A Clinical Feedback System in Ostomy Care
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|ClinicalTrials.gov Identifier: NCT03841071|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 18, 2019
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 the present paper, we describe a study protocol for evaluating the effect of a clinical feedback system on adaption process of a patient with an ostomy, in terms of the patients' perceived experience with the clinical feedback system.
Methods: In this non-randomised controlled study, we include patients who had recently performed colostomy, ileostomy, or urostomy surgery, and those who have had an ostomy for more than a year. The intervention 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. For comparison, we use published results of a historical control group comprising ostomy patients who have received standard care and have completed the same self-reported measures as the patients using the clinical feedback system. The main outcome is the last observed Ostomy Adjustment Scale score among those who have completed at least 2 consultations using the clinical feedback system. The last observed Short Form-36 score among those who have completed at least 2 consultations is also compared with that in the historical group. A 5-item scale is used to measure patient satisfaction with the consultation.
Discussion: This study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.
|Condition or disease||Intervention/treatment|
|Ostomy Quality of Life Adaptation, Psychological||Other: ROM/CFS intervention|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|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?|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
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.
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.
- The patient's subjective adaptation to the physical, psychological, and social changes that occur after ostomy surgery [ Time Frame: >3 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.
- Generic health-related quality of life [ Time Frame: >3 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.
- The patients' satisfaction with the consultation [ Time Frame: >3 months follow-up ]The Session rating scale, using the five item scores seperately (lowest possible score is 0 and the highest 10). Higher scores represent better outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841071
|Contact: Kirsten L Indrebø, McSfirstname.lastname@example.org|
|Contact: John R Andersen, PhDemail@example.com|
|Førde Hospital Trust||Recruiting|
|Førde, Norway, 6812|
|Contact: Kirsten L Indrebø, McS|
|Principal Investigator:||John R Andersen, PhD||Førde Hospital Trust|