Clinical trial NCT05988229: Tools to Improve Discharge Equity (TIDE) Pilot RCT
Official title: Tools to Improve Discharge Equity (TIDE) at Hospital Discharge for Patients With Limited English Proficiency: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospital Discharge
Keywords: Limited English proficiency
Hospital Discharge Teaching
Spanish speaking
Haitian Creole speaking
Cape Verdean Creole speaking
Vietnamese speaking
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization stratified by language and level of care (observation unit versus inpatient floor)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will test the impact of a package of linguistically appropriate discharge teaching tools against current standard of care for patients with Limited English proficiency (LEP) in an unblinded randomized controlled trial. The tools include an expanded medication calendar in English and the patients' preferred language, pictographics to illustrate return precautions (what signs/symptoms require further evaluation), an audio recording of the nurse reviewing the After Visit Summary (composed by providers) to allow for review by patients and caretakers after discharge.

The investigators will evaluate the effectiveness of the package of discharge teaching tools on patients' understanding/recall, key implementation outcomes, and secondary clinical outcomes via a structured interview 1-2 weeks after discharge and chart review 30 days after discharge.

The objectives of this research study are:

1. test the effectiveness of a linguistically appropriate toolkit for improving patient understanding of discharge instruction content
2. Assess the feasibility and fidelity of the intervention in anticipation of a multi-site implementation trial
3. assess the feasibility and appropriateness of the linguistically appropriate toolkit to nurses and in-person interpreters
4. to assess the acceptability of the intervention to patients and their satisfaction with it
5. to collect data on implementation context in anticipation for a multi-site trial
6. to collect preliminary data on the toolkit's impact on clinical outcomes including medication adherence and hospital re-utilization.


Eligibility criteria: Inclusion Criteria:

Patients

* Labeled in medical record as preferring one of the following four languages: Spanish, Haitian Creole, Cape Verdean Creole, or Vietnamese
* Admitted to medicine team at BMC
* Age 18 years or older
* Being discharged home (to the community)
* Admitted to Boston Medical Center (BMC) hospital units (Menino 7 East, 7 West, and Menino Observation)

Nurses and Interpreters

* Caring for patient enrolled in trial

Family/Visitors

* Present at time of discharge for patient enrolled in trial

Exclusion Criteria:

Patients

* On airborne infections precautions
* On clostridium difficile (C diff) precautions
* On suicide precautions
* Nurse report of participant displaying cognitive impairment, delirium, or aggression
* Enrolled in trial during a prior admission

Nurses and Interpreters

* None

Family/Visitors

* None

Primary outcomes:
measure: Patient understanding of discharge instructions
timeFrame: 1-2 weeks post discharge
measure: Patient understanding of primary diagnosis of hospitalization
timeFrame: 1-2 weeks post discharge
Secondary outcomes:
measure: Implementation effectiveness
timeFrame: 18 months
measure: Hospital re-utilization
timeFrame: 30 days
measure: Number of participants with completion of primary care follow-up
timeFrame: 30 days
measure: Participant participation in discharge teaching
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Family Medicine
name: Kirsten Austad, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: