Impact of Pharmacist-led Care Navigation Mediated by Digital Health Tools on Hospital Readmissions
27 de agosto de 2026 actualizado por: Hospital de Clinicas de Porto Alegre
Impact of Pharmacist-led Care Navigation Mediated by Digital Health Tools on Hospital Readmissions After Discharge: a Randomized Clinical Trial.
Hospitalizations for Primary Care-Sensitive Conditions (PCSCs) are potentially avoidable hospital admissions that may be prevented when Primary Health Care provides effective and timely care through prevention, early diagnosis, appropriate management of chronic conditions, and control of acute episodes.
This study proposes an open-label, pragmatic, cluster-randomized clinical trial to evaluate the effectiveness of continuous telecare, supported by digital health tools, in the post-discharge follow-up of patients hospitalized for PCSCs.
The main outcome will be the occurrence of non-elective hospital readmissions and urgent or emergency care visits within 180 days after discharge, compared with usual care.
The intervention will include pharmacist-led teleconsultations, a communication channel through a messaging app, and the development of an individualized care plan. Participants in the control group will receive the usual care provided by the healthcare network.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
3220
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Bianca V Bianchini, PhD
- Número de teléfono: +55 51 31914125
- Correo electrónico: bianca@noharm.ai
Ubicaciones de estudio
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Porto Alegre, Brasil
- Hospital de Clinicas de Porto Alegre
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Individuals aged 18 years or older;
- Residing in the municipality of Porto Alegre;
- Hospitalized at Hospital de Clínicas de Porto Alegre for selected Primary Care-Sensitive Conditions (PCSCs): respiratory diseases (such as asthma, chronic obstructive pulmonary disease, and tuberculosis), cardiovascular diseases (such as arterial hypertension, angina, and heart failure), cerebrovascular diseases (such as stroke), and metabolic diseases (such as diabetes mellitus).
Exclusion Criteria:
- Individuals who are unable to be contacted by telephone;
- Individuals with language or cognitive barriers that cannot be overcome with the assistance of a caregiver or legal representative;
- Individuals participating in another clinical trial that conflicts with the present study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Pharmacist-led teleconsultations
Continuous pharmacist-led care program supported by digital health tools, which will include: three pharmacist teleconsultations, with the first consultation within 15 days after hospital discharge, the second within 30 days, and the third within 90 days; an open communication channel through a messaging app; an individualized care plan; and referrals to Primary Health Care professionals, when necessary.
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Continuous pharmacist-led care program supported by digital health tools, which will include: three pharmacist teleconsultations, with the first consultation within 15 days after hospital discharge, the second within 30 days, and the third within 90 days; an open communication channel through a messaging app; an individualized care plan; and referrals to other Primary Health Care professionals, when necessary.
Otros nombres:
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Sin intervención: Usual care
Usual care provided by the hospital and Primary Health Care services, without implementation of the structured pharmacist-led care program supported by digital health tools.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge
Periodo de tiempo: From enrollment until 180 days after hospital discharge
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Occurrence of non-elective hospital readmissions and visits to urgent and emergency care services within 180 days after hospital discharge, assessed through patient/caregiver reports during follow-up visits and electronic medical records.
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From enrollment until 180 days after hospital discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants who died within 180 days after hospital discharge
Periodo de tiempo: From enrollment until 180 days after hospital discharge
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Proportion of participants who died within 180 days after hospital discharge, assessed through caregiver reports and medical records.
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From enrollment until 180 days after hospital discharge
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Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan
Periodo de tiempo: From enrollment until 180 days after hospital discharge
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Proportion of participants who fully or predominantly completed the actions outlined in the individualized care plan, as documented in pharmacist teleconsultations and medical records.
An individualized care plan will be developed for each participant based on the Clinical Protocols and Therapeutic Guidelines of the Brazilian Ministry of Health and will include agreed-upon actions.
Throughout the follow-up period, completion of the planned actions will be documented.
Participants will be considered adherent to the care plan if there is documentation that they completed all planned actions or at least 75% of them within the defined period.
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From enrollment until 180 days after hospital discharge
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Satisfaction with continuous pharmacist-led care
Periodo de tiempo: From enrollment until 180 days after hospital discharge
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Satisfaction with continuous pharmacist-led care will be assessed using the Net Promoter Score (NPS), based on the standard question: "On a scale from 0 to 10, how likely are you to recommend pharmacist-led telecare to a friend or family member?".
Respondents will be classified as promoters (score 9-10), passives (score 7-8), or detractors (score 0-6).
The NPS will be calculated as the difference between the percentage of promoters and the percentage of detractors, resulting in a score ranging from -100 to +100 (NPS = % Promoters - % Detractors).
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From enrollment until 180 days after hospital discharge
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Diego Gnatta, PhD, Federal University of Rio Grande do Sul
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de enero de 2029
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
27 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Atributos de la enfermedad
- Condiciones Patológicas, Signos y Síntomas
- Condiciones Sensibles a la Atención Ambulatoria
- Referencia y consulta
- Práctica profesional
- Organización y administración
- Administración de Servicios de Salud
- Prestación de atención médica
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud comunitarios
- Economía y organizaciones de la atención médica
- Telemedicina
- Gestión de atención al paciente
- Financiamiento, organizado
- Ciencias económicas
- Parte D de Medicare
- Seguros, Servicios Farmacéuticos
- Seguro de Salud
- Seguro
- Medicare
- Monitoreo de pacientes remotos
- Consulta remota
- Servicios farmacéuticos
- Gestión de la Terapia Medicamentosa
- Servicios Farmacéuticos, En Línea
- Community Pharmacy Services
Otros números de identificación del estudio
- 2026-0354
- 99456126.3.0000.5327 (Otro identificador: Certificate of Presentation for Ethical Assessment)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
There is no plan to make individual participant data available to external researchers.
The study protocol approved by the institutional Research Ethics Committee does not include the sharing of individual participant data with researchers outside the primary research team.
Individual participant data collected in this study include sensitive personal health information and will be used exclusively for the purposes specified in the approved study protocol.
Study findings will be disseminated through scientific publications and other scientific communications using aggregate data.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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