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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM115677 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TB Infection ECHO | Other | A six-month virtual telementoring course regarding TB infection testing and treatment that incorporates didactics, case presentation, and discussion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Case Submission | Percentage of cases submitted by participants on time during the ECHO 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: ECHO Session Timing |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown Family Medicine Department | Pawtucket | Rhode Island | 02860 | United States |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aim 1: Key Informant Interviews |
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| Aim 2: RI LTBI ECHO Program Participants |
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| Aim 3: Retrospective Chart Review |
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Aim 3 (retrospective chart review) data were collected from an electronic medical record (EMR) and were de-identified in nature.
Credentials were not collected so cannot be provided.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 1: Key Informant Interviews | RI 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. |
| BG001 | Aim 2: RI LTBI ECHO Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | one participant's age is unknown |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility: Participant Attendance | Number of consented participants attending each expansion for community healthcare outcomes (ECHO) session who consented to participate in the course | The number of consented participants who attended the RI LTBI ECHO program | Posted | Number | participants | 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 |
|
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Adverse events were not collected since the intervention in this study was educational in nature.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RI LTBI ECHO Program 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daria Szkwarko, PI | Kent Hospital | 401-921-7981 | 77981 | szkwarkd@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2021 | May 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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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.
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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 |
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) |
| 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 | 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) | 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 | 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) | 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 | 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) | 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: Communication With ECHO Hub | 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) | 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 |
| Interviews were conducted between October 2, 2019 and June 17, 2020 |
| NOT COMPLETED |
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| NOT COMPLETED |
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Some as well as several new individuals 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. |
| BG002 | Aim 3: Retrospective Chart Review | Individuals > 18 years identified via a retrospective chart review who had a positive interferon gamma release assay test or TST and/or ICD-10 codes for LTBI between April 2019 and April 2020. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 4 individuals from Aim 1 also participated in Aim 2. 8 individuals only participated in Aim 2. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 4 individuals from Aim 1 also participated in Aim 2. 8 individuals only participated in Aim 2. | Count of Participants | Participants |
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| Race (NIH/OMB) | 4 individuals from Aim 1 also participated in Aim 2. 8 individuals only participated in Aim 2. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Years out of training | 4 individuals from Aim 1 also participated in Aim 2. 8 individuals only participated in Aim 2. | Count of Participants | Participants |
|
| Credentials | Credentials of the participant to distinguish whether they are a primary care clinician (MD, DO, NP) vs a nurse (RN). | 4 individuals from Aim 1 also participated in Aim 2. 8 individuals only participated in Aim 2. | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | Feasibility: Participant Retention | Percentage of registered participants attending one of the last two ECHO sessions | Number of consented participants who attended sessions 5 or 6 | Posted | Count of Participants | Participants | 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 |
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| Primary | 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of patients screened | 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. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of patients started on tx | 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. |
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| 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 | data were not collected | Posted | Three-months prior, ECHO course, three- months post |
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| 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. | data were not collected | Posted | Three-months prior, ECHO course, three- months post |
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| Secondary | Feasibility: Case Submission | Percentage of cases submitted by participants on time during the ECHO course | Participants who were asked to submit a case | Posted | Count of Participants | Participants | 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 |
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| Secondary | Feasibility: ECHO Session Timing | 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) | Data were not collected | Posted | 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 |
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| Secondary | Feasibility: Connectivity | 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) | Data were not collected | Posted | 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 |
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| Secondary | Feasibility: Videoconferencing Equipment | 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) | Data were not collected | Posted | 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 |
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| Secondary | Feasibility: Content Expert Facilitation | 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) | Participation in post session evaluations was voluntary. Not all 9 consented participants who completed any of the evaluations completed all of the evaluations. | Posted | Mean | Standard Deviation | score on a scale | 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 |
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| Secondary | Feasibility: Communication With ECHO Hub | 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) | Data were not collected | Posted | 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 |
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| Other Pre-specified | Primary Care Providers' and Nurses' Reported Frequency in Conducting LTBI Screening | 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. | Posted | Count of Participants | Participants | Interviews were conducted between October 2, 2019 and June 17, 2020 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
| Between 18 and 65 years |
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| >=65 years |
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| Title | Measurements |
|---|---|
| <=18 years |
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| Between 18 and 65 years |
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| >=65 years |
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| Title | Measurements |
|---|---|
| <=18 years |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| < 5 years out of training |
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| 5 or more years out of training |
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| unknown |
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| Nurse |
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| Not Applicable |
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| Session 3 |
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| Session 4 |
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| Session 5 |
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| Session 6 |
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