Clinical trial NCT02402881: Education Bundle to Decrease Patient Refusal of VTE Prophylaxis
Official title: Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Deep Venous Thrombosis
Pulmonary Embolism
Keywords: venous thromboembolism
deep venous thrombosis
pulmonary embolism
blood clots
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-30
Enrollment: 19652
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
timeFrame: 15 Months
Secondary outcomes:
measure: Number of Participants With Venous Thromboembolism
timeFrame: 15 Months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elliott R Haut, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.