Promoting compliance with pre- and intraoperative measures to prevent surgical site infections by tailored interventions for infection prevention and control professionals: results of a cluster-randomised controlled trial based on 905 surgical operations

https://drks.de/search/en/trial/DRKS00015502 Abstract Objectives To test whether psychologically tailored implementation interventions for infection prevention and control (IPC) professionals increase compliance with clinical interventions to prevent surgical site infections (SSI). Trial design Pragmatic parallel-group cluster-randomised controlled trial (C-RCT). Methods Participants: The C-RCT was conducted in six hospitals (clusters). All four general/visceral and five orthopaedics/trauma surgery departments participated. Within these, IPC team members and in-house IPC stakeholders received the C-RCT interventions, and the IPC team addressed physicians and nurses. Surgical operations represented the units of observation (N=905). Interventions: The primary intervention was a psychologically tailored two-day on-site workshop. Tailoring used baseline assessments guided by COM-B (Capabilities|Opportunities|Motivation-Behaviour-model) and was implemented by selecting behaviour change techniques. “Usual practice”-hospitals received interventions after follow-up (waiting control). Objective: The primary hypothesis pertained to the units of observation. Outcome: The primary outcome was compliance with evidence-based SSI-preventive peri-operative clinical interventions. Four pre- and six intraoperative measures could be analysed. Randomisation: Hospitals were randomised (1:1) by the Clinical Trial Centre, University of Leipzig. Masking: Open-label. Results Numbers randomised: Three clusters each. Numbers analysed: All clusters were analysed. Outcome: Surgical cap compliance was the only single measure with a significant interaction between “study arm (tailoring vs. usual practice)” and “study phase (follow-up vs. baseline) and a significant change after tailoring: multiple logistic regression analysis revealed rates of 67.7% (95%-CI: 65.7%|68.9%) at baseline and 90.8% (88.7%|93%) at follow-up in the tailoring arm, vs. 71% (68.6%|73.4%) and 57.1% (54.8%|59.5%) in the control arm. For the count variable constructed across all 10 measures and its median split, interactions were significant as well. General linear modelling showed means of 7 measures at baseline (6.9|7.2) and 7.9 (7.8|8.1) at follow-up after tailoring, vs. 7.5 (7.3|7.7), and 7.3 (7.2|7.5) in the control arm. Regression revealed 35.5% of surgical operations with ≥8 measures at baseline (34.1%|36.8%) and 72.7% at follow-up (71.4%|74.1%) after tailoring (control arm: 58%, 56.5%|59.5%, and 46.4%, 44.9%|48%). Harms: No evidence. Conclusions: This study provides C-RCT evidence that psychologically tailored implementation interventions for IPC professionals may increase SSI-preventive pre- and intraoperative compliance. Trial registration: German Clinical Trial Registry (19-November-2018; https://drks.de/search/en/trial/DRKS00015502). Funding: German Federal Ministry of Health (grant-ID: ANNIE2016-55-038).