Tools to Improve Discharge Equity (TIDE) Pilot RCT

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

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

Conditions
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Hospital Discharge

Intervention / Treatment
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* Other: Toolkit to improve discharge equity


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization stratified by language and level of care (observation unit versus inpatient floor)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discharge equity tools<br>Participants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge. | Other: Toolkit to improve discharge equity<br>* Linguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching.<br>|
| No Intervention: Standard of hospital discharge care<br>Participants randomized into this arm will receive the standard of care at hospital discharge. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limited English proficiency, Hospital Discharge Teaching, Spanish speaking, Haitian Creole speaking, Cape Verdean Creole speaking, Vietnamese speaking