Healthy Men Age 50 Who Are Considering PSA ScreeningNCT01241656
Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1
A study testing DESI for home viewing, DESI for viewing at Shared Medical Appointment and Option of SMA and DESI or DESI only in people with Healthy Men Age 50 Who Are Considering PSA Screening, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men Age 50 Who Are Considering PSA Screening
- What is being tested?
- DESI for home viewing, DESI for viewing at Shared Medical Appointment and Option of SMA and DESI or DESI only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,521 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
About this study
Official title: Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1
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.
Read the 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.
- Being tested
- DESI for home viewing, DESI for viewing at Shared Medical Appointment, Option of SMA and DESI or DESI only
- Keywords
- Prostate cancer, Decision support intervention (DESI), Shared medical appointments (SMA), Comparative effectiveness research (CER)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESI for home viewingBehavioural
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 AppointmentBehavioural
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 onlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mail DVD | Experimental | Not described Receives: Behavioral: DESI for home viewing |
| Invite to SMA to view and discuss DESI | Experimental | Not described Receives: Behavioral: DESI for viewing at Shared Medical Appointment |
| SMA and DVD | Experimental | Not described Receives: Behavioral: Option of SMA and DESI or DESI only |
| Encouraged to talk to physician | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA test vs. No PSA test
We will determine whether a DESI viewing had an impact on testing.
Measured: 12 month follow-up
Healthcare utilization and costs
All prostate specific health care utilization and cost will be estimate for each group.
Measured: 12 month follow-up
Secondary outcomes (3)
DESI viewing
Did the patient view the decision support intervention or not?
Measured: 4 months after mailings
Decision specific knowledge
Patient's knowledge will be assessed with a validated 10-item measure.
Measured: 4 months after mailings
Discussion with provider
Patients will be asked if they discussed prostate cancer screening with a healthcare provider.
Measured: 4 months after mailings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Men Age 50 Who Are Considering PSA ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Alto Medical Foundation, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Carmen L Lewis, MD, MPH, Principal investigator, University of North Carolina, Chapel HillMing Tai-Seale, Ph.D, MPH, Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241656
- Sponsor's protocol ID
- 10-1317
- Other IDs
- 1R18AE000023-01
- Status last verified
- Jun 2013
- First submitted
- 15 Nov 2010
- Last updated
- 25 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25666221
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1
- ClinicalTrials.gov ID
- NCT01241656
- Acronym / sponsor ID
- 10-1317
- Keywords
- Prostate cancer, Decision support intervention (DESI), Shared medical appointments (SMA), Comparative effectiveness research (CER)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,521 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Palo Alto Medical Foundation, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mail DVD | Experimental | Behavioral: DESI for home viewing |
| Invite to SMA to view and discuss DESI | Experimental | Behavioral: DESI for viewing at Shared Medical Appointment |
| SMA and DVD | Experimental | Behavioral: Option of SMA and DESI or DESI only |
| Encouraged to talk to physician | No intervention | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DESI for home viewingDecision 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. | Behavioural | Mail DVD |
| DESI for viewing at Shared Medical AppointmentShared 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. | Behavioural | Invite to SMA to view and discuss DESI |
| Option of SMA and DESI or DESI onlyShared 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. | Behavioural | SMA and DVD |
Primary outcome
PSA test vs. No PSA test
Time frame: 12 month follow-up
We will determine whether a DESI viewing had an impact on testing.
Healthcare utilization and costs
Time frame: 12 month follow-up
All prostate specific health care utilization and cost will be estimate for each group.
3 secondary outcomes
DESI viewing
Time frame: 4 months after mailings
Decision specific knowledge
Time frame: 4 months after mailings
Discussion with provider
Time frame: 4 months after mailings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
- Derived from this study: PubMed 25666221Lewis 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen L Lewis, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Ming Tai-Seale, Ph.D, MPH principal investigator
Palo Alto Medical Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DESI for home viewing, DESI for viewing at Shared Medical Appointment and Option of SMA and DESI or DESI only in people with Healthy Men Age 50 Who Are Considering PSA Screening, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA test vs. No PSA test (time frame: 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.