Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial

Abstract

Background: International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice. We sought to determine whether a national, multifaceted intervention could improve adherence to guidelines, especially for patients at high risk of nonvariceal upper gastrointestinal bleeding.

Methods: In this randomized trial, we stratified hospitals by region and size and allocated sites to either the control or experimental group. Health care workers in the experimental group were given published guidelines, generic algorithms, stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops. These interventions were implemented over a 12-month period after randomization, with performance feedback and benchmarking. The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management, determined by chart review, was adjusted according to site characteristics and possible within-site dependencies. We also report the rates of adherence to other recommendations.

Results: Forty-three sites were randomized to the experimental (n=21) or control (n=22) groups. In our primary analysis, we compared patients before (experimental group: n=402 patients; control group: n=424 patients) and after (experimental group: n=361 patients; control group: n=389 patients) intervention. Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention (experimental group: 9.8%; control group: 4.8%; p=0.99) after adjustment for the rate of adherence before the intervention (experimental group: 13.2%; control group: 7.1%). The adherence rates to other guidelines were similar and decreased over time, varying between 5% and 93%.

Interpretation: This national knowledge translation-based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding. Adherence was not improved by an educational intervention, which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers (Trial registration: ClinicalTrials.gov, no. MCT-88113).

Trial registration: ClinicalTrials.gov NCT00840008.

Figure 1:

Selection of hospitals and patients for inclusion in the trial.

Figure 2:

Timetable of randomization, intervention, follow-up and data collection. Chart numbers shown do not include an additional 10% duplicate independent data entry for validation purposes. Data collection timelines were tabulated based on conservative estimates (based on pilot testing) of case volumes of 4–5 eligible patients weekly in the period of care and 4–5 charts abstracted weekly in the data collection period. The timelines allowed additional time for data collection (3–5 weeks if a 2-week turn-around was allowed for the preparation of feedback sheets).