Improving Rhode Island's Tuberculosis Preventive Services in Primary Care

Latent Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04188041
• Other study ID #: 1370981-4
• Secondary ID: U54GM115677
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2022
• Source: Kent Hospital, Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 31, 2022
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
United States	Brown Family Medicine Department	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Kent Hospital, Rhode Island	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: Participant Attendance	Proportion of registered participants attending each ECHO session	Six-month ECHO course
Primary	Feasibility: Participant Retention	Proportion of registered participants attending one of the last two ECHO sessions	Six-month ECHO course
Primary	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.	Six-month ECHO course
Primary	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.	Six-month ECHO course
Primary	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.	Six-month ECHO course
Primary	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
Primary	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	Feasibility: Case Submission	Proportion of cases submitted on time during the ECHO course	Six-month ECHO course
Secondary	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)	Six-month ECHO course
Secondary	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)	Six-month ECHO course
Secondary	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)	Six-month ECHO course
Secondary	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)	Six-month ECHO course
Secondary	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)	Six-month ECHO course