Trial Outcomes & Findings for Building an Optimal Hand Hygiene Bundle (NCT NCT02223455)

NCT ID: NCT02223455

Last Updated: 2019-10-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: phase 1 (7-12 months) thru phase 3 (19-21 months)
• Results posted on: 2019-10-04

Participant Flow

Unit of analysis: inpatient wards/units

Participant milestones

Measure	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. 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.	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. 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.	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. 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.
Overall Study STARTED	0 19	0 19	0 20
Overall Study COMPLETED	0 19	0 19	0 20
Overall Study NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Building an Optimal Hand Hygiene Bundle

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

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

Population: Entry and exit HH compliance were calculated for units in each treatment group. Crude (unadjusted) change in HH compliance from baseline to follow-up was assessed for each intervention group using Fisher's exact test.

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.

Outcome measures

Measure	Single Hand Hygiene Sign n=19 inpatient wards/units 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. Hand Hygiene Compliance 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.	Hand Hygiene Signs Changed Monthly n=19 inpatient wards/units 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. Hand Hygiene Compliance 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.	Hand Hygiene Signs Changed Weekly n=20 inpatient wards/units 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. Hand Hygiene Compliance 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.
Hand Hygiene Compliance Room Entry	-0.4 percentage of change in HH compliance Interval -20.5 to 23.0	1.8 percentage of change in HH compliance Interval -21.5 to 29.7	-1.3 percentage of change in HH compliance Interval -17.9 to 17.4
Hand Hygiene Compliance Room Exit	-3.7 percentage of change in HH compliance Interval -16.4 to 10.2	-5.2 percentage of change in HH compliance Interval -16.2 to 6.7	1.8 percentage of change in HH compliance Interval -11.1 to 16.1

Adverse Events

Single Hand Hygiene Sign

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hand Hygiene Signs Changed Monthly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hand Hygiene Signs Changed Weekly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Reisinger

CADRE - Iowa City VAHCS

Phone: 319-338-0581

Email: heather.reisinger@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place