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临床试验/NCT02906033
NCT02906033已完成不适用

The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes

Hospital District of Helsinki and Uusimaa1 个研究点 分布在 1 个国家目标入组 517 人开始时间: 2016年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
517
试验地点
1
主要终点
Change From Baseline to Follow-up in Health Related Quality of Life

研究概览

简要总结

The aim of the study is to improve the surgical patients' care process. The objective is to explore the effect of a new perioperative practice model on 1) patient outcomes (satisfaction, surgery-related anxiety and quality of life), 2) nursing outcomes (organizational engagement), and 3) organization outcomes (timeline of surgical care process).

详细描述

Study design:

A longitudinal untreated control group design with pre- and posttests will be followed.

Setting and sampling:

The study will be conducted at the Helsinki University Hospital; more specifically at the operating department K of the Peijas Hospital. The randomized patient sampling will include voluntary adult surgical patients undergoing a hip or a knee replacement procedure. The patients will be recruited during their preoperative visit (approx. 2-3 weeks prior to the operation), and an informed consent will be obtained. Approximately 12-16 patients per day are scheduled for the preoperative visits, summing up to 60-80 recruitments per week. A control group (Group A) and an experimental (intervention) group (Group B) will be formed. The sample size was checked with power analysis (2 sided test) with the following parameters: value for α = 0.05, value for power 0.8, and value for common standard deviation 0.1. The sample size for both groups (A and B) was set at 175. Considering the potential drop-out, approx. 30%, the final sample size was determined to be 245 per group. The randomization will be performed by an independent third party (i.e., nurses at the preoperative clinic). The eligible patients will draw one of two cards; one indicating that an invitation to participate the study will be given to them, and the other being empty. Patients for the Group A will be recruited on the first week and the patients for the Group B on the second week. This pattern will be repeated until the desired amount of patients is recruited. This stratification will ensure that the two groups will not be contaminated in the ward where the post-operative visits will be carried out.

Data collection and instruments:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the patient has been scheduled for a primary elective hip or a knee replacement procedure under spinal anesthesia
  • the patient is 18 years of age or older
  • the patient is able to participate in the study either in Finnish or Swedish
  • the patient is able to give his/her written consent to participate the study
  • the patient is willing to participate the study
  • the patients operation time is scheduled on Monday through Thursday in the operating department K in the Peijas hospital

排除标准

  • 未提供

结局指标

主要结局

Change From Baseline to Follow-up in Health Related Quality of Life

时间窗: Baseline and at 3 months follow up

The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. The 15 dimensions are: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental functioning, discomfort and symptoms, depression, distress, vitality, and sexual activity The respondent chooses one of the five levels for each dimension that best describes his or her state of health at present moment; the best level is 1 and the worst is 5. The single index score (15D score), representing the overall HRQoL on a 0-1 scale (1=full health, 0=being dead). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group.

次要结局

  • Change in Surgery-related STATE Anxiety From Baseline to Follow-up(Baseline and at 3 months follow-up)
  • Quality of Perioperative Care as Experienced by Surgical Patients(One-point measurement on the day of discharge (on average on the 3rd day after surgery))
  • Change in Surgery-related TRAIT Anxiety From Baseline to Follow-up(Baseline and at 3 months follow-up)

研究者

发起方
Hospital District of Helsinki and Uusimaa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristiina Junttila

Director of Nursing Research Center

Hospital District of Helsinki and Uusimaa

研究点 (1)

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