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Completed

NCT Number: NCT05988229

Tools to Improve Discharge Equity (TIDE) Pilot RCT

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient understanding of discharge instructions

    Time frame: 1-2 weeks post discharge

    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.

  2. Patient understanding of primary diagnosis of hospitalization

    Time frame: 1-2 weeks post discharge

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

Secondary outcomes

  1. Implementation effectiveness

    Time frame: 18 months

    Effectiveness will be assessed by observations of and comments from patients, nurses and visitors from qualitative interviews related to the adoption, acceptability, appropriateness, and feasibility of the discharge process

  2. Hospital re-utilization

    Time frame: 30 days

    Assessed by a combined outcome of admission or emergency department (ED) visit within 30 days of index discharge

  3. Number of participants with completion of primary care follow-up

    Time frame: 30 days

    Assessed from participants' medical records

  4. Participant participation in discharge teaching

    Time frame: 1-2 weeks

    Participants are observed by a research team member during discharge teaching and will document the number of questions asked.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Tools to Improve Discharge Equity (TIDE) at Hospital Discharge for Patients With Limited English Proficiency: A Randomized Controlled Trial

Acronym: TIDE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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