Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports

NCT02985476 | Completed DMC

• 1 other identifier: 40189
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Electronic health records; Health records personal

Outcome Measures

Primary Outcomes (1)

• 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.

  The number of participants with adverse events leading to a hospital admission or otherwise, threatening the health and well being of participating patients and reported to a health professional graded according to causality and seriousness of event. Access to General Practitioner and secondary care hospital based data for the participant in paper and electronic form will provide details of relevant primary and secondary care attendances, acute admissions and outpatient appointments.

  6 months

Secondary Outcomes (5)

• Effectiveness: The cost of National Health Services resources used by participants in primary and secondary care.

  6 months

• Patient- centeredness: Participant satisfaction with disease related care provided as assessed by Inflammatory Bowel Disease Service Satisfaction Questionnaire (ISSQ, derived from the GESQ).

  6 months

• Patient- centeredness: Participant satisfaction with disease related care provided as assessed by EQ5D.

  6 months

• 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.

  6 months

• Equity: Whether the social status of participants affects the size of differences in the other four outcome criteria.

  6 months

Study Arms (2)

Interventional

ACTIVE COMPARATOR

Care as usual plus 8 weekly ELIJAH health reports shared with the participant and General Practitioner for 6 months i.e.: My history, My plan, My Update delivered via post or by email (dependant on participant preference) in addition to care as usual.

Other: Health reports

Observational

NO INTERVENTION

Care as usual dictated by disease pathway of diagnosed inflammatory bowel disease i.e.; access to out-patient and in-patient hospital based care and community health resources via General Practitioner.

Interventions

Health reports OTHER

Participants were sent 3 sets of individualised, educationally enriched health reports about their diagnosed inflammatory bowel disease history, care plan and updates on their recent health status, results or encounters with health care services.

Interventional

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• a. Participants who are unable to comprehend the study.

Sponsors & Collaborators

• Phedra Dodds: lead
• Swansea University: collaborator
• The Health Foundation: collaborator

Study Sites (1)

Neath Port Talbot Hospital

Port Talbot, West Glamorgan, SA12 7BX, United Kingdom

Location

Related Publications (7)

• Travis SP, Stange EF, Lemann M, Oresland T, Bemelman WA, Chowers Y, Colombel JF, D'Haens G, Ghosh S, Marteau P, Kruis W, Mortensen NJ, Penninckx F, Gassull M; European Crohn's and Colitis Organisation (ECCO). European evidence-based Consensus on the management of ulcerative colitis: Current management. J Crohns Colitis. 2008 Mar;2(1):24-62. doi: 10.1016/j.crohns.2007.11.002. Epub 2008 Jan 18. No abstract available.

  PMID: 21172195 BACKGROUND

• 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.

  PMID: 21172194 BACKGROUND

• Williams JG, Cheung WY, Russell IT, Cohen DR, Longo M, Lervy B. Open access follow up for inflammatory bowel disease: pragmatic randomised trial and cost effectiveness study. BMJ. 2000 Feb 26;320(7234):544-8. doi: 10.1136/bmj.320.7234.544.

  PMID: 10688560 BACKGROUND

• Robinson A, Thompson DG, Wilkin D, Roberts C; Northwest Gastrointestinal Research Group. Guided self-management and patient-directed follow-up of ulcerative colitis: a randomised trial. Lancet. 2001 Sep 22;358(9286):976-81. doi: 10.1016/S0140-6736(01)06105-0.

  PMID: 11583752 BACKGROUND

• Osman LM, Abdalla MI, Beattie JA, Ross SJ, Russell IT, Friend JA, Legge JS, Douglas JG. Reducing hospital admission through computer supported education for asthma patients. Grampian Asthma Study of Integrated Care (GRASSIC). BMJ. 1994 Feb 26;308(6928):568-71. doi: 10.1136/bmj.308.6928.568.

  PMID: 8093148 BACKGROUND

• 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.

  PMID: 21172215 BACKGROUND

• 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.

  PMID: 19208715 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• John G Williams, MSc

  Professor of Health Services Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Nurse

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: December 7, 2016
• Study Start: May 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

GB (1)