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OpenTrials
Completed

NCT Number: NCT04188041

Improving Rhode Island's Tuberculosis Preventive Services in Primary Care

This study explores primary care team members' knowledge, attitudinal, and skill gaps related to latent tuberculosis infection (LTBI) testing and treatment. The gaps identified will inform the design of a survey and telementoring educational program (tuberculosis (TB) infection ECHO course). The EMR data query will further explore the reach of the expansion for community healthcare outcomes (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.

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Key information

Conditions

Latent Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown Family Medicine Department

Pawtucket, Rhode Island, 02860, United States

About this study

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, 25 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, 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. 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 (RI).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TB Infection ECHO

Other

A six-month virtual telementoring course regarding TB infection testing and treatment that incorporates didactics, case presentation, and discussion

Primary outcomes

  1. 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

    Number of consented participants attending each expansion for community healthcare outcomes (ECHO) session who consented to participate in the course

  2. 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

    Percentage of registered participants attending one of the last two ECHO sessions

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

  6. Reach: LTBI Testing

    Time frame: Three-months prior, ECHO course, three- months post

    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

  7. Reach: LTBI Treatment

    Time frame: Three-months prior, ECHO course, three- months post

    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 outcomes

  1. 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

    Percentage of cases submitted by participants on time during the ECHO course

  2. 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

    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)

  3. 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

    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)

  4. 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

    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)

  5. 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

    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)

  6. 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

    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)

Other outcomes

  1. Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening

    Time frame: Interviews were conducted between October 2, 2019 and June 17, 2020

    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.

Sponsors and collaborators

Lead sponsor

Kent Hospital, Rhode Island

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Improving Rhode Island's Tuberculosis Preventive Services in Primary Care: A Mixed-Methods Evaluation of an Innovative Telementoring Model

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 5, 2019
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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