- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02723370
Implementation of Evidence Based Practices for Colonoscopy: The Strategies to Improve Colonoscopy Study (STIC)
Understanding Variability in Success of Quality Improvement for Colonoscopy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Over 14 million colonoscopies are performed annually in the U.S. About 25% of patients that undergo colonoscopy have inadequate bowel preparation, an impediment to identifying cancer and pre-cancerous growths. The adenoma miss rate for patients with inadequate bowel preparation can be as high as 48%. The primary goal of the Strategies to Improve Colonoscopy (STIC) study is to conduct formative research on a multi-component implementation strategy to increase staff adoption of evidence-based practices (i.e. split-dosing of the medication, low-literacy materials, teach-back) for educating patients and improving the adequacy of bowel preparation for colonoscopy.
Investigators will compare the effect of physician education about evidence based practices for colonoscopy alone, versus education plus a staff implementation toolkit to improve quality of colonoscopy (i.e. adequacy of bowel preparation). Physicians in both study groups will receive education on the evidence-based practices. Staff who work for physicians in the initial intervention group will receive a multi-component implementation strategy for the evidence-based practices, consisting of staff education, a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, a consultation to integrate materials and teach-back into workflow, and a website with additional training and patient materials. The initial intervention period will be followed by a replication study where the delayed intervention group will receive the intervention.
Investigators will compare change in colonoscopy quality outcomes from before to after implementation of interventions for the two study groups: a) overall; and for b) Medicaid versus other insurance using administrative and medical record data with interrupted time series analysis. Investigators will also examine factors that influence adoption of the evidence based practices using structured physician, staff and patient surveys.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Physicians who perform colonoscopies at 6 participating endoscopy centers
- Staff who work for participating physicians and provide education for bowel preparation before colonoscopy
- Patients who had an outpatient colonoscopy at a participating endoscopy center during study period
Exclusion Criteria:
- none
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Initial Intervention
Staff will receive the intervention during the initial intervention period.
|
Staff will receive a multi-component implementation strategy for evidence based practices (EBPs) for colonoscopy, including split-dosing of bowel preparation, low literacy education materials for patients, and teach-back procedure.
The implementation strategy includes a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, consultation to integrate materials and teach-back into workflow and a website with additional training and patient materials.
|
|
Sperimentale: Delayed Intervention
Staff will receive the intervention during the replication study.
|
Staff will receive a multi-component implementation strategy for evidence based practices (EBPs) for colonoscopy, including split-dosing of bowel preparation, low literacy education materials for patients, and teach-back procedure.
The implementation strategy includes a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, consultation to integrate materials and teach-back into workflow and a website with additional training and patient materials.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Percent of patients with adequate of bowel preparation as indicated by a Boston Bowel Preparation Scale (BBPS) score > 6 or an Aronchick scale score of fair or better.
Lasso di tempo: 5 month intervention period
|
5 month intervention period
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adoption of Evidence Based Practices
Lasso di tempo: At baseline and after 5 month intervention period
|
Staff report of how frequently they use the EBPs and toolkit.
5 point likert scale from 1 (Never) to 5 (Always).
|
At baseline and after 5 month intervention period
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Rebecca Lobb, ScD, MPH, Washington University School of Medicine
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 201401089
- R21CA184282 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .
Prove cliniche su Staff multi-component implementation strategy
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