- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03257579
Myocardial Infarction Prescription Duration Adherence Study (MIPAD)
Length of Initial Prescription at Hospital Discharge and Long-term Medication Adherence for Elderly Patients Post-Myocardial Infarction: An Interventional Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The overarching goal of this study is to reduce the morbidity and mortality of post-MI patients through improved long-term cardiac medication adherence.
The specific objectives include: 1. Assess the impact on long-term cardiac medication adherence following the implementation of a standardized increase in discharge prescription length to 90-days with 3 repeats in post-MI patients as compared to education alone and usual care; 2. Assess the cost implications of the intervention as compared to usual care; 3. Compare clinical outcomes between longer (>60 days) versus shorter prescription durations; 4. Collect baseline information to inform a multi-centre interventional study (i.e., simple monthly proportions of 1-year adherence by hospitals in Ontario).
Intervention:1. Policy Change implementing a standardized discharge prescription form available on all wards where MI patients are managed at HHS that includes a 90-day supply with 3 repeats for all cardiac medications, and education alone provided at SJH and NHS 2. Educational materials will be disseminated to all involved health care providers (e.g., physicians, residents, nurses) at the start of the intervention period to ensure the new discharge prescriptions are understood and used. Furthermore, extensive outreach to community pharmacies in LHIN IV will be undertaken with help from Ontario Pharmacists' Association (OPA) and Ontario Pharmacy Evidence Network (OPEN).
3. Education (e.g., emails, mail-outs, site visits) will recur every 3-4 months during the intervention period. Furthermore, monthly monitoring will ensure standardized prescription forms and point of care reminders are implemented at all intervention sites.
The intervention group will be exposed to this intervention post-MI and include all eligible patients at HHS/SJH/NHS in the 6-months post-intervention implementation.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Hamilton, Ontario, Canadá, L8L 2X2
- Hamilton General Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Use of Ontario Drug Benefits (ODB-Age >65 years, social assistance, and disability);
- Cardiac catheterization during an index admission with an MI;
- Evidence of obstructive coronary artery disease;
- Discharged alive
- Ontario Residents (Ontario, Canada)
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 90 Day Supply
Intervention: At Hamilton Health Sciences a policy change implementing a standardized discharge prescription form of a 90-day supply with 3 repeats for all cardiac medications available on all wards where MI patients are managed.
|
Policy Change implementing a 90 day standardized discharge prescription form with 3 repeats for all cardiac medications available on all wards where MI patients are managed at Hamilton Health Sciences sites
|
Experimental: Education Alone
At St. Joseph's Hospital and Niagara Health System education regarding the benefits of lengthening prescriptions to a 90 day supply with 3 repeats for all cardiac medications will be implemented.
|
Education Alone provided at St. Joseph's Hospital and Niagara Health System
|
Sin intervención: Control
Remaining Ontario cardiac sites will receive usual care and act as concurrent control group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of Patients with High Adherence
Periodo de tiempo: One year
|
Increased proportion of patients with high adherence (proportion of days covered (PDC) >80%) for the combined four cardiac medications classes at one year
|
One year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Difference in adherence of medication classes
Periodo de tiempo: One year
|
Difference in proportion with high adherence (mean PDC >80%) to the individual cardiac medication classes
|
One year
|
Difference in combined and individual medications as measured by Proportion of Days Covered (PDC)
Periodo de tiempo: One year
|
Difference in mean of Proportion of Days Covered (PDC >80%) of the combined cardiac medications as compared to PDC of individual cardiac medications classes as collected by Ontario Drug Benefits usage and reported to the Institute of Clinical Evaluative Sciences (ICES).
|
One year
|
Discharge Prescription Length
Periodo de tiempo: One year
|
Difference in discharge prescription length (<90 days and ≥90 days)
|
One year
|
Clinical outcomes as measured by number of participants who experience death, myocardial infarction, coronary revascularization, and hospital readmission
Periodo de tiempo: One year
|
Difference in proportion of participants experiencing death, myocardial infarction, coronary revascularization and hospital readmission at one year at each interventional site compared to control sites, as reported by Cardiac Care Network and analyzed by ICES.
|
One year
|
Cost implications
Periodo de tiempo: One year
|
Cost implications of interventions of each arm
|
One year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jon-David Schwalm, MD,FRCPC,MSc, 905-577-1423
Publicaciones y enlaces útiles
Publicaciones Generales
- Schwalm JD, Ivers NM, Bouck Z, Taljaard M, Natarajan MK, Nguyen F, Hijazi W, Thavorn K, Dolovich L, McCready T, O'Brien E, Grimshaw JM. Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study. BMC Med. 2022 Jun 21;20(1):213. doi: 10.1186/s12916-022-02401-5.
- Schwalm JD, Ivers NM, Bouck Z, Taljaard M, Natarajan MK, Dolovich L, Thavorn K, McCready T, O'Brien E, Grimshaw JM. Length of Initial Prescription at Hospital Discharge and Long-Term Medication Adherence for Elderly, Post-Myocardial Infarction Patients: Protocol for an Interrupted Time Series Study. JMIR Res Protoc. 2020 Nov 4;9(11):e18981. doi: 10.2196/18981.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2979
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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