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College of Nursing > Faculty Funded Research
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Heart failure is a significant public health problem. Currently there are over five million Americans, predominantly older adults, suffering from heart failure. These patients are expected to follow complex medication regimen and self-management practices at home to stay healthy and prevent getting admitted to hospitals. A mobile application (HeartMapp) is proposed to act as a health coach by reminding patients to follow health care providers' recommendations at home. Decision making on heart failure symptoms are often confusing and challenging for patients. The HeartMapp offers automated feedback to patients based on the patients' weight, heart rate, and symptoms entered in HeartMapp. Thus, patients are alerted when symptoms are mild to take the next step and prevent worsening and readmissions. Under new regulations, if these patients are readmitted within 30-days after discharge from hospital, the hospitals are not reimbursed, as well as penalized if the readmission rates are higher than a government set limit. Reducing readmission penalty for heart failure will provide financial benefit for health care organizations by generating revenue. Therefore, hospitals are also interested in finding ways to keep patients engaged in their self-management. In order to make HeartMapp available, this project needs to better understand the complex health care ecosystem, i.e., all the players in this market, the customers and the value that HeartMapp provides to them, the users and buyers and the approval process, and the revenue streams and resources needed to make it happen.
HeartMapp is an easy to use non-pharmacological, non-invasive application developed with five main features as intervention options: 1) assessment of daily weight, blood pressure, and chronic heart failure (CHF) symptoms with automated feedback to enhance decision making for management of symptoms; 2) exercise including physical activity (walking) and deep breathing to improve physical health and well-being; 3) real time vital signs monitoring utilizing a wearable Bluetooth device; 4) CHF info that includes audio enabled interactive CHF education to improve knowledge; and 5) Stats, a graphical module that displays trends on patient performance. From the technical standpoint, HeartMapp is currently available in the Android platform but it needs to be updated and enhanced to include the features coming out of this I-Corps project and translated into other software platforms (iOS and Windows) to expand the customer base. The current vision is to create a startup company or collaborate with an existing company to host the software and market the technology and license it to be included as part of existing solutions. The final report of I-Corps project will serve as a guiding document to: 1) submit a Phase I SBIR proposal in order to update the technology and test the HeartMapp for its efficacy in improving self-management of patients with CHF and thus potentially curb costly readmissions; 2) submit a Phase II SBIR proposal to take the technology to the market place; 3) Create a startup company or join an existing company interested in the commercialization of HeartMapp; and/or 4) find investors to provide the necessary funding to achieve our goals.
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Dr. Susan C. McMillan (Principal Investigator)
PATIENT OUTCOMES OF A SELF-CARE MANAGEMENT APPROACH TO CANCER SYMPTOMS: A CLINICAL TRIAL
Start Date: August 1, 2013
End Date: September 30, 2016
Regardless of the treatments they undergo, cancer patients endure a variety of difficult symptoms throughout their disease experience with averages ranging from seven to 14 symptoms per patient. Cancer-related symptoms, especially when symptoms are very intense, distressing, frequent, or interfere with daily activities, can lead to depression, anxiety, and diminished quality of life. Improving cancer patients’ ability to self-manage difficult symptoms has the potential to diminish patient suffering, improve quality of life, and decrease emergency room visits and associated healthcare costs.
We propose to test a brief and effective intervention with patients seen in a cancer center, with the goal of teaching patients symptom management skills for self-identified symptoms of highest priority to patients. The proposed randomized clinical trial will test the efficacy of the COPE intervention with patients with symptoms of moderate to high intensity, distress, frequency, or interference with their lives as a result of their cancer. We will include 300 patients from a large comprehensive cancer center with large numbers of outpatients with breast, colorectal, lung, and prostate cancers. After consenting, patients will be randomly assigned to one of three groups. Group III will receive the COPE intervention plus usual care. This group will receive three individual intervention sessions.
During the first intervention visit at the cancer center, this group will be taught the COPE intervention in a session focusing on the patient's self-identified most bothersome symptom. Role modeling and additional instruction will be provided via video, and patients will receive the Home Care Guide for Cancer and a copy of the video to take home. Two subsequent visits with the patient during regularly scheduled clinic visits will reinforce the principles of COPE and the use of the home care guide, and will help patients apply this approach to managing other symptoms.
In addition, they will get two phone calls encouraging them to apply COPE principles. Group II will receive three supportive visits from the research team at the cancer center and subsequent meetings during clinic visits, plus two subsequent supportive telephone calls, matched for time with the COPE group. Group I, the control group receiving usual care, will receive no additional attention from our interventionists. Data will be collected weekly for nine weeks about symptoms (intensity, frequency, interference, appraisal of distress), beliefs in their ability to self-manage symptoms, and barriers to self-management. Quality of life, anxiety, and depression will be assessed at baseline and weeks 4, 8, and 12. We predict that the COPE group will show significant improvement in depression, anxiety, quality of life, symptom intensity, distress, frequency and interference, self-management, and perceived barriers to care, as well as decreased use of healthcare resources, such as the emergency room, compared with the two control groups.
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INTERACTION BETWEEN INFANTS WITH NEONATAL ABSTINENCE SYNDROME AND THEIR MOTHERS
(SNRS Research Grant Award)
Start Date: 3/8/2013
End Date: 3/7/2016
The aim of this study is to describe the interactions between infants with neonatal abstinence syndrome (NAS) and their mothers and evaluate the influence of the psychological characteristics on the interactions. It is proposed that women with positive urine drug screens commonly exhibit behaviors that increase the distress of their infant, and are unable to read the infant cues for readiness to interact. A comparative, descriptive design of the real time behaviors between mothers and their infants with NAS will be used to identify behaviors unique to this high-risk dyad. The target population is a convenience sample of 40 mothers and their infants admitted to the NICU with NAS. Women will be video-taped with their infant during two visits, one of which includes an episode of feeding. Assessments of maternal self-efficacy, anxiety, mood and stress will be collected following each videotaping, and her response to her feelings about the visit. The nurse caring for the infant will complete an assessment of the visit to specifically identify any concerns. The results of this study will identify the nature of the interactions, and enable development of nursing interventions in the NICU that will enhance parenting in this high risk population.
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FEEDING INTERVENTION FOR INFANTS WITH NEONATAL SYNDROME (NAS)
Children’s Board of Hillsborough County
Start date: 10/1/2015
End Date: 9/30/2016
Parent Funding Sponsor: USF Health Women’s Health Collaborative Grant – 2015 – 2016 WHC Foundation
Title: An intervention to Improve Feeding Success in Infants with Neonatal Abstinence Syndrome
Project co-funding will partner with the primary project funded from the USF Women’s Health Collaborative. This project will allow us to evaluate the video teaching Intervention with the target population of pregnant women in drug treatment, as well as with national experts. The women will evaluate the video for necessity, acceptability, feasibility, and effectiveness, while the panel of experts will evaluate it for validity of the content. The intervention video will be presented to women who are pregnant for the first time and who are enrolled in the drug treatment program at DACCO. After the viewing, data will be gather to measure its effectiveness. After initial analysis of this research project we will submit for NIH funding in order to test the video Intervention in a randomized controlled trial. If found to be helpful, we anticipate that the 10,000 infants born annually with NAS in the US have the potential to be impacted positively.
Parent Abstract: USF Health Women’s Health Collaborative Grant – 2015 – 2016 WHC Foundation
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ORAL CARE INTERVENTION IN MECHANICALLY VENTILATED ADULTS
National Institutes of Health
Start date: 1-APR-2001
End Date: 31-JUL-2018
Despite its prominent position in bedside care, there is little evidence to judge the benefits or associated risks of nurse-administered tooth brushing for mechanically ventilated adults, and the optimal frequency of tooth brushing in the critically il has never been experimentally determined. This project will complete the examination of oral care interventions in mechanically ventilated adults with a randomized clinical trial of tooth brushing frequency (once, twice, or three times daily) focused on conclusively defining the benefit and risk of varied frequencies, and identification of moderating patient-level factors for risk and benefit. The project's overall goal is to determine optimal tooth brushing frequency for mechanically ventilated adults. Optimal tooth brushing frequency is important for control of dental plaque and reduction of oral inflammation; it is likely to improve patient comfort, improve efficiency of nursing care, and may reduce systemic sequellae related to oral inflammation.
The primary aims of the proposed project are: 1) Evaluate the clinical equivalence (non- inferiority) o three tooth brushing frequencies on oral health (dental plaque and mucosal inflammation) in critically ill adults receiving mechanical ventilation; and 2) Quantify and compare the safety of three tooth brushing frequencies on serious adverse outcomes, including ventilator associated complications and clinically relevant HAIs. A secondary aim is to investigate patient factors that influence tooth brushing frequency benefit and risk in critically ill adults. These objectives willbe accomplished using a prospective, randomized, experimental design. Subjects (n=345) will be randomly assigned within 24 hours of intubation to one of three intervention groups which differ in frequency of tooth brushing delivered by study personnel (once, twice, or three times daily). Dental plaque (UM-OHI score, with observations documented and augmented by use of a digital intraoral camera), mucosal inflammation (gingival crevicular fluid IL-1�), and HAIs will be assessed daily during the intervention period. The data analysis will focus on providing definitive clinical practice guidance through joint evaluation of non-inferiority (comparison of dental plaque between groups by analysis of covariance) and quantification of number needed to harm. Repeated measures linear mixed models (treating dental plaque and mucosal inflammation as separate outcome variables) will provide insight as to specific patient-level factors that may modify the clinical effectiveness and safety profile associated with frequency of tooth brushing. Information about efficacy and safety of each frequency of tooth brushing will provide a clear recommendation for optimal tooth brushing frequency with direct translation to clinical practice.
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