Improving the Health Care in Inflammatory Bowel Disease.

NCT ID: NCT02770599

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-15
• Study Completion Date: 2025-07-20

Brief Summary

Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Traditionally IBD patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has been a shift in the health care service from conventional follow - up (CF) to a rising numbers of health care models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. Patients have directly access to the IBD nurse who performing independently consultations at the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. Data will be collected from medical records and patient questionnaires. Investigators plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics committee and application to the Data protection Officer has been submitted. All participants are asked for provide written consent. The results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. A well-established MDT can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.

Conditions

Crohn Disease; Colitis, Ulcerative

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

IBD multidisciplinary team model (MDT)

IBD multidisciplinary team model including IBD nurse

IBD multidisciplinary team model including IBD nurse

Intervention Type: OTHER

IBD multidisciplinary team model including IBD nurse

IBD conventionally follow up model (CF)

IBD patient treated by doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service.

No interventions assigned to this group

Interventions

IBD multidisciplinary team model including IBD nurse

IBD multidisciplinary team model including IBD nurse

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnose duration > 2 years, to ensure that the patients have some experience with IBD and their follow-up system, respectively

Exclusion Criteria

• Non-Norwegian patients who will have difficulties understanding the questionnaires
• patients with cognitive disabilities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann-Ragnhild Broderstad, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Health Faculty, Institute of Community Health,

Locations

University Hospital of North Norway

Harstad, , Norway

Countries

Norway

Other Identifiers

2013/1397(REK)

Identifier Type: -

Identifier Source: org_study_id