- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05387213
Nurse Practitioner Led Implementation of Team Huddles in Long-Term Care Homes
18 maja 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
42
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Ontario
-
Kitchener, Ontario, Kanada, N2A 1Y5
- Long-Term Care Home
-
Sarnia, Ontario, Kanada
- Long-Term Care Home
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Brak interwencji: Huddle non-attendees
Participants in this arm did not participate in huddles
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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).
Ramy czasowe: 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.
|
20 weeks
|
|
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)
Ramy czasowe: 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.
|
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?"
Ramy czasowe: 20 weeks
|
Respondents rate their health on a 5-point scale ranging from poor (0) to excellent (4), where higher scores indicate better health.
|
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?"
Ramy czasowe: 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.
|
20 weeks
|
|
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).
Ramy czasowe: 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.
|
20 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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.
Ramy czasowe: 15 weeks
|
Average and range of huddle duration were measured.
|
15 weeks
|
|
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.
Ramy czasowe: 15 weeks
|
Attendance of categories of staff at huddles was summarized as percentage of total huddles attended.
|
15 weeks
|
|
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.
Ramy czasowe: 15 weeks
|
Data was summarized as total number of huddles delivered and number of huddles delivered per week.
|
15 weeks
|
|
Adherence to huddle structure was self-reported by the nurse practitioner using HOT (Edbrooke-Childs et al., 2018) as part of process evaluation.
Ramy czasowe: 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.
|
15 weeks
|
|
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.
Ramy czasowe: 1 year
|
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.
|
1 year
|
|
Aggression of residents residing on the intervention and control units will be measured with the Aggressive Behaviour Scale before and after implementation of huddles.
Ramy czasowe: 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.
|
1 year
|
|
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.
Ramy czasowe: 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.
|
1 year
|
|
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.
Ramy czasowe: 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.
|
1 year
|
|
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.
Ramy czasowe: 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.
|
1 year
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Katherine S McGilton, KITE Research Institute - Toronto Rehabilitation Institute
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 maja 2021
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2021
Ukończenie studiów (Rzeczywisty)
1 listopada 2021
Daty rejestracji na studia
Pierwszy przesłany
13 maja 2022
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 maja 2022
Pierwszy wysłany (Rzeczywisty)
24 maja 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
24 maja 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
18 maja 2022
Ostatnia weryfikacja
1 maja 2022
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 20-6298
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
No IPD will be shared with other researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .