Trial document




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  DRKS00015502

Trial Description

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Title

Surgical site infections and antibiotics consumption: a multi-centered cluster-randomized controlled trial of tailored education to promote compliance with guidelines to prevent surgical site infections (WACH)

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Trial Acronym

WACH

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URL of the Trial

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Brief Summary in Lay Language

In the WACH-trial, interventions to promote health care workers’ compliance with guidelines to prevent surgical site infections (SSI) are evaluated which are tailored based on conceptions from compliance psychology and behaviour change sciences. The rationale for this is that SSI continue to be among the most prevalent nosocomial infections in Germany, and their prevention is critical to the success of surgical procedures. Thus, compliance with SSI-preventive measures as well as its determinants are empirically assessed in the fields of orthopaedics and abdominal surgery in six hospitals in four German states, and analysed in terms of strengths and weaknesses in half of the hospitals. Educational interventions tailored on this basis will then be implemented. Interventions delivered by the WACH-project team (primarily workshops) address relevant stakeholders such as the hygiene team, physician and nursing managers, pharmacists as well as controllers. Interventions or intervention options which are jointly developed in this context then address clinical staff, and are delivered by the abovementioned stakeholders. It is expected that the tailored interventions will lead to higher compliance with SSI-preventive measures compared to “usual care”, and thus to lower rates of SSIs (effectiveness). To evaluate their cost-effectiveness, a health economic evaluation will be performed.

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Brief Summary in Scientific Language

In the WACH-trial, interventions to promote health care workers’ compliance with guidelines to prevent surgical site infections (SSI) are evaluated which are tailored based on conceptions from compliance psychology and behaviour change sciences. The rationale for this is that SSIs continue to be among the most prevalent nosocomial infections in Germany, and their prevention is critical to the success of surgical procedures. In the cluster-randomized controlled trial, compliance with SSI-preventive measures as well as its multiple determinants are empirically assessed in the fields of orthopaedics and abdominal surgery in six hospitals in four German states. For half of the hospitals a SWOT-analysis will be performed and educational interventions tailored on this basis will then be implemented. Interventions delivered by the WACH-project team (primarily workshops) address relevant stakeholders such as the hygiene team, physician and nursing managers, pharmacists as well as controllers. Interventions or intervention options which are jointly developed in this context then address clinical staff, and are delivered by the abovementioned stakeholders. It is expected that the tailored interventions will lead to higher compliance with SSI-preventive measures compared to “usual care”, and thus to lower rates of SSIs (effectiveness). To evaluate their cost-effectiveness, a health economic evaluation will be performed.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015502
  •   2018/10/19
  •   [---]*
  •   yes
  •   Approved
  •   034/18-ek , Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   ANNIE2016-55-038  (Förderkennzeichen der Finanzierungsquelle (Bundesverwaltungsamt für das Bundesministerium für Gesundheit))
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Health Condition or Problem studied

  •   Surgical site infections
  •   T81.4 -  Infection following a procedure, not elsewhere classified
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Interventions/Observational Groups

  •   Tailored interventions: Psychologically tailored educational stimuli and possibly other interventions (e.g. training sessions or feedback discussions) based on an empirical assessment of compliance determinants.
  •   Usual care interventions
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Guideline compliance rates (incl. antibiotic usage), pre- and postintervention, behavioral observation via standardised checklists and observations sheets (partly existing, partly self-developed) by trained observers

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Secondary Outcome

Surgical site infections, pre- and postintervention, standard surveillance methods (microbiology; partly existing and partly self-developed questionnaires)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Actual
  •   2018/10/25
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

1. Number of beds: > 30
2. Surgical specialist hospital with regular stationary execution of abdominal and orthopedic/traumatology surgeries
3. Parts of the AWMF guideline and/or the KRINKO recommendation are already applied

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Exclusion Criteria

1. Participation in other (research) projects which influence the endpoints of this evaluation study (as assessed by the principal investigator)
2. Restructuring measures in the next three years (from start of the study) which are relevant to the endpoints of the study and were planned before the study start (as assessed by the principal investigator, examples: planned serious modification/fluctuation of employees, especially in terms of executive leadership, planned modification in the establishment of the AWMF-guideline/KRINKO recommendation.

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Addresses

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    • Institut für Hygiene, Krankenhaushygiene und Umweltmedizin
    • Ms.  Prof. Dr. med.  Iris Freya  Chaberny 
    • Liebigstraße 22 (Haus 7)
    • 04103  Leipzig
    • Germany
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    • Medizinische Hochschule Hannover, Zentrum Öffentliche Gesundheitspflege, Forschungs- und Lehreinheit Medizinische Psychologie
    • Mr.  Prof. Dr. phil. Dipl.-Psych.   Thomas  von Lengerke  
    • Carl-Neuberg-Str. 1, OE 5430
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Zentrum Öffentliche Gesundheitspflege, Institut für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung, Center for Health Economics Research
    • Mr.  Prof. Dr. rer. pol. Dipl.-Volksw.  Christian   Krauth 
    • Carl-Neuberg-Str. 1, OE 5410
    • 30625  Hannover
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Institut für Hygiene, Krankenhaushygiene und Umweltmedizin
    • Ms.  Prof. Dr. med.  Iris Freya  Chaberny 
    • Liebigstraße 22 (Haus 7)
    • 04103  Leipzig
    • Germany
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    • Institut für Hygiene, Krankenhaushygiene und Umweltmedizin
    • Ms.  Prof. Dr. med.  Iris Freya  Chaberny 
    • Liebigstraße 22 (Haus 7)
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Bundesverwaltungsamt für das Bundesministerium für Gesundheit (Förderkennzeichen: ANNIE2016-55-038)
    • Ms.  Heike  Rogler 
    • Eupener Straße 125
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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  •   973
  •   973
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Trial Publications, Results and other Documents

  •   Tomsic I, Chaberny IF, Heinze NR, Krauth C, Schock B, von Lengerke T. The Role of Bundle Size for Preventing Surgical Site Infections after Colorectal Surgery: Is More Better? [Letter to the Editor]. J Gastrointest Surg. 2018;22(4):765-766
  •   Tomsic I, Heinze NR, Chaberny IF, Krauth C, Schock B, von Lengerke T. Implementation interventions in preventing surgical site infections in abdominal surgery: a systematic review. BMC Health Serv Res. 2020;20(1):236. doi: 10.1186/s12913-020-4995-z
  •   von Lengerke T, Schock B, Hartlep I, Schipper P., Tomsic I, Krauth C, Chaberny IF. Promoting compliance with surgical site infection prevention guidelines by psychologically tailored interventions: study protocol of the multi-center parallel-group cluster-randomized controlled "WACH"-trial. [Abstract]. Antimicrob Resist Infect Control. 2019;8(1):30
  •   von Lengerke T, Tomsic I, Gossé F, Ebadi E, Hartlep I, Schipper P, Schock B, Chaberny IF. Planning is distinct from motivation and capabilities in explaining surgical site infection-preventive compliance: results from a single-centre, small sample but high response surgey of orthopaedic physicians in Hannover. [Abstract]. Antimicrob Resist Infect Control. 2019;8(1):69
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* This entry means the parameter is not applicable or has not been set.