Trial Outcomes & Findings for Education Bundle to Decrease Patient Refusal of VTE Prophylaxis (NCT NCT02402881)
NCT ID: NCT02402881
Last Updated: 2020-01-06
Results Overview
This is the percentage of venous thromboembolism (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
NA
Target enrollment
19652 participants
Primary outcome timeframe
15 Months
Results posted on
2020-01-06
Participant Flow
16 medical and surgical hospital units were included, intensive care units were excluded. Convenience sample of 4 units (2 surgical and 2 medical) received the intervention. The remaining 12 units (5 surgical and 7 medical) served as control and received no intervention. Pre-Intervention data were retrospectively assessed
Participant milestones
| Measure |
Intervention
Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
|
Control
Patients will receive only the standard practices of care
|
|---|---|---|
|
Pre-Intervention Study Period
STARTED
|
2222
|
5657
|
|
Pre-Intervention Study Period
COMPLETED
|
2222
|
5657
|
|
Pre-Intervention Study Period
NOT COMPLETED
|
0
|
0
|
|
Post-Intervention Study Period
STARTED
|
3111
|
8662
|
|
Post-Intervention Study Period
COMPLETED
|
3111
|
8662
|
|
Post-Intervention Study Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
Baseline characteristics by cohort
| Measure |
Intervention
n=5333 Participants
Patient Visits received the Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
This trial treats each visit as a separate enrollment and as a result it is only appropriate to consider the participant at the visit level. The outcomes assessed for this trial were analyzed on the patient visit level, as each visit represents a totally unique participant outcome. For example, Patient A might receive all doses during the first admission to the hospital but the same Patient A might miss doses during a second hospitalization. Similarly, Patient A might have been in Arm 1 during the first hospitalization and in Arm 2 during the second hospitalization.
|
Control
n=14319 Participants
Patient Visits received the only the standard practices of care. This trial treats each visit as a separate enrollment and as a result it is only appropriate to consider the participant at the visit level. The outcomes assessed for this trial were analyzed on the patient visit level, as each visit represents a totally unique participant outcome. For example, Patient A might receive all doses during the first admission to the hospital but the same Patient A might miss doses during a second hospitalization. Similarly, Patient A might have been in Arm 1 during the first hospitalization and in Arm 2 during the second hospitalization.
|
Total
n=19652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Pre-Intervention
|
53.9 Years
STANDARD_DEVIATION 17.4 • n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
56.3 Years
STANDARD_DEVIATION 16.9 • n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
55.6 Years
STANDARD_DEVIATION 17.1 • n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Age, Continuous
Post-Intervention
|
54.6 Years
STANDARD_DEVIATION 17.6 • n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
55.8 Years
STANDARD_DEVIATION 16.9 • n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
55.5 Years
STANDARD_DEVIATION 17.1 • n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Sex: Female, Male
Pre-Intervention · Female
|
1153 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
2687 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
3840 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Sex: Female, Male
Pre-Intervention · Male
|
1069 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
2970 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4039 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Sex: Female, Male
Post-Intervention · Female
|
1587 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4074 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
5661 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Sex: Female, Male
Post-Intervention · Male
|
1524 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4588 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
6112 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Pre-Intervention · Black
|
941 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
2307 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
3248 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Pre-Intervention · White
|
1088 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
2850 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
3938 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Pre-Intervention · Asian
|
44 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
117 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
161 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Pre-Intervention · Native American
|
9 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
12 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
21 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Pre-Intervention · Others
|
140 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
371 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
511 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Post-Intervention · Black
|
1308 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
3469 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4777 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Post-Intervention · White
|
1533 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4432 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
5965 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Post-Intervention · Asian
|
73 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
167 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
240 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Post-Intervention · Native American
|
4 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
14 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
18 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Race/Ethnicity, Customized
Post-Intervention · Others
|
193 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
580 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
773 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Hospital Unit Type
Pre-Intervention · Surgical
|
1155 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
2530 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
3685 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Hospital Unit Type
Pre-Intervention · Medical
|
1067 Participants
n=2222 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
3127 Participants
n=5657 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4194 Participants
n=7879 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Hospital Unit Type
Post-Intervention · Surgical
|
1647 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4076 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
5723 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
|
Hospital Unit Type
Post-Intervention · Medical
|
1464 Participants
n=3111 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
4586 Participants
n=8662 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
6050 Participants
n=11773 Participants • Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
|
PRIMARY outcome
Timeframe: 15 MonthsPopulation: Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
This is the percentage of venous thromboembolism (VTE) prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse.
Outcome measures
| Measure |
Intervention
n=5333 Participants
Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
|
Control
n=14319 Participants
Patients will receive only the standard practices of care.
|
|---|---|---|
|
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
Post-Intervention
|
5.6 Percentage of nonadministration
Interval 3.1 to 9.9
|
13.3 Percentage of nonadministration
Interval 9.6 to 18.5
|
|
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
Pre-Intervention
|
9.1 Percentage of nonadministration
Interval 5.2 to 16.2
|
13.6 Percentage of nonadministration
Interval 9.8 to 18.7
|
SECONDARY outcome
Timeframe: 15 MonthsPopulation: Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. 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 patient education intervention.
This is the number of participants with VTE events as documented in the electronic health record.
Outcome measures
| Measure |
Intervention
n=5333 Participants
Patient-centered education bundle: A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
|
Control
n=14319 Participants
Patients will receive only the standard practices of care.
|
|---|---|---|
|
Number of Participants With Venous Thromboembolism
Post-Intervention
|
6 Participants
|
17 Participants
|
|
Number of Participants With Venous Thromboembolism
Pre-Intervention
|
7 Participants
|
14 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place