Hospital DischargeTIDENCT05988229
Tools to Improve Discharge Equity (TIDE) Pilot RCT
A study testing Toolkit to improve discharge equity in people with Hospital Discharge, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Discharge
- What is being tested?
- Toolkit to improve discharge equity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2023to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- Nurses and Interpreters
- Caring for patient enrolled in trial
- Family/Visitors
- Present at time of discharge for patient enrolled in trial
Who cannot join
- 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
Show all 10Show fewer
- Nurses and Interpreters
- None
- Family/Visitors
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Hospital Discharge
- Being tested
- Toolkit to improve discharge equity
- Keywords
- Limited English proficiency, Hospital Discharge Teaching, Spanish speaking, Haitian Creole speaking, Cape Verdean Creole speaking, Vietnamese speaking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toolkit to improve discharge equityOther
Linguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching.
| Study group | Role | What they receive |
|---|---|---|
| Discharge equity tools | Experimental | Participants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-2 weeks post discharge
Secondary outcomes (4)
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
Measured: 18 months
Hospital re-utilization
Assessed by a combined outcome of admission or emergency department (ED) visit within 30 days of index discharge
Measured: 30 days
Number of participants with completion of primary care follow-up
Assessed from participants' medical records
Measured: 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.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Dec 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital DischargeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization stratified by language and level of care (observation unit versus inpatient floor)
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Austad, MD MPH, Principal investigator, Boston Medical Center, Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988229
- Sponsor's protocol ID
- H-43873
- Acronym
- TIDE
- Status last verified
- Oct 2024
- First submitted
- 4 Aug 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39810841
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools to Improve Discharge Equity (TIDE) at Hospital Discharge for Patients With Limited English Proficiency: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05988229
- Acronym / sponsor ID
- TIDE / H-43873
- Conditions
- Hospital Discharge
- Keywords
- Limited English proficiency, Hospital Discharge Teaching, Spanish speaking, Haitian Creole speaking, Cape Verdean Creole speaking, Vietnamese speaking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomization stratified by language and level of care (observation unit versus inpatient floor)
| Arm | Type | Receives |
|---|---|---|
| Discharge equity tools | Experimental | Other: Toolkit to improve discharge equityParticipants randomized into this arn will receive the toolkit of linguistically appropriate discharge teaching aids at hospital discharge. |
| Standard of hospital discharge care | No intervention | –Participants randomized into this arm will receive the standard of care at hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- Patients
- On airborne infections precautions
- On clostridium difficile (C diff) precautions
- On suicide precautions
- Nurse report of participant displaying cognitive impairment, delirium, or aggression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toolkit to improve discharge equityLinguistically appropriate discharge teaching aids: a medication calendar, pictographics added to the after visit summary (AVS), and an audio recording of the discharge teaching. | Other | Discharge equity tools |
Primary outcome
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.
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.
4 secondary outcomes
Implementation effectiveness
Time frame: 18 months
Hospital re-utilization
Time frame: 30 days
Number of participants with completion of primary care follow-up
Time frame: 30 days
Participant participation in discharge teaching
Time frame: 1-2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39810841Austad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Austad, MD MPH principal investigator
Boston Medical Center, Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toolkit to improve discharge equity in people with Hospital Discharge, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient understanding of discharge instructions (time frame: 1-2 weeks post discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05988229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.