Education Bundle to Decrease Patient Refusal of VTE Prophylaxis

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02402881
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 19,652
• Location: 1
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site Per Month: 456.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolism	Behavioral: Patient-centered education bundle	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19652 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Patient-Centered Education Bundle to Decrease Patient Refusal of Venous Thromboembolism (VTE) Prophylaxis
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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; 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.
No Intervention: Control Patients will receive only the standard practices of care

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Participants With Venous Thromboembolism [15 Months]

   This is the number of participants with VTE events as documented in the electronic health record.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Medical Institutions	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Elliott R Haut, MD PhD, Johns Hopkins University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 10, 2018

More Information

Additional Information:

• 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"
• The Johns Hopkins Armstrong Institute for Patient Safety and Quality Website "Preventing Venous Thromboembolism"

Publications

• 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.
• 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
• 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. Review.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02402881
• Other Study ID Numbers: IRB00057117
• First Posted: Mar 30, 2015
• Last Update Posted: Jan 6, 2020
• Last Verified: Dec 1, 2019

• Keywords provided by Johns Hopkins University: venous thromboembolism; deep venous thrombosis; pulmonary embolism; blood clots
• Additional relevant MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis

Study Results

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

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Patients will receive only the standard practices of care
Period Title: Pre-Intervention Study Period
STARTED	2222	5657
COMPLETED	2222	5657
NOT COMPLETED	0	0
Period Title: Pre-Intervention Study Period
STARTED	3111	8662
COMPLETED	3111	8662
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	5333	14319	19652
Age (Years) [Mean (Standard Deviation) ]
Pre-Intervention	53.9 (17.4)	56.3 (16.9)	55.6 (17.1)
Post-Intervention	54.6 (17.6)	55.8 (16.9)	55.5 (17.1)
Sex: Female, Male (Count of Participants)
Female	1153 21.6%	2687 18.8%	3840 19.5%
Male	1069 20%	2970 20.7%	4039 20.6%
Female	1587 29.8%	4074 28.5%	5661 28.8%
Male	1524 28.6%	4588 32%	6112 31.1%
Race/Ethnicity, Customized (Count of Participants)
Black	941 17.6%	2307 16.1%	3248 16.5%
White	1088 20.4%	2850 19.9%	3938 20%
Asian	44 0.8%	117 0.8%	161 0.8%
Native American	9 0.2%	12 0.1%	21 0.1%
Others	140 2.6%	371 2.6%	511 2.6%
Black	1308 24.5%	3469 24.2%	4777 24.3%
White	1533 28.7%	4432 31%	5965 30.4%
Asian	73 1.4%	167 1.2%	240 1.2%
Native American	4 0.1%	14 0.1%	18 0.1%
Others	193 3.6%	580 4.1%	773 3.9%
Hospital Unit Type (Count of Participants)
Surgical	1155 21.7%	2530 17.7%	3685 18.8%
Medical	1067 20%	3127 21.8%	4194 21.3%
Surgical	1647 30.9%	4076 28.5%	5723 29.1%
Medical	1464 27.5%	4586 32%	6050 30.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention	Control
Arm/Group Description	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.	Patients will receive only the standard practices of care.
Measure Participants	5333	14319
Pre-Intervention	9.1	13.6
Post-Intervention	5.6	13.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments	We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Venous Thromboembolism
Description	This is the number of participants with VTE events as documented in the electronic health record.
Time Frame	15 Months

Outcome Measure Data

Analysis Population Description

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/Group Title	Intervention	Control
Arm/Group Description	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.	Patients will receive only the standard practices of care.
Measure Participants	5333	14319
Pre-Intervention	7 0.1%	14 0.1%
Post-Intervention	6 0.1%	17 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments	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.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments	We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	15 Months
Arm/Group Title	Intervention		Control
Arm/Group Description	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.		Patient Visits received only the standard practices of care.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5333 (0%)		0/14319 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5333 (0%)		0/14319 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5333 (0%)		0/14319 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.