Quality of Life Impact After Enhanced Follow-up of Ostomy Patients

Study Overview
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Brief Summary
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In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists. The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites. The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.

Detailed Description
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France currently has about 80,000 ostomy patients. Stoma placement exposes patients to many surgical or peristomal skin complications which could impair the quality of life of the ostomy patient. The management of ostomy patients varies from institution to institution and according to how the patient's medical equipment is supplied as well as whether or not specialised personnel are available. In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the delivery of equipment by HHNs, meeting a need for patient follow-up and accompaniment. This increased preference of HHNs to use specialist nurses seems to be explained by the added benefits. Early international studies have demonstrated the impact of an enterostomal therapy nurse follow-up on the improvement of ostomy patient's quality of life (QoL) relative to their health. However, none of the studies available today on follow-ups performed by an enterostomal therapist included the French population. Furthermore, the studies show methodological gaps, a limited time span and are based on strong hypotheses. In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists. The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites. The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.

Official Title
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Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care

Conditions
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Stoma Ileostomy, Stoma Colostomy, Quality of Life

Intervention / Treatment
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* Other: stoma follow-up
* Other: standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥ 18 years Patients with a stoma placed less than 10 days ago Patients who had a stoma during their current hospitalisation Patients informed verbally and in writing via the information sheet and who signed the informed consent form. Exclusion Criteria: Patients in palliative care Patients participating in another clinical study interested in the management of ostomy patients Patients not enrolled in a social security system or with the CMU (Couverture maladie universelle [Universal Health Coverage]) Patients under judicial protection or under guardianship Patients deprived of freedom (in prison and psychiatric patients being treated without consent) Patients with difficulties understanding or reading French

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, randomised, comparative, controlled, national and multi-centre study with minimal risks and constraints to routine care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK. | Other: standard of care<br>* routine management of stoma<br>|
| Experimental: interventional group<br>The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites. | Other: stoma follow-up<br>* delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of patient | scale 0-100 | 3 and 6 months | 
| Quality of life | Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean | 1, 2, 3 and 6 months | 
| Quality of life | EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean | 1, 2, 3 and 6 months | 
| Cost | • Calculation of resource use at 3 and 6 months per expenditure item (use of services, drug use, medical device and home healthcare service use, MCO (Médecine chirurgie obstétrique [Obstetric surgery]) hospitalisations and SSR (Soins de suite et de réadaptation [Follow-up care and rehabilitation]) hospitalisations) for each group. | 3 and 6 months | 
| Morbidity | readmission rate | 3 and 6 months |