Tools to Improve Discharge Equity (TIDE) Pilot RCT

NCT ID: NCT05988229

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2024-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Hospital Discharge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Block randomization stratified by language and level of care (observation unit versus inpatient floor)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Discharge equity tools

Participants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge.

Group Type EXPERIMENTAL

Toolkit to improve discharge equity

Intervention Type OTHER

Linguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching.

Standard of hospital discharge care

Participants randomized into this arm will receive the standard of care at hospital discharge.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Toolkit to improve discharge equity

Linguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsten Austad, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center, Family Medicine

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Austad K, Thai C, Zavatti A, Nguyen N, Bautista-Hurtado D, Kenney P, Lugo N, Lee JH, Lanney H, Xuan Z, Cordova-Ramos EG, Drainoni ML, Jack B. Tools to improve discharge equity: Protocol for the pilot TIDE trial. Contemp Clin Trials Commun. 2024 Dec 21;43:101419. doi: 10.1016/j.conctc.2024.101419. eCollection 2025 Feb.

Reference Type DERIVED
PMID: 39810841 (View on PubMed)

Other Identifiers

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H-43873

Identifier Type: -

Identifier Source: org_study_id

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