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Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers

5 maja 2020 zaktualizowane przez: Unity Health Toronto

A Randomized Trial to Compare the Effects of a Novel Versus Traditional Systematic Review Format on the Ability of Health Care Managers and Policy Makers to Understand and Apply Evidence

The purpose of this project is to identify and use our knowledge on the barriers and facilitators to using systematic reviews (SR) by health care managers (HCM) and policy markers (PM) to develop and test a novel format for presentation of SR for HCM and PM. We will invite HCM and PM from hospitals and regional authorities in Ontario, Alberta, and British Columbia to participate in a randomized-control trial. Participants will receive a link to an online consent survey, and then be randomly allocated to receive access to a novel SR or its traditional presentation. There is no time limit to completing the task, and participants are able to save their responses and finish later. Participants are able to withdraw from the study by not completing the task.

Przegląd badań

Szczegółowy opis

Despite advances in the conduct and reporting of traditional systematic reviews, current evidence suggests that they are used infrequently by health care managers and policy makers in decision making. Managers and policy makers have suggested that concise presentation positively affects the use of systematic reviews. The purpose of this randomized controlled trial is to assess the impact of a traditional systematic review format compared with the innovative format on the ability of health care managers and policy makers to understand the evidence in the review and apply it to a relevant health care decision making scenario.

The two end-user groups have different formatting needs and we will therefore run 2 parallel studies, randomizing each group separately. Once participants have consented to participate, a computer generated randomization process will allocate them to one of 2 arms (1:1 ratio). Participants will either receive either a traditional format or a novel format. Unequal block randomization will be used and allocation will be concealed through central assignment. Outcomes assessors will be blinded and participants will be blinded to the citation of the review so that the traditional version will not be easily accessible in its original format from the relevant journal.

This study will be the first study to engage health care managers and policy makers in the testing of formats for presentation of research evidence relevant to their needs. The results of the project will help increase the uptake of systematic review results in health care management policy decision-making, ultimately leading to informed decision making and positively impacting the health of Canadians.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

257

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
      • Toronto, Ontario, Kanada, M5B 1W8
        • St. Michael's Hospital

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

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Health care managers from the Alberta SCNs, CAHO in Ontario, the RHAs and AQESSS in Quebec and RHAs from BC will be invited to participate.
  • Policy makers/analysts from the Ontario, BC, Alberta and Quebec Ministries of Health

Exclusion Criteria:

  • Health care managers or policy makers who are unwilling or unable to give informed consent.

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: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Novel systematic review format
A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers. Participants receiving the intervention will be asked to read and answer questions using a novel systematic review format.
A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers.
Brak interwencji: Traditional systematic review format
Control participants will be asked to read and answer questions using a traditional systematic review format.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format
Ramy czasowe: This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
The proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format to the scenario as measured by agreement with an expert panel's recommendation. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of appropriate application of the evidence. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
This measure will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Comprehension of the review
Ramy czasowe: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Comprehension of the review - defined as the proportion of participants (health care managers or policy makers) who accurately define the bottom line from the systematic review as defined by an expert panel. A panel of 4 health care managers or policy makers from our research team and 2 content experts. Their answers will provide the definition of the bottom line from the systematic review. Two investigators who will be blind to allocation will independently determine if the participant's answer agrees with that from the expert panel. Disagreements will be resolved by a third investigator, independently. Agreement between investigators will be reported using the kappa statistic.
This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Intention to use evidence
Ramy czasowe: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Intention to use evidence - collected through a 12-item likert scale survey. The survey has good face validity amongst policy makers and managers. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Perceived tentativeness of research findings
Ramy czasowe: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Perceived tentativeness of research findings - collected through a 6-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Provisional opinion about the intervention
Ramy czasowe: This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).
Provisional opinion about the intervention - collected through a 14-item likert scale survey. This has been pre-tested to make sure that the items are intelligible to people and to achieve high levels of face validity and reliability. The mean and SD of each item in the survey will be reported and we will provide a summary score of all items and convert it to a percentage.
This measures will be assessed at the particular time the intervention is administered (i.e., at the time the participant reads the systematic review format, an average of 2 hours).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Sharon e Straus, Unity Health Toronto

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)

16 maja 2017

Zakończenie podstawowe (Rzeczywisty)

30 listopada 2019

Ukończenie studiów (Rzeczywisty)

30 listopada 2019

Daty rejestracji na studia

Pierwszy przesłany

5 stycznia 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 lutego 2017

Pierwszy wysłany (Oszacować)

2 lutego 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 maja 2020

Ostatnia weryfikacja

1 maja 2020

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • SMH-312381

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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 .

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