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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 | No Intervention | Patients will receive only the standard practices of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-centered education bundle | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Venous Thromboembolism | This is the number of participants with VTE events as documented in the electronic health record. | 15 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliott R Haut, MD PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23799091 | Background | Shermock KM, Lau BD, Haut ER, Hobson DB, Ganetsky VS, Kraus PS, Efird LE, Lehmann CU, Pinto BL, Ross PA, Streiff MB. Patterns of non-administration of ordered doses of venous thromboembolism prophylaxis: implications for novel intervention strategies. PLoS One. 2013 Jun 14;8(6):e66311. doi: 10.1371/journal.pone.0066311. Print 2013. | |
| 20569760 |
| Label | URL |
|---|---|
| PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology" | View source |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Patients will receive only the standard practices of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Intervention Study Period |
| |||||||||||||
| Post-Intervention Study Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of nonadministration | 15 Months |
|
15 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elliott R Haut, MD PhD | The Johns Hopkins University | 410-502-3122 | ehaut1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2018 | Dec 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Fanikos J, Stevens LA, Labreche M, Piazza G, Catapane E, Novack L, Goldhaber SZ. Adherence to pharmacological thromboprophylaxis orders in hospitalized patients. Am J Med. 2010 Jun;123(6):536-41. doi: 10.1016/j.amjmed.2009.11.017. |
| Background | Maynard GA, Varga EA, Friedman RJ, Brownstein AP, Ansell JE. Deep vein thrombosis and pulmonary embolism: Awareness and prophylaxis practices reported by recently hospitalized patients. Society of Hospital Medicine Annual Meeting. 2011 |
| 35969933 | Derived | Owodunni OP, Lau BD, Wang J, Shaffer DL, Kraus PS, Holzmueller CG, Aboagye JK, Hobson DB, Varasteh Kia M, Armocida S, Streiff MB, Haut ER. Effectiveness of a Patient Education Bundle on Venous Thromboembolism Prophylaxis Administration by Sex. J Surg Res. 2022 Dec;280:151-162. doi: 10.1016/j.jss.2022.07.015. Epub 2022 Aug 12. |
| 30646370 | Derived | Haut ER, Aboagye JK, Shaffer DL, Wang J, Hobson DB, Yenokyan G, Sugar EA, Kraus PS, Farrow NE, Canner JK, Owodunni OP, Florecki KL, Webster KLW, Holzmueller CG, Pronovost PJ, Streiff MB, Lau BD. Effect of Real-time Patient-Centered Education Bundle on Administration of Venous Thromboembolism Prevention in Hospitalized Patients. JAMA Netw Open. 2018 Nov 2;1(7):e184741. doi: 10.1001/jamanetworkopen.2018.4741. |
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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. | Count of Participants | Participants |
|
| Hospital Unit Type | This refers to the unit of hospital where participants were seen; either surgical or medical units. | 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. | Count of Participants | Participants |
|
| OG001 | Control | Patients will receive only the standard practices of care. |
|
|
|
| Secondary | Number of Participants With Venous Thromboembolism | This is the number of participants with VTE events as documented in the electronic health record. | 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. | Posted | Count of Participants | Participants | 15 Months |
|
|
|
|
| 0 |
| 5,333 |
| 0 |
| 5,333 |
| 0 |
| 5,333 |
| EG001 | Control | Patient Visits received only the standard practices of care. | 0 | 14,319 | 0 | 14,319 | 0 | 14,319 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| Male |
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| Asian |
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| Native American |
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| Others |
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| White |
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| Asian |
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| Native American |
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| Others |
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| Medical |
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| Post-Intervention |
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|