Clinical trial NCT03841071: A Clinical Feedback System in Ostomy Care
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?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ostomy
Quality of Life
Adaptation, Psychological
Lead sponsor: Helse Forde
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
name: Norwegian Nurses Organisation
First posted: 2019-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program at a outpatient ostomy clinic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery
timeFrame: From the 3 months follow-up after surgery to the 12 months follow-up.
Secondary outcomes:
measure: Generic health-related quality of life
timeFrame: From the 3 months follow-up after surgery to the 12 months follow-up.
Other outcomes:
measure: The patients' satisfaction with the consultation
timeFrame: At the 12 months follow-up after surgery.
Locations:
city: Førde
country: Norway
facility: Førde Hospital Trust
Study officials:
affiliation: Førde Hospital Trust
name: John R Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Psychometric Properties of New Subscales of the Ostomy Adjustment Scale: A Cross-Sectional Study. Patient Relat Outcome Meas. 2021 Mar 15;12:65-75. doi: 10.2147/PROM.S300604. eCollection 2021.
citation: Indrebo KL, Aasprang A, Olsen TE, Andersen JR. A new model of patient-reported outcome monitoring with a clinical feedback system in ostomy care: rationale, description and evaluation protocol. Health Qual Life Outcomes. 2020 Jan 15;18(1):12. doi: 10.1186/s12955-019-1261-3.