- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01348802
A Randomized Trial Comparing "Push" Versus "Pull" Technology for Mobilizing Pain Evidence Into Practice Across Different Health Professions
Přehled studie
Detailní popis
The Problem: Pain affects all Canadians during acute injury or disease. Chronic noncancer pain affects 29% of Canadians, half of whom are unable to participate in their usual work/social roles. Pain is the primary reason that patients consult health practitioners. Research has shown the benefits, harms, and costs of numerous interventions for pain, but uptake of this knowledge is far from satisfactory. Optimizing pain care requires ready access and use of best evidence within and across different disciplines and settings.
The Research Question: The purpose of this randomized trial is to determine whether a technology-based "push" of new, high-quality pain research to physicians, nurses, rehabilitation and psychology professionals results in better knowledge and clinical decision-making around pain, when offered in addition to traditional "pull" evidence technology. A secondary objective is to identify disciplinary variations in response to evidence and differences in the patterns of accessing research evidence.
The Study Sample: 670 Physicians, nurses, occupational/physical therapists and psychologists ((80/group X 2 comparison groups X 4 disciplines) + 30 for dropouts)will be recruited through professional associations, websites/conferences and social media. This provides > 90% power to detect main effects; 80% power for subgroup effects.
Outcome Measures: The primary outcomes are uptake and application of evidence. Uptake will be determined by embedded tracking of what research is accessed during use of the intervention. A random subset of 30 participants/discipline will undergo chart-stimulated recall (CSR) to assess the nature and depth of evidence utilization in actual case management (0, 9 months). A different random subset of 30 participants/discipline will be tested for their skills in accessing evidence using a standardized simulation test (final 3 months). Secondary outcomes include usage and self-reported evidence-based practice attitudes and behaviours (0, 3, 9, 15, 18 months).
Intervention/Methods: Participants who agree to this study of a free literature service will be randomly allocated to Push + Pull versus Pull evidence support. Push + Pull is evidence on pain that is extracted from medical, nursing and rehabilitation journals and appraised for quality and relevance and sent out to clinicians (derived from the successful MacPLUS/Evidence Updates), delivered by e-mail alerts or available for searches of the accumulated database). Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database. The trial will begin with a 3-month (repeated) baseline, during which average participant use of the standard PULL resource will be monitored. Participants will then be randomly allocated to receive PUSH + PULL or continue to use the PULL resource. After six months, participants will cross over to the alternate intervention for an additional six months. To complete the trial, both groups will finish with three months of PUSH + PULL access.
Analyses: The investigators will use an analysis of covariance (ANCOVA), where discipline and setting are covariates to assess differential responses across main effects of Push + Pull vs. Pull. Content analysis of the CSR interview will be use to describe the application of evidence within actual cases.
Impact/Timeliness: The trial will inform our understanding on information preferences and behaviours across disciplines/practice settings. If this intervention is effective, sustained support will come through professional/health system initiatives emerging to optimize pain management in Canada.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8S 1C7
- McMaster University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- licensed physicians, nurses, occupational therapists (OT), physical therapists (PT), or psychologists who see patients at least 1 day/week;
- fluent in English;
- have access to a computer at home or at work which has unrestricted access to the World Wide Web,
- have an active email account
Exclusion Criteria:
- currently participating in other knowledge translation interventions
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Push + Pull
Push + Pull is evidence on pain that is extracted from medical, nursing, psychology and rehabilitation journals, appraised for quality and relevance, and delivered to clinicians by e-mail alerts or available for searches of the accumulated database.
|
Push + Pull is evidence on pain that is extracted from medical, nursing, psychology and rehabilitation journals, appraised for quality and relevance, and delivered to clinicians by e-mail alerts or available for searches of the accumulated database.
|
|
Komparátor placeba: Pull
Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database.
|
Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Application of evidence (chart-stimulated recall)
Časové okno: 0, 9 months
|
A random subset of 30 participants/discipline will undergo chart-stimulated recall to assess the nature and depth of evidence utilization in actual case management.
|
0, 9 months
|
|
Skill at accessing research evidence
Časové okno: 15 months
|
A different random subset of 30 participants/discipline will be tested for their skills in accessing evidence using a standardized simulation test.
|
15 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Usage of PainPLUS
Časové okno: Every month
|
Embedded tracking of number/frequency of article access and type of evidence.
Level of satisfaction with PainPLUS
|
Every month
|
|
Attitudes about Evidence-Based Practice Questionnaire
Časové okno: 0, 3, 9, 15, and 18 months
|
Knowledge/Attitude/Behaviour Questionnaire
|
0, 3, 9, 15, and 18 months
|
|
Familiarity/Access to Technology
Časové okno: 0 months
|
0 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Joy MacDermid, PhD, McMaster University
Publikace a užitečné odkazy
Obecné publikace
- MacDermid JC, Law M, Buckley N, Haynes RB. "Push" versus "Pull" for mobilizing pain evidence into practice across different health professions: a protocol for a randomized trial. Implement Sci. 2012 Nov 24;7:115. doi: 10.1186/1748-5908-7-115.
- Arumugam V, MacDermid JC, Walton D, Grewal R. The yield and usefulness of PAIN+ and PubMed databases for accessing research evidence on pain management: a randomized crossover trial. Arch Physiother. 2021 Apr 1;11(1):9. doi: 10.1186/s40945-021-00100-7.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CIHR-228972
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Bolest
-
Liu JiuhongDokončenoRebound Pain | Lipozomální bupivakainČína
-
University of VirginiaZatím nenabírámeArtroplastika ramene | Interscalene Block | Rebound PainSpojené státy
-
Karaman Training and Research HospitalDokončeno
-
Ajou University School of MedicineNábor
-
Beijing Sport UniversityZatím nenabírámePatellofemoral Pain, PFP
-
Beijing Sport UniversityZatím nenabíráme
-
Istanbul University - CerrahpasaNáborPatellofemoral Pain, PFPTurecko (Türkiye)
-
Pamukkale UniversityZatím nenabírámePatellofemoral Pain, PFPTurecko (Türkiye)
-
Beijing Sport UniversityDokončenoPatellofemoral Pain, PFPČína
-
The First Affiliated Hospital of Xiamen UniversityNáborRebound Pain | Artroskopická operace kolena | OliceridinČína
Klinické studie na Push + Pull
-
Chinese University of Hong KongNational Heart Centre SingaporeDokončenoSrdeční selháníSingapur
-
University Hospital, GhentGhent University, BelgiumNáborPediatrie | Centrální žilní katétrBelgie
-
McMaster Children's HospitalRegional Medical Associates of HamiltonDokončenoŠokovat | Fluidní terapie | Pediatrie | ResuscitaceKanada
-
Johann Wolfgang Goethe University HospitalDokončenoMíra peristomální infekce | Postintervenční krvácení | Postintervenční míra úmrtnostiNěmecko
-
University of MichiganDokončenoPoužití látkySpojené státy
-
Riphah International UniversityNáborAdhezivní kapsulitidaPákistán
-
Azienda USL Reggio Emilia - IRCCSDokončeno
-
Riphah International UniversityAktivní, ne náborSportovní fyzikální terapiePákistán
-
Maharishi Markendeswar University (Deemed to be...DokončenoSubluxace dolního rameneIndie
-
Zunyi Medical CollegeThe First Affiliated Hospital of Zhengzhou University; Guizhou Provincial People... a další spolupracovníciZatím nenabírámeHirschsprungova nemoc | Celková aganglióza tlustého střeva | Duhamel | SoaveČína