Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward

NCT ID: NCT02403973

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-11-30

Brief Summary

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.

Detailed Description

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.

Patient characteristics were compared using a confidence interval of 95%. The SF-36 was analyzed with a two-sample t-test. The IN2005E was analyzed by a cross-tabulation of the data using the χ² test in SPSS 17.0. The significance level was set to < 0.05.

Conditions

Breast Cancer

Keywords

Patient hotel; Patient Satisfaction; Perioperative care; IN2005E

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient hotel group

Group Type: OTHER

IN2005E

Intervention Type: OTHER

IN2005E is a validated questionnaire that measures patient satisfaction

Ward group

Group Type: OTHER

IN2005E

Intervention Type: OTHER

IN2005E is a validated questionnaire that measures patient satisfaction

Interventions

IN2005E

IN2005E is a validated questionnaire that measures patient satisfaction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indikator - Institutet för kvalitetsindikatorer

UNKNOWN

Sponsor Role: collaborator

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Madleen Huzell

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2010/38-31/4

Identifier Type: -

Identifier Source: org_study_id