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| ID | Type | Description | Link |
|---|---|---|---|
| 2016255 | Other Identifier | REC West |
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| Name | Class |
|---|---|
| Western Norway University of Applied Sciences | OTHER |
| Norwegian Nurses Organisation | OTHER |
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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.
The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROM/CFS intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion criteria:
Exclusion criteria:
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Patients who have undergone urostomy, colostomy, or ileostomy operations, and who are included in the routine follow-up program at a outpatient ostomy clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten L Indrebø, McS | Contact | 4795966010 | kirsten.lerum.indrebo@helse-forde.no | |
| John R Andersen, PhD | Contact | 4748278186 | john.roger.andersen@helse-forde.no |
| Name | Affiliation | Role |
|---|---|---|
| John R Andersen, PhD | Førde Hospital Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Førde Hospital Trust | Recruiting | Førde | 6812 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36691880 | Derived | 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. | |
| 33758568 | Derived | 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. |
| Label | URL |
|---|---|
| Study approval from the Regional Committees for Medical and Health Research Ethics (REC) | View source |
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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.
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.
Supporting information is freely available from The Central Contact Person: Kirsten L Indrebø. Email: kirsten.lerum.indrebo@helse-forde.no.
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| 31941516 | Derived | 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. |