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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
Danderyd Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    March 17, 2015
    Last Updated
    March 30, 2015
    Sponsor
    Danderyd Hospital
    Collaborators
    Indikator - Institutet för kvalitetsindikatorer
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    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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