Testing New Formats for the Presentation of Research Evidence to Health Care Managers and Policy Makers
5 maggio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
257
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Nessun intervento: Traditional systematic review format
Control participants will be asked to read and answer questions using a traditional systematic review format.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of participants (health care managers or policy makers) who appropriately consider and apply the evidence from each systematic review format
Lasso di tempo: 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).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Comprehension of the review
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Sharon e Straus, Unity Health Toronto
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 maggio 2017
Completamento primario (Effettivo)
30 novembre 2019
Completamento dello studio (Effettivo)
30 novembre 2019
Date di iscrizione allo studio
Primo inviato
5 gennaio 2017
Primo inviato che soddisfa i criteri di controllo qualità
1 febbraio 2017
Primo Inserito (Stima)
2 febbraio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 maggio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 maggio 2020
Ultimo verificato
1 maggio 2020
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SMH-312381
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .