SWITCH- Surgical Ward Innovation: Telemonitoring Controlled by Healthdot Evaluation of Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Evaluation of the implementation of a continuous monitoring method on the surgical ward
研究概览
简要总结
This observational clinical, single center trial is designed to evaluate the implementation of an already validated smart monitoring device, the Philips Healthdot, on one surgical ward at the Catharina hospital in Eindhoven, The Netherlands.
This study is performed during 6 months in which all patients admitted to one surgical ward will be enrolled. Implementation is established by a step-by-step approach in which the current manually performed spot check monitoring (blood pressure, oxygen saturation, respiratory rate, heart rate, temperature and pain score), with the early warning score (EWS), is continued besides smart monitoring with the Healthdot (respiratory rate, heart rate and physical activity) during the first three months (phase 1). This phase aims at optimizing the infrastructure, education of hospital staff and practice with application/ activation and interpretation of the device. Upward of 4 months, Healthdot monitoring will be the primary monitoring method and spot check monitoring is only performed additionally in case of doubt about clinical condition or requirement of additional vital parameters.
Evaluation of the implementation will be performed with a focus group and various questionnaire regarding fidelity, acceptability, adoption, feasibility, appropriateness and costs. Thereby additional analysis regarding monitoring algorithms will be performed.
详细描述
This project is a 6 months monocenter prospective cohort study at the Catharina hospital in the Netherlands. Every patient admitted to the one surgery department will receive a Healthdot. Implementation of the Healthdot will be performed stepwise. During phase 1 (month 1-3, the pre-implementation phase), the current standard method of care with manual spot checks and EWS will be continued. During this phase Healthdots will be applied only for training purposes in preparation to the implementation phase, phase 2 (month 3-6). This phase consists of primarily Healthdot monitoring and manual spot checks only if indicated. After these 6 months, the implementation will be evaluated and optimized and potentially extended.
Participants:
The main research population for answering the research objectives are the nurses working at the specific surgical ward at the Catharina hospital.
In total amount of 500 patients, 250 during each phase, admitted to one surgical ward at the Catharina hospital will participate and receive a Healthdot as the new standard of care. These patients will sign informed consent for use of anonymized data. This population differs in age, gender, admission cause, admission duration and comorbidities but reflects the demographics of the general population on this ward which is essential to investigate implementation and prevent selection bias.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered in the national register of medical professions (Big register)
- •Appointed as a nurse at the Catharina hospital and working at the surgical department during the study period
- •Willingness to participate in the core group for evaluation of the implementation
- •Registered in the national register of medical professions (Big register)
- •Appointed at the Catharina hospital as a physician or resident during the study period.
- •Willingness to participate in the core group for evaluation of the implementation
排除标准
- •Nurses & Physicians
- •Termination of employment within the study period
- •No voluntarily participation in the core group evaluation meetings
- •Contra-indications for applying Healthdot
- •Known to have severe allergy for the tissue adhesive used in the Healthdot.
- •Any skin condition, for example prior severe rash, discoloration, scars or open wounds at the area of application
- •Pregnant, or breastfeeding
- •Use of topicals that are known to irritate the skin at the application area (such as medical and non-medical creams or lotions)
- •Patient with active implantable device such as a Implantable Cardiac Defibrillator (ICD) or pacemaker
- •Unable to understand instructions
- •Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
- •Transfer to a different ward during hospitalization
结局指标
主要结局
Evaluation of the implementation of a continuous monitoring method on the surgical ward
时间窗: Conducted on a daily base during the entire study, month 1-6
Workload: the experienced workload for nursing staff during the implementation of the Healthdot measured with the IWS and during focus group analysis
次要结局
- Algorithm improvement(After completing of the study at 6 months)
- Feasibility of the Healthdot(3 focus groups sessions at month 3, 5 and 6)
- Appropriateness(Evaluated after at month 4 and 6)
- Adoption(3 focus groups sessions at month 3, 5 and 6)
- Usability(Evaluated after at month 4 and 6)
- Acceptability(Evaluated at month 4 and 6)
- Feasibility and effectiveness(Manual time measurement during month 1-6, 2 times a week at different days)
- Costs(After completing of the study at 6 months)
研究者
Friso Schonck
Medical Docter (M.D.)
Catharina Ziekenhuis Eindhoven