Trial Outcomes & Findings for Improving Rhode Island's Tuberculosis Preventive Services in Primary Care (NCT NCT04188041)

Last Updated: 2024-07-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome 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

Results posted on

2024-07-19

Participant Flow

Aim 1: one participant was excluded because it turned out they did not actually conduct primary care which was an inclusion criterion. Aim 2: completing the pre and post surveys was voluntary after consent. Several participants did not voluntarily complete both surveys. Aim 3: retrospective chart review was only completed for one site before the ECHO course

Participant milestones

Participant milestones
Measure	Aim 1: Key Informant Interviews Primary care team members who consented to participate in key informant interviews regarding their knowledge, attitudes, and skills about latent tuberculosis infection testing and treatment.	Aim 2: RI LTBI ECHO Participants Rhode Island (RI) Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.	Aim 3: Retrospective Chart Review A retrospective chart review was completed at Blackstone Valley Community Health Center to review LTBI treatment patterns among primary care providers. An EMR query was performed for patients \> 18 years who had a documented interferon gamma release assay test or TST and/or ICD-10 codes for LTBI between April 2019 and April 2020.
Aim 1: Key Informant Interviews STARTED	25	0	0
Aim 1: Key Informant Interviews COMPLETED	24	0	0
Aim 1: Key Informant Interviews NOT COMPLETED	1	0	0
Aim 2: RI LTBI ECHO Program Participants STARTED	4	8	0
Aim 2: RI LTBI ECHO Program Participants COMPLETED	3	5	0
Aim 2: RI LTBI ECHO Program Participants NOT COMPLETED	1	3	0
Aim 3: Retrospective Chart Review STARTED	0	0	51
Aim 3: Retrospective Chart Review COMPLETED	0	0	51
Aim 3: Retrospective Chart Review NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

one participant's age is unknown

Baseline characteristics by cohort

PRIMARY outcome

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

Population: The number of consented participants who attended the RI LTBI ECHO program

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

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=12 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Feasibility: Participant Attendance Session 1	9 participants
Feasibility: Participant Attendance Session 2	7 participants
Feasibility: Participant Attendance Session 3	8 participants
Feasibility: Participant Attendance Session 4	8 participants
Feasibility: Participant Attendance Session 5	8 participants
Feasibility: Participant Attendance Session 6	6 participants
Feasibility: Participant Attendance Launch Session	10 participants

PRIMARY outcome

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

Population: Number of consented participants who attended sessions 5 or 6

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

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=12 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Feasibility: Participant Retention	9 Participants

PRIMARY outcome

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.

Population: Consented Survey Participants who participated in the RI LTBI ECHO and responded to the pre-survey and/or post-survey question. "Please rate your confidence in performing each of the areas of latent TB infection practice below: Assessing a patient's risk for TB infection" 1=Not at all confident, 2=Not very confident, 3=moderately confident, 4=very confident, 5=extremely confident

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.

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=12 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Impact: Procedural Knowledge Pre-Survey	3.09 score on a scale Standard Deviation 0.51
Impact: Procedural Knowledge Post-Survey	4.25 score on a scale Standard Deviation 0.66

PRIMARY outcome

Population: Consented participants who responded to both pre- and post-surveys were asked to participate voluntarily. All 12 participants answered some of the pre-survey questions (only 6 answered the question of interest). Out of the 12, only 8 responded to the post survey. Of the 8, 7 answered the question of interest.

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.

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=12 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Impact: Self-reported LTBI Screening Percentage by Participants on Pre- and Post-ECHO Course Surveys Pre-Survey	45.67 percentage of patients screened Standard Deviation 38.6
Impact: Self-reported LTBI Screening Percentage by Participants on Pre- and Post-ECHO Course Surveys Post Survey	25.86 percentage of patients screened Standard Deviation 25.99

PRIMARY outcome

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.

Population: Participation in the surveys was voluntary so not all participants answered all questions. All 12 participants answered some of the pre-survey questions (only 4 answered the question of interest). Out of the 12, only 8 responded to the post survey. Of those 8, 5 answered the question of interest.

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.

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=12 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Impact: Participants' Self-reported LTBI Treatment Percentages on Pre- and Post ECHO Surveys Pre-Survey	50 percentage of patients started on tx Standard Deviation 50
Impact: Participants' Self-reported LTBI Treatment Percentages on Pre- and Post ECHO Surveys Post-Survey	11 percentage of patients started on tx Standard Deviation 19.6

PRIMARY outcome

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

Population: data were not collected

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

Outcome measures

Outcome data not reported

PRIMARY outcome

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

Population: data were not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Participants who were asked to submit a case

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

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=6 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Feasibility: Case Submission	6 Participants

SECONDARY outcome

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

Population: Data were not collected

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data were not collected

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data were not collected

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Participation in post session evaluations was voluntary. Not all 9 consented participants who completed any of the evaluations completed all of the evaluations.

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)

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=9 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Feasibility: Content Expert Facilitation Session 1	4.83 score on a scale Standard Deviation 0.41
Feasibility: Content Expert Facilitation Session 2	4.86 score on a scale Standard Deviation 0.38
Feasibility: Content Expert Facilitation Session 3	4.43 score on a scale Standard Deviation 0.79
Feasibility: Content Expert Facilitation Session 4	4.71 score on a scale Standard Deviation 0.49
Feasibility: Content Expert Facilitation Session 5	4.83 score on a scale Standard Deviation 0.41
Feasibility: Content Expert Facilitation Session 6	4.33 score on a scale Standard Deviation 0.82

SECONDARY outcome

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

Population: Data were not collected

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)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	RI LTBI ECHO Program Participants n=24 Participants RI Primary care team members who participated in the Rhode Island Latent Tuberculosis ECHO program and consented to be part of aim 2. Participants were asked to complete a pre and post course survey.
Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening Never conduct TB screening	3 Participants
Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening Infrequently conduct TB screening	14 Participants
Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening Frequently conduct TB screening	7 Participants

Adverse Events

RI LTBI ECHO Program Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daria Szkwarko, PI

Kent Hospital

Phone: 401-921-7981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place