Trial Outcomes & Findings for Safe Critical Care: Testing Improvement Strategies (NCT NCT00975923)

Last Updated: 2016-01-12

Results Overview

Central line associated bloodstream infections(CLABSI) and ventilator associated pneumonias (VAP) using Centers for Disease Control and Prevention definitions as number of events per 1,000 device days, data collection and surveillance methods.

Recruitment status

COMPLETED

Study phase

Target enrollment

59 participants

Primary outcome timeframe

18 Months: 3-month baseline and quarterly post-intervention periods

Results posted on

2016-01-12

Participant Flow

Leaders of all medical centers with at least 1 adult or pediatric ICU received an invitation to participate in a Quality Improvement initiative. Hospitals willing to participate were matched on geographic location and ICU volume and then randomized into either the Collaborative or Tool Kit Group in December 2005.

Participant milestones

Participant milestones
Measure	Collaborative Group One group of hospitals is randomly allocated to the Collaborative Group	Tool Kit Group One group of hospitals is allocated randomly to the Tool Kit Group
Overall Study STARTED	30	30
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Collaborative Group One group of hospitals is randomly allocated to the Collaborative Group	Tool Kit Group One group of hospitals is allocated randomly to the Tool Kit Group
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Safe Critical Care: Testing Improvement Strategies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collaborative Group n=30 Participants One group of hospitals is randomly allocated to the Collaborative Group	Tool Kit Group n=30 Participants One group of hospitals is allocated randomly to the Tool Kit Group	Total n=60 Participants Total of all reporting groups
Age, Customized Pediatric ICU (Age < 18 years)	0 Hospitals n=5 Participants	0 Hospitals n=7 Participants	0 Hospitals n=5 Participants
Age, Customized Adult ICU (Age >= 18 years)	30 Hospitals n=5 Participants	30 Hospitals n=7 Participants	60 Hospitals n=5 Participants
Sex/Gender, Customized Average % Female	49.7 Percentage of ICU female patient volume STANDARD_DEVIATION 5.7 • n=5 Participants	50.3 Percentage of ICU female patient volume STANDARD_DEVIATION 7.7 • n=7 Participants	50 Percentage of ICU female patient volume STANDARD_DEVIATION 6 • n=5 Participants
ICU annual patient volume	568 ICU patients/year n=5 Participants	578 ICU patients/year n=7 Participants	570 ICU patients/year n=5 Participants
ICU mortality rate	5.7 ICU mortality rate/year STANDARD_DEVIATION 3.1 • n=5 Participants	7.1 ICU mortality rate/year STANDARD_DEVIATION 3.6 • n=7 Participants	6 ICU mortality rate/year STANDARD_DEVIATION 3.5 • n=5 Participants
Medicare case-mix weight	1221 Medicare Case-Mix Index/year STANDARD_DEVIATION 1007 • n=5 Participants	1295 Medicare Case-Mix Index/year STANDARD_DEVIATION 1110 • n=7 Participants	1250 Medicare Case-Mix Index/year STANDARD_DEVIATION 1000 • n=5 Participants

PRIMARY outcome

Timeframe: 18 Months: 3-month baseline and quarterly post-intervention periods

Population: A cluster randomized trial randomly assigned hospitals to either the Collaborative or Tool Kit groups, stratified by region within the United States and ICU volume. Implementation and analysis was at the level of the ICU. One of the 30 hospital in the Tool Kit Group was sold, leaving 29 hospitals. Analysis was conducted per protocol.

Outcome measures

Outcome measures
Measure	Collaborative Group n=30 Participants Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit	Tool Kit Group n=29 Participants Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
CLABSI and VAP Rates Baseline CLABSI	1.84 events/1000 device days Interval 0.0 to 3.83	2.42 events/1000 device days Interval 0.65 to 6.8
CLABSI and VAP Rates 3 Month CLABSI	2.24 events/1000 device days Interval 0.54 to 4.69	2.47 events/1000 device days Interval 1.48 to 5.35
CLABSI and VAP Rates 6 Month CLABSI	2.28 events/1000 device days Interval 0.0 to 3.73	2.54 events/1000 device days Interval 0.0 to 4.98
CLABSI and VAP Rates 12 month CLABSI	1.18 events/1000 device days Interval 0.0 to 2.71	1.17 events/1000 device days Interval 0.0 to 3.61
CLABSI and VAP Rates 18 Month CLABSI	2.76 events/1000 device days Interval 0.0 to 4.67	1.16 events/1000 device days Interval 0.0 to 5.46
CLABSI and VAP Rates Baseline VAP	2.14 events/1000 device days Interval 0.0 to 6.09	3.49 events/1000 device days Interval 0.0 to 7.04
CLABSI and VAP Rates 3 Month VAP	3.01 events/1000 device days Interval 0.0 to 9.11	3.32 events/1000 device days Interval 0.0 to 8.25
CLABSI and VAP Rates 6 Month VAP	2.72 events/1000 device days Interval 0.0 to 7.09	4.61 events/1000 device days Interval 0.0 to 9.37
CLABSI and VAP Rates 12 Month VAP	2.67 events/1000 device days Interval 0.0 to 4.47	2.66 events/1000 device days Interval 0.0 to 4.82
CLABSI and VAP Rates 18 Month VAP	2.93 events/1000 device days Interval 0.0 to 7.63	2.06 events/1000 device days Interval 0.0 to 6.59

SECONDARY outcome

Timeframe: 18 months

Population: per protocol

Follow-up survey of ICU nurse and quality managers for all participating medical centers from Jan 2008 through April 2008 included questions about the implementation of process interventions: Access and use of clinical guidelines tools, access and use of quality improvement tools, and types of quality improvement implementation strategies.

Outcome measures

Outcome measures
Measure	Collaborative Group n=26 Participants Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit	Tool Kit Group n=19 Participants Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
Access of Tools and Use of Quality Improvement Strategies Clinical Tool Use	61 Percentage of ICUs	49 Percentage of ICUs
Access of Tools and Use of Quality Improvement Strategies Data Tools	56 Percentage of ICUs	30 Percentage of ICUs
Access of Tools and Use of Quality Improvement Strategies Strategies	69 Percentage of ICUs	54 Percentage of ICUs

Adverse Events

Collaborative Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tool Kit Group

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

Dr. Theodore Speroff

Vanderbilt University School of Medicine

Phone: 615-636-9476

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place