- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04043468
Audit and Feedback Interventions With Primary Care Nursing Teams
Effects of an Action Support Component in Audit and Feedback Interventions With Primary Care Nursing Teams: A Pragmatic Trial
Audit and feedback (A&F) aims to improve practices by providing professionals with a summary of their performance. A major limitation to its effectiveness is a persistent intention-action gap following the feedback that prevents the translation of planned actions into concrete changes in practice. In nursing, the lack of coordination within nursing teams contributes to this gap and therefore limits their capacity for action. The objective of this study is to evaluate the effects of an A&F intervention enhanced with an action support component on the primary care nursing teams' capacity to improve performance compared to a standard A&F intervention.
A pragmatic cluster randomised controlled trial with analysis of implementation fidelity will be conducted. Four nursing organizations will receive standard A&F, while the other four will receive A&F with a support component. We will measure performance using clinical administrative data from an electronic database based on wound care episodes. Performance indicators will be measured 3 times: at the beginning of the study (T1), after 6 months (T2) and after 12 months (T3). The feedback meetings will take place between times 1 and 2, then between times 2 and 3. The intervention group will receive the support component in the form of structured focus groups in addition to the feedback meetings. Changes in rates of seven nursing-sensitive indicators (continuity, planning and adjusting of the treatment plan, initial assessment, education, frequency and number of consultations and duration of episodes) will be measured to evaluate the effects of A&F on performance.
The results are expected to inform of the effectiveness of A&F in order to improve its design and deployment. The potential impact on the improvement of practices is significant, considering that wound care is one of the main conditions in primary care for which nursing staff have a high degree of autonomy.
Przegląd badań
Szczegółowy opis
Audit and feedback (A&F) is an intervention that aims to improve professionals practices by providing professionals with a summary of their performance over a period of time. A&F has 1) an audit phase, in which performance indicators are measured and 2) a feedback phase, in which the indicators are reported to the professionals to encourage reflexive practice and determine an action plan. Although its effectiveness has been demonstrated, it is widely accepted that this type of intervention is highly variable and that its design has considerable room for improvement. A major limitation to the effectiveness of A&F is a persistent intention-action gap encounters by professionals following the feedback. This gap prevents the translation of planned actions into concrete changes in practice. In nursing, an aspect that contributes to this gap is a lack of coordination of actions within nursing teams, which limits their capacity for collective action.
Purpose and objectives: The purpose of this study is to evaluate the effects of an A&F intervention enhanced with an action support component on the primary care nursing teams' capacity to improve performance compared to a standard A&F intervention. This study has two specific objectives: 1) to measure the effects of the addition of structured focus groups during an enhanced A&F intervention on the performance levels of the process and outcome indicators compared with the measured effects of standard A&F intervention; and 2) to analyze the effects of the implementation fidelity of the standard and enhanced A&F interventions on the effectiveness of A&F.
Method: A pragmatic cluster randomised controlled trial with analysis of implementation fidelity will be conducted. Eight primary care nursing organizations will be included. Four of them will receive a standard A&F intervention, while the remaining four will receive an AF intervention with a support component. Performance will be measured using clinical administrative data from an electronic database currently used to compile statistics on the services provided and the users of Local community service centers (CLSC) in Quebec. Performance will be measured from wound care episodes of patients who had a follow-up during the study period. Four process indicators (continuity, planning and adjusting of the treatment plan, initial assessment and education) and three outcome indicators (frequency and number of consultations and duration of episodes) sensitive to nursing care will be measured 3 times: at the beginning of the study (T1), after 6 months (T2) and after 12 months (T3). The feedback meetings will take place between times 1 and 2, then between times 2 and 3. The intervention group will receive the support component in the form of structured focus groups in addition to the feedback meetings, twice between each of the time periods. Models of generalized estimating equations will be adjusted to analyze differences in performance in each group. An analysis of implementation fidelity will be conducted in parallel of the pragmatic trial using grids of observations in each of the settings
Typ studiów
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- The inclusion and exclusion criteria are at two levels: 1) primary care organizations and 2) wound care episodes that will be used to measure performance improvement. Nursing organizations that offer services seven days a week will be included so that they can measure all the selected indicators and use the I-CLSC software in their daily practice. Wound care episodes with a minimum duration of 7 days and an episode start during the measurement period will be included. These two criteria are applied in order to measure the seven indicators.
Exclusion Criteria:
- Wound care episodes in palliative care will be excluded, as the indicators were selected for episodes of wound care with healing potential. Such episodes are identifiable by codes in the database.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Improved A&F intervention
Two feedback sessions and four structured focus groups
|
Audit and feedback (A&F) is an intervention that aims to improve professionals practices by providing professionals with a summary of their performance over a period of time.
|
Aktywny komparator: Standard A&F intervention
Two feedback sessions
|
Audit and feedback (A&F) is an intervention that aims to improve professionals practices by providing professionals with a summary of their performance over a period of time.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Continuity
Ramy czasowe: Change from baseline continuity at 6 and 12 months.
|
Percentage of care episodes in which at least 50 % of the consultations are provided by the same professional
|
Change from baseline continuity at 6 and 12 months.
|
Planning and adjusting of the treatment plan
Ramy czasowe: Change from baseline Planning and adjusting of the treatment plan at 6 and 12 months.
|
Percentage of care episodes in which at least 75 % of the consultations are with an RN
|
Change from baseline Planning and adjusting of the treatment plan at 6 and 12 months.
|
Education
Ramy czasowe: Change from baseline Education at 6 and 12 months.
|
Percentage of care episodes in which at least one education session is provided
|
Change from baseline Education at 6 and 12 months.
|
Initial assessment
Ramy czasowe: Change from baseline Initial assessment at 6 and 12 months.
|
Percentage of care episodes in which a RN performs a wound assessment in the first consultation
|
Change from baseline Initial assessment at 6 and 12 months.
|
Frequency
Ramy czasowe: Change from baseline Frequency at 6 and 12 months.
|
Percentage of care episodes with no more than three consultations per week as of the second week
|
Change from baseline Frequency at 6 and 12 months.
|
Duration
Ramy czasowe: Change from baseline Duration at 6 and 12 months.
|
Percentage of care episodes lasting 42 days or less
|
Change from baseline Duration at 6 and 12 months.
|
Intensity
Ramy czasowe: Change from baseline Intensity at 6 and 12 months.
|
Percentage of care episodes with no more than 22 consultations
|
Change from baseline Intensity at 6 and 12 months.
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CharlesLeMoyne
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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 .
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