Tools to Improve Discharge Equity (TIDE) Pilot RCT (TIDE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hospital Discharge
• Intervention / Treatment: Other: Toolkit to improve discharge equity

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsten Austad, MD MPH; Phone Number: (617) 414-4459; Email: kirsten.austad@bmc.org
• Study Contact Backup: Name: Brian Jack, MD; Email: brian.jack@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Kirsten Austad, MD MPH; Phone Number: 817-414-4459; Email: kirsten.austad@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Discharge equity tools; Participants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge.	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.
No Intervention: Standard of hospital discharge care; Participants randomized into this arm will receive the standard of care at hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hospital re-utilization	Assessed by a combined outcome of admission or emergency department (ED) visit within 30 days of index discharge	30 days
Number of participants with completion of primary care follow-up	Assessed from participants' medical records	30 days
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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Kirsten Austad, MD MPH, Boston Medical Center, Family Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Spanish speaking; Limited English proficiency; Hospital Discharge Teaching; Haitian Creole speaking; Cape Verdean Creole speaking; Vietnamese speaking
• Other Study ID Numbers: H-43873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No