Inflammatory Bowel DiseasesELIJAHNCT02985476
Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports
A study testing Health reports in people with Inflammatory Bowel Diseases, run by Phedra Dodds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Health reports
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who are unable to comprehend the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neath Port Talbot Hospital
Port Talbot, West Glamorgan, SA12 7BX
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Health reports
- Keywords
- Electronic health records, Health records personal
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health reportsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Effectiveness: The cost of National Health Services resources used by participants in primary and secondary care.
The indirect costs of participant use of National Health services across primary and secondary care including General Practitioner visits, in-patient stays, operations, outpatient visits, investigations, Accident and Emergency attendances, open access service use and medication use will be compared. A direct cost of the intervention i.e.: the time taken by the clinician to formulate the elements of the ELIJAH intervention will be assessed. Both indirect and direct costs will be formulated via a comparrison of the PSSRU and National Schedule of reference Costs.
Measured: 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).
Participant satisfaction of the care they receive.
Measured: 6 months
Patient- centeredness: Participant satisfaction with disease related care provided as assessed by EQ5D.
Participant satisfaction of the care they receive.
Measured: 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.
Recognition of participants noting increased symptoms , the time of reporting symptoms and response time of health professionals to respond.
Measured: 6 months
Equity: Whether the social status of participants affects the size of differences in the other four outcome criteria.
The number of participants designated by deprivation score (more or less deprived) using analysis of postcodes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMay 2010
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phedra Dodds
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University, The Health Foundation
- Responsible party
- Sponsor-investigator, Phedra Dodds, Swansea University
- Investigators
- John G Williams, MSc, Principal investigator, Professor of Health Services Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985476
- Sponsor's protocol ID
- 40189
- Acronym
- ELIJAH
- Status last verified
- Dec 2016
- First submitted
- 13 Sep 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: De-identified individual participant data for the primary and secondary outcomes data will be made available upon completion of reporting of the trial.
Publications
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.
PubMed 21172195Stange 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.
PubMed 21172194Williams 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.
PubMed 10688560Robinson 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.
PubMed 11583752Osman 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.
PubMed 8093148Politi 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.
PubMed 21172215Richardson 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.
PubMed 19208715
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports
- ClinicalTrials.gov ID
- NCT02985476
- Acronym / sponsor ID
- ELIJAH / 40189
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Electronic health records, Health records personal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Phedra DoddsUniversity, hospital or other
- Collaborators
- Swansea University, The Health Foundation
- Study start
- May 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Other: Health reportsCare 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. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are unable to comprehend the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health reportsParticipants 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. | Other | Interventional |
Primary outcome
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.
Time frame: 6 months
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.
5 secondary outcomes
Effectiveness: The cost of National Health Services resources used by participants in primary and secondary care.
Time frame: 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).
Time frame: 6 months
Patient- centeredness: Participant satisfaction with disease related care provided as assessed by EQ5D.
Time frame: 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.
Time frame: 6 months
Equity: Whether the social status of participants affects the size of differences in the other four outcome criteria.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Background: PubMed 21172195Travis 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.
- Background: PubMed 21172194Stange 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.
- Background: PubMed 10688560Williams 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.
- Background: PubMed 11583752Robinson 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.
- Background: PubMed 8093148Osman 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.
- Background: PubMed 21172215Politi 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.
- Background: PubMed 19208715Richardson 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.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data for the primary and secondary outcomes data will be made available upon completion of reporting of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John G Williams, MSc principal investigator
Professor of Health Services Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health reports in people with Inflammatory Bowel Diseases, run by Phedra Dodds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985476, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.