Improving Rhode Island's Tuberculosis Preventive Services in Primary Care

NCT04188041 | Completed Results

• 2 other identifiers: 1370981-4U54GM115677
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Latent Tuberculosis

Keywords

Project ECHO; primary care

Outcome Measures

Primary Outcomes (7)

• Feasibility: Participant Attendance

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

  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

• Feasibility: Participant Retention

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

  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

• Impact: Procedural Knowledge

  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.

  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.

• Impact: Self-reported LTBI Screening Percentage by Participants on Pre- and Post-ECHO Course Surveys

  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.

  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.

• Impact: Participants' Self-reported LTBI Treatment Percentages on Pre- and Post ECHO Surveys

  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.

  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.

• 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

  Three-months prior, ECHO course, three- months post

• 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.

  Three-months prior, ECHO course, three- months post

Secondary Outcomes (6)

• Feasibility: Case Submission

  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

• Feasibility: ECHO Session Timing

  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

• Feasibility: Connectivity

  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

• Feasibility: Videoconferencing Equipment

  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

• Feasibility: Content Expert Facilitation

  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

Other Outcomes (1)

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

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

Study Arms (3)

Qualitative

NO INTERVENTION

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).

Quantitative

OTHER

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.

Other: TB Infection ECHO

Retrospective chart review

OTHER

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.

Other: TB Infection ECHO

Interventions

TB Infection ECHO OTHER

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

Quantitative; Retrospective chart review

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• \< 18 years of age
• Primary care team members who do not primarily work in Rhode Island

Sponsors & Collaborators

• Kent Hospital, Rhode Island: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Brown Family Medicine Department

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daria Szkwarko, PI
• Organization: Kent Hospital

szkwarkd@gmail.com

401-921-7981

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Medicine

Model Details: 25 primary care team members will be purposively sampled to undergo key informant interviews regarding LTBI testing and treatment knowledge, attitudinal, and skill gaps. Then, 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. Paired data from pre- and post-course surveys will be analyzed accordingly depending on the distribution of results.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: October 2, 2019
• Primary Completion: March 24, 2021
• Study Completion: July 31, 2022
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)