Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electronic Referral and Booking of Outpatient Day Case Surgery Compared With Traditional Referral Routines. (one-stop)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692497
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 6, 2008
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
waiting time [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
cost effectiveness [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Referral and Booking of Outpatient Day Case Surgery Compared With Traditional Referral Routines.
Official Title  ICMJE Costs-effectiveness and Waiting Time for Direct Electronic Referral and Booking of Outpatient Day Case Surgery Compared With Traditional Referral Routines. A Randomised Controlled Trial
Brief Summary We want in this study to investigate the cost-effectiveness and waiting time of direct electronic referral and booking of outpatient surgery compared to the traditional patient pathway where the patient is seen at the outpatient clinic prior to surgery.
Detailed Description

Waiting time from referral to day case outpatient surgery is unacceptable long. In Norway it is as much as 48 weeks for common conditions like gallstones, inguinal hernia and sinus pilonidalis. Electronic standardised referrals sent by the Norwegian Healthcare Network, and booking of surgery by the general practitioner might be a way to reduce the waiting time and increase the cost effectiveness of outpatient surgery.

The trial is designated as a randomized controlled trial were selected patients (inguinal hernia, gall stone disease and sinus pilonoidalis) referred to the university hospital, were either randomized to direct electronic referral and booking for outpatient surgery (one stop), or using the traditional patient pathway where all patients are seen at the outpatient clinic several weeks before surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Referral and Consultation
  • Telemedicine
  • Surgery, Outpatient
  • Surgery, Day
  • Medical Records Systems, Computerized
  • Health Services Research
  • Health Care Surveys
Intervention  ICMJE Behavioral: one stop (Electronic standardised referrals and appointment bookings)
The one stop strategy is a set of interventions directed at GPs referring to the University Hospital. The interventions include: Guidelines for referral, standardised electronic referrals, booking for outpatient surgery and a patient information form.
Study Arms  ICMJE
  • Active Comparator: 1
    The one stop strategy is a set of interventions directed at GPs referring to the University Hospital. The interventions include: Guidelines for referral, standardised electronic referrals, booking for outpatient surgery and a patient information form.
    Intervention: Behavioral: one stop (Electronic standardised referrals and appointment bookings)
  • No Intervention: 2
    Patients in the control group are randomised to use the regular patient pathway prior to day case outpatient surgery. All these patients are referred to the surgical outpatient clinic. At the outpatient clinic patients are examined by a surgeon and indications for surgery is decided by the surgeon. If indicated, patients are then referred to outpatient surgery and the surgical procedure is performed several weeks after the examination.
Publications * Augestad KM, Revhaug A, Vonen B, Johnsen R, Lindsetmo RO. The one-stop trial: does electronic referral and booking by the general practitioner (GPs) to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol. BMC Surg. 2008 Aug 11;8:14. doi: 10.1186/1471-2482-8-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2008)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients were eligible if they were diagnosed by their GP for an inguinal hernia, sinus pilonidalis or gallstone disease which require surgical treatment.

Exclusion Criteria:

  • Patients with medical conditions making them unfit for outpatient surgery admitted to the surgical department prior to surgery are not eligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00692497
Other Study ID Numbers  ICMJE P REK NORD 122/2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rolv-Ole Lindsetmo, MD, PhD University of Tromso
Study Chair: Roar Johnsen, MD, PhD, Prof. University of North Norway
Study Director: Knut M Augestad, MD Norwegian Centre for Telemedicine and Department of Gastrointestinal Surgery, University Hospital of North Norway, Norway
PRS Account University Hospital of North Norway
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP