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

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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.

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
Official Title  ICMJE Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention
    Providers and Patients in the intervention will receive the educational intervention
    Intervention: Behavioral: Educational Shared Decision-Making Intervention
  • No Intervention: Usual Care
    Providers and Patients in the control arm will receive usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Margarita Echeverri, PhD, MSc 5045206719 mechever@xula.edu
Contact: Michael Hoerger, PhD, MSCR (504) 314-7545 mhoerger@tulane.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03869216
Other Study ID Numbers  ICMJE 684
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Xavier University of Louisiana.
Study Sponsor  ICMJE Xavier University of Louisiana.
Collaborators  ICMJE Tulane University
Investigators  ICMJE
Principal Investigator: Margarita Echeverri, PhD, MSc Xavier University of Louisiana.
Principal Investigator: Michael Hoerger, PhD, MSCR Tulane University
PRS Account Xavier University of Louisiana.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP