A Clinical Feedback System in Ostomy Care

• Conditions: Adaptation, Psychological; Ostomy; Quality of Life
• Interventions: Other: ROM/CFS intervention

• Registration Number: NCT03841071
• Lead Sponsor: Helse Forde

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-25
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ROM/CFS intervention	ROM/CFS intervention	The ROM/CFS group (N\>100), consists of patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program of the outpatient ostomy clinic at the Department of Surgery, Førde Central Hospital from April 2018 to June 2021.

Primary Outcome Measures

Name	Time	Method
The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery	From 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 Outcome Measures

Name	Time	Method
Generic health-related quality of life	From 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.

Trial Locations

Locations (1)

Førde Hospital Trust; 🇳🇴 Førde, Norway