Clinical Trials Directory

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UnknownNCT03841071

A Clinical Feedback System in Ostomy Care

Use of the Ostomy Adjustment Scale (OAS) as a Routine Outcome Measure of Adaptation to Life With an Ostomy Along With a Clinical Feedback System in the Follow-up of Ostomy Patients; Does it Promote Adaptation to the Life With an Ostomy?

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Helse Forde · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. In this project, we describe a new model of ostomy care, where a clinical feedback system (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We also present a plan for evaluating patients experience with the CFS and their clinical outcomes. Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy surgery. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (HRQoL), as well as patient experiences and satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction with care will be measured with the Generic Short Patient Experiences Questionnaire. Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and HRQoL with the Short Form 36. Discussion: This study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.

Detailed description

The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.

Conditions

Interventions

TypeNameDescription
OTHERROM/CFS interventionThe intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings.

Timeline

Start date
2018-04-01
Primary completion
2021-06-01
Completion
2021-06-01
First posted
2019-02-15
Last updated
2019-10-25

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT03841071. Inclusion in this directory is not an endorsement.