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Improving Rhode Island's Tuberculosis Preventive Services in Primary Care

Primary Purpose

Latent Tuberculosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TB Infection ECHO
Sponsored by
Kent Hospital, Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Latent Tuberculosis focused on measuring Project ECHO, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown Family Medicine Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

Qualitative

Quantitative

Retrospective chart review

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

Feasibility: Participant Attendance
Proportion of registered participants attending each ECHO session
Feasibility: Participant Retention
Proportion of registered participants attending one of the last two ECHO sessions
Impact: Procedural knowledge
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.
Impact: Self- reported LTBI screening
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.
Impact: Self- reported LTBI treatment
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.
Reach: LTBI testing
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
Reach: LTBI treatment
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.

Secondary Outcome Measures

Feasibility: Case Submission
Proportion of cases submitted on time during the ECHO course
Feasibility: ECHO session timing
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)
Feasibility: Connectivity
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)
Feasibility: Videoconferencing Equipment
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)
Feasibility: Content expert facilitation
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)
Feasibility: Communication with ECHO hub
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)

Full Information

First Posted
December 2, 2019
Last Updated
March 26, 2022
Sponsor
Kent Hospital, Rhode Island
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04188041
Brief Title
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
Official Title
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care: A Mixed-Methods Evaluation of an Innovative Telementoring Model
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kent Hospital, Rhode Island
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study explores primary care team members' knowledge, attitudinal, and skill gaps related to LTBI testing and treatment. The gaps identified will inform the design of a survey and telementoring educational program (TB infection ECHO course). The EMR data query will further explore the reach of the ECHO model. The hypothesis for this study is that the TB infection ECHO course will be feasible, will have a significant impact on primary care provider participants' learning and performance related to LTBI testing and treatment in their primary care practices, and will increase the number of LTBI tests and treatment prescribed in primary care.
Detailed Description
This pilot study will use a mixed-methods design called an exploratory sequential translational research design. In this type of study design, the initial qualitative phase informs the design of an intervention (in this case a TB infection ECHO) and an instrument (in this case structured surveys) to study the intervention. The third phase implements the designed intervention and/or instrument to collect data and quantitatively assess the outcomes of interest (in this case feasibility and impact). The final aspect of the third phase explores an EMR data query to assess the reach of the intervention (providers' testing and treatment in the real world). In Aim 1, 30 primary care team members from our Brown Family Medicine, Care New England, and federally qualified health center networks will be purposively sampled to undergo key informant interviews regarding LTBI 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). In Aim 2, at least 20 additional 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. In Aim 3, data will be extracted from two ECHO participants' clinic sites before, during, and after ECHO implementation. Data will include information about LTBI testing and treatment to understand the reach and impact of the intervention of providers' testing and treatment behavior. This study will lead to an ECHO research framework that can be used for future ECHO courses that address other diseases in Rhode Island.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
Project ECHO, primary care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
30 primary care team members will be purposively sampled to undergo key informant interviews regarding LTBI testing and treatment knowledge, attitudinal, and skill gaps. Then, 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. Paired data from pre- and post-course surveys will be analyzed accordingly depending on the distribution of results.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qualitative
Arm Type
No Intervention
Arm Description
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).
Arm Title
Quantitative
Arm Type
Other
Arm Description
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.
Arm Title
Retrospective chart review
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TB Infection ECHO
Intervention Description
A six-month virtual telementoring course regarding TB infection testing and treatment that incorporates didactics, case presentation, and discussion
Primary Outcome Measure Information:
Title
Feasibility: Participant Attendance
Description
Proportion of registered participants attending each ECHO session
Time Frame
Six-month ECHO course
Title
Feasibility: Participant Retention
Description
Proportion of registered participants attending one of the last two ECHO sessions
Time Frame
Six-month ECHO course
Title
Impact: Procedural knowledge
Description
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.
Time Frame
Six-month ECHO course
Title
Impact: Self- reported LTBI screening
Description
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.
Time Frame
Six-month ECHO course
Title
Impact: Self- reported LTBI treatment
Description
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.
Time Frame
Six-month ECHO course
Title
Reach: LTBI testing
Description
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
Time Frame
Three-months prior, ECHO course, three- months post
Title
Reach: LTBI treatment
Description
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.
Time Frame
Three-months prior, ECHO course, three- months post
Secondary Outcome Measure Information:
Title
Feasibility: Case Submission
Description
Proportion of cases submitted on time during the ECHO course
Time Frame
Six-month ECHO course
Title
Feasibility: ECHO session timing
Description
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)
Time Frame
Six-month ECHO course
Title
Feasibility: Connectivity
Description
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)
Time Frame
Six-month ECHO course
Title
Feasibility: Videoconferencing Equipment
Description
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)
Time Frame
Six-month ECHO course
Title
Feasibility: Content expert facilitation
Description
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)
Time Frame
Six-month ECHO course
Title
Feasibility: Communication with ECHO hub
Description
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)
Time Frame
Six-month ECHO course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Brown Family Medicine Department
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Rhode Island's Tuberculosis Preventive Services in Primary Care

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