- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07813325
Closing the Gap in Language With Audio Instructions: An Exploratory Pilot Study
Significance: Not all patients can read discharge instructions even when the documentation is provided in their preferred language. Our emergency department strives to provide language-concordant discharge instructions to all patients; however, we do not have access to written instructions in Haitian creole, K'iche, or other less commonly spoken languages. Providers often give these patients discharge instructions in English, or the next closest language, such as French for our Haitian creole speaking patients, or Spanish for K'iche speaking patients. Discharge instructions are also provided verbally using a language-concordant phone interpreter. However, connectivity issues and interpreter access often pose challenges to effective communication and verbal instructions are often an overwhelming amount of information to process and remember. At Women and Infants Hospital, the most vulnerable populations are Haitian Creole and K'iche, but those of Spanish speaking descent are also at risk.
Hypothesis/Outcomes: For patients who cannot read in their preferred language, if they are provided audio instructions in their preferred language, these instructions will be acceptable, feasible, and useful to patients.
Procedures:
- Establish Degree of the Problem
Administer initial exploratory survey (part of the post-intervention survey) to:
- Determine literacy
- Preferred mode of instructions: written vs audio vs video
- Satisfaction of discharge instructions from previous experiences
Provide Intervention
- Work with interpreter services to interpret audio instructions in Spanish, Haitian Creole and K'iche for the following complaints: Labor/Preterm Labor, Vaginal Bleeding in Pregnancy (2TM/3TM and threatened miscarriage), Fetal Kick Counts
- Store Audio Instructions on an online database with associated QR code.
Post-Intervention Survey
- Medical student will verbally go through the post-intervention survey with patients
- To be provided within 48-72 hours post-discharge
- Medical student to confirm telephone number and good time to call.
- Will include an extra question concerning how many times they listened to the audio recording VS having the QR code record the number of listens.
Post-Intervention Survey Questions
Patient identification question:
- Name
- DOB
- MRN
- What is your preferred language?
- Are you able to understand written text? Y N
- Have you ever been asked if you understand written text in the healthcare setting?
- If you have received written instructions from any hospital prior, what was your satisfaction with them?
- On a scale of 0-10, how helpful were the audio discharge instructions?
- Did you feel confident in the instructions you received? Y N
- How many times did you or your family members listen to the audio recording?
- Would you use the audio discharge tool in the future?
- Would you recommend the audio discharge tool to others?
- In your own words, can you describe how the audio discharge tool helped you understand your medical care?
- Can you tell us one thing you learned from the instructions?
- Is there another form of instructions you prefer: Written, Audio only, Video with Audio
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Rose Ann Huynh, MD, MS
- Numer telefonu: 15042510803
- E-mail: rhuynh@carene.org
Kopia zapasowa kontaktu do badania
- Nazwa: Joni Harris, MS, CCRP
- Numer telefonu: 48553 401-274-1122
- E-mail: jonharris@wihri.org
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Pregnant patients with intrauterine pregnancies of all gestational ages
- Preferred language is Spanish, Haitian Creole or K'iche
- Discharge plan or order in place
- Chief Complaint/Diagnosis is:
- Labor/Preterm Labor
- Vaginal Bleeding in Pregnancy (2TM/3TM and threatened miscarriage)
- Decreased fetal movement
- Access to a smart phone
Exclusion Criteria:
- Declines intervention
- Does not have one of the above chief complaints/diagnoses
- Preferred language is Spanish and are literate in Spanish
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Patients illiterate in their preferred language who received audio instructions
audio discharge patient education provided in preferred language
|
audio instructions in preferred language
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patient Acceptability of Audio Discharge Instructions
Ramy czasowe: From enrollment to 72 hours after discharge/provision of patient audio education
|
Patient acceptability of the audio discharge instructions will be assessed using 5-point Likert-type response options for satisfaction with the instructions, ease of access, helpfulness, and confidence in the instructions received.
Responses range from 1 (Very Dissatisfied) to 5 (Very Satisfied), with higher scores indicating greater acceptability and a better outcome.
|
From enrollment to 72 hours after discharge/provision of patient audio education
|
|
Feasibility of Intervention
Ramy czasowe: From enrollment to conclusion of data collection.
|
To be determined by 2 measures:
|
From enrollment to conclusion of data collection.
|
|
Usefulness of Audio Discharge Instructions to Patients
Ramy czasowe: From enrollment to 72 hours after discharge/provision of patient audio education
|
Perceived usefulness of the audio discharge instructions will be assessed using 2 measures:
|
From enrollment to 72 hours after discharge/provision of patient audio education
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Rose Ann Huynh, MD, MS, Women and Infants Hospital Rhode Island
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- WIH-2323225
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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