- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Rose Ann Huynh, MD, MS
- Número de telefone: 15042510803
- E-mail: rhuynh@carene.org
Estude backup de contato
- Nome: Joni Harris, MS, CCRP
- Número de telefone: 48553 401-274-1122
- E-mail: jonharris@wihri.org
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Patients illiterate in their preferred language who received audio instructions
audio discharge patient education provided in preferred language
|
audio instructions in preferred language
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Acceptability of Audio Discharge Instructions
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rose Ann Huynh, MD, MS, Women and Infants Hospital Rhode Island
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- WIH-2323225
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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