California | 94301 | United States | ||
| University of North Carolina, Chapel Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25666221 | Derived | Lewis CL, Adams J, Tai-Seale M, Huang Q, Knowles SB, Nielsen ME, Pignone MP, Walter LC, Frosch DL. A Randomized Controlled Effectiveness Trial for PSA Screening Decision Support Interventions in Two Primary Care Settings. J Gen Intern Med. 2015 Jun;30(6):810-6. doi: 10.1007/s11606-015-3214-9. Epub 2015 Feb 10. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| DESI for viewing at Shared Medical Appointment | Behavioral | 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 | Behavioral | 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. |
|
| 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 |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided