Trial Outcomes & Findings for Fostering Shared Decision-making About Prostate Cancer Screening Among Clinicians and African American Men (NCT NCT03869216)

Last Updated: 2025-12-29

Results Overview

The Observing Patient Involvement (OPTION) Scale was used for the coding of the SDM. The total OPTION scale ranges from 0 to 48. Higher values on the scale mean higher patient involvement in the decision-making process.

Recruitment status

COMPLETED

Study phase

Target enrollment

161 participants

Primary outcome timeframe

One month after audio-recorded visit

Results posted on

2025-12-29

Participant Flow

Prospective participants were identified through the medical records and were invited to participate in the study. Those willing to participate were enrolled in the study after signing the consent and HIPPA forms. Participants were had the option to opt out of the study anytime.

After completing the baseline, participants were assigned randomly to the intervention or control arms

Participant milestones

Participant milestones
Measure	Intervention Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care Patients in the control arm will receive usual care
Overall Study STARTED	80	81
Overall Study Completed Baseline	79	76
Overall Study Completed the Intervention	73	0
Overall Study Had the Medical Appointment	62	64
Overall Study Completed Follow-up	60	53
Overall Study COMPLETED	60	53
Overall Study NOT COMPLETED	20	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care Patients in the control arm will receive usual care
Overall Study prostate removed during the study	1	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	3	12
Overall Study Changed clinical site or moved out of city	5	9
Overall Study No primary care appointment scheduled	10	4
Overall Study Death	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=79 Participants Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care n=76 Participants Patients in the control arm will receive usual care	Total n=155 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Asian	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Black or African American	79 Participants n=174 Participants	76 Participants n=166 Participants	155 Participants n=167 Participants
Race (NIH/OMB) White	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Region of Enrollment United States	79 participants n=174 Participants	76 participants n=166 Participants	155 participants n=167 Participants
Participants with a family history of prostate cancer No family history	66 Participants n=174 Participants	58 Participants n=166 Participants	124 Participants n=167 Participants
Participants with a family history of prostate cancer Have family history	13 Participants n=174 Participants	18 Participants n=166 Participants	31 Participants n=167 Participants
Age, Customized 40-49 years old	10 Participants n=174 Participants	18 Participants n=166 Participants	28 Participants n=167 Participants
Age, Customized 50-59 years old	30 Participants n=174 Participants	27 Participants n=166 Participants	57 Participants n=167 Participants
Age, Customized 60-69 years old	39 Participants n=174 Participants	31 Participants n=166 Participants	70 Participants n=167 Participants
Sex: Female, Male Female	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Sex: Female, Male Male	79 Participants n=174 Participants	76 Participants n=166 Participants	155 Participants n=167 Participants

PRIMARY outcome

Timeframe: One month after audio-recorded visit

Population: The OPTION Scale was applied only to patients who had attended the medical appointment (62 in the intervention group, and 64 in the control group). Because one recording in the control group could not be completed (the audio-recording device was damaged), only 63 recordings were evaluated in that group.

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care n=63 Participants Patients in the control arm will receive usual care
Shared Decision-making	12.54 Units on a scale Standard Deviation 11.0198	12.15 Units on a scale Standard Deviation 10.4026

SECONDARY outcome

Timeframe: Up to 24 weeks after the audio-recorded visit

Population: The QD was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group).

The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made.

Outcome measures

Outcome measures
Measure	Intervention n=60 Participants Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care n=53 Participants Patients in the control arm will receive usual care
Quality of Decision (QD)	82.23 units on a scale Standard Deviation 13.503	80.45 units on a scale Standard Deviation 13.925

SECONDARY outcome

Timeframe: Through study completion, an average of 1 year

Population: Congruence was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group).

The Intention-to-Screen score ranges from 0 to 1. Score = 0 means no intention to receive the PSA test while score = 1 means intention to receive the PSA test. Preference-concordant decision making will be scored as 1 (POSITIVE) for those patients with Intention-to-Screen value = 1 who actually receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 who did not receive it. Preference-concordant decision making will be scored as 0 (NEGATIVE) for those patients with Intention-to-Screen value = 1 who did not receive the PSA test during the study timeframe, or for those patients with Intention-to-Screen value = 0 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.

Outcome measures

Outcome measures
Measure	Intervention n=60 Participants Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care n=53 Participants Patients in the control arm will receive usual care
Preference-Congruent Decision Making Participants with Congruence Score = 0	24 Number of participants	13 Number of participants
Preference-Congruent Decision Making Participants with Congruence Score = 1	36 Number of participants	40 Number of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 1 year

Population: Acceptability was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group).

Participants complete a structured questionnaire to rate the acceptability of the enrollment process, study procedures, and their overall satisfaction with the study. The score ranges from 10 to 50. Higher scores mean higher acceptability of study procedures.

Outcome measures

Outcome measures
Measure	Intervention n=60 Participants Patients in the intervention will receive the educational intervention Educational Shared Decision-Making Intervention: The intervention includes a web-based patients' decision aid about PSA-based prostate cancer screening, risks and preferences. The providers receive a summary of the USPSTF 2018 guidelines and main components of the Agency for Healthcare Research and Quality (AHRQ) SHARE curriculum, a link to a video of a prototypical shared decision making conversation, and a laminated shared decision making reminder card.	Usual Care n=53 Participants Patients in the control arm will receive usual care
Acceptability	42.43 unit on a scale Standard Deviation 5.318	43.17 unit on a scale Standard Deviation 4.590

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margarita Echeverri, Professor of Social and Behavioral Sciences

Xavier University of Louisiana

Phone: 504-520-6719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place