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?
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 8, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 25, 2019
October 1, 2019
3.2 years
February 8, 2019
October 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Generic health-related quality of life
From the 3 months follow-up after surgery to the 12 months follow-up.
Other Outcomes (1)
The patients' satisfaction with the consultation
At the 12 months follow-up after surgery.
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program at a outpatient ostomy clinic.
You may qualify if:
- \>18 years of age
- Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months
- Being able to read and write Norwegian
You may not qualify if:
- \< The 3 weeks follow-up after surgery are not included
- Patients who have their ostomy removed \<12 months after surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Fordelead
- Western Norway University of Applied Sciencescollaborator
- Norwegian Nurses Organisationcollaborator
Study Sites (1)
Førde Hospital Trust
Førde, 6812, Norway
Related Publications (3)
Indrebo KL, Aasprang A, Olsen TE, Andersen JR. Factors associated with leakage in patients with an ostomy: A cross-sectional study. Nurs Open. 2023 Jun;10(6):3635-3645. doi: 10.1002/nop2.1612. Epub 2023 Jan 24.
PMID: 36691880DERIVEDIndrebo 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.
PMID: 33758568DERIVEDIndrebo 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.
PMID: 31941516DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
John R Andersen, PhD
Førde Hospital Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2019
First Posted
February 15, 2019
Study Start
April 1, 2018
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
October 25, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available from the corresponding author upon reasonable request after publication. The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.
- Access Criteria
- Supporting information is freely available from The Central Contact Person: Kirsten L Indrebø. Email: kirsten.lerum.indrebo@helse-forde.no.
The dataset generated during this study will not be publicly available as the patient consent and approval from the Regional Committee for Medical and Health Research Ethics prevents sharing of individual patient level data in public repositories. However, the data will be available from the corresponding author upon reasonable request.