Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05591586
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-04-21
First Post:
2022-09-22
Brief Title:
Mobile Video Interpretation to Optimize Communication Across Language Barriers
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Mobile Video Interpretation to Optimize Communication Across Language Barriers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mVOCAL
Brief Summary:
Patients and families with limited English proficiency LEP andor who use a language other than English for medical care LOE experience substantial barriers to communication in the healthcare setting leading to medical care that is less safe less efficient less effective and inequitable Professional interpreter use has repeatedly been shown to improve outcomes and reduce disparities yet it remains widely underused This study will test two discrete scalable implementation strategies for improving professional interpreter use in primary care while collecting detailed information about mechanisms of action and costs that will be applicable to many sites of care and contribute meaningfully to the goal of reducing communication-based disparities The investigators hypothesize that improving provider knowledge confidence and interpreter access will change behavior under real-world conditions
Detailed Description:
This study will be conducted over a series of 4 phases
Phase 0 15 months The study team will enroll 55 primary care providers from 4-8 enrolled primary care clinics within the WWAMI region Enrolled providers will complete a baseline survey and a baseline in-depth qualitative interview exploring baseline barriers facilitators moderators necessary prerequisites and proximal outcomes of professional interpreter use in their current clinic setting Providers will receive a gift card for completing the survey and a gift card for completing the 30-60 minute interview For participating providers who cannot receive direct incentives per local policy lunch or equivalent incentive will be provided During this phase we will calculate baseline interpreter use for each enrolled provider by matching interpreter vendor invoice data to visits with patients listed as preferring a language other than English for medical care over the past 6 months
Phase 1 9 months The study team will randomize enrolled providers 11 to either web-based educational modules or mobile video interpreting mVI stratified by clinic and baseline interpreter use For education-assigned providers they will receive access to the online modules and begin receiving weekly reminder emails They will also receive a tip sheet for making the best use of the current interpreter services they have access to in their clinic mVI-assigned providers will have mVI downloaded onto their preferred device smartphone or tablet or be issued a study smartphone if they do not want to use their own They will be shown how to use it and receive a tip sheet for optimal mVI use in clinic The study team will then begin 9 months of data collection for phase 1
In addition to tracking interpreter use the study team will also begin recruiting patients or parents of pediatric patients with LOE to participate in one of 3 data collection activities The study team will enroll patients or parents of pediatric patients who are being seen by an enrolled provider for an acute concern and who prefer one of the top 7 non-English languages in the area Spanish Vietnamese Somali Amharic Russian Ukrainian Marshallese to complete a post-visit survey n662 total 331 during phase 1 Patients will be approached by telephone before the visit or in-person in the waiting room prior to the clinic visit then the survey will be administered immediately after the visit via tablet or up to 7 days after the visit online or over the telephone The survey will collect patient reported communication quality interpretation satisfaction demographic information and patient reported diagnosis The survey will be administered via REDCap using an audio feature that will allow participants to read or listen to the survey questions in their preferred language for care Patients will receive a gift card or cash for completing the survey Patients who report a concern about how communication occurred on the survey along with a randomly-selected subset of others will be invited to complete a 20 to 30 minutes interview to provide greater detail about how communication and interpretation occurred and what their experience of it was like n75 total 38 during Phase 1 Whenever possible the interview will be completed immediately after the survey while the patient or family is still in the clinic If the patient wishes to participate but they are unable to stay or their language is different than the bilingual research coordinators the interview will be conducted over the telephone within 7 days of the clinic visit The interview will be conducted by a research coordinator bilingual in the patients preferred language Patients will receive a gift card or cash for completing the interview
The investigators will also be requesting permission to video record a subset of patient visits n200 total 100 during Phase 1 Video recording will occur over a 3 to 4-week block of time in each clinic during each of Phases 1 and 2 Patients or parents of pediatric patients who prefer one of the top of 7 non-English language as well as a set of patients who indicate English as their language for care and are being seen by an enrolled provider for any visit reason will be eligible and approached in the waiting room prior to the clinic visit Those who consent to video recording will have a video camera mounted in the corner of the patient room and will have their encounter video-recorded
During Phase 1 providers that will complete a 2nd in-depth qualitative interview revisiting some of the barriers facilitators moderators necessary prerequisites and proximal outcomes from the 1st interview and assessing experiences and perceived change in behavior with the assigned strategy They will receive a gift card or other equivalent incentive per local policy for completing the 30-60 minute interview
Phase 2 9 months At the beginning of phase 2 the investigators will calculate interpreter use for enrolled providers during Phase 1 Providers will be rank-ordered by interpreter use within assigned strategy Those with interpreter use in the top tertile will receive an email of positive feedback and be encouraged to continue with their originally assigned strategy Providers with interpreter use in the lowest two tertiles will undergo a 2nd round of randomization either to continue with the originally assigned strategy or to add the 2nd strategy on top of the 1st Those assigned to continue with the initially assigned strategy will receive a brief check-in from study staff to be sure they know how to access and interact with their assigned strategy Those assigned to the 2nd strategy will receive access to it as described above
Patient data collection will continue as described for Phase 1 with ongoing recruitment for patient surveys n331 for Phase 2 interviews n37 for Phase 2 and video recording n100 for Phase 2
Providers will complete a 3rd in-depth interview during Phase 2 again assessing barriers facilitators moderators necessary prerequisites and proximal outcomes from the 1st interview and eliciting experiences and perceived change in behavior with the assigned strategy or strategies They will receive a gift card or equivalent incentive per local policy for completing the 30-60 minute interview
During Phase 2 the study team will begin abstracting provider-reported diagnosis from clinic visit chart notes for patients who completed the survey Abstraction will be completed by a trained abstractor blinded to provider assigned strategy and continue into Phase 3
Diagnosis concordance coding will begin at the end of Phase 2 Two trained coders will compare patient-reported diagnosis collected through the survey and professionally translated into English to provider-documented diagnosis abstracted from the chart Each pair will be coded as yes concordant no not concordant or unclearinsufficient information using the standard of whether a follow-up provider would be likely to understand what the patient was seen or treated for based on the information provided by the patient Disagreements will be resolved through discussion with input from the PI as needed All coders will be blinded to provider assigned strategy and patient information during the coding process
Coding of qualitative interviews and video recordings will also begin at the end of Phase 2 These will be conducted by trained research coordinators under the supervision of study investigators
Phase 3 9 months During phase 3 the investigators will provide access to mVI and the educational modules for any enrolled providers who would like them The investigators will continue to measure interpreter use and will track uptake of both strategies by providers who were not initially assigned to them The study team will not continue patient surveys interviews and video recording during this phase Providers will be asked to complete a final survey re-assessing constructs from the Theoretical Domains Framework that were measured at baseline and eliciting time and out-of-pocket costs related to each strategy
During phase 3 diagnosis chart abstraction will be completed as will diagnosis concordance coding Qualitative coding and analysis and video recording coding and analysis will continue throughout phase 3
During this phase the investigators will work with each clinic to develop a sustainment plan informed by a review of the site-specific barriers to interpreter use identified in the final survey and interviews
Phase 4 18 months This final study phase will be dedicated to analysis and results dissemination Provider participation will be complete and access to mVI and the educational modules for study purposes will be discontinued although investigators will work with clinics to establish methods for ongoing access should the clinics wish to pursue this option
Provider interpreter use during the 6 month follow-up period Phase 3 will be calculated and shared with clinics Study staff will continue qualitative and video-recording coding and analysis along with our quantitative analyses related to overall interpreter use patient comprehension and the cost-effectiveness of each strategy mVI education or both for improving interpreter use and patient comprehension
During this time the investigators will also refine our preliminary causal pathway models exploring potential mechanisms by which mVI and education may be operating to improve interpreter use andor patient comprehension
Phase 0 15 months The study team will enroll 55 primary care providers from 4-8 enrolled primary care clinics within the WWAMI region Enrolled providers will complete a baseline survey and a baseline in-depth qualitative interview exploring baseline barriers facilitators moderators necessary prerequisites and proximal outcomes of professional interpreter use in their current clinic setting Providers will receive a gift card for completing the survey and a gift card for completing the 30-60 minute interview For participating providers who cannot receive direct incentives per local policy lunch or equivalent incentive will be provided During this phase we will calculate baseline interpreter use for each enrolled provider by matching interpreter vendor invoice data to visits with patients listed as preferring a language other than English for medical care over the past 6 months
Phase 1 9 months The study team will randomize enrolled providers 11 to either web-based educational modules or mobile video interpreting mVI stratified by clinic and baseline interpreter use For education-assigned providers they will receive access to the online modules and begin receiving weekly reminder emails They will also receive a tip sheet for making the best use of the current interpreter services they have access to in their clinic mVI-assigned providers will have mVI downloaded onto their preferred device smartphone or tablet or be issued a study smartphone if they do not want to use their own They will be shown how to use it and receive a tip sheet for optimal mVI use in clinic The study team will then begin 9 months of data collection for phase 1
In addition to tracking interpreter use the study team will also begin recruiting patients or parents of pediatric patients with LOE to participate in one of 3 data collection activities The study team will enroll patients or parents of pediatric patients who are being seen by an enrolled provider for an acute concern and who prefer one of the top 7 non-English languages in the area Spanish Vietnamese Somali Amharic Russian Ukrainian Marshallese to complete a post-visit survey n662 total 331 during phase 1 Patients will be approached by telephone before the visit or in-person in the waiting room prior to the clinic visit then the survey will be administered immediately after the visit via tablet or up to 7 days after the visit online or over the telephone The survey will collect patient reported communication quality interpretation satisfaction demographic information and patient reported diagnosis The survey will be administered via REDCap using an audio feature that will allow participants to read or listen to the survey questions in their preferred language for care Patients will receive a gift card or cash for completing the survey Patients who report a concern about how communication occurred on the survey along with a randomly-selected subset of others will be invited to complete a 20 to 30 minutes interview to provide greater detail about how communication and interpretation occurred and what their experience of it was like n75 total 38 during Phase 1 Whenever possible the interview will be completed immediately after the survey while the patient or family is still in the clinic If the patient wishes to participate but they are unable to stay or their language is different than the bilingual research coordinators the interview will be conducted over the telephone within 7 days of the clinic visit The interview will be conducted by a research coordinator bilingual in the patients preferred language Patients will receive a gift card or cash for completing the interview
The investigators will also be requesting permission to video record a subset of patient visits n200 total 100 during Phase 1 Video recording will occur over a 3 to 4-week block of time in each clinic during each of Phases 1 and 2 Patients or parents of pediatric patients who prefer one of the top of 7 non-English language as well as a set of patients who indicate English as their language for care and are being seen by an enrolled provider for any visit reason will be eligible and approached in the waiting room prior to the clinic visit Those who consent to video recording will have a video camera mounted in the corner of the patient room and will have their encounter video-recorded
During Phase 1 providers that will complete a 2nd in-depth qualitative interview revisiting some of the barriers facilitators moderators necessary prerequisites and proximal outcomes from the 1st interview and assessing experiences and perceived change in behavior with the assigned strategy They will receive a gift card or other equivalent incentive per local policy for completing the 30-60 minute interview
Phase 2 9 months At the beginning of phase 2 the investigators will calculate interpreter use for enrolled providers during Phase 1 Providers will be rank-ordered by interpreter use within assigned strategy Those with interpreter use in the top tertile will receive an email of positive feedback and be encouraged to continue with their originally assigned strategy Providers with interpreter use in the lowest two tertiles will undergo a 2nd round of randomization either to continue with the originally assigned strategy or to add the 2nd strategy on top of the 1st Those assigned to continue with the initially assigned strategy will receive a brief check-in from study staff to be sure they know how to access and interact with their assigned strategy Those assigned to the 2nd strategy will receive access to it as described above
Patient data collection will continue as described for Phase 1 with ongoing recruitment for patient surveys n331 for Phase 2 interviews n37 for Phase 2 and video recording n100 for Phase 2
Providers will complete a 3rd in-depth interview during Phase 2 again assessing barriers facilitators moderators necessary prerequisites and proximal outcomes from the 1st interview and eliciting experiences and perceived change in behavior with the assigned strategy or strategies They will receive a gift card or equivalent incentive per local policy for completing the 30-60 minute interview
During Phase 2 the study team will begin abstracting provider-reported diagnosis from clinic visit chart notes for patients who completed the survey Abstraction will be completed by a trained abstractor blinded to provider assigned strategy and continue into Phase 3
Diagnosis concordance coding will begin at the end of Phase 2 Two trained coders will compare patient-reported diagnosis collected through the survey and professionally translated into English to provider-documented diagnosis abstracted from the chart Each pair will be coded as yes concordant no not concordant or unclearinsufficient information using the standard of whether a follow-up provider would be likely to understand what the patient was seen or treated for based on the information provided by the patient Disagreements will be resolved through discussion with input from the PI as needed All coders will be blinded to provider assigned strategy and patient information during the coding process
Coding of qualitative interviews and video recordings will also begin at the end of Phase 2 These will be conducted by trained research coordinators under the supervision of study investigators
Phase 3 9 months During phase 3 the investigators will provide access to mVI and the educational modules for any enrolled providers who would like them The investigators will continue to measure interpreter use and will track uptake of both strategies by providers who were not initially assigned to them The study team will not continue patient surveys interviews and video recording during this phase Providers will be asked to complete a final survey re-assessing constructs from the Theoretical Domains Framework that were measured at baseline and eliciting time and out-of-pocket costs related to each strategy
During phase 3 diagnosis chart abstraction will be completed as will diagnosis concordance coding Qualitative coding and analysis and video recording coding and analysis will continue throughout phase 3
During this phase the investigators will work with each clinic to develop a sustainment plan informed by a review of the site-specific barriers to interpreter use identified in the final survey and interviews
Phase 4 18 months This final study phase will be dedicated to analysis and results dissemination Provider participation will be complete and access to mVI and the educational modules for study purposes will be discontinued although investigators will work with clinics to establish methods for ongoing access should the clinics wish to pursue this option
Provider interpreter use during the 6 month follow-up period Phase 3 will be calculated and shared with clinics Study staff will continue qualitative and video-recording coding and analysis along with our quantitative analyses related to overall interpreter use patient comprehension and the cost-effectiveness of each strategy mVI education or both for improving interpreter use and patient comprehension
During this time the investigators will also refine our preliminary causal pathway models exploring potential mechanisms by which mVI and education may be operating to improve interpreter use andor patient comprehension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None