Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549036
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching PDC program to promote Shared Decision Making SDM for prostate cancer screening among Veterans at the Veterans Health Administration VA Prostate cancer is commonly screen detected using PSA a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans The investigators results will enhance understanding of the efficacy cost-effectiveness and sustainability of PDC interventions for SDM promotion across communication formats in the VA Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services
Detailed Description:
Prostate cancer is the most common non-cutaneous malignancy among men in the United States accounting for one third of new cancer diagnoses in VA Prostate Cancer is commonly detected using prostate-specific antigen PSA a non-specific test whose use in prostate cancer screening has led to modest population-level survival benefits at the cost of over-detection of low-risk disease Recognizing this trade off USPSTF and VHA Clinical Preventive Services recommend a Shared Decision Making SDM approach to PSA screening Regardless of whether they ultimately elect PSA screening or not patients should discuss the best evidence for and against it with clinicians and be supported to make high quality decisions In spite of broad support for these recommendations SDM is challenging to implement because primary care providers see it as too time consuming and have insufficient training and support to perform it Moreover primary care office visits are notoriously too brief to address the multitude of recommended beneficial preventive interventions There is an urgent need to incorporate SDM paradigms into routine VA clinical practice An ideal intervention accomplishing this would improve decision quality at low cost and be acceptable to Veterans and clinicians
The primary challenge to implementing routine PSA SDM counseling is clinic workflow One solution may be to enlist non-clinician healthcare team members to offer SDM counseling Decision coaches can provide non-directive support to help patients weigh options prepare for provider discussions and implement decisions Decision coaches improve knowledge and promote SDM In a pilot program the investigators group trained lay health workers as decision coaches to counsel Black men considering PSA screening in a non-VA community care setting There is an urgent need to expand this approach to all men considering PSA screening and adapt it to the VA setting The investigators propose training Veteran peers who are well-known to promote healthful behaviors among Veterans to be decision coaches to promote SDM among Veterans considering PSA screening This peer-led approach may provide excellent counseling at acceptable cost and decreased clinician burden
The objective of this study is to test the efficacy of a Veteran-peer-navigator-led decision-coaching program PDC to facilitate SDM for PSA screening at VA NY Harbor The investigators will randomize Veterans seeking primary care to receive 1 a standard of care screening decision aid DA along with PDC on PSA screening intervention or 2 the same DA without counseling control The outcomes of interest are decision quality PSA utilization acceptability and cost of the PDC program with the goal of future system-wide dissemination Additionally since VA is dedicated to promoting health equity through telehealth the investigators will explore the effects of patient race Black versus non-Black and communication format in-person versus telehealth
The primary challenge to implementing routine PSA SDM counseling is clinic workflow One solution may be to enlist non-clinician healthcare team members to offer SDM counseling Decision coaches can provide non-directive support to help patients weigh options prepare for provider discussions and implement decisions Decision coaches improve knowledge and promote SDM In a pilot program the investigators group trained lay health workers as decision coaches to counsel Black men considering PSA screening in a non-VA community care setting There is an urgent need to expand this approach to all men considering PSA screening and adapt it to the VA setting The investigators propose training Veteran peers who are well-known to promote healthful behaviors among Veterans to be decision coaches to promote SDM among Veterans considering PSA screening This peer-led approach may provide excellent counseling at acceptable cost and decreased clinician burden
The objective of this study is to test the efficacy of a Veteran-peer-navigator-led decision-coaching program PDC to facilitate SDM for PSA screening at VA NY Harbor The investigators will randomize Veterans seeking primary care to receive 1 a standard of care screening decision aid DA along with PDC on PSA screening intervention or 2 the same DA without counseling control The outcomes of interest are decision quality PSA utilization acceptability and cost of the PDC program with the goal of future system-wide dissemination Additionally since VA is dedicated to promoting health equity through telehealth the investigators will explore the effects of patient race Black versus non-Black and communication format in-person versus telehealth
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None