- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05387213
Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes
18 de mayo de 2022 actualizado por: Katherine McGilton, Toronto Rehabilitation Institute
Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes During COVID-19
A pre-experimental design to conduct a process evaluation and to compare the outcomes after implementing team huddles for the intervention and control groups.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Staff working in long-term care (LTC) homes during COVID-19 frequently reported lack of communication, collaboration, and teamwork, all of which are associated with staff dissatisfaction, health concerns, perceived of lack of support and moral distress.
The purpose of this study was to introduced regular huddles, led by a Nurse Practitioner, to support LTC staff during COVID-19.
The objectives were to evaluate the process of huddle implementation and to examine differences between staff attending and not attending the huddles on outcomes of moral distress, job satisfaction, perceived support from the Nurse Practitioner, and health and mental health.
Furthermore, we hypothesize that regular huddles can lead to improvements in resident-centred care and resident outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
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.
Ubicaciones de estudio
-
-
Ontario
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Kitchener, Ontario, Canadá, N2A 1Y5
- Long-Term Care Home
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Sarnia, Ontario, Canadá
- Long-Term Care Home
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- All staff working at the LTC home
- All residents living in the home between January and December 2021
Exclusion Criteria:
- N/A
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Huddle attendees
Participants in this arm participated in huddles
|
Brief multidisciplinary meeting occurring twice a week for staff working at a LTC home led by a Nurse Practitioner.
Huddles focused on discussing resident-care and staff-wellbeing.
|
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Sin intervención: Huddle non-attendees
Participants in this arm did not participate in huddles
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall morals distress and situations associated with COVID-19 in LTC settings contributing to moral distress were measured in the intervention and control arms using the Moral Distress in Dementia Care Instrument (Iaboni et al., 2021).
Periodo de tiempo: 20 weeks
|
Moral Distress in Dementia Care is a ten-item checklist, where respondents are asked to rate moral distress associated with each item on a 5-point scale ranging from none (1) to an extremely large amount (5).
Higher scores represent more moral distress.
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20 weeks
|
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Overall job satisfaction with current role was measured in the intervention and control arms using a single question asking, "How satisfied are you overall with your current job in the LTC home?" (Dolbier et al., 2005)
Periodo de tiempo: 20 weeks
|
The single-item question was high reliability and validity (Dolbier et al., 2005) and has been used in previous studies in LTC homes (Schwendimann et al., 2016).
Respondents rate job satisfaction on a 4-point scale ranging from strongly dissatisfied (1) to strongly satisfied (4), where higher scores indicate more satisfaction.
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20 weeks
|
|
Overall health was measured in the intervention and control arms using a single question from Statistics Canada (2022) asking, "In general, how would you say your health is?"
Periodo de tiempo: 20 weeks
|
Respondents rate their health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better health.
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20 weeks
|
|
Mental health was measured in the intervention and control arms using a single question from Statistics Canada (2022) asking, "In general, how would you say your mental health is?"
Periodo de tiempo: 20 weeks
|
Respondents rate their mental health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better mental health.
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20 weeks
|
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Perceived support from the nurse practitioner leading the huddles was measured in the intervention and control arms, assessed using the Supportive Supervisory Scale (McGilton 2010).
Periodo de tiempo: 20 weeks
|
The 5-item scale asks respondents to rate their perception of support from the nurse practitioner in 5 situations on a 5-point scale ranging from never (0) to always (5), where higher scores indicate more perceived support.
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20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The duration of each huddle in minutes was recorded by the nurse practitioner using the Huddle Observation Tool (HOT) (Edbrooke-Childs et al., 2018) as part of process evaluation.
Periodo de tiempo: 15 weeks
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Average and range of huddle duration were measured.
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15 weeks
|
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The attendance of different staff categories (i.e. personal support worker, registered practical nurse) at each huddle was recorded by the nurse practitioner using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Periodo de tiempo: 15 weeks
|
Attendance of categories of staff at huddles was summarized as percentage of total huddles attended.
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15 weeks
|
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The frequency of delivery of huddles by the nurse practitioner was self-reported using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Periodo de tiempo: 15 weeks
|
Data was summarized as total number of huddles delivered and number of huddles delivered per week.
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15 weeks
|
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Adherence to huddle structure was self-reported by the nurse practitioner using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Periodo de tiempo: 15 weeks
|
Data included huddle topic and aim, sharing of a positive event, maintaining a collaborative culture, and creation of a risk management plan and was summarized as number of huddles adhering to the structure.
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15 weeks
|
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Depressive symptoms of residents residing on the intervention and control units will be measured with the Depression Rating Scale before and after implementation of huddles.
Periodo de tiempo: 1 year
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This is a quality indicator obtained from the Resident Assessment Instrument - Minimum Data Set (RAI-MDS) 2.0.
Depression Rating Scale is based on the following items: negative statements (E1a), persistent anger (E1d), expression of unrealistic fears (E1f), repetitive health complaints (E1h), repetitive anxious complaints (E1ii), sad, pained, worried facial expression (E1l), crying, tearfulness (E1m).
The score ranges from 0 to 14, where a score of 3 or more may indicate a potential or actual problem with depression.
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1 year
|
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Aggression of residents residing on the intervention and control units will be measured with the Aggressive Behaviour Scale before and after implementation of huddles.
Periodo de tiempo: 1 year
|
This is a quality indicator obtained from the RAI-MDS 2.0.
Aggressive Behaviour Scale is based on the following items: verbally abusive (E4b), physically abusive (E4c), socially inappropriate/disruptive behaviour (E4d), resists care (E4e).
Scores range from 0 to 12, where higher scores indicate higher levels of aggressive behaviour.
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1 year
|
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The cognitive status of residents on the intervention and control units will be measured with the Cognitive Performance Scale before and after implementation of huddles.
Periodo de tiempo: 1 year
|
This is a quality indicator obtained from the RAI-MDS 2.0.
Cognitive Performance Scale is based on the following items: comatose (B1), short-term memory (B2a), cognition skills for daily decision-making (B4), expressive communication (C4), eating (G1hA).
The sores range from 0 to 6, where higher scores indicate more severe cognitive impairment.
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1 year
|
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Changes in health, end-stage disease, and signs and symptoms of residents on the intervention and control units will be measured using the CHESS scale before and after implementation of huddles.
Periodo de tiempo: 1 year
|
This is a quality indicator obtained from the RAI-MDS 2.0.
CHESS is based on the following items: decline in cognition (B6), decline in ADL (G9), dehydration (J1c), edema (J1g), shortness of breath (J1l), vomiting (J1o), end-stage disease (J5c), weight loss (K3a), leaving food uneaten (K4c).
The score ranges from 0 to 5, where higher scores indicate higher levels of medical complexity and are associated with adverse outcomes.
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1 year
|
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Changes in social engagement of residents on the intervention and control units will be measured with the Index of Social Engagement (ISE) before and after implementation of huddles.
Periodo de tiempo: 1 year
|
This is a quality indicator obtained from the RAI-MDS 2.0.
ISE is based on the following items: at ease interacting with others (F1a), at ease doing planned or structured activities (F1b), at ease doing self-initiated activities (F1c), establishes own goals (F1d), pursues involvement in the life of the facility (F1e), accepts invitations into most group activities (F1f).
The scores range from 0-6, where higher scores indicate higher levels of social engagement.
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1 year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Katherine S McGilton, KITE Research Institute - Toronto Rehabilitation Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Dolbier CL, Webster JA, McCalister KT, Mallon MW, Steinhardt MA. Reliability and validity of a single-item measure of job satisfaction. Am J Health Promot. 2005 Jan-Feb;19(3):194-8. doi: 10.4278/0890-1171-19.3.194.
- Schwendimann R, Dhaini S, Ausserhofer D, Engberg S, Zuniga F. Factors associated with high job satisfaction among care workers in Swiss nursing homes - a cross sectional survey study. BMC Nurs. 2016 Jun 6;15:37. doi: 10.1186/s12912-016-0160-8. eCollection 2016.
- McGilton KS. Development and psychometric testing of the Supportive Supervisory Scale. J Nurs Scholarsh. 2010 Jun;42(2):223-32. doi: 10.1111/j.1547-5069.2009.01323.x.
- Iaboni A, Quirt H, Engell K, Kirkham J, Stewart S, Grigorovich A, Kontos P, McMurray J, Levy A, Bingham K, Rodrigues K, Astell A, Flint AJ, Maxwell C. Barriers and facilitators to person-centred infection prevention and control: results of a survey about the Dementia Isolation Toolkit. BMC Geriatr. 2022 Jan 25;22(1):74. doi: 10.1186/s12877-022-02759-4.
- Edbrooke-Childs J, Hayes J, Sharples E, Gondek D, Stapley E, Sevdalis N, Lachman P, Deighton J. Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards. BMJ Qual Saf. 2018 May;27(5):365-372. doi: 10.1136/bmjqs-2017-006513. Epub 2017 Sep 19.
Enlaces Útiles
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 (Actual)
14 de mayo de 2021
Finalización primaria (Actual)
1 de noviembre de 2021
Finalización del estudio (Actual)
1 de noviembre de 2021
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2022
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2022
Publicado por primera vez (Actual)
24 de mayo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 20-6298
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
No IPD will be shared with other researchers.
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
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. .