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A Clinical Feedback System in Ostomy Care

NCT03841071 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-10-25

No results posted yet for this study

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.

Conditions

  • Ostomy
  • Quality of Life
  • Adaptation, Psychological

Interventions

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.

Sponsors & Collaborators

  • Norwegian Nurses Organisation

    collaborator OTHER

  • Western Norway University of Applied Sciences

    collaborator OTHER

  • Helse Forde

    lead OTHER

Principal Investigators

  • John R Andersen, PhD · Førde Hospital Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841071 on ClinicalTrials.gov