- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02723370
Implementation of Evidence Based Practices for Colonoscopy: The Strategies to Improve Colonoscopy Study (STIC)
Understanding Variability in Success of Quality Improvement for Colonoscopy
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
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.
Ramy czasowe: 5 month intervention period
|
5 month intervention period
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Adoption of Evidence Based Practices
Ramy czasowe: 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
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Rebecca Lobb, ScD, MPH, Washington University School of Medicine
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 201401089
- R21CA184282 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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 .