Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IN2005E
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Patient hotel, Patient Satisfaction, Perioperative care, IN2005E
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient hotel group
Ward group
Arm Description
Outcomes
Primary Outcome Measures
Patient satisfaction regarding provided care associated with surgery for breast cancer
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02403973
First Posted
March 17, 2015
Last Updated
March 30, 2015
Sponsor
Danderyd Hospital
Collaborators
Indikator - Institutet för kvalitetsindikatorer
1. Study Identification
Unique Protocol Identification Number
NCT02403973
Brief Title
Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward
Official Title
Randomized Clinical Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel Versus a General Surgical Ward
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
Indikator - Institutet för kvalitetsindikatorer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Patient hotel, Patient Satisfaction, Perioperative care, IN2005E
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient hotel group
Arm Type
Other
Arm Title
Ward group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
IN2005E
Intervention Description
IN2005E is a validated questionnaire that measures patient satisfaction
Primary Outcome Measure Information:
Title
Patient satisfaction regarding provided care associated with surgery for breast cancer
Description
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)
Time Frame
in average 1 day
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
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Trial Comparing Perioperative Care for Breast Cancer Patients at a Patient Hotel vs a General Surgical Ward
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