Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement

Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement ORDER NOW FOR CUSTOMIZED AND ORIGINAL ESSAY PAPERS ON Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement Review the Topic Materials and the work completed in NRS-433V to formulate a PICOT statement for your capstone project. Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement A PICOT starts with a designated patient population in a particular clinical area and identifies clinical problems or issues that arise from clinical care. The intervention should be an independent, specified nursing change intervention. The intervention cannot require a provider prescription. Include a comparison to a patient population not currently receiving the intervention, and specify the timeframe needed to implement the change process. Formulate a PICOT statement using the PICOT format provided in the assigned readings. The PICOT statement will provide a framework for your capstone project. In a paper of 500-750 words, clearly identify the clinical problem and how it can result in a positive patient outcome. Make sure to address the following on the PICOT statement: Evidence-Based Solution Nursing Intervention Patient Care Health Care Agency Nursing Practice Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required. This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion. You are required to submit this assignment to LopesWrite. Please refer to the directions in the Student Success Center. MY PICOT QUESTION WILL BE P: NON AMBULATORY PATIENTS I: TURNING & REPOSITIONING EVERY 2 HOURS C: PRESSURE RELIEVING AND REDISTRIBUTING MATTRESSES O: PREVENTION OF PRESSURE ULCERS T: DURING THEIR HOSPITAL STAY PURPOSE OF THIS IS TO FIND OUT IF REPOSITIONING OF PATIENTS IS ACTUALLY BETTER AT PREVENTING PRESSURE ULCERS IN NON AMBULATORY PATIENTS. ONLY USE THE CITATIONS I ATTACH PLEASE. INCLUDE AT LEAST 3, Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement hapu_1.pdf hapu_4.pdf hapu_2.pdf hapu_5.pdf hapu_6.pdf Pickham et al. Trials (2016) 17:190 DOI 10.1186/s13063-016-1313-5 STUDY PROTOCOL Open Access Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial David Pickham1,2*, Betsy Ballew2, Kristi Ebong3, Julie Shinn4, Mary E. Lough1 and Barbara Mayer1 Abstract Background: Pressure ulcers are insidious complications that affect approximately 2.5 million patients and account for approximately US$11 billion in annual health care spending each year. To date we are unaware of any study that has used a wearable patient sensor to quantify patient movement and positioning in an effort to assess whether adherence to optimal patient turning results in a reduction in pressure ulcer occurrence. Methods/design: This study is a single-site, open-label, two-arm, randomized controlled trial that will enroll 1812 patients from two intensive care units. All subjects will be randomly assigned, with the aid of a computer-generated schedule, to either a standard care group (control) or an optimal pressure ulcer-preventative care group (treatment). Optimal pressure ulcer prevention is defined as regular turning every 2 h with at least 15 min of tissue decompression. All subjects will receive a wearable patient sensor (Leaf Healthcare, Inc., Pleasanton, CA, USA) that will detect patient movement and positioning. This information is relayed through a proprietary mesh network to a central server for display on a user-interface to assist with nursing care. This information is used to guide preventative care practices for those within the treatment group. Patients will be monitored throughout their admission in the intensive care unit. Discussion: We plan to conduct a randomized control trial, which to our knowledge is the first of its kind to use a wearable patient sensor to quantify and establish optimal preventative care practices, in an attempt to determine whether this is effective in reducing hospital-acquired pressure ulcers. Trial registration: ClinicalTrials.gov, NCT02533726. Background Pressure ulcers are insidious complications that affect approximately 2.5 million patients and account for approximately US$11 billion in annual health care spending each year [1]. Acutely ill patients are at risk for the development of pressure ulcers due to immobility, reduced perfusion, and prolonged duration of mechanical ventilation [2]. In 2008 the Centers for Medicare and Medicaid Services discontinued reimbursement for facility-acquired pressure ulcers (also known as hospital-acquired pressure ulcers, HAPUs), as these are considered an avoidable * Correspondence: [email protected] 1 General Medical Disciplines, Stanford Medicine, Menlo Park, CA, USA 2 Office of Research, Patient Care Services, Stanford Health Care, Stanford, CA, USA Full list of author information is available at the end of the article complication often described as a “never event.” Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement Given the tremendous burden that pressure ulcers place on the individual patient and the health care system, there is a substantial need for improved prevention methods [3, 4]. Pressure ulcers form when there is sustained pressure, predominately over bony prominences such as the sacrum, heels, occiput, and shoulders. Unrelieved pressure causes compression of cellular tissue, impaired blood flow, and can lead to localized tissue damage and cellular death. Pressure ulcers initially appear as areas of reddened skin but can quickly develop into large open wounds if the pressure is not relieved. To prevent pressure ulcers, the currently accepted standard of care is to turn patients at least every 2 h, day and night. However, there are no published research studies that support the every 2-h turning schedule in © 2016 Pickham et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Pickham et al. Trials (2016) 17:190 critically ill patients. Notwithstanding, studies have estimated that compliance with patient-turning protocols are around 60 % and that a significant number of patients are not being turned as frequently as recommended [5, 6]. In intensive care units (ICUs), compliance to turning protocols is even lower, ranging from 38 to 51 % [7, 8]. Potential explanations for this low compliance include low prioritization of turning, difficulty in monitoring a patient’s position, ineffective turn reminders/alerts, and sub-optimal caregiver staffing ratios – all of which hinder efforts to prevent pressure ulcers. To improve adherence to turning as a preventative practice, Leaf Healthcare Inc. (Pleasanton, CA, USA) has developed a patient-monitoring system designed to optimize patient-turning practices. This system is composed of a small, single, wearable patient sensor that adheres to a patient’s chest, similar to a standard telemetry electrode. The sensor communicates wirelessly to a central monitoring station about the patient’s current position (upright, supine/back, right side, left side) and time-to-next-turn. Data for all patients are displayed on a User-Dashboard, allowing staff to easily identify patients who are in need of turning. The system also allows caregivers to identify restricted positions due to existing pressure ulcers or surgical wounds, as well as to create personalized turning protocols, by varying the degree of turn angle and/or tissue decompression thresholds. Two single-center clinical studies have been completed using the monitoring equipment. Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement A small first-in-human Institutional Review Board (IRB)-approved study was performed to test the feasibility of the patient sensor, mesh network, and monitoring system, and to collect baseline data regarding turning protocol compliance. After this, a second single-center IRB-approved clinical study tested the efficacy, usability, and safety of the monitoring system (ClinicalTrials.gov #NCT02005692). After implementation of the system, compliance to patient turning was reported to have increased significantly from 64 to 98 % [9]. To date, the study team are unaware of any study that has used a wearable patient sensor to quantify patient movement and positioning, in an effort to assess whether adherence to optimal patient turning results in a reduction in pressure ulcer occurrence. As such, the following protocol describes the study to be conducted to evaluate whether optimal patient turning, defined as regular turning every 2 h with at least 15 min of tissue decompression, reduces HAPUs in acutely ill patients. Page 2 of 8 and testing of the patient-monitoring system to account for potential observer bias (the Hawthorne effect). The true intent of the technology will be obfuscated to patients and clinical staff in an effort to record baseline data that more accurately represent current turning practices within these units. These pilot data will also be used to determine minimum turning thresholds for the main study and to assess the representativeness of the main study’s control group. A convenient sample of 25 subjects will be enrolled from each participating unit. Randomization All subjects will be randomly assigned, with the aid of a computer-generated schedule, to receive either standard care (control group) or optimal pressure ulcer preventative care (treatment group). To minimize the risk of predicting the treatment assignment, randomization is performed in permuted blocks of two, four, and six, with random variation of block sizes. To minimize bias at the patient level, randomization is further stratified by unit of admission and admitting service, either medicine or surgery (Fig. 1). Once randomized, each subject will receive a nominal study identification number based on the unit of admission and admitting service. The lowest available number will be provided to each subject in sequential order. Study population This study will enroll all patients admitted to two ICUs. These patients are critically ill with exacerbations of acute and chronic medical conditions, or are receiving aggressive post-surgical care for neurological, cardiac, or trauma-related conditions. They typically have altered levels of consciousness and are dependent on clinical staff for activities of daily living. Due to immobility and other clinical factors these patients are at high risk for developing pressure ulcers. As it is infeasible to gain written consent from this patient population and, due to the minimal risk of the study procedures, a waiver of individual authorization has been granted by Stanford University’s IRB (see Ethics approval section). Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement Therefore, all patients over the age of 18 years admitted to one of the two ICUs will be enrolled in the study. Patients under 18 years of age, those with a known allergy to skin adhesive, or who possess a physical barrier preventing the application of the monitoring sensor, are not eligible for inclusion. Recruitment/Intervention Methods/design Design This study is a single-site, open-label, two-arm, randomized controlled trial. As this is an open-label trial, a short observation pilot study will be undertaken during installation Upon admission to a study unit and as part of standard care, the patient receives a complete “head-to-toe” assessment of their skin. This is performed by two registered nurses (RNs). Any pre-existing pressure ulcer that is detected during this assessment is documented in the Pickham et al. Trials (2016) 17:190 Page 3 of 8 T Medical C ICU 1 Treatment T Surgical C Arrival T Medical C ICU 2 Control T Surgical C Fig. 1 Randomization schema. Stratification by unit and admitting service team electronic medical record (EMR). After initial standard admission procedures are performed, and within the first hour of arrival, nursing staff will place a patient sensor (Leaf Healthcare, Pleasanton, CA, USA) in a predefined location on the patient’s chest (Fig. 2). If an exclusion condition is present, this will be documented and the patient will not be enrolled in the study and will not receive a patient sensor. For patients included in the study, the unit secretary will provide nursing staff with a patient sensor after associating the sensor’s serial number with the patient’s specific information. This is automatically derived from an Admission-Discharge-Transfer (ADT) data stream communicating directly with the Leaf Patient Monitoring System. At this time the unit secretary will open an envelope, pre-filled with the computer-generated randomized group allocation. A patient sticker will be affixed to the back of the randomization card and stored in a secure location for later retrieval and verification of correct randomization and enrollment. The patient will then be enrolled in either a treatment or control group. When a subject is enrolled in the treatment group, the User-Dashboard will be turned “on,” allowing the sensor to communicate the patient’s position and movements (Fig. 3). The clinical team will review this information and be guided by visual displays to provide pressure ulcer-prevention turning practices. With the use of the User-Dashboard, nurses will be prompted to perform pressure ulcer preventative care, namely patient turning with satisfactory tissue decompression for 15 min, at least every 2 h (optimal). If a patient does not receive the full time of tissue decompression, the Leaf Patient Monitoring System automatically adjusts, proportionally reducing the time-to-next-turn. For example, if the patient was on their back and moved to their right side, but returned to their back within 7–8 min, the time-tonext-turn will be adjusted reciprocally from 2 h to 1 h. This ensures that patients receive at least 15 min of tissue decompression every 2 h. If the subject is enrolled in the control group, the unit secretary will turn the User-Dashboard “off” by selecting the “control patient” check-box in the Leaf Patient Pickham et al. Trials (2016) 17:190 Page 4 of 8 the patient will be discharged automatically from the Leaf Patient Monitoring System. Technology The Leaf Patient Monitoring System is a proprietary system developed by Leaf Healthcare Inc. Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement (Pleasanton, CA, USA) [10]. The Leaf Patient Monitoring System is a wireless monitoring system that enables personalized turning protocols. A wireless, wearable, single-patient sensor communicates a patient’s body position and movement, through a proprietary mesh network of relay antennas placed throughout the study units to a central monitoring system (Fig. 4). The Leaf Turn Management System accesses an industry standard Health Level Seven International (HL7)-ADT data stream. This allows for simplified and accurate patient enrollment and seamless tracking of patient movement throughout the study units. For data security, all data generated from the Leaf Patient Monitoring System are transferred and stored within the institution’s firewall to secure servers. The Leaf Turn Management System is the User-Dashboard that displays an individual patient’s positioning and movement data to the clinical team. Data management Fig. 2 Location of patient-monitoring sensor. *Used with permission from Leaf Healthcare, Inc. Monitoring System. This will turn the sensor information off and therefore not display any information to the User-Dashboard. Patients in the control group will continue to receive standard care practices, that is, pressure ulcer-prevention activities initiated by nurses using their usual care routines. Nursing care will not be “optimized” by the Leaf Patient Monitoring System, with the system withholding any data related to turning frequency, position schedule, and decompression time. The patient sensor will continue to collect these data for the purposes of research analysis only. Each patient’s participation within the study begins within the first hour of arrival to a study unit and ends upon discharge or transfer from the study unit. Upon leaving the unit, the patient sensor will be removed and Proprietary turning data will be acquired from the Leaf Patient Monitoring System. Compliance to preventative turning care will be defined by two measures. The first will sum the overall time the patient is overdue for turning care, divided by the total monitoring time, and will be reported as a percentile of time. For example, if a patient was on the unit for 4 h and did not receive preventative turning care at the second hour, but instead at the third hour (1 h overdue), then the patient’s care was in compliance for 3 of the 4 h of their length of stay. This would, therefore, represent a time in compliance of 75 %. If they received the turn on schedule, the compliance would be at 100 %. The second measure will divide a patient’s length of stay into 2 h turning blocks. In the above example, if the patient was turned once in their 4 h stay, compliance to turning would equal 50 %. Although we believe that the time in compliance is more appropriate than the proportion of turns within 2 h blocks, we will test and report on both measures as the latter reflects current clinical care practices. Pressure ulcer staging The National Pressure Ulcer Advisory Panel (NPUAP) staging criteria will be used to stage all HAPUs [11]. Assignment: Learning from Theatre acquired Pressure Ulceration PICOT Statement Staging will be completed by an expert RN blinded to the patients’ study allocation. Adjudication will occur with the study team for any wounds that are difficult to stage. Pickham et al. Trials (2016) 17:190 Page 5 of 8 Fig. 3 User-Dashboard – Leaf Patient Monitoring Interface. *Used with permission from Leaf Healthcare, Inc. Stage I, non-blanchable erythema: intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area. The area may be painful, firm, soft, warmer or cooler as compared to adjacent tissue. Category I may be difficult to detect in individuals with dark skin tones. This stage may indicate “at risk” persons Stage II, partial thickness skin loss: partial-thickness loss of dermis presenting as a shallow, open ulcer with a red-pink wound bed, without slough. This may also present as an intact or open/ruptured serum-filled or sero-sanginous-filled blister. It presents as a shiny or dry, shallow ulcer without slough or bruising*. This category should not be used to describe skin tears, tape burns, incontinence-associated dermatitis, maceration or excoriation. *Bruising indicates deep tissue injury Stage III, full-thickness skin loss: full-thickness tissue loss. Subcutaneous fat may be visible but bone, tendon or muscle are not exposed. Slough may be present but does not obscure the depth of tissue loss. This may include undermining and tunneling. The depth of a category/stage III pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleoli have no (adipose) subcutaneous tissue and category/stage III ulcers Fig. 4 Wearable patient sensor communication network. *Used with permission from Leaf Healthcare, Inc. Pickham et al. Trials (2016) 17:190 can be shallow. In contrast, areas of significant adiposity can develop extremely deep category/ stage III pressure ulcers. Bone/tendon is not visible or directly palpable Stage IV, full-thickness tissue loss: full-thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present. This stage often includes undermining and tunneling. The depth of a category/stage IV pressure ulcer varies by anatomical location. The bridge of the nose, ear, occiput and malleoli have no (adipose) subcutaneous tissue and these ulcers can be shallow. Category/ stage IV ulcers can extend into muscle and/or supporting structures (e.g., fascia, tendon or joint capsule) making osteomyelitis or osteitis likely to occur. Exposed bone/muscle is visible or directly palpable Data collection Patient demographics and clinical data will be obtained from the Stanford Translational Research Integrated Database Environment (STRIDE). STRIDE is a clinical data warehouse that is maintained by the Stanford University School of Medicine and is updated in near real time directly from the EMR used at Stanford Health Care. All data generated from the study will be managed and stored using REDCap electronic data capture tools, hosted by Stanford University. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies [12]. Study endpoints Primary The following endpoints will be evaluated: Difference in compliance rates with preventative turning practices between the treatment and control groups, as continuously measured by the Leaf Patient Monitoring System during the patients’ ICU stay Difference in the proportion of HAPUs between the treatment and control groups Secondary Page 6 of 8 Sample size calculation Using a two-sided Z test of the difference between proportions with 80 % power and a 5 % significance level, a sample size of 1812 patients, 906 in each group, will be sufficient to detect a clinically important difference of 50 % between the groups in the rate of HAPUs. This assumes that a 50 % difference represents a change from a prevalence rate of 5 % for pressure ulcers in the control group, to a rate of 2.5 % for pressure ulcers in the treatment group. Conservatively, with an estimated enroll … Get a 10 % discount on an order above $ 100 Use the following coupon code : NURSING10