- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188041
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care: A Mixed-Methods Evaluation of an Innovative Telementoring Model
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhode Island
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Pawtucket, Rhode Island, United States, 02860
- Brown Family Medicine Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- > 18 years of age
- Primary care team members in Rhode Island including doctors, nurses, nurse practitioners, physician assistants, or other healthcare providers who are involved in primary care.
Exclusion Criteria:
- < 18 years of age
- Primary care team members who do not primarily work in Rhode Island
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Retrospective chart review
Pilot a retrospective electronic medical record (EMR) data review to examine RI primary care providers' testing and treatment before and after ECHO implementation and evaluate the model's reach.
In Aim 3, data will be retrospectively extracted from two participants' clinics to research RI primary care providers' testing and treatment patterns before and after the ECHO course.
The two clinics will be identified once Aim 2 is completed.
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A six-month virtual telementoring course regarding TB infection testing and treatment that incorporates didactics, case presentation, and discussion
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No Intervention: Qualitative
Specific Aim 1: Explore the specific knowledge, attitudinal, and skills gaps to TB infection testing and treatment among primary care team members in RI through qualitative key informant interviews. In Aim 1, 25 primary care team members from the Brown Family Medicine and Care New England networks will be purposively sampled to undergo key informant interviews regarding TB infection testing and treatment knowledge, attitudinal, and skill gaps. Questions will be asked to ascertain gaps throughout the entire latent TB infection care cascade. The results from Aim 1 will be used to design the survey instrument and the curriculum for an innovative, telementoring program (TB infection ECHO). |
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Other: Quantitative
Specific Aim 2: Design and evaluate an evidence-based telementoring intervention (ECHO model) that addresses the identified TB infection gaps in Aim 1, and evaluate this model for feasibility as well as its impact on primary care team member knowledge and TB infection testing and treatment in RI. 12 primary care team members will be recruited to participate in a virtual six-month TB infection ECHO course.
Participants will be asked to complete quantitative surveys before and after the course as well as post-session surveys following each session.
Survey questions will assess feasibility measures related to process, resources, and management and impact measures related to learning and performance.
Paired data from pre- and post-course surveys will be analyzed accordingly depending on the distribution of results.
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A six-month virtual telementoring course regarding TB infection testing and treatment that incorporates didactics, case presentation, and discussion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility: Participant Attendance
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Number of consented participants attending each expansion for community healthcare outcomes (ECHO) session who consented to participate in the course
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Feasibility: Participant Retention
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Percentage of registered participants attending one of the last two ECHO sessions
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Impact: Procedural Knowledge
Time Frame: Pre-survey was emailed 2 weeks prior to the course and could be filled out anytime before a participant attended their first session. The post-survey was emailed immediately following the final session (3/4/2021) and were completed within three weeks.
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Change in participants' confidence in assessing a patient's risk for tuberculosis (TB) infection based on a likert scale rating (1=not at all confident and 5=extremely confident) included in the pre- and post- structured surveys administered before and after the ECHO intervention.
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Pre-survey was emailed 2 weeks prior to the course and could be filled out anytime before a participant attended their first session. The post-survey was emailed immediately following the final session (3/4/2021) and were completed within three weeks.
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Impact: Self-reported LTBI Screening Percentage by Participants on Pre- and Post-ECHO Course Surveys
Time Frame: Pre-survey was emailed 2 weeks prior to the course and could be filled out anytime before a participant attended their first session. The post-survey was emailed immediately following the final session (3/4/2021) and were completed within three weeks.
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Change in participants' self-reported estimates of patients screened for TB infection.
Participants estimated their screening percentage on a sliding scale from 0-100%.
Mean estimates will be calculated for the pre- and post- structured survey responses administered before and after the ECHO intervention.
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Pre-survey was emailed 2 weeks prior to the course and could be filled out anytime before a participant attended their first session. The post-survey was emailed immediately following the final session (3/4/2021) and were completed within three weeks.
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Impact: Participants' Self-reported LTBI Treatment Percentages on Pre- and Post ECHO Surveys
Time Frame: Pre-survey was emailed two weeks prior to the course and could be filled out anytime before a participant attended their first session. The post-survey was emailed immediately following the final session on 3/4/2021 and were completed within three weeks.
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Change in participants' self-reported estimates of patients treated for TB infection.
Participants will estimate the percentage of patients started on any TB treatment on a sliding scale from 0-100%.
Mean percentages will be calculated between the pre- and post- structured survey responses administered before and after the ECHO intervention.
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Pre-survey was emailed two weeks prior to the course and could be filled out anytime before a participant attended their first session. The post-survey was emailed immediately following the final session on 3/4/2021 and were completed within three weeks.
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Reach: LTBI Testing
Time Frame: Three-months prior, ECHO course, three- months post
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Proportion(# of TB tests/# of visits) of patients tested for LTBI in a health center population before, during and after ECHO implementation to assess providers' behavior change.
This data will be obtained from an electronic medical record data query
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Three-months prior, ECHO course, three- months post
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Reach: LTBI Treatment
Time Frame: Three-months prior, ECHO course, three- months post
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Patient level LTBI treatment before, during and after ECHO implementation to assess providers' behavior change.
Proportion(# of TB treatment initiated/# of patients diagnosed with LTBI) of patients treated for LTBI in a health center population before, during and after ECHO implementation to assess providers' behavior change.
This data will be obtained from an electronic medical record data query.
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Three-months prior, ECHO course, three- months post
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility: Case Submission
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Percentage of cases submitted by participants on time during the ECHO course
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Feasibility: ECHO Session Timing
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Percentage of participants' who agree that session timing was convenient.
This will be collected monthly from post-session surveys via a likert scale (1=strongly disagree and 5=strongly agree)
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Feasibility: Connectivity
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Percentage of participants' who agree that connectivity was adequate during the ECHO session.
This will be collected monthly from post-session surveys via a likert scale (1=strongly disagree and 5=strongly agree)
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Feasibility: Videoconferencing Equipment
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Percentage of participants' who agree that videoconferencing equipment was adequate during the ECHO session.
This will be collected monthly from post-session surveys via a likert scale (1=strongly disagree and 5=strongly agree)
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Feasibility: Content Expert Facilitation
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Participants rating of whether the speaker demonstrated excellent educational skills.
This will be collected monthly from post-session surveys via a likert scale (1=strongly disagree and 5=strongly agree)
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Feasibility: Communication With ECHO Hub
Time Frame: Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Percentage of participants' who agree that the communication with the ECHO hub team was adequate during the ECHO session.
This will be collected monthly from post-session surveys via a likert scale (1=strongly disagree and 5=strongly agree)
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Session 1 10/8/20; Session 2 11/5/20; Session 3 12/10/20; Session 4 1/7/21; Session 5 2/4/21; Session 6 3/4/21
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening
Time Frame: Interviews were conducted between October 2, 2019 and June 17, 2020
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Qualitative interviews were conducted with primary care providers and nurses in RI regarding their knowledge, attitudes, and skills regarding LTBI management.
A key focus of the interview was related to frequency of conducting LTBI screening.
Here we summarize the frequency of providers and nurses who reported never conducting TB screening, infrequently conducting TB screening, or frequently conducting TB screening.
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Interviews were conducted between October 2, 2019 and June 17, 2020
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1370981-4
- U54GM115677 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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