Trial Outcomes & Findings for Educating Nurses About Venous Thromboembolism (VTE) Prevention (NCT NCT02301793)

Last Updated: 2019-05-17

Results Overview

This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse

Recruitment status

COMPLETED

Study phase

Target enrollment

933 participants

Primary outcome timeframe

(Baseline); approximately 3 months later (Post-Education)

Results posted on

2019-05-17

Participant Flow

Nurses were identified using our centralized education directory that associates nurses with their designated departments and hospital floors. On July 23, 2014, nurses were cluster randomized by floor to receive one of two education modules about VTE prevention. Nurses were asked to complete their assigned education module by October 23, 2014.

Pre Education Study Period reflects the baseline participants information (patient visits). Post Education Study Period reflects the participants information following the implementation of the nurse education intervention.

Unit of analysis: Patient visits

Participant milestones

Participant milestones
Measure	Contemporary Education Format Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format	Traditional Education Format Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over. Intervention: Nurse education in traditional format Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
Pre Education Study Period STARTED	0 2722	0 2603
Pre Education Study Period COMPLETED	0 2722	0 2603
Pre Education Study Period NOT COMPLETED	0 0	0 0
During and Post Education Study Period STARTED	488 6566	445 5355
During and Post Education Study Period COMPLETED	405 6566	396 5355
During and Post Education Study Period NOT COMPLETED	83 0	49 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contemporary Education Format n=2722 Patient Visit Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format	Traditional Education Format n=2603 Patient Visit Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over. Intervention: Nurse education in traditional format Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.	Total n=5325 Patient Visit Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 16.9 • n=2722 Patient Visit	56.3 years STANDARD_DEVIATION 17.3 • n=2603 Patient Visit	56 years STANDARD_DEVIATION 17.1 • n=5325 Patient Visit
Sex: Female, Male Female	1435 Patient Visit n=2722 Patient Visit • The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.	1186 Patient Visit n=2603 Patient Visit • The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.	2621 Patient Visit n=5325 Patient Visit • The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.
Sex: Female, Male Male	1287 Patient Visit n=2722 Patient Visit • The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.	1417 Patient Visit n=2603 Patient Visit • The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.	2704 Patient Visit n=5325 Patient Visit • The numbers of patients were 2,722 and 2603, in the dynamic and static groups respectively. While the unique number of patients were 1925, and 2021 respectively.
Race (NIH/OMB) American Indian or Alaska Native	4 Patient Visit n=2722 Patient Visit	7 Patient Visit n=2603 Patient Visit	11 Patient Visit n=5325 Patient Visit
Race (NIH/OMB) Asian	46 Patient Visit n=2722 Patient Visit	50 Patient Visit n=2603 Patient Visit	96 Patient Visit n=5325 Patient Visit
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Patient Visit n=2722 Patient Visit	0 Patient Visit n=2603 Patient Visit	0 Patient Visit n=5325 Patient Visit
Race (NIH/OMB) Black or African American	1106 Patient Visit n=2722 Patient Visit	980 Patient Visit n=2603 Patient Visit	2086 Patient Visit n=5325 Patient Visit
Race (NIH/OMB) White	1367 Patient Visit n=2722 Patient Visit	1396 Patient Visit n=2603 Patient Visit	2763 Patient Visit n=5325 Patient Visit
Race (NIH/OMB) More than one race	199 Patient Visit n=2722 Patient Visit	170 Patient Visit n=2603 Patient Visit	369 Patient Visit n=5325 Patient Visit
Race (NIH/OMB) Unknown or Not Reported	0 Patient Visit n=2722 Patient Visit	0 Patient Visit n=2603 Patient Visit	0 Patient Visit n=5325 Patient Visit
Region of Enrollment United States	2722 Patient Visit n=2722 Patient Visit	2603 Patient Visit n=2603 Patient Visit	5325 Patient Visit n=5325 Patient Visit

PRIMARY outcome

Timeframe: (Baseline); approximately 3 months later (Post-Education)

Population: The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.

This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse

Outcome measures

Outcome measures
Measure	Contemporary Education Format n=6835 patient visits Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format	Traditional Education Format n=5941 patient visits Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over. Intervention: Nurse education in traditional format Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
Non Administration of Prescribed VTE Prophylaxis Medication Doses Pre-Education	10.8 percentage of nonadministration Interval 7.7 to 15.0	14.5 percentage of nonadministration Interval 10.2 to 20.4
Non Administration of Prescribed VTE Prophylaxis Medication Doses Post-Education	9.2 percentage of nonadministration Interval 6.6 to 12.8	13.5 percentage of nonadministration Interval 9.6 to 19.1

SECONDARY outcome

Timeframe: 3-12 months after end of study

Population: Data were not collected

Did the intervention decrease rates of VTE among hospitalized patients?

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-12 months after end of study

Population: Data were not collected

Did the intervention decrease rates of DVT among hospitalized patients?

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-12 months after end of study

Population: Data were not collected

Did the intervention decrease rates of PE among hospitalized patients?

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; approximately 3 months later (post education)

Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?

Outcome measures

Outcome measures
Measure	Contemporary Education Format n=6835 patient visits Nurses in this arm received education about venous thromboembolism (VTE) in a web-based contemporary interactive format. Intervention: Nurse education in contemporary format Nurse education in contemporary format: Education about VTE was delivered through a web-based contemporary interactive format	Traditional Education Format n=5941 patient visits Nurses in this arm received education about venous thromboembolism (VTE) in a web-based traditional linear PowerPoint format with voice over. Intervention: Nurse education in traditional format Nurse education in traditional format: Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal Pre-Education	5.6 percentage of patient refused doses Interval 3.1 to 10.0	7.3 percentage of patient refused doses Interval 4.0 to 13.2
Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal Post-Education	5.1 percentage of patient refused doses Interval 2.8 to 9.0	7.0 percentage of patient refused doses Interval 3.8 to 12.6

Adverse Events

Contemporary Education Format

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Education Format

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

Elliott R Haut M.D, PhD, Associate Professor of Surgery, Anesthesiology &Critical Care Medicine

Johns Hopkins Medical Institutions

Phone: 410-502-3122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place