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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD007595 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Tulane University | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care.
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 an educational intervention for 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 their primary care providers (PCPs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients in the intervention will receive the educational intervention |
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| Usual Care | No Intervention | Patients in the control arm will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Shared Decision-Making Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Shared Decision-making | 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. | One month after audio-recorded visit |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Decision (QD) | The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made. | Up to 24 weeks after the audio-recorded visit |
| Preference-Congruent Decision Making |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | 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. | Through study completion, an average of 1 year |
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margarita Echeverri, PhD, MSc | Xavier University of Louisiana. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
De-identified summary of participant data for all primary and secondary outcomes measures will be made available.
Data will be available within 6 months of study completion
Data access request will be reviewed by the Institutional Review Board (IRB) and principal investigators. Requestors will be required to sign a Data Access Agreement
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After completing the baseline, participants were assigned randomly to the intervention or control arms
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Patients in the control arm will receive usual care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shared Decision-making | 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | One month after audio-recorded visit |
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From enrollment until end of follow-up, up to 12 months
This is an educational intervention that did not cause any risk to participants for serious adverse events. During the follow-up call, we recorded information about participants' life events such as being diagnosed with prostate cancer or passing away for natural causes, although these events were not directly related to their participation in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Significant delays in the advance of the study, were caused by events that were not under our control: Coronavirus disease (COVID19) pandemic and major Hurricanes Zeta and Ida). Because of the restrictions in the city and clinics, several participants moved out and/or did not update their contact information. To address COVID19 restrictions it was necessary to update the study protocol to conduct all activities online and have the new Institutional Review Board approvals in the clinical sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margarita Echeverri, Professor of Social and Behavioral Sciences | Xavier University of Louisiana | 504-520-6719 | mechever@xula.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2020 | Sep 26, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Parallel assignment
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The patients are the unit of randomization and physicians do not know what patients are assigned to the intervention or control arm.
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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.
| Through study completion, an average of 1 year |
| Lost to Follow-up |
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| Changed clinical site or moved out of city |
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| No primary care appointment scheduled |
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| Death |
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| BG001 | Usual Care | Patients in the control arm will receive usual care |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants with a family history of prostate cancer | Count of Participants | Participants |
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| OG001 | Usual Care | Patients in the control arm will receive usual care |
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| Secondary | Quality of Decision (QD) | The total QD score ranges from 0 to 100. Higher percentage scores mean higher quality of the decision made. | The QD was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group). | Posted | Mean | Standard Deviation | units on a scale | Up to 24 weeks after the audio-recorded visit |
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| Other Pre-specified | Acceptability | 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. | Acceptability was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group). | Posted | Mean | Standard Deviation | unit on a scale | Through study completion, an average of 1 year |
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| Secondary | Preference-Congruent Decision Making | 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. | Congruence was assessed only for patients who completed the follow-up (60 in the intervention group, and 53 in the control group). | Posted | Number | Number of participants | Through study completion, an average of 1 year |
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| 1 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Usual Care | Patients in the control arm will receive usual care | 1 | 76 | 0 | 76 | 0 | 76 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |