PCORI funds implementation projects to promote the use of findings from PCORI-funded studies. This project focuses on implementing findings from the completed PCORI-funded research project: Can Nurse and Patient Education Reduce Missed Doses of Medications to Prevent Blood Clots in Hospitals?
1. What were the results from the original PCORI-funded research study?
This project focuses on implementing findings from a completed PCORI study, which showed that a single, web-based nurse education module can have a dramatic effect on missed doses of venous thromboembolism (VTE) prophylaxis administration (blood clot prevention) in hospitalized patients. It also showed that a patient-centered education bundle delivered to hospitalized patients reduces missed doses by nearly 50 percent. The program showed similar benefits in medical and surgical floors at a university-affiliated hospital and are equally effective at a smaller, community nonteaching hospital.
2. Why is this research finding important?
Trauma, or injury, is a well-known risk factor for hospital-associated VTE. The clinically meaningful results from our previous studies are promising because missed doses of prescribed prophylaxis are a serious problem, with up to 15 percent of doses not given to patients. The main reason for missed doses is patient refusal, and the refusal rate for these injections is significantly higher than for other medicines. Importantly, missed doses of VTE prophylaxis are associated with VTE events (blood clots), particularly in trauma surgery patients. Our validated education modules for nurses and patients are inexpensive and practical to reduce missed doses of medication to prevent blood clots among patients.
3. What is the goal of this project?
The primary objective is to help nurses and patients make informed decisions regarding VTE prevention and reduce the occurrence of blood clots in injured patients. Our aims are:
- To implement the validated nurse education module and patient-centered education tool at 10 trauma centers in an existing research hospital network (CLOTT)
- To examine data on missed and refused doses of VTE prophylaxis and study the intervention’s impact on VTE outcomes in trauma patients at high risk for VTE events
- To conduct a qualitative study to tailor the intervention to the different healthcare settings and computer systems so that it can be implemented nationally
4. What is the project team doing?
We will use two implementation models to expand this successful intervention and study its benefit. We will use the four-step Translating Evidence into Practice (TRIP) implementation framework. The second model we will use is the Consolidated Framework for Implementation Research (CFIR) that will guide our semistructured interviews with physicians, nurses, patients, information technology (IT) members, and other key stakeholders to identify barriers and facilitators when implementing the new VTE prevention practices.
The intervention will be implemented in three steps: (1) all bedside nurses will complete the online, interactive, scenario-based education module, (2) the electronic alert will be built into each site’s electronic health record (EHR) system, (3) the patient-centered education bundle and real-time alert will launch. Before the program starts, the Johns Hopkins VTE collaborative multidisciplinary group will train physician, nurse, and/or pharmacist champions at each intervention site, using materials (posters, slides, handouts, videos) previously developed in the completed Dissemination and Implementation Award project.
We will use existing data infrastructure and the trauma registry at each center to measure our program’s impact. The registry includes patient demographics, vital signs, injury characteristics, and outcomes for every injured patient.
We estimate that 3,535 nurses working on 60 hospital floors/units will complete the online education module. We estimate that a diverse group of approximately 32,300 injured patients will be admitted during the implementation and may receive the patient-centered education. The scope of the project will be large as trauma is a leading killer of Americans under age 46. If we show the program can be implemented into trauma centers in the CLOTT network, we plan to scale nationwide using the collaborations with our key stakeholder trauma organizations. The potential to influence clinical care is enormous, as over 1 million patients are admitted to trauma centers across the country per year.
5. How is the team evaluating this project?
We will use a wide range of measures to evaluate our intervention and show it is successful. Some will be quantitative clinical outcomes (missed doses, VTE events). Others will be classic implementation science metrics (adoption, feasibility, fidelity, penetration). Still others fall under the category of qualitative research to include information gleaned from structured interviews of key stakeholders and online surveys of the frontline nurses at all sites.
We have a robust data analysis plan driven by clinical researchers and health informaticians. We will examine the following objective outcomes: (1) rates of nonadministration of prescribed doses of VTE prophylaxis; (2) rates of patient refusal of VTE prophylaxis; (3) rates of missed doses for reasons other than refusal; and (4) incidence of VTE events. We will compare data at each site using a pre versus postintervention analysis, with each site serving as its own internal control. Our primary outcome is administration of prescribed VTE prophylaxis medication. Our secondary outcomes include VTE and the proportion of patients who receive all doses as prescribed.
The qualitative analysis plan includes structured interviews with stakeholders (physicians, nurses, and IT professionals) from across the sites. We will use purposeful sampling to enrich our data with a wide range of diverse opinions from the early adopters, to the stragglers, and all in between. If we have sites that cannot fulfill all aspects of the intervention, they will be interviewed to learn as much as possible about the barriers encountered to influence further growth of the program. The semistructured interviews will be thematically coded and analyzed to identify common themes. We will administer a deidentified electronic, web-based survey to frontline nurses to ask about their perception of VTE prevention, clinical practice habits, and attitudes towards the patient education intervention.
6. How is the team involving patients and others in making sure the findings reach people who can use them?
We have engaged stakeholders and decision makers at each clinical site. Initially, we hosted a webinar with 50 attendees from the CLOTT network (including trauma surgeons, nursing leaders, IT experts, and research staff). We have secured the commitment of nursing leadership and the frontline nursing staff who will be responsible for completing the nurse education module and implementing the patient education component. We have also received support from the chief medical information officers to work with us to facilitate data transfers from the EHR as well as to build an electronic alert system into their local EHR when a dose is missed. Additionally, we have secured the support of the trauma medical directors (TMD) and the trauma program managers that their trauma registrars will work to extract from the trauma registry and transfer data to the central repository at Johns Hopkins University. The CLOTT network has recognized the issue of missed doses of VTE prophylaxis and has data showing that over 40 percent of patients miss at least one dose.
We have collaborated with the National Blood Clot Alliance (NBCA) and the North American Thrombosis Forum and we will continue to do so. These organizations represent the largest patient advocacy organizations for blood clot prevention in the United States. They have a wealth of patient, clinician, and policy making experience. We have a newer, similar collaboration with the Patient Safety Movement Foundation. As a patient-centered, shared decision making intervention, the input of patient stakeholders will be critical at every step of the implementation process.
We have partnered with two individuals who represent patient and family perspectives. Leslie Lake (chair of the NBCA board of directors and a pulmonary embolism patient) and Vonda Vaden Bates (widow of a patient who died after a trauma-associated pulmonary embolism) will be directly involved in the project. They will participate in monthly webinars or conference calls and help direct the plans for the overall project, review written materials, and speak to local groups about their perspectives from a patient and family member with experience with VTE.
7. How will this project help ensure future uptake and use of findings from patient-centered outcomes research?
If we prove the effectiveness and feasibility of implementing our interventions to help nurses and patients make informed decisions regarding VTE prevention and reduce the occurrence of blood clots, we will expand the project nationally through our partnering organizations to rapidly scale to hundreds of trauma centers across the country.
Original PCORI-funded Research Project
Note: Results from the original project have completed PCORI’s Peer Review and are available here.
Related PCORI Dissemination and Implementation Project
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.