“The "I-aid": A new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”.|
|- candidate number||11283|
|- NTR Number||NTR3332|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-mrt-2012|
|- Secondary IDs||2011_370 METC AMC|
|- Public Title||“The "I-aid": A new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”.|
|- Scientific Title||“The "I-aid": A new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”.|
|- ACRONYM||I-aid trial|
|- hypothesis||To provide evidence whether a new perioperative care pathway for patients requiring an ileo- or colostomy reduces complication rates and improves quality of life against acceptable costs.|
|- Healt Condition(s) or Problem(s) studied||Ileostomy, Colostomy, Feces, Leakage, Skin irritation, Morbidity, Costs|
|- Inclusion criteria||1. All patients who receive a planned end or loop colo- or ileostomy;|
2. Age between 18 and 85 years;
3. Written informed consent.
|- Exclusion criteria||1. Life expectancy of less than one year;|
2. BMI > 35 or < 18;
3. Emergency surgery;
4. ASA IV;
5. Insufficient command of the Dutch language or cognitively unable to complete Dutch questionnaires;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-apr-2014|
|- Target number of participants||210|
|- Interventions||We intend to investigate the costs and effectiveness of a new, uniform ostomy care pathway (the “I-aid”) to improve the quality of care and quality of life of patients who will receive an ostomy. The project covers the investigation of a more elaborate instruction and closer monitoring programme in the perioperative and outpatient phases, particularly by the stoma care nurses.
Present-day care fails in terms of a large variation in care for these ileostomy patients, while the possession of such a stoma is cumbersome, may induce a serious physical and psychological burden, and may lead to serious stoma-related complications, most of which are preventable or can be limited by proper instruction, surveillance and timely action.|
Hence, the aim of this project is to investigate whether and to which extent the proposed new care pathway will lead to a reduction in the number of stoma-related complications and a better quality of life at acceptable costs, as compared with the standard perioperative care for ostomate patients.
Implementing a different care pathway:
Individual contributing centres will be clustered in three and, subsequently, randomly assigned to five different wedges that will receive the I-aid care pathway according to a sequential rollout over a number of time periods (see flowchart). Each cluster of three hospitals will start with the standard peri-operative care protocol during a period of three months. After three months, three of the fifteen centres will be selected randomly to start with the I-aid care pathway and continue to do so for the remainder of the study. This will be repeated each time a new quarter begins. The patients cannot choose between the different kinds of pathways. During the sixth quarter the final three centres will start to introduce the I-aid care pathway, so that by the end of the study, all hospitals will have adopted the I-aid care pathway. The study will follow the validity criteria as described by Fan et al. (Fan 2010).
The standard peri-operative pathway:
In short, the standard peri-operative care protocol, as defined by the stoma working group, prescribes the following actions:
Four to six weeks before the operation the patient will visit the outpatients clinic of the stomatherapist: to inform the patient and his relatives about the surgical procedure, the anticipated stoma and its consequences. Quality of life questionnaire (EQ-5D) will be asked to fill in. Also the patient will be asked to fill in a stoma care diary during the first three months after surgery.
Two weeks after the operation the patient will visit the outpatients clinic of the stomatherapist and the surgeon.
One and three month there will also be a visit at the outpatient clinic of the stomatherapist. The patients have to fill in another quality of life questionnaire (stomaqol).
The I-aid peri-operative care pathway:
The stomatherapists will visit the patient pre-operative, one month and three months at home. The Quality of life questionnaires and the stoma care diary will be asked to fill in at the same time.
|- Primary outcome||1. The percentage of patients with one or more stoma-related complications occurring within three months after receiving the ostomy. This time interval is chosen because within this period the stoma reaches its final shape and the vast majority of complications occurs. Stoma-related complications are: peristomal leakage, skin irritation, stomal dehiscence, retraction, protrusion, or stenosis, infection, and hemorrhage, according to standard predefined criteria;|
2. Patients’ quality of life, measured by means of the validated Stoma-Qol questionnaire (Prieto 2005), consisting of 20 items scored on a 4-point scale, and the EQ-5D to enable calculation of QALYs. These parameters will be assessed before surgery and 1 and 3 months after receiving the stoma.
|- Secondary outcome||Number and costs during the follow-up period of used stoma materials, outpatient visits, readmissions, the personnel involved, as well as the out-of-pocket expenses by patients.|
|- Timepoints||Stoma-related complications occurring within three months after receiving the stoma will be recorded during the outpatient or home visits. This will yield the percentages of patients with a stoma-related complication in both intervention groups.|
In addition, patients will be asked to complete the EQ-5D at baseline and the StomaQol after one and three months of follow-up, to generate health status scoring profiles over time, which will subsequently be transposed into health utilities using population based tariffs of time trade-off ratings of health states. The internationally most frequently applied UK tariffs will be used for the main analysis (Dolan 1997), with the impact of alternative, Dutch tariffs (Lamers 2005) assessed by sensitivity analysis. Based on the health utility scores over time, QALYs will be calculated by taking the product sum of the health utility scores and the periods in-between successive measurements during the three months of follow-up.
|- Trial web site||www.iaid-studie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.F. Sier|
|- CONTACT for SCIENTIFIC QUERIES|| M.F. Sier|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||“The "I-aid": a new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”
To provide evidence whether a new perioperative care pathway for patients requiring an ileo- or colostomy reduces complication rates and improves quality of life against acceptable costs. Previous national surveys among ostomates and stoma care nurses have shown variation in care. Literature shows the incidence of stoma-related complications is high, indicating room for improvement. Our recent pilot study indicated that additional postoperative home visits by stoma care nurses help improve stoma care and avoid complications. Hence, a care pathway comprising careful perioperative instruction and postoperative follow-up may provide a better quality of care for these patients.
Fifteen-centre cluster randomised clinical study with a stepped wedge design, so that at the end of the study all centres will have adopted the new care pathway.
Patients receiving an ileostomy or colostomy for any inflammatory or malignant distal bowel disorders or a trauma.
Current perioperative ostomy care vs. a new pre- and postoperative ostomy care pathway
("I-aid") including home visits.
Stoma-related complications within 3 months after the ostomy has been placed, stoma-related quality of life, number of readmissions, number and costs of consumables used for stoma care, number of outpatient and home visits and personnel involved within the follow-up period.
Sample size calculation / data analysis:
A total of 210 patients are needed to detect a 50% reduction in stoma-related complication rate (from 50% to 25%) with a power of 80% and at a one-sided alpha of 0.05.
From a societal perspective, the costs per stoma-related complication and costs per quality adjusted life year will be calculated and compared between the two care groups, with a time horizon of 3 months.
Two months of study preparation, 18-month inclusion period, 3 months of follow-up and 1 month to finalise data-analysis and reporting; this totals 24 months.
|- Main changes (audit trail)|
|- RECORD||5-mrt-2012 - 19-nov-2012|
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