Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00475631 |
| Other study ID # |
H03-70532 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2003 |
Study information
| Verified date |
May 2017 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Purpose:
The purpose of the study is to complete a cost analysis of the different methods used for
clubfoot treatment.
Objectives:
Short-term objective: To explore the experience of British Columbia Children's Hospital
(BCCH) with costs and outcomes related to the various forms of clubfoot management since 1984
to present.
Long-term objective: To use the information gathered in this project and apply it to future
studies in the clubfoot research program and to do a complete cost-benefit analysis.
Hypothesis: The hypothesis of the study is that the BCCH clubfoot treatment program has
better outcomes in terms of reduced financial costs than the traditional surgical management.
Description:
Inclusion criteria:
All patients who were diagnosed and treated for idiopathic clubfoot at BCCH between January
1984 and present are eligible for the study. Patients whose clubfoot is a secondary diagnosis
to another disorder (mal-position, neuromuscular disorder and chromosomal abnormality) are
excluded from this study.
Database design:
Using information gathered from literature review and interviews with several of the
orthopaedic surgeons at BCCH the most common treatment methods for clubfoot and the ones that
are and have been in use in BCCH were identified. Six treatment methods were then described
in detail. These treatment methods are: comprehensive release, posterio-medial release,
posterior release, Kite-method, Ponseti-method and BCCH-method. From all different
treatment-steps possible "units" were designed. The units that were designed are: initial
consult, clinic visit, consult physiotherapist, consult occupational therapist, OT-splint,
consult orthotist, X-ray, Boots and Bars, AFO by orthotist, custom orthotic, shoes, surgery,
cast applied during surgery, surgery second foot, surgery extra, anaesthesia extra 1-3,
daycare surgery, overnight stay in hospital, gastrosoleus defunctioning using Botox, Botox,
gait analysis and non-clubfoot related hospital encounter. Per unit there are more treatment
"options" available. For example in the unit "clinic visit", there are 18 options, such as
clinic visit, clinic visit with manipulation and casting using plaster of paris below knee,
clinic visit with manipulation and casting using plaster of paris above knee, clinic visit
with manipulation and casting using 3-M soft cast below knee. Within the unit "X-ray" there
are 3 options such as unilateral X-ray of the foot, bilateral X-ray of the foot, X-ray of the
pelvis.
More units were designed that are not part of the treatment, but do have their impact on the
costs concerning the treatment and therefore have to be considered. These units are: number
of persons traveling, days away form home, lost wages, air transportation, ground transport,
mileage, accommodation and meals.
All these units, together with patient demographics (patient ID, last name, first name,
gender, hometown and distance to BCCH) and intervention type (one of the 6 treatment-regimes
that the patient fits in) formed the database, which was set up in the Microsoft Excel
program.
Patient Data collection:
All patients that are eligible for this study were identified using the hospital data
retrieval system. The patient's hospital medical records will be collected and chart review
will be performed. Patient data will be entered into the database, using one line for every
visit (either as an inpatient or as an outpatient) to the hospital.
Costing Data collection:
Direct costs: A detailed breakdown of all "parts" constituting the units was performed.
Costing information on all these parts was then obtained using a great variety of sources,
including the MSP-billing book, personal communication with a pharmacy- representative and
interviews with nursing representatives, an expert in the financial department and experts in
the decision support department.
General overhead costs: The general overhead costs will be determined using information from
the decision support services and from the Orthopaedic department.
Data analysis: It is a cost analysis between the different methods of orthopaedic treatment
for clubfoot. Statistical analysis will be completed on all continuous variables. Statistical
analysis will be completed using SAS Statistical Software (SAS Institute, Cary, NC).
