Trial Outcomes & Findings for Toronto Thromboprophylaxis Patient Safety Initiative (NCT NCT01869075)

NCT ID: NCT01869075

Last Updated: 2014-09-23

Results Overview

Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk. Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control. Appropriate VTE prophylaxis was defined as: in "Hip Fracture Surgery" - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in "Major General Surgery" - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in "Acute Medical Illness" - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay. Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1895 participants

Primary outcome timeframe

End of study (end of phase 2) - measured over duration of hospital stay.

Results posted on

2014-09-23

Participant Flow

Recruitment of study sites not individual patients.

After site enrolment, baseline data was collected for all sites in order to establish sample size for phases 1 and 2.

Participant milestones

Participant milestones
Measure
AMI - Knowledge Translation Toolkit
AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
AMI - Usual Care
Usual care provided at the hospital
MGS - Knowledge Translation Toolkit
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
MGS - Usual Care
Usual care provided at the hospital
HFS - Knowledge Translation Toolkit
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
HFS - Usual Care
Usual care provided at the hospital
Phase 0 (Baseline)
STARTED
0
418
0
416
0
341
Phase 0 (Baseline)
COMPLETED
0
418
0
416
0
341
Phase 0 (Baseline)
NOT COMPLETED
0
0
0
0
0
0
Phase 1
STARTED
45
75
45
75
30
90
Phase 1
COMPLETED
45
75
45
75
30
90
Phase 1
NOT COMPLETED
0
0
0
0
0
0
Phase 2
STARTED
90
30
75
45
75
45
Phase 2
COMPLETED
90
30
75
45
75
45
Phase 2
NOT COMPLETED
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Toronto Thromboprophylaxis Patient Safety Initiative

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AMI - Knowledge Translation Toolkit
AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
AMI - Usual Care
n=341 Participants
Usual care as provided at the hospital.
MGS - Knowledge Translation Toolkit
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
MGS - Usual Care
n=416 Participants
Usual Care as provided at the hospital.
HFS - Knowledge Translation Toolkit
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
HFS - Usual Care
n=418 Participants
Usual Care as provided at the hospital.
Total
n=1175 Participants
Total of all reporting groups
Age, Customized
18 years and older
341 participants
n=107 Participants
416 participants
n=7 Participants
418 participants
n=30 Participants
1175 participants
n=3 Participants
Sex: Female, Male
Female
NA Participants
n=107 Participants
NA Participants
n=7 Participants
NA Participants
n=30 Participants
NA Participants
n=3 Participants
Sex: Female, Male
Male
NA Participants
n=107 Participants
NA Participants
n=7 Participants
NA Participants
n=30 Participants
NA Participants
n=3 Participants

PRIMARY outcome

Timeframe: End of study (end of phase 2) - measured over duration of hospital stay.

Population: The number of participants in the analysis was 720. In phase 1, there were 360 patients included and in phase 2, an additional 360 patients were included. The outcomes by end of study (end of phase 2) are reported. The patients in control (usual care) and intervention (Knowledge Translation toolkit) were compared.

Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk. Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control. Appropriate VTE prophylaxis was defined as: in "Hip Fracture Surgery" - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in "Major General Surgery" - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in "Acute Medical Illness" - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay. Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study.

Outcome measures

Outcome measures
Measure
AMI - Knowledge Translation Toolkit
n=135 Participants
AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
AMI - Usual Care
n=105 Participants
Usual care as provided at the hospital
MGS - Knowledge Translation Toolkit
n=120 Participants
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
MGS - Usual Care
n=120 Participants
Usual Care as provided at the hospital
HFS - Knowledge Translation Toolkit
n=105 Participants
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
HFS - Usual Care
n=135 Participants
Usual Care as provided at the hospital
Percentage of Patients Prescribed Appropriate VTE Prophylaxis
64 percentage of patients
Interval 0.89 to 3.36
62 percentage of patients
Interval 0.89 to
67 percentage of patients
54 percentage of patients
85 percentage of patients
76 percentage of patients

Adverse Events

AMI - Knowledge Translation Toolkit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

AMI - Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MGS - Knowledge Translation Toolkit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MGS - Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

HFS - Knowledge Translation Toolkit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

HFS - Usual Care

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

Artemis Diamantouros

Sunnybrook HSC

Phone: 416-480-6100

Results disclosure agreements

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