Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of VTE Prophylaxis (ENACT)

Patient Education Bundle vs. Nurses Feedback and Coaching to Prevent Missed Doses of Venous Thromboembolism (VTE) Prophylaxis: A Crossover, Cluster Randomized Controlled Trial

VTE associated harm is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications. In order to ensure best practices, and administer a defect-free VTE prevention nurses must understand and educate patients on the importance of the VTE prophylaxis. We propose to conduct a randomized trial comparing the effect of a validated, real-time patient education bundle (PEB), to a program of nurse feedback and coaching (NFC) provided by nurse leaders.

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis (Disorder)
• Intervention / Treatment: Behavioral: Patient education bundle (PEB),; Behavioral: Nurse feedback and coaching (NFC)

Detailed Description

Missed doses of prescribed Venous Thromboembolism (VTE) pharmacologic prophylaxis is a significant problem. Data on patients admitted to The Johns Hopkins Hospital found approximately 12% of prescribed doses of pharmacologic VTE prophylaxis were not administered. There were several reasons for these missed doses. The leading reason (nearly 60% of missed doses) was patient or family member refusal for any reason.

Based on data collected by the Maryland Health Services Cost Review Commission (HSCRC) in the Maryland hospital-acquired conditions (MHAC) program, during 2011 half of patients who developed confirmed VTE at The Johns Hopkins Hospital were not administered one or more doses of prescribed VTE prophylaxis. These data indicate that missed or refused doses of VTE prophylaxis represent a significant and under-recognized contributor to sub-optimal VTE prophylaxis that will erode the beneficial impact of current efforts to improve rates of VTE prophylaxis ordering by physicians.

As part of a Patient-Centered Outcomes Research Institute (PCORI)-funded project, the investigators have developed a registry of missed doses of VTE prophylaxis that includes data on missed doses of VTE prophylaxis.

Primary hypothesis Both interventions (PEB and NFC) will improve medication administration (as measured by missed doses)

Secondary hypotheses

1. Combining both interventions (PEB and NFC) will decrease patient refusal of VTE prophylaxis
2. Combining both interventions (PEB and NFC) will decrease missed doses for reasons other than patient refusal

3. Overall, PEB intervention will be more effective than NFC in reducing missed doses for any reason:

   1. The PEB intervention will be more effective than NFC in reducing in reducing patient refusal
   2. The NFC intervention will be more effective than PEB in reducing missed doses for other reasons of missed doses other than patient refusal
4. There will be a differential effect on medicine and surgery floors
5. There will be a differential effect by patient level characteristics (race, age, sex)
6. There will be a differential effect on high vs. low performing floors
7. There will be a differential effect dependent on pharmacological dosing regimen (i.e. medication, frequency)
8. There will be an overall decline in the incidence of VTE events (all, DVT, PE)

Design A single institution, crossover, cluster randomized controlled trial (x-cRCT).

Intervention

In the PEB arm, the intervention will include:

A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.

In the NFC arm, the intervention will include:

Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.

• Study Type: Interventional
• Enrollment (Actual): 9657
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medical Institutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

1. Eligible floors are defined as:

   A. All medical and surgical floors (non- intensive care units) B. 16 total floors (10 medicine, 6 surgery)

2. Eligible Patients are defined as: All patients on assigned floors except:

A. Patient data for those transferred between floors will be excluded. B. Patient data for those on floors during the cross-over time will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient education bundle (PEB); A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.	Behavioral: Patient education bundle (PEB),; A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.
Placebo Comparator: Nurse feedback and coaching (NFC); Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.	Behavioral: Nurse feedback and coaching (NFC); Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Missed doses of VTE prophylaxis	Proportion of VTE prophylaxis doses not administered	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient refused doses of VTE prophylaxis	Proportion of VTE prophylaxis doses not administered due to patient/family refusal	1 year
Missed doses of VTE prophylaxis for reasons other than patient refusal	Proportion of VTE prophylaxis doses not administered due to reasons other than patient/family refusal	1 year
VTE events (all VTE, DVT, PE)	Proportion of VTE events recorded	1 year
Patient satisfaction	surveys and HCAHPS scores	1 year
Nurse Satisfaction	surveys	1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Elliott R Haut, MD. PhD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• Lau BD, Shaffer DL, Hobson DB, Yenokyan G, Wang J, Sugar EA, Canner JK, Bongiovanni D, Kraus PS, Popoola VO, Shihab HM, Farrow NE, Aboagye JK, Pronovost PJ, Streiff MB, Haut ER. Effectiveness of two distinct web-based education tools for bedside nurses on medication administration practice for venous thromboembolism prevention: A randomized clinical trial. PLoS One. 2017 Aug 16;12(8):e0181664. doi: 10.1371/journal.pone.0181664. eCollection 2017.
• Lau BD, Streiff MB, Kraus PS, Hobson DB, Shaffer DL, Aboagye JK, Pronovost PJ, Haut ER. Missed Doses of Venous Thromboembolism (VTE) Prophylaxis at Community Hospitals: Cause for Alarm. J Gen Intern Med. 2018 Jan;33(1):19-20. doi: 10.1007/s11606-017-4203-y. No abstract available.
• Streiff MB, Carolan HT, Hobson DB, Kraus PS, Holzmueller CG, Demski R, Lau BD, Biscup-Horn P, Pronovost PJ, Haut ER. Lessons from the Johns Hopkins Multi-Disciplinary Venous Thromboembolism (VTE) Prevention Collaborative. BMJ. 2012 Jun 19;344:e3935. doi: 10.1136/bmj.e3935.
• Haut ER, Lau BD, Kraus PS, Hobson DB, Maheshwari B, Pronovost PJ, Streiff MB. Preventability of Hospital-Acquired Venous Thromboembolism. JAMA Surg. 2015 Sep;150(9):912-5. doi: 10.1001/jamasurg.2015.1340. No abstract available.
• Streiff MB, Lau BD, Hobson DB, Kraus PS, Shermock KM, Shaffer DL, Popoola VO, Aboagye JK, Farrow NA, Horn PJ, Shihab HM, Pronovost PJ, Haut ER. The Johns Hopkins Venous Thromboembolism Collaborative: Multidisciplinary team approach to achieve perfect prophylaxis. J Hosp Med. 2016 Dec;11 Suppl 2:S8-S14. doi: 10.1002/jhm.2657.
• Haut ER, Owodunni OP, Wang J, Shaffer DL, Hobson DB, Yenokyan G, Kraus PS, Farrow NE, Canner JK, Florecki KL, Webster KLW, Holzmueller CG, Aboagye JK, Popoola VO, Kia MV, Pronovost PJ, Streiff MB, Lau BD. Alert-Triggered Patient Education Versus Nurse Feedback for Nonadministered Venous Thromboembolism Prophylaxis Doses: A Cluster-Randomized Controlled Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e027119. doi: 10.1161/JAHA.122.027119. Epub 2022 Sep 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Venous Thromboembolism, Deep Venous Thrombosis, Clots
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Thrombosis; Venous Thrombosis; Venous Thromboembolism
• Other Study ID Numbers: IRB00157201; DI-1603-34596 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No