Deep Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
venous thromboembolism, deep venous thrombosis, pulmonary embolism, blood clots
Brief summary
The investigators have recently developed a registry of missed doses of VTE prophylaxis that includes retrospective data on missed doses of VTE prophylaxis. To decrease rates of VTE prophylaxis refusal, the group has developed 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 education sheet and an educational video. The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE.
Detailed description
Background This research group's published pilot study reported that nearly 12% of prescribed doses of pharmacologic VTE prophylaxis are not administered and almost 60% of missed doses are due to patient or family member refusal. Fanikos et al found that 44% of missed doses of VTE prophylaxis were due to patient refusal. In a survey of 500 recently hospitalized patients, the National Blood Clot Alliance found that only 28% and 15% respectively had basic knowledge of deep venous thrombosis (DVT) or pulmonary embolism (PE) despite the fact that 15% of participants had a history and 43% had a family history of either condition. Given these high rates of patient refusal of VTE prophylaxis and significant knowledge gaps regarding VTE, there is an urgent need to educate patients and families on the importance and benefits of compliance with VTE prophylaxis. The proposed patient-centered education bundle will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page education sheet and an educational video. The investigators hypothesize that patient refusal of VTE prophylaxis is associated with significant knowledge gaps among patients regarding patients' risk of developing VTE and the benefits of VTE prophylaxis and that delivering an education bundle to patients that refuse VTE prophylaxis will improve compliance with VTE prophylaxis and decrease rates of VTE. Objectives Primary objective: is to determine the impact of delivering a patient education intervention bundle on rates of VTE prophylaxis non-administration. Secondary objective: is to determine the impact of delivering a patient education intervention bundle on rates of VTE. Methods The investigators have developed a real-time alert that notifies a member of the research team whenever a patient misses patients' dose of VTE prophylaxis. This interventional study will take place on on four hospital floors. Whenever a nurse educator receives an alert from any of the included floors indicating that a dose of VTE prophylaxis has been missed, she/he will visit the floor, and approach the nurse in charge of that patient to find out the reason for the missed dose. If the dose was missed as a result of patient refusal, the nurse educator will visit the patient and deliver the education bundle comprised of: 1) a one-on-one education session, 2) the patient education sheet and 3) the patient education video depending on patient preference. The intervention will be in real time for doses missed on business days between 8.00am and 4.00pm and at the start of the next business day for doses missed during non-business hours or on weekends. The investigators anticipate that the study will continue for 5 years and the investigators anticipate a total of 1000 patients during the study duration.
Interventions
BEHAVIORALPatient-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.
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses | 15 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Venous Thromboembolism | 15 Months | This is the number of participants with VTE events as documented in the electronic health record. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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. | 5,333 |
| Control 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. | 14,319 |
| Total | 19,652 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous Post-Intervention | 54.6 Years STANDARD_DEVIATION 17.6 | 55.8 Years STANDARD_DEVIATION 16.9 | 55.5 Years STANDARD_DEVIATION 17.1 |
| Age, Continuous Pre-Intervention | 53.9 Years STANDARD_DEVIATION 17.4 | 56.3 Years STANDARD_DEVIATION 16.9 | 55.6 Years STANDARD_DEVIATION 17.1 |
| Hospital Unit Type Post-Intervention Medical | 1464 Participants | 4586 Participants | 6050 Participants |
| Hospital Unit Type Post-Intervention Surgical | 1647 Participants | 4076 Participants | 5723 Participants |
| Hospital Unit Type Pre-Intervention Medical | 1067 Participants | 3127 Participants | 4194 Participants |
| Hospital Unit Type Pre-Intervention Surgical | 1155 Participants | 2530 Participants | 3685 Participants |
| Race/Ethnicity, Customized Post-Intervention Asian | 73 Participants | 167 Participants | 240 Participants |
| Race/Ethnicity, Customized Post-Intervention Black | 1308 Participants | 3469 Participants | 4777 Participants |
| Race/Ethnicity, Customized Post-Intervention Native American | 4 Participants | 14 Participants | 18 Participants |
| Race/Ethnicity, Customized Post-Intervention Others | 193 Participants | 580 Participants | 773 Participants |
| Race/Ethnicity, Customized Post-Intervention White | 1533 Participants | 4432 Participants | 5965 Participants |
| Race/Ethnicity, Customized Pre-Intervention Asian | 44 Participants | 117 Participants | 161 Participants |
| Race/Ethnicity, Customized Pre-Intervention Black | 941 Participants | 2307 Participants | 3248 Participants |
| Race/Ethnicity, Customized Pre-Intervention Native American | 9 Participants | 12 Participants | 21 Participants |
| Race/Ethnicity, Customized Pre-Intervention Others | 140 Participants | 371 Participants | 511 Participants |
| Race/Ethnicity, Customized Pre-Intervention White | 1088 Participants | 2850 Participants | 3938 Participants |
| Sex: Female, Male Post-Intervention Female | 1587 Participants | 4074 Participants | 5661 Participants |
| Sex: Female, Male Post-Intervention Male | 1524 Participants | 4588 Participants | 6112 Participants |
| Sex: Female, Male Pre-Intervention Female | 1153 Participants | 2687 Participants | 3840 Participants |
| Sex: Female, Male Pre-Intervention Male | 1069 Participants | 2970 Participants | 4039 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5,333 | 0 / 14,319 |
| other Total, other adverse events | 0 / 5,333 | 0 / 14,319 |
| serious Total, serious adverse events | 0 / 5,333 | 0 / 14,319 |
Outcome results
Primary
Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
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.
Time frame: 15 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses | Pre-Intervention | 9.1 Percentage of nonadministration |
| Intervention | Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses | Post-Intervention | 5.6 Percentage of nonadministration |
| Control | Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses | Pre-Intervention | 13.6 Percentage of nonadministration |
| Control | Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses | Post-Intervention | 13.3 Percentage of nonadministration |
Comparison: Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.p-value: <0.05Mixed Models Analysis
Secondary
Number of Participants With Venous Thromboembolism
This is the number of participants with VTE events as documented in the electronic health record.
Time frame: 15 Months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With Venous Thromboembolism | Pre-Intervention | 7 Participants |
| Intervention | Number of Participants With Venous Thromboembolism | Post-Intervention | 6 Participants |
| Control | Number of Participants With Venous Thromboembolism | Pre-Intervention | 14 Participants |
| Control | Number of Participants With Venous Thromboembolism | Post-Intervention | 17 Participants |
Comparison: Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.p-value: <0.05Mixed Models Analysis