A Clinical Feedback System in Ostomy Care

Quality of Life Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03841071
• Other study ID #: 2016255
• Secondary ID: 2016255
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2019
• Source: Helse Forde
• Contact: Kirsten L Indrebø, McS
• Phone: 4795966010
• Email: kirsten.lerum.indrebo[@]helse-forde.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adaptation, Psychological
• Ostomy
• Quality of Life

Intervention

Other:
• ROM/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.

Locations

Country	Name	City	State
Norway	Førde Hospital Trust	Førde

Sponsors (3)

Lead Sponsor	Collaborator
Helse Forde	Norwegian Nurses Organisation, Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The patients' satisfaction with the consultation	The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes.	At the 12 months follow-up after surgery.
Primary	The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery	The summary score of the Ostomy Adjustment Scale (lowest possible score is 34 and the highest 204). Higher scores represent better outcomes.	From the 3 months follow-up after surgery to the 12 months follow-up.
Secondary	Generic health-related quality of life	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.	From the 3 months follow-up after surgery to the 12 months follow-up.

External Links

•   Study approval from the Regional Committees for Medical and Health Research Ethics (REC)