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BACKGROUND: The United States continues to experience an alarming rise in opioid use that includes women who become pregnant and related neonatal abstinence syndrome (NAS) in newborns. Most newborns experiencing NAS require nonpharmacological care, which entails, most importantly, maternal involvement with the newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies when they are pregnant; however, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, partly because no education, training, or other interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. OBJECTIVE: In this paper, we describe a mixed methods, multistage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled trial. METHODS: Stage 1 will include 20 semistructured interviews with a panel of neonatology experts, NAS care providers, and mothers with experience caring for NAS-affected newborns to gather their recommendations on the management of NAS and explore their perspectives on the care of these newborns. The findings will guide the adaptation of existing mobile NAS tools for high-risk pregnant women. In stage 2, we will test the usability, acceptability, and feasibility of the adapted mobile tool via surveys with 10 pregnant women receiving opioid agonist therapy (OAT). Finally, in stage 3, we will randomize 30 high-risk pregnant women receiving OAT to either receive the adapted mobile NAS caregiving tool or usual care. We will compare these women on primary outcomes-maternal drug relapse and OAT continuation-and secondary outcomes-maternal-newborn bonding; length of newborn hospital stays; readmission rates; breastfeeding initiation and duration; and postpartum depression and anxiety at 4, 8, and 12 weeks postpartum. RESULTS: This project was funded in July 2020 and approved by the institutional review board in April 2020. Data collection for stage 1 began in December 2020, and as of January 2021, we completed 18 semistructured interviews (10 with NAS providers and 8 with perinatal women receiving OAT). Common themes from all interviews will be analyzed in spring 2021 to inform the adaptation of the NAS caregiving tool. The results from stage 1 are expected to be published in summer 2021. Stage 2 data collection will commence in fall 2021. CONCLUSIONS: The findings of this study have the potential to improve NAS care and maternal-newborn outcomes and lead to commercialized product development. If effective, our new tool will be well suited to tailoring for other high-risk perinatal women with substance use disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT04783558; https://clinicaltrials.gov/ct2/show/NCT04783558. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27382.
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BACKGROUND: Despite evidence for the efficacy of strict neonatal abstinence syndrome (NAS) treatment protocols, no national standardized education, diagnosis or treatment strategy is available. OBJECTIVES: To describe the development and preliminary usability of an electronic bedside primer and decision support tool for medical providers, with embedded, interactive education and reference modules. METHODS: A panel of NAS experts established a standard operating procedure for the best practices of NAS management and developed an interactive mobile primer and reference and assessment tool to assess NAS with a curriculum and decision support system. We tested the feasibility and usability of this tool with n = 8 users, including registered nurses, last-year undergraduate nursing students and neonatal physicians. RESULTS: Participants rated the usability of the modules positively, with an average rating of 4.5 (scale of "1 = Strongly disagree" to "5 = Strongly agree"). Participants appreciated the ability to score the infant at the bedside using real time electronic entry. Seven users noted that the electronic device entry would be as accurate as paper or computer-based Electronic Medical Records entry and one user indicated it would potentially be more accurate during post-usability interviews. Users recommended improvements to the curriculum, including increasing detail of definitions and adding videos for additional NAS signs. CONCLUSION: The assessment tool appears to be acceptable and usable by potential users. The strong ratings across users provides support for further testing whether its acceptability and usability remain high in a hospital setting, while assessing the impact on clinical outcomes such as newborn hospital length of stay.
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BACKGROUND: Substance use disorder (SUD) affects over 20 million adults and costs over $700 billion annually in the United States. It is one the greatest health care challenges we face. OBJECTIVE: This research project seeks to enhance the standard practice of Screening, Brief Intervention, and Referral to Treatment (SBIRT) through a mobile solution easily incorporated into primary care that will promote shared decision making and increase referral and adherence to specialty care through continued follow-up care. METHODS: This research will conduct an Office of Management and Budget (OMB)-approved randomized controlled trial (RCT) in primary care and SUD specialty service providers. The RCT will recruit a total of 500 SUD patients. Recruited patients will be randomized into control and intervention arms. Both arms will take initial baseline and exit (30 days) surveys to evaluate self-reported substance use and specialty service utilization. The control arm patients will receive usual care. The intervention group patients will receive technology-enhanced SBIRT and a mobile follow-up program to track goals and substance use at home. The RCT tracks participants for 30 days after the primary care encounter. We will collect feedback from the patients during the 30 days and count the number of patients who use specialty care services in specialty care programs for tobacco, alcohol, and drug abuse (both from self-reporting and from the service providers). RESULTS: RCT and data collection are underway. We expect to report the data results in 2018. CONCLUSIONS: We expect that significantly more intervention group patients will receive specialty SUD care within 30 days following the SBIRT encounter at the primary care clinic compared to the control group. We also expect that the intervention group patients will report a greater reduction in substance use and a greater drop in Drug Abuse Screening Test and Addition Severity Index scores within 30 days.
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BACKGROUND: Clinical decision support systems (CDSS) are important tools to improve health care outcomes and reduce preventable medical adverse events. However, the effectiveness and success of CDSS depend on their implementation context and usability in complex health care settings. As a result, usability design and validation, especially in real world clinical settings, are crucial aspects of successful CDSS implementations. OBJECTIVE: Our objective was to develop a novel CDSS to help frontline nurses better manage critical symptom changes in hospitalized patients, hence reducing preventable failure to rescue cases. A robust user interface and implementation strategy that fit into existing workflows was key for the success of the CDSS. METHODS: Guided by a formal usability evaluation framework, UFuRT (user, function, representation, and task analysis), we developed a high-level specification of the product that captures key usability requirements and is flexible to implement. We interviewed users of the proposed CDSS to identify requirements, listed functions, and operations the system must perform. We then designed visual and workflow representations of the product to perform the operations. The user interface and workflow design were evaluated via heuristic and end user performance evaluation. The heuristic evaluation was done after the first prototype, and its results were incorporated into the product before the end user evaluation was conducted. First, we recruited 4 evaluators with strong domain expertise to study the initial prototype. Heuristic violations were coded and rated for severity. Second, after development of the system, we assembled a panel of nurses, consisting of 3 licensed vocational nurses and 7 registered nurses, to evaluate the user interface and workflow via simulated use cases. We recorded whether each session was successfully completed and its completion time. Each nurse was asked to use the National Aeronautics and Space Administration (NASA) Task Load Index to self-evaluate the amount of cognitive and physical burden associated with using the device. RESULTS: A total of 83 heuristic violations were identified in the studies. The distribution of the heuristic violations and their average severity are reported. The nurse evaluators successfully completed all 30 sessions of the performance evaluations. All nurses were able to use the device after a single training session. On average, the nurses took 111 seconds (SD 30 seconds) to complete the simulated task. The NASA Task Load Index results indicated that the work overhead on the nurses was low. In fact, most of the burden measures were consistent with zero. The only potentially significant burden was temporal demand, which was consistent with the primary use case of the tool. CONCLUSIONS: The evaluation has shown that our design was functional and met the requirements demanded by the nurses' tight schedules and heavy workloads. The user interface embedded in the tool provided compelling utility to the nurse with minimal distraction.
