Clinical trial NCT02985476: Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports
Official title: Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Electronic health records
Health records personal
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: Swansea University
name: The Health Foundation
First posted: 2016-12-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluated the extent to which a shared health record facilitated better communication, increase individual responsibility for health care and reduce demand for health resources.

The study made individualised reports available to patients and General Practitioners and gave much more detail about participants chronic disease and treatments, and evaluated its effectiveness in a randomised controlled feasibility trial.

One third of patients received care as usual, two thirds of patients received the intervention.

Detailed description: Chronic illness is a major cause of health problems. Self-management programmes can improve care and reduce healthcare resource use, but rely on well educated patients who are able to take responsibility for their care, have effective communication with health care providers, and easy access to appropriately triaged services.

This study utilised Inflammatory Bowel Disease as an exemplar of chronic disease management.

To inform the intervention the investigators held a focus group with patients who told the investigators about their concerns relating to education, care planning and communication about their condition. The participants expressed a preference for individualised information about their care, and plans of what to do if symptoms increase.

The investigators departmental electronic patient record (GeneCIS), was extended to provide personalised, educationally enriched information to each participant about their Inflammatory Bowel Disease. The investigators customised GeneCIS to develop output reports i.e.: "My History", "My plan" and "My Update", that attach specific educational information to the detailed, structured clinical data held on the system, and shared this with participants and their General Practitioner.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of Inflammatory Bowel Disease, specifically Ulcerative Colitis or Crohn's Disease.
2. Aged 18 to 90 years.
3. Under the care of Consultant Gastroenterologists.
4. Patient registered with collaborating General Practitioner practice.

Exclusion Criteria:

a. Participants who are unable to comprehend the study.

Primary outcomes:
measure: Safety: Number of participants with adverse events as assessed by access to the primary and secondary care participant data and collated via the ELIJAH Adverse Event screening form.
timeFrame: 6 months
Secondary outcomes:
measure: Effectiveness: The cost of National Health Services resources used by participants in primary and secondary care.
timeFrame: 6 months
measure: Patient- centeredness: Participant satisfaction with disease related care provided as assessed by Inflammatory Bowel Disease Service Satisfaction Questionnaire (ISSQ, derived from the GESQ).
timeFrame: 6 months
measure: Patient- centeredness: Participant satisfaction with disease related care provided as assessed by EQ5D.
timeFrame: 6 months
measure: Timeliness: The average elapsed time between the onset of a new inflammatory bowel disease related issue needing a healthcare intervention for a participant, and the start of that care.
timeFrame: 6 months
measure: Equity: Whether the social status of participants affects the size of differences in the other four outcome criteria.
timeFrame: 6 months
Other outcomes:
Locations:
city: Port Talbot
country: United Kingdom
facility: Neath Port Talbot Hospital
state: West Glamorgan
Study officials:
affiliation: Professor of Health Services Research
name: John G Williams, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Stange EF, Travis SP, Vermeire S, Reinisch W, Geboes K, Barakauskiene A, Feakins R, Flejou JF, Herfarth H, Hommes DW, Kupcinskas L, Lakatos PL, Mantzaris GJ, Schreiber S, Villanacci V, Warren BF; European Crohn's and Colitis Organisation (ECCO). European evidence-based Consensus on the diagnosis and management of ulcerative colitis: Definitions and diagnosis. J Crohns Colitis. 2008 Mar;2(1):1-23. doi: 10.1016/j.crohns.2007.11.001. Epub 2008 Jan 18. No abstract available.
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citation: Politi P, Bodini P, Mortilla MG, Beltrami M, Fornaciari G, Formisano D, Munkholm P, Riis L, Wolters F, Hoie O, Katsanos K, O'Morain C, Shuhaibar M, Lalli P, De Falco M, Pereira S, Freitas J, Odes S, Stockbrugger RW; European Collaborative Study Group on Inflammatory Bowel Disease. Communication of information to patients with inflammatory bowel disease: A European Collaborative Study in a multinational prospective inception cohort. J Crohns Colitis. 2008 Sep;2(3):226-32. doi: 10.1016/j.crohns.2008.01.007. Epub 2008 May 16.
citation: Richardson G, Bloor K, Williams J, Russell I, Durai D, Cheung WY, Farrin A, Coulton S. Cost effectiveness of nurse delivered endoscopy: findings from randomised multi-institution nurse endoscopy trial (MINuET). BMJ. 2009 Feb 10;338:b270. doi: 10.1136/bmj.b270.