Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05591586 |
| Other study ID # |
STUDY00003332 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 24, 2022 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
April 2023 |
| Source |
Seattle Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients and families with limited English proficiency (LEP) and/or 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.
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 1:1 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 (n=662 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 (n=75 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 coordinator's, 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 patient's 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 (n=200 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 (n=331 for Phase 2), interviews (n=37 for Phase 2), and video recording
(n=100 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 unclear/insufficient
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 and/or patient comprehension.
