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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03841071
Enrollment
100
Registered
2019-02-15
Start date
2018-04-01
Completion date
2021-06-01
Last updated
2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adaptation, Psychological, Ostomy, Quality of Life

Brief 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.

Interventions

OTHERROM/CFS intervention

The 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.

Sponsors

Western Norway University of Applied Sciences
CollaboratorOTHER
Norwegian Nurses Organisation
CollaboratorOTHER
Helse Forde
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>18 years of age * Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months * Being able to read and write Norwegian

Exclusion criteria

* \< The 3 weeks follow-up after surgery are not included * Patients who have their ostomy removed \<12 months after surgery

Design outcomes

Primary

MeasureTime frameDescription
The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgeryFrom the 3 months follow-up after surgery to the 12 months follow-up.The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.

Secondary

MeasureTime frameDescription
Generic health-related quality of lifeFrom the 3 months follow-up after surgery to the 12 months follow-up.The two summary scores of the Short Form-36 (Physical Component Score and Mental Component Score). The lowest possible score is 0 and the highest 100. Higher scores represent better outcomes.

Other

MeasureTime frameDescription
The patients' satisfaction with the consultationAt the 12 months follow-up after surgery.The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes.

Countries

Norway

Contacts

Primary ContactKirsten L Indrebø, McS
kirsten.lerum.indrebo@helse-forde.no4795966010
Backup ContactJohn R Andersen, PhD
john.roger.andersen@helse-forde.no4748278186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026