Development and Implementation of Surgical Safety Checklists for Patients to Use Before Admission, Before Discharge and After Discharge (PASC) - a Stepped Wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8,559
- 试验地点
- 4
- 主要终点
- Number of embolism associated with the hospital stay
研究概览
简要总结
Building on the Norwegian Patient Safety Program's target areas, the Patients' Surgical Checklist (PASC) will empower surgical patients to become more involved in their own safety and contribute to preventive safety measures. A safety checklist for patients to use has been developed and validated for use in surgical patients. In a Stepped Wedge Cluster RCT effects of patients using their own checklists to avoid preventable patient harm are examined. The project will re-use existing health and personal data collected from patient records and patient reported data as outcome measures. A consortium of all relevant stakeholders and users participate: two hospitals with seven surgical clusters, patient representatives, representatives of general practitioners, and interdisciplinary in-hospital professionals. The important project partners are information and communications technology companies (Helse-Vest IKT and CheckWare service delivery), general practitioners, and national and international research partners leading in the field of patient safety, implementation science and health economics.
详细描述
The PASC consist of measures that enable patients to optimize their own health prior to surgery and for discharge from hospital. The checklist addresses risk areas as pre-operative information and preparations, post-operative information, and post-operative plans and follow-up. Pre-operative risk areas are contact information, medication safety, health status, optimizing health and nutritional status, dental status, comprehend critical information, preparation two weeks before surgery, communication with surgical ward, and discharge planning. Post-operative risk areas are prevention of complications, medication safety, activity restriction, and pain relief.
The checklist has been developed in cooperation with patients, patients' representatives, surgeons, general practitioners, ward doctors, nurses, pharmacists, clinical nutritionists, safety officers, hospital managers, information technology experts and the researchers. The intervention include paper and electronically versions of the checklist. Of eligible surgical wards, seven were randomly selected based on power calculation. All the invited wards agreed to participate. Surgical patients from these wards, in two Norwegian hospitals, will be invited to participate in the trial. Based on data from a validation and feasibility study of PASC, the power analysis suggest to include 38 patients per month (on average), per cluster over 20 months, as the lowest number of participants to detect a 5% (33.3% relative risk reduction). An intra-cluster-correlation at 0.05, and type I and type II error at 0.05 and 0.20, respectively, were assumed.
The outcomes of this study are primarily patient outcomes (morbidity and mortality). The study further assess outcomes on nutritional status (MST form), implementation (acceptability, appropriateness and feasibility survey), health economic (EQ-5D-3L) data, and health literacy (HLQ), from surveys and forms.
Based on power calculation, 350 questionnaires will be distributed in each arm of the trial (baseline and internvention).
Focus group interviews with content analysis will be applied to assess patients and health care personnel's experiences with patients' use of PASC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All participants are masked for the study outcomes. In intervention arm, the participants are not masked for the checklist intervention.
Care Providers are masked for patients receiving the intervention and for outcomes.
Outcome assessors are masked for patients receiving the intervention. Investigators are partially masked for the outcomes across clusters in the intervention phase
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
- •Elective surgery.
- •Age over 18 years.
- •Able to use Norwegian language.
- •Patients must have had surgery 2-4 weeks before inclusion for the focus group interviews.
排除标准
- •Must be cognitive able to use the checklist.
- •Age under 18 years.
- •Non-surgical procedures.
结局指标
主要结局
Number of embolism associated with the hospital stay
时间窗: Up to 30 days
Number of embolies
Number of infections
时间窗: Up to 30 days
Numbers of infections
Number of mechanical implant complications
时间窗: Up to 30 days
Number of mechanical implant complications
Number of re-operations
时间窗: Up to 30 days
Number of re-operations
Number of complications associated with the participants surgery
时间窗: Up to 30 days
Total numbers of complications
Number of complications within respiratory system
时间窗: Up to 30 days
Number of respiratory complications
Number of complications within cardio-thoracic system
时间窗: Up to 30 days
Number of cardio-thoracic complications
Number of nervous system complications
时间窗: Up to 30 days
Number of nervous system complications
Volume of bleeding associated with operation
时间窗: Up to 30 days
Volume of bleedings in mL
Number of re-admissions
时间窗: Up to 30 days
Number of re-admissions
次要结局
- Rate of patient scores on EQ5D(Up to 3 months)
- Rate of patient scores on Health Literacy Questionaire(Up to 3 months post discharge)
- Rates of Checklist Implementation Survey scores(Up to 3 months post discharge)
- Number of deaths associated with surgery(Up to 90 days)