. A Randomized Controlled Trial Comparing Videoconference and Outpatient Stoma Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Primary Endpoint
- Changes in quality of life
Study Overview
Brief Summary
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.
Detailed Description
There has been substantial development in the uses of VC among medical personnel [1]. Therefore, new applications of VC are emerging, such as surgical telementoring, trauma and emergency medicine, postoperative follow-up of patients, education of medical personnel, and multidisciplinary team meetings [2]. VC has a great and unused potential, this is recently described in an "invited commentary" in World Journal of Surgery [3]. Furthermore, during recent years, the cost of VC equipment has become less expensive, and advanced technical skills are not required to use the system.
Patients with stoma problems are a large and resource demanding group. Each year there are performed several hundred consultations at the surgical outpatient clinic at University Hospital of North-Norway for this patient group. These patients are surgically treated at the gastrointestinal, urological and gynaecological department.
The visual component is critical to give patients with stoma problems the best care, VC will therefore be well suited for this patient group [4, 5]. Furthermore, the infrastructure for VC in northern Norway is well developed for VC. In the county of Finnmark, Troms and Nordland there are a VC network, all linked together through the Norwegian Health Network.
The purpose of this study is to obtain insight into quality of life (QoL) among patients followed up in a hospital outpatient setting or by VC, and into the incremental cost-effectiveness ratio from the point of view of health care and of society.
Methods and design Study design This study is a randomized controlled trial where patients either will be randomized to follow up at the surgical outpatient clinic (control group) or by VC (intervention group
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stoma patients
Exclusion Criteria
- •Not able to travel,
- •Accepted written consent
Outcomes
Primary Outcomes
Changes in quality of life
Time Frame: up to two years
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 Outcomes
- Cost effectiveness(up to two years)