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Trial record 14 of 130441 for:    Change

Compliance With Hand Hygiene in Nursing Homes: Go for a Sustainable Effect (CHANGE) (CHANGE)

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ClinicalTrials.gov Identifier: NCT02817282
Recruitment Status : Enrolling by invitation
First Posted : June 29, 2016
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Institute for Public Health and the Environment (RIVM)
Information provided by (Responsible Party):
Radboud University

Brief Summary:

Hand hygiene (HH) appears to be a simple, non-complex procedure to prevent healthcare-associated infections (HAIs), implementation in daily routine is difficult. The residential setting and specific population pose challenges to optimal HH compliance. This study aims to develop and to evaluate an evidence based multi-component implementation strategy aimed at the promotion of HH in Dutch nursing homes(NHs). A strategy to improve HH compliance in Dutch NHs will be developed. This strategy addresses the specific barriers and facilitators of NHs' infrastructure, healthcare workers (HCWs) and socio-cultural setting. The strategy will be tested in a stepped wedge cluster randomized design which is based on a random sequential roll-out of the implementation strategy to all participating NHs (n=20) for comparison. Data are collected during six consecutive four month periods with an initial baseline period for all NHs.

During each period 1200 opportunities for HH are observed, using the gold standard of direct and unobtrusive observations, according to the Five Moments for HH of the World Health Organization. HAIs incidence densities, collected in the sentinel surveillance network for infectious diseases in nursing homes (SNIV), will be evaluated in parallel.

A multi component implementation strategy, combining activities aimed at individual HCWs, teams and the organization will be used. The individual level includes education, skills, action planning, reminders and feedback. The team level includes activities that focus on social influence, strengthening of leadership by gaining active commitment and initiative of ward management. The organizational level addresses the structural context and institutional management support.

To assess the cost implications of the CHANGE strategy, an economic evaluation will be conducted from a healthcare perspective. The cost-effectiveness of improved HH, defined here as the costs for the CHANGE strategy minus less costs for treating infections, divided by the difference between HAIs before and after the intervention period, will be calculated. A process evaluation will be performed during and after the intervention to investigate the feasibility of the implementation strategy and to illuminate the mechanisms and processes responsible for the results and their variation within the NHs.


Condition or disease Intervention/treatment Phase
Infectious and Communicable Diseases Other: Hand hygiene implementation strategy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Compliance With Hand Hygiene in Nursing Homes: Go for a Sustainable Effect (CHANGE)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Hand hygiene implementation strategy
The implementation strategy will be tested in a stepped wedge cluster randomized trial which is based on a random sequential roll-out of the CHANGE implementation strategy to all participating NHs (n=20) for comparison. All groups (hence all NHs) start with the control situation (no CHANGE implementation activities) at the beginning of the study. At each time point, a new group of five NHs crosses over from the control situation to the implementation situation. Each group will start the implementation phase of 4 months at a different time point, directly after one of the measurements periods (Point of Time (PT) 0, PT1, PT2, PT3, PT4, PT5). The time point a group crosses over is randomized (over the groups).
Other: Hand hygiene implementation strategy
Implementation strategy: Individual oriented activities. Education based on the different determinants influencing HCWs' behavior. Reminders for supporting the actual performance of HH; by distributing posters. Performance feedback for awareness. Goal setting will be encouraged and the feedback will be used to help HCWs evaluate their success and determine how they could best adapt their behavior in order to reach their goal. Organisational oriented activities. Products and facilities: The physical environment will be adapted by improving the availability of hand based hand rub. Team-oriented activities; The social environment will be adapted by training at a group and individual level, to improve social and descriptive norms. Positive role models will be stimulated through this training.




Primary Outcome Measures :
  1. Hand hygiene compliance [ Time Frame: two year ]
    Data are collected during six consecutive periods of 4 month each (Point of time (PT) 0,PT1,PT2,PT3,PT4 and PT5); 1200 opportunities for HH compliance in the NH's are observed during each time period. At each data collection period (PT0-PT5) 60 opportunities for HH compliance, in 12-15 HCWs, per NH will be observed


Secondary Outcome Measures :
  1. Healthcare associated infections [ Time Frame: 2 years ]
    The incidence of HAIs in the participating NHs will be collected through the routine SNIV surveillance. In this surveillance network, infections are reported weekly through a web-based application. Only new episodes of an infection are registered



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Nursing homes has to join the incidence registration of the national network SNIV (Surveillance Network of Infectious diseases in Nursing homes)

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817282


Sponsors and Collaborators
Radboud University
National Institute for Public Health and the Environment (RIVM)
Investigators
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Principal Investigator: Marlies Hulsher, Prof Dr UMC Radboud

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02817282     History of Changes
Other Study ID Numbers: 50-53000-98-113
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection