Education Bundle to Decrease Patient Refusal of VTE Prophylaxis

NCT02402881 | Completed Results

• 1 other identifier: IRB00057117
• Study Type: interventional
• Target: 19,652
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolism

Keywords

venous thromboembolism; deep venous thrombosis; pulmonary embolism; blood clots

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Venous Thromboembolism

  15 Months

Study Arms (2)

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.

Behavioral: Patient-centered education bundle

Control

NO INTERVENTION

Patients will receive only the standard practices of care

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients on the four trial floors who miss at least one dose of VTE prophylaxis will be included in the study.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Johns Hopkins University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Related Publications (5)

• 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.

  PMID: 23799091 BACKGROUND

• 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.

  PMID: 20569760 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

  BACKGROUND

• 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.

  PMID: 35969933 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.

  PMID: 30646370 DERIVED

Related Links

• PCORI Website Page - "Improving Patient-Nurse Communication to Prevent a Life-Threatening Complication"
• PCORI Website Page - "Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology"

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Results Point of Contact

• Title: Elliott R Haut, MD PhD
• Organization: The Johns Hopkins University

ehaut1@jhmi.edu

410-502-3122

Study Officials

• Elliott R Haut, MD PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Locations

US (1)