Tools to Improve Discharge Equity (TIDE) Pilot RCT

Hospital Discharge Clinical Trial

— TIDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988229
• Other study ID #: H-43873
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Boston Medical Center
• Contact: Kirsten Austad, MD MPH
• Phone: (617) 414-4459
• Email: kirsten.austad[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hospital Discharge

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Implementation effectiveness	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	18 months
Secondary	Medication adherence	This outcome will be assessed using the modified Morisky Medication Adherence Scale (MMAS-8) which is an 8 item instrument. Each scale comprises five items that are scored on a Likert-type scale, where 1 = strongly disagree, 2 = disagree, 3 = uncertain, 4 = agree and 5 = strongly agree. Higher scores indicate stronger beliefs in the necessity of medication and greater concerns about taking it.	1-2 weeks
Secondary	Hospital re-utilization	Assessed by a combined outcome of admission or emergency department (ED) visit within 30 days of index discharge	30 days
Secondary	Number of participants with completion of primary care follow-up	Assessed from participants' medical records	30 days
Secondary	Participant participation in discharge teaching	Participants are observed by a research team member during discharge teaching and will document the number of questions asked.	1-2 weeks