Clinical trial NCT02770599: Improving the Health Care in Inflammatory Bowel Disease.
Official title: IMPROVING THE HEALTH CARE IN INFLAMMATORY BOWEL DISEASE. A Clinical Study Comparing Two Different Outpatient Follow-up Models by Measuring Patient Reported Health Related Quality of Life, Quality of Care, Adherence and Clinical Outcomes.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Colitis, Ulcerative
Keywords: IBD
HRQoL
QoC
Adherence
IBD nurse
MDT
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2016-05-12
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Inflammatory bowel disease belonging two different out patient follow-up models; IBD multidisciplinary team including IBD specialist nurse or conventionally follow -up model, respectively.

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.


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

Primary outcomes:
measure: Health related quality of life
timeFrame: during autumn of 2016
Secondary outcomes:
measure: Quality of care
timeFrame: during autumn of 2016
Other outcomes:
measure: Adherence associated to IBD medications
timeFrame: during autumn of 2016
Locations:
city: Harstad
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: The Health Faculty, Institute of Community Health,
name: Ann-Ragnhild Broderstad, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: