“The "I-aid": A new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”.

“The "I-aid": a new care pathway to improve quality of care and quality of life in ileostomy and colostomy patients”



Objective:

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.



Study design:

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.



Study population:

Patients receiving an ileostomy or colostomy for any inflammatory or malignant distal bowel disorders or a trauma.



Intervention:

Current perioperative ostomy care vs. a new pre- and postoperative ostomy care pathway
("I-aid") including home visits.



Outcome measures:

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.



Economic evaluation:

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.



Time schedule:

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.

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.

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.

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.