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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Educational Shared Decision-Making Intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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.|
|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|
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
- 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.
- 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.
- Prostate Cancer Screening Knowledge: Total score ranges from 0 to 14. Higher values mean higher knowledge of prostate cancer screening.
- Decision Confidence: Total score ranges from 12 to 36. Higher values mean higher confidence in the decision made.
- Self-efficacy questionnaire: Total score ranges from 12 to 120. Higher values mean higher efficacy in the communication used during the shared decision encounter.
- 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.
- 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.
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
|Contact: Margarita Echeverri, PhD, MScfirstname.lastname@example.org|
|Contact: Michael Hoerger, PhD, MSCR||(504) email@example.com|
|United States, Louisiana|
|Tulane Medical Center||Not yet recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Michael Hoerger, PhD 504-314-7545 firstname.lastname@example.org|
|Principal Investigator:||Margarita Echeverri, PhD, MSc||Xavier University of Louisiana.|
|Principal Investigator:||Michael Hoerger, PhD, MSCR||Tulane University|