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临床试验/NCT02403973
NCT02403973已完成不适用

Randomized Clinical Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel Versus a General Surgical Ward

Danderyd Hospital0 个研究点目标入组 151 人开始时间: 2010年4月1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
151
主要终点
Patient satisfaction regarding provided care associated with surgery for breast cancer

研究概览

简要总结

To explore the possible benefit of a patient hotel, a study was undertaken to test the hypothesis that perioperative care at a patient hotel would be valued better than care in a general ward. The study focuses solely on the patients' perspective and satisfaction of the care provided.

详细描述

The study was designed as a prospective randomised controlled trial, carried out at a single centre (Danderyds University Hospital). The protocol was approved by the Ethical committee for human studies.

With a primary outcome that perioperative care at the hotel would be valued 15-20% higher than care in a general ward, a power analysis, two-sided with α = 0.05, indicated that a sample size of 150 was needed to attain a power of 80%.

The patients were randomised to receive pre- and postoperative care either in a general surgical ward or at a patient hotel by using a sealed envelope method.

To evaluate the patients' experiences of the care provided at the ward and the hotel, respectively, the Swedish validated version of the adult inpatient survey of 2005 (IN2005-E) was used.

Adjacent to the discharge from the ward or hotel, the patient was provided with the IN2005-E questionnaire, which was filled out before the patient left the facility. The filled out form was sealed in an envelope by the patient herself and thereafter sent to a separate institute (Indikator) for further analysis. Indikator is responsible for the majority of the statistical analysis of patient surveys in Sweden.

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
None

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a breast tumour, who were to undergo surgical treatment in order to remove a known cancer or to exclude cancerous changes in a diagnosed tumour

排除标准

  • Insulin dependent diabetes
  • Severe impairment of mobility
  • A known coagulopathy
  • Cancer surgery with a coherent primary reconstruction
  • Severe cardiac illness
  • An inability to understand Swedish
  • Mental incapacity.

结局指标

主要结局

Patient satisfaction regarding provided care associated with surgery for breast cancer

时间窗: in average 1 day

The IN2005-E is a quantitative questionnaire, based upon the Picker Adult Inpatient Questionnaire and is commonly used to examine specific aspects of patient satisfaction. The IN2005-E is comprised by questions that focus on whether a specific event occurred or not, rather than letting the patients rate their care in terms of how satisfied they are. By this design the influence of outside factors is reduced. The conceptual basis and design of the original questionnaire has been described in detail elsewhere (Cleary PD, Edgman-Levitan S, Roberts M, Moloney TW, McMullen W, Walker JD, Delbanco TL. "Patients evaluate their hospital care: a national survey". Health Affairs 1991; 10; 254-267. Cleary PD, Edgman-Levitan S, Walker JD, Gerteis M, Delbanco TL. "Using patient reports to improve the medical care: a preliminary report from 10 hospitals". Quality Management in Health Care 1993; 2: 31-8. http://nhssurveys.org/surveys/712)

次要结局

未报告次要终点

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Madleen Huzell

M.D.

Danderyd Hospital

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