Tools to Improve Discharge Equity (TIDE) Pilot RCT

NCT05988229 | Completed

• 1 other identifier: H-43873
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Hospital Discharge

Keywords

Limited English proficiency; Hospital Discharge Teaching; Spanish speaking; Haitian Creole speaking; Cape Verdean Creole speaking; Vietnamese speaking

Outcome Measures

Primary Outcomes (2)

• Patient understanding of discharge instructions

  Assessed by a composite score of six key domains of discharge instructions (primary diagnosis, self-care instructions, return precautions, medication changes, medication indications, follow-up) as determined by two physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.

  1-2 weeks post discharge

• Patient understanding of primary diagnosis of hospitalization

  Determined by two physician adjudicators (1=poor, 4 = near perfect). Higher scores demonstrate better understanding.

  1-2 weeks post discharge

Secondary Outcomes (4)

• Implementation effectiveness

  18 months

• Hospital re-utilization

  30 days

• Number of participants with completion of primary care follow-up

  30 days

• Participant participation in discharge teaching

  1-2 weeks

Study Arms (2)

Discharge equity tools

EXPERIMENTAL

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

Other: Toolkit to improve discharge equity

Standard of hospital discharge care

NO INTERVENTION

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

Interventions

Toolkit to improve discharge equity 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.

Discharge equity tools

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 39810841 DERIVED

Study Officials

• Kirsten Austad, MD MPH

  Boston Medical Center, Family Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization stratified by language and level of care (observation unit versus inpatient floor)

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: December 6, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)