NCT02223455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 4, 2019

Completed
Last Updated

October 4, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

August 20, 2014

Results QC Date

July 19, 2019

Last Update Submit

September 11, 2019

Conditions

Keywords

Methicillin-resistant Staphylococcus aureus (MRSA)Infection Control (IC)Hospital-associated infections (HAI)Hand Hygiene (HH)ComplianceHealth Care Workers (HCWs)

Outcome Measures

Primary Outcomes (1)

  • Hand Hygiene Compliance

    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.

    phase 1 (7-12 months) thru phase 3 (19-21 months)

Study Arms (3)

Single Hand Hygiene Sign

PLACEBO COMPARATOR

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.

Other: Hand Hygiene Signs

Hand Hygiene Signs Changed Monthly

ACTIVE COMPARATOR

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.

Other: Hand Hygiene Signs

Hand Hygiene Signs Changed Weekly

ACTIVE COMPARATOR

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.

Other: Hand Hygiene Signs

Interventions

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.

Hand Hygiene Signs Changed MonthlyHand Hygiene Signs Changed WeeklySingle Hand Hygiene Sign

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1873, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cross InfectionPatient Compliance

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Heather Reisinger
Organization
CADRE - Iowa City VAHCS

Study Officials

  • Heather S Reisinger, PhD

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 22, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2016

Study Completion

March 1, 2019

Last Updated

October 4, 2019

Results First Posted

October 4, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

As requested

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
August 2020 for 7 years
Access Criteria
IRB and VA Research and Development approval of protocol for sharing

Locations