- 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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
Genders Eligible for Study
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 |
---|---|
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, 30 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). |
|
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. 20 primary care team members will be recruited to participate in a virtual six-month TB infection ECHO course.
Participants will 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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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Participant Attendance
Time Frame: Six-month ECHO course
|
Proportion of registered participants attending each ECHO session
|
Six-month ECHO course
|
Feasibility: Participant Retention
Time Frame: Six-month ECHO course
|
Proportion of registered participants attending one of the last two ECHO sessions
|
Six-month ECHO course
|
Impact: Procedural knowledge
Time Frame: Six-month ECHO course
|
Change in participants' confidence in knowing TB infection testing and treatment procedures 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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Six-month ECHO course
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Impact: Self- reported LTBI screening
Time Frame: Six-month ECHO course
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Change in participants' self-reported estimates of patients screened for TB infection.
Participants will estimate their screening on a 5 item scale with 0 patients being the lowest and >50 patients being the highest.
Change in scores will be calculated between the pre- and post- structured survey responses administered before and after the ECHO intervention.
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Six-month ECHO course
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Impact: Self- reported LTBI treatment
Time Frame: Six-month ECHO course
|
Change in participants' self-reported estimates of patients treated for TB infection.
Participants will estimate their TB treatment on a 5 item scale with 0 patients being the lowest and >50 patients being the highest.
Change in scores will be calculated between the pre- and post- structured survey responses administered before and after the ECHO intervention.
|
Six-month ECHO course
|
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 |
---|---|---|
Feasibility: Case Submission
Time Frame: Six-month ECHO course
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Proportion of cases submitted on time during the ECHO course
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Six-month ECHO course
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Feasibility: ECHO session timing
Time Frame: Six-month ECHO course
|
Proportion 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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Six-month ECHO course
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Feasibility: Connectivity
Time Frame: Six-month ECHO course
|
Proportion 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)
|
Six-month ECHO course
|
Feasibility: Videoconferencing Equipment
Time Frame: Six-month ECHO course
|
Proportion 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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Six-month ECHO course
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Feasibility: Content expert facilitation
Time Frame: Six-month ECHO course
|
Proportion of participants' who agree that the quality of content expert facilitation 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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Six-month ECHO course
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Feasibility: Communication with ECHO hub
Time Frame: Six-month ECHO course
|
Proportion 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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Six-month ECHO course
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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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