|- candidate number||1668|
|- NTR Number||NTR508|
|- Date ISRCTN created||20-feb-2007|
|- date ISRCTN requested||13-dec-2005|
|- Date Registered NTR||15-sep-2005|
|- Secondary IDs||945-14-411 |
|- Public Title||Introduction of a breast cancer care programme in ultra short stay (ambulatory/24 stay setting) in 4 early adopter centres: implementation and evaluation.|
|- Scientific Title||Introduction of a breast cancer care programme in ultra short stay (ambulatory/24 stay setting) in 4 early adopter centres: implementation and evaluation.|
|- hypothesis||There is no hypothesis in this implementation study, that is designed to record facilitating and inhibiting factors when an accepted and well functioning care programme is introduced in four early adopter hospitals.|
|- Healt Condition(s) or Problem(s) studied||Breast cancer|
|- Inclusion criteria||Breast cancer patients of all ages undergoing all types of surgical interventions for breast cancer. |
|- Exclusion criteria||Contraindications are those related to the physiology of the patient, and therefore not age or any of the surgery types employed in the treatment of breast cancer.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-dec-2004|
|- planned closingdate||1-dec-2007|
|- Target number of participants||400|
|- Interventions||A comprehensive care programme for breast cancer surgery in ultra short stay; in 4 early adopter hospitals.|
|- Primary outcome||Percent patients in ultra short stay, |
- percent patients treated according to protocol,
- cost-effectiveness of the care programme and implementation programme.
|- Secondary outcome||1. Patient satisfaction; |
2. Degree of involvement of home care nursing);
a. access time to out patient department,
b. time spent in the diagnostic process,
c. access time to the surgical procedure,
d. surgical quality of care (complications, nr of re-operations),
e. patient satisfaction.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.F. Meyenfeldt|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. M.F. Meyenfeldt|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM), Department of Surgery|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Implementation objective(s) / Research question(s): |
The aim of the knowledge transfer activities in this project is to inform relevant stakeholders about a set of interventions to support establishing a comprehensive care programme for breast cancer surgery in ultra short stay (the Univ Hosp Maastricht (uhM) breast cancer care programme).
Pre-post uncontrolled prospective trial.
Study population(s)/ Datasets:
All types of surgery for breast cancer patients of all ages.
Intervention to be implemented:
A comprehensive care programme for breast cancer surgery in ultra short stay; in 4 early adopter hospitals.
Implementation of the uhM breast cancer care programme will be put forward by a hospital-specific tailored implementation programme that will be adapted through the plan-do-study-act cycle, and that will be aimed at solving the barriers.
Tailored multifaceted implementation techniques, providing insight, inducing change and acceptance, and feed back to maintain the changes will be used
Outcome measures and Process idicators:
- Primary (percent patients in ultra short stay, percent patients treated according to protocol, cost-effectiveness of the care programme and implementation programme);
- Secondary (patient satisfaction, degree of involvement of home care nursing);
Process indicators (access time to out patient department, time spent in the diagnostic process, access time to the surgical procedure, surgical quality of care (complications, nr of re-operations), patient satisfaction).
Assuming the difference between the pre- and post-implementation period being 30% (uhM 71%) 40 patients are needed in each group to demonstrate statistical relevance with a power of 0.90.
Economic evaluation (if Applicable):
The cost-effectiveness of the programme (as compared to usual care, i.e. breast cancer surgery on an inpatient basis) will be calculated expressed as the incremental costs per Quality Adjusted Life Year (QALY).
The cost-effectiveness analysis will be performed from the societal perspective, with a time horizon of 6 weeks.
Thirty six months total study length. Four phases:
1. inventory of existing care, preparation of implementation strategies 6 months; baseline measurement 6 months;
2. pilot implementation 6 months;
3. running of the comprehensive care programme 12 months;
4. evaluation, with consolidation 6 months.
breast, cancer, surgery, ambulatory, implementation.
|- Main changes (audit trail)|
|- RECORD||15-sep-2005 - 13-jan-2010|