Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03869216
Recruitment Status : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Tulane University
Information provided by (Responsible Party):
Xavier University of Louisiana.

Brief Summary:
This behavioral clinical trial assesses the efficacy of a dual-pronged intervention for Primary Care Providers and African American males to increase shared decision making about PSA-based screening for prostate cancer. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Educational Shared Decision-Making Intervention Not Applicable

Detailed Description:

The 2018 U.S. Preventive Services Task Force (USPSTF) final recommendation states that male patients and their providers engage in a shared-decision making process about the benefits and harms of PSA-based screening. As characterized by the USPSTF, these conversations are particularly important for African American men given increased ambiguity due to the lack of PSA-based research specific to this population and increased risk of prostate cancer mortality attributed to late stage at diagnosis and more aggressive prostate cancer phenotypes seen in African American men.

The goal of this randomized behavioral clinical trial is to advance the translation path of implementing the decision-making process in clinical encounters by evaluating the efficacy of a dual-pronged intervention for Primary Care Providers and African American males to increase shared decision making about PSA-screening versus usual care. The intervention will use multimedia educational training materials to increase understanding of prostate cancer, PSA-based screening, and shared decision making among patients and PCPs


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Care Provider)
Masking Description: The physician is the unit of randomization and patients are nested within physician. Patients of intervention physicians will receive the intervention, and patients of control physicians will receive usual care.
Primary Purpose: Prevention
Official Title: Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Providers and Patients in the intervention will receive the educational intervention
Behavioral: Educational Shared Decision-Making Intervention
The patient side of the intervention includes a web-based decision aid about prostate cancer screening. The provider intervention includes the USPSTF 2018 guidelines and a summary video, components of the AHRQ SHARE curriculum, a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.

No Intervention: Usual Care
Providers and Patients in the control arm will receive usual care



Primary Outcome Measures :
  1. Shared decision-making [ Time Frame: One month after audio-recorded visit ]
    Patient-provider visits will be audio-recorded and coded for the extent of shared decision making about prostate cancer using a defined scheme. The Observing Patient Involvement (OPTION) Scale will be used for the coding. Total OPTION scale ranges from 0 to 48. Higher values mean higher patient involvement during the shared decision making process.


Secondary Outcome Measures :
  1. Quality of Decision (QD) [ Time Frame: Up to one 24 weeks after the audio-recorded visit ]

    A summed total score of the following four subscales. The total QD score ranges from 30 to 200. Higher scores mean higher quality of the decision made.

    1. Prostate Cancer Screening Knowledge: Total score ranges from 0 to 14. Higher values mean higher knowledge of prostate cancer screening.
    2. Decision Confidence: Total score ranges from 12 to 36. Higher values mean higher confidence in the decision made.
    3. Self-efficacy questionnaire: Total score ranges from 12 to 120. Higher values mean higher efficacy in the communication used during the shared decision encounter.
    4. Satisfaction with Decision: Total score ranges from 6 to 30. Higher values mean higher satisfaction with the decision made.

  2. Preference-Congruent Decision Making [ Time Frame: Through study completion, an average of 1 year ]

    The Intention-to-Screen score ranges from 1 to 10. Vales from 1 to 5 mean no intention to receive the PSA test while values from 6 to 10 mean intention to receive the PSA.

    Preference-concordant decision making will be scored as 1 (POSITIVE) for those patients with Intention-to-Screen values from 6 to 10 who actually receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen values from 1 to 5 who did not receive it.

    Preference-concordant decision making will be scored as 0 (NEGATIVE) for those patients with Intention-to-Screen values from 6 to 10 who did not receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen values from 1 to 5 who did receive it.

    A congruence score of 1 means congruence between patient intention and real action, while a congruence score of 0 means patient in-congruence between intention and real action.



Other Outcome Measures:
  1. Acceptability [ Time Frame: Through study completion, an average of 1 year ]
    Participants will complete a structured questionnaire to rate the acceptability of the enrollment process, the delivery of the intervention, and their overall satisfaction with the study. The score ranges from 12 to 60. Higher scores mean higher acceptability with the intervention procedures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Patient Inclusion Criteria:

  • Receiving care at the clinical sites
  • Identify as African American male
  • Ages 40-69 years old
  • Provider-estimated life expectancy of at least 10 years

Patient Exclusion Criteria:

  • Personal history of prostate cancer at the time of consent
  • Cognitive impairment that would interfere with participation in the study
  • Unable to complete any aspect of the intervention within the specified time limit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869216


Contacts
Layout table for location contacts
Contact: Margarita Echeverri, PhD, MSc 5045206719 mechever@xula.edu
Contact: Michael Hoerger, PhD, MSCR (504) 314-7545 mhoerger@tulane.edu

Locations
Layout table for location information
United States, Louisiana
Tulane Medical Center Not yet recruiting
New Orleans, Louisiana, United States, 70112
Contact: Michael Hoerger, PhD    504-314-7545    mhoerger@tulane.edu   
Sponsors and Collaborators
Xavier University of Louisiana.
Tulane University
Investigators
Layout table for investigator information
Principal Investigator: Margarita Echeverri, PhD, MSc Xavier University of Louisiana.
Principal Investigator: Michael Hoerger, PhD, MSCR Tulane University

Layout table for additonal information
Responsible Party: Xavier University of Louisiana.
ClinicalTrials.gov Identifier: NCT03869216     History of Changes
Other Study ID Numbers: 684
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified summary of participant data for all primary and secondary outcomes measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access request will be reviewed by the IRB Board and principal investigators. Requestors will be required to sign a Data Access Agreement

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xavier University of Louisiana.:
Prostate cancer
Primary Care
PSA-screening
African American males

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases