Videoconference Stoma Consultation - Full Text View

Purpose

Background:

Videoconference (VC) is a common clinical tool and has huge potential to alter medical practice and to offer patients the best expertise in treatment and follow-up in spite of long distances, especially in rural areas. Studies upon selected patient groups have shown that VC is safe and cost-effective. However, RCT of VC patients with stoma problems have never been performed.

Patients with stoma problems are resource demanding patients. The University Hospital North Norway (UNN) has several hundred consultations for this patient group each year, serving the population in North Norway.

Methods: In this randomised controlled trial (RCT), patients are either randomised to a VC consultation or a regular consultation at the outpatient clinic. All patients with a stoma that needs special attention are eligible for inclusion. Patients randomised to the VC group, are set-up to a meeting at the nearest VC studio located to their home community. There will be educated VC- stoma nurses that will participate in the clinical examination at the hospital outpatient clinic and at the rural VC studio.

Endpoints: Primary endpoints are patient satisfaction and quality of life. Secondary endpoints are number of consultations and cost effectiveness.

Sample size calculations showed that 170 patients had to be included in the trial.

The investigators hypothesize that postoperative follow-up of stoma patients by VC will not have any impact on patients' quality of life compared to Hospital outpatient follow-up. Furthermore, the investigators hypothesize that the incremental cost-effectiveness ratio will improve.

Condition	Intervention
Surgical Stomas	Other: Videoconference stoma care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Videoconference in Stoma Out-patient Clinic. A Randomized Controlled Trial

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:

Changes in quality of life [ Time Frame: up to two years ] [ Designated as safety issue: No ]
We aim to compare quality of life measured with EQ-5D questionnaires among patients followed up by VC vs those followed up at the surgical outpatient clinic at 1, 3, 6, 9, 12, 15, 18, 21, 24 months of follow-up. We hypothesize that patients followed up by VC will experience similar or higher scores on quality of life measures during followup.

Secondary Outcome Measures:

Cost effectiveness [ Time Frame: up to two years ] [ Designated as safety issue: No ]
Economic evaluation questionnaire, incorporated in the QOL questionnaire, is given to the patients and requested to fill out at baseline and at 1, 3 6, 9, 12, 15, 18, 21 and 24 months after inclusion. It has been developed to enable calculation of costs related to patient examinations such as patient- and family-related costs due to outpatient visits, VC visits, laboratory tests, radiographs/ultrasound, examinations due stoma complications, treatment of complications, traveling, production losses, co-payments and other patient expenses.

Estimated Enrollment:	170
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Traditional stoma care Being discharged from a hospital with a stoma is a challenge to the patient's quality of life in many aspects. Optimal stoma function and care is essential to keep quality of life best possible. Videoconference can be a useful tool to help patients cope with stoma problems without travelling long distances to a surgical outpatient clinic.	Other: Videoconference stoma care Stoma patients are randomized to videoconference stoma care or surgical outpatients clinic stoma care
Experimental: Videoconference Stoma Consultations Videoconference Stoma Consultations	Other: Videoconference stoma care Stoma patients are randomized to videoconference stoma care or surgical outpatients clinic stoma care

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stoma patients

Exclusion Criteria:

Not able to travel,
Accepted written consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600508

Sponsors and Collaborators

University Hospital of North Norway

Investigators

Principal Investigator:

Rolv-Ole Lindsetmo, MD, PhD, MPH

Institute of Clinical Medicine, Tromsø University, Norway, Univertsity Hospital of North Norway

More Information

Publications:

Jarvis-Selinger S, Chan E, Payne R, Plohman K, Ho K. Clinical telehealth across the disciplines: lessons learned. Telemed J E Health. 2008 Sep;14(7):720-5. Review.

Augestad KM, Lindsetmo RO. Overcoming distance: video-conferencing as a clinical and educational tool among surgeons. World J Surg. 2009 Jul;33(7):1356-65. Review.

Doarn CR. The power of video conferencing in surgical practice and education. World J Surg. 2009 Jul;33(7):1366-7.

Shannon RJ. Telemedicine in wound healing. Int Wound J. 2005 Sep;2(3):239-40.

Wilbright WA, Birke JA, Patout CA, Varnado M, Horswell R. The use of telemedicine in the management of diabetes-related foot ulceration: a pilot study. Adv Skin Wound Care. 2004 Jun;17(5 Pt 1):232-8.

[No authors listed] EuroQol--a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990 Dec;16(3):199-208.

Campbell MJ, Julious SA, Altman DG. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons. BMJ. 1995 Oct 28;311(7013):1145-8. Review. Erratum in: BMJ 1996 Jan 13;312(7023):96.

Roset M, Badia X, Mayo NE. Sample size calculations in studies using the EuroQol 5D. Qual Life Res. 1999 Sep;8(6):539-49.

Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.

Rumpsfeld M, Arild E, Norum J, Breivik E. Telemedicine in haemodialysis: a university department and two remote satellites linked together as one common workplace. J Telemed Telecare. 2005;11(5):251-5.

Moseng D. [Teledermatology--experiences from Northern Norway]. Tidsskr Nor Laegeforen. 2000 Jun 20;120(16):1893-5. Norwegian.

Nordal EJ, Moseng D, Kvammen B, Løchen ML. A comparative study of teleconsultations versus face-to-face consultations. J Telemed Telecare. 2001;7(5):257-65.

Wallace P, Haines A, Harrison R, Barber J, Thompson S, Jacklin P, Roberts J, Lewis L, Wainwright P; Virtual Outreach Project Group. Joint teleconsultations (virtual outreach) versus standard outpatient appointments for patients referred by their general practitioner for a specialist opinion: a randomised trial. Lancet. 2002 Jun 8;359(9322):1961-8.

Haukipuro K, Ohinmaa A, Winblad I, Linden T, Vuolio S. The feasibility of telemedicine for orthopaedic outpatient clinics--a randomized controlled trial. J Telemed Telecare. 2000;6(4):193-8.

Harno K, Arajärvi E, Paavola T, Carlson C, Viikinkoski P. Clinical effectiveness and cost analysis of patient referral by videoconferencing in orthopaedics. J Telemed Telecare. 2001;7(4):219-25.

Ohinmaa A, Vuolio S, Haukipuro K, Winblad I. A cost-minimization analysis of orthopaedic consultations using videoconferencing in comparison with conventional consulting. J Telemed Telecare. 2002;8(5):283-9.

Jones SM, Banwell PE, Shakespeare PG. Telemedicine in wound healing. Int Wound J. 2004 Dec;1(4):225-30. Review.

Responsible Party:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT01600508 History of Changes
Other Study ID Numbers:	2009/1432a (REK)
Study First Received:	April 3, 2012
Last Updated:	May 16, 2012
Health Authority:	Norway: Data Protection Authority

Keywords provided by University Hospital of North Norway:

stoma care
videoconference
costs
quality of life

ClinicalTrials.gov processed this record on May 21, 2013