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

NCT02817282 | Completed DMC

• 1 other identifier: 50-53000-98-113
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infectious and Communicable Diseases

Outcome Measures

Primary Outcomes (1)

• Hand hygiene compliance

  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

  two year

Secondary Outcomes (1)

• Healthcare associated infections

  2 years

Study Arms (1)

Hand hygiene implementation strategy

OTHER

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

Interventions

Hand hygiene implementation strategy OTHER

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.

Hand hygiene implementation strategy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• National Institute for Public Health and the Environment (RIVM): collaborator

Related Publications (1)

• Teerenstra S, Taljaard M, Haenen A, Huis A, Atsma F, Rodwell L, Hulscher M. Sample size calculation for stepped-wedge cluster-randomized trials with more than two levels of clustering. Clin Trials. 2019 Jun;16(3):225-236. doi: 10.1177/1740774519829053. Epub 2019 Apr 24.

  PMID: 31018678 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlies Hulsher, Prof Dr

  UMC Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: June 29, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share