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Building an Optimal Hand Hygiene Bundle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02223455
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 20, 2014
First Posted Date  ICMJE August 22, 2014
Results First Submitted Date  ICMJE July 19, 2019
Results First Posted Date  ICMJE October 4, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE October 1, 2014
Actual Primary Completion Date August 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
Hand Hygiene Compliance [ Time Frame: phase 1 (7-12 months) thru phase 3 (19-21 months) ]
Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research & Development (HSR&D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
Hand Hygiene Compliance [ Time Frame: phase 1 (7-12 months) thru phase 3 (19-21 months) ]
Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research & Development (HSR&D) funded study (IIR 09-099). Both compliance and MRSA infection rates will be collected monthly throughout the project for each of the 59 units.
Change History Complete list of historical versions of study NCT02223455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
MRSA Acquisition [ Time Frame: phase 1 (7-12 months) thru phase 3 (19-21 months) ]
The secondary outcome measure is MRSA acquisition. MRSA infection rates will be collected monthly throughout the project for each of the 59 units.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Building an Optimal Hand Hygiene Bundle
Official Title  ICMJE Building an Optimal Hand Hygiene Bundle: A Mixed Methods Approach
Brief Summary Hand hygiene is the single most effective practice in preventing the spread of hospital-acquired infections. Despite the strength of the evidence, hospital staff continue to sanitize their hands less than half of the time required by guidelines. Effective interventions are needed to improve hand hygiene compliance rates among hospital staff, but most are of poor quality and do not examine the specific effects of individual interventions. This study will build a "bundle" of three hand hygiene interventions using a research design that allows for the effectiveness of each intervention to be measured individually and combined.
Detailed Description

The two specific aims and associated hypotheses of CREATE Project 2 include:

  1. Identify combinations of hand-hygiene intervention strategies that optimize hand-hygiene compliance and that could form an evidence-based hand-hygiene bundle for Veterans Health Administration (VHA) implementation.

    Hypothesis 1: Combinations of interventions will increase compliance rates more than single interventions.

    Aim 1 will entail a 30-month cluster-randomized controlled trial that will sequentially test three individual hand-hygiene interventions - hand-hygiene point-of-use reminder signs to serve as an environmental cue to action, individual hand sanitizers, and health care worker hand cultures - to identify an optimal combination of interventions to increase hand-hygiene compliance. The trial will be conducted in 59 hospital units in 10 VA hospitals in order to test the efficacy of individual and then sequentially added interventions to determine their incremental impact on hand-hygiene compliance.

    The focus for this clinical trial will be on Aim 1--Single Hand Hygiene Sign changes.

  2. Identify institutional, organizational, ward/ICU, and individual level facilitators and barriers to implementing hand-hygiene interventions.

Hypothesis 2: Facilitators and barriers will pattern around contextual factors such as level of leadership support and organization of infection control programs.

Aim 2 will entail a qualitative process evaluation that includes site visits to purposefully selected sites, semi-structured interviews, and observations to examine barriers and facilitators to the interventions and develop contextual insight for implementing and scaling-up the intervention at additional sites as a national initiative.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Hand Hygiene
  • Health Care Associated Infection
  • Compliance
Intervention  ICMJE Other: Hand Hygiene Signs
Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.
Study Arms  ICMJE
  • Placebo Comparator: Single Hand Hygiene Sign
    Wards/units in this arm of the study will have the same hand hygiene sign posted by the hand sanitizer dispensers outside each patient room. The sign will not change.
    Intervention: Other: Hand Hygiene Signs
  • Active Comparator: Hand Hygiene Signs Changed Monthly
    Intervention: Hand Hygiene Signs Changed Monthly Hand hygiene signs will be changed monthly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.
    Intervention: Other: Hand Hygiene Signs
  • Active Comparator: Hand Hygiene Signs Changed Weekly
    Intervention: Hand Hygiene Signs Changed Weekly Hand hygiene signs will be changed weekly on wards/units randomized to this arm of the study. Signs will be posted by the hand hygiene sanitizer outside each patient room.
    Intervention: Other: Hand Hygiene Signs
Publications * Vander Weg MW, Perencevich EN, O'Shea AMJ, Jones MP, Vaughan Sarrazin MS, Franciscus CL, Goedken CC, Baracco GJ, Bradley SF, Cadena J, Forrest GN, Gupta K, Morgan DJ, Rubin MA, Thurn J, Bittner MJ, Reisinger HS. Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2019 Oct 2;2(10):e1913823. doi: 10.1001/jamanetworkopen.2019.13823.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2014)
59
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date August 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Wards/units at 10 VA medical centers: hand hygiene observations of healthcare works on these wards/units

Exclusion Criteria:

None

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02223455
Other Study ID Numbers  ICMJE CRE 12-289
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: As requested
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: August 2020 for 7 years
Access Criteria: IRB and VA Research and Development approval of protocol for sharing
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heather S Reisinger, PhD Iowa City VA Health Care System, Iowa City, IA
PRS Account VA Office of Research and Development
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP