Clinical trial NCT04188041: 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
Overall status: COMPLETED
Phase: NA
Conditions: Latent Tuberculosis
Keywords: Project ECHO
primary care
Lead sponsor: Kent Hospital, Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2019-12-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: OTHER

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.

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, 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).

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

Primary outcomes:
measure: Feasibility: Participant Attendance
timeFrame: 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
measure: Feasibility: Participant Retention
timeFrame: 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
measure: Impact: Procedural Knowledge
timeFrame: 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.
measure: Impact: Self-reported LTBI Screening Percentage by Participants on Pre- and Post-ECHO Course Surveys
timeFrame: 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.
measure: Impact: Participants' Self-reported LTBI Treatment Percentages on Pre- and Post ECHO Surveys
timeFrame: 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.
measure: Reach: LTBI Testing
timeFrame: Three-months prior, ECHO course, three- months post
measure: Reach: LTBI Treatment
timeFrame: Three-months prior, ECHO course, three- months post
Secondary outcomes:
measure: Feasibility: Case Submission
timeFrame: 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
measure: Feasibility: ECHO Session Timing
timeFrame: 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
measure: Feasibility: Connectivity
timeFrame: 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
measure: Feasibility: Videoconferencing Equipment
timeFrame: 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
measure: Feasibility: Content Expert Facilitation
timeFrame: 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
measure: Feasibility: Communication With ECHO Hub
timeFrame: 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:
measure: Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening
timeFrame: Interviews were conducted between October 2, 2019 and June 17, 2020
Locations:
city: Pawtucket
country: United States
facility: Brown Family Medicine Department
state: Rhode Island
Study officials:
References: