<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985476</url>
  </required_header>
  <id_info>
    <org_study_id>40189</org_study_id>
    <nct_id>NCT02985476</nct_id>
  </id_info>
  <brief_title>Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports</brief_title>
  <acronym>ELIJAH</acronym>
  <official_title>Electronic Linkage for Inflammatory Bowel Disease to Deliver Joint Access to Health Reports</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Phedra Dodds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swansea University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Health Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swansea University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluated the extent to which a shared health record facilitated better&#xD;
      communication, increase individual responsibility for health care and reduce demand for&#xD;
      health resources.&#xD;
&#xD;
      The study made individualised reports available to patients and General Practitioners and&#xD;
      gave much more detail about participants chronic disease and treatments, and evaluated its&#xD;
      effectiveness in a randomised controlled feasibility trial.&#xD;
&#xD;
      One third of patients received care as usual, two thirds of patients received the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic illness is a major cause of health problems. Self-management programmes can improve&#xD;
      care and reduce healthcare resource use, but rely on well educated patients who are able to&#xD;
      take responsibility for their care, have effective communication with health care providers,&#xD;
      and easy access to appropriately triaged services.&#xD;
&#xD;
      This study utilised Inflammatory Bowel Disease as an exemplar of chronic disease management.&#xD;
&#xD;
      To inform the intervention the investigators held a focus group with patients who told the&#xD;
      investigators about their concerns relating to education, care planning and communication&#xD;
      about their condition. The participants expressed a preference for individualised information&#xD;
      about their care, and plans of what to do if symptoms increase.&#xD;
&#xD;
      The investigators departmental electronic patient record (GeneCIS), was extended to provide&#xD;
      personalised, educationally enriched information to each participant about their Inflammatory&#xD;
      Bowel Disease. The investigators customised GeneCIS to develop output reports i.e.: &quot;My&#xD;
      History&quot;, &quot;My plan&quot; and &quot;My Update&quot;, that attach specific educational information to the&#xD;
      detailed, structured clinical data held on the system, and shared this with participants and&#xD;
      their General Practitioner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <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.</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: The cost of National Health Services resources used by participants in primary and secondary care.</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient- centeredness: Participant satisfaction with disease related care provided as assessed by Inflammatory Bowel Disease Service Satisfaction Questionnaire (ISSQ, derived from the GESQ).</measure>
    <time_frame>6 months</time_frame>
    <description>Participant satisfaction of the care they receive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient- centeredness: Participant satisfaction with disease related care provided as assessed by EQ5D.</measure>
    <time_frame>6 months</time_frame>
    <description>Participant satisfaction of the care they receive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <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.</measure>
    <time_frame>6 months</time_frame>
    <description>Recognition of participants noting increased symptoms , the time of reporting symptoms and response time of health professionals to respond.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Equity: Whether the social status of participants affects the size of differences in the other four outcome criteria.</measure>
    <time_frame>6 months</time_frame>
    <description>The number of participants designated by deprivation score (more or less deprived) using analysis of postcodes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health reports</intervention_name>
    <description>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.</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of Inflammatory Bowel Disease, specifically Ulcerative Colitis or&#xD;
             Crohn's Disease.&#xD;
&#xD;
          2. Aged 18 to 90 years.&#xD;
&#xD;
          3. Under the care of Consultant Gastroenterologists.&#xD;
&#xD;
          4. Patient registered with collaborating General Practitioner practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a. Participants who are unable to comprehend the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John G Williams, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Health Services Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neath Port Talbot Hospital</name>
      <address>
        <city>Port Talbot</city>
        <state>West Glamorgan</state>
        <zip>SA12 7BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21172195</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21172194</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10688560</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11583752</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8093148</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21172215</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19208715</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 3, 2016</last_update_submitted>
  <last_update_submitted_qc>December 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Swansea University</investigator_affiliation>
    <investigator_full_name>Phedra Dodds</investigator_full_name>
    <investigator_title>Consultant Nurse</investigator_title>
  </responsible_party>
  <keyword>Electronic health records</keyword>
  <keyword>Health records personal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>De-identified individual participant data for the primary and secondary outcomes data will be made available upon completion of reporting of the trial.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985476
org study id: 40189
nct id: NCT02985476
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
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
description: 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.
measure: Effectiveness: The cost of National Health Services resources used by participants in primary and secondary care.
time frame: 6 months
description: 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.
measure: 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
description: Participant satisfaction of the care they receive.
measure: Patient- centeredness: Participant satisfaction with disease related care provided as assessed by EQ5D.
time frame: 6 months
description: Participant satisfaction of the care they receive.
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.
time frame: 6 months
description: Recognition of participants noting increased symptoms , the time of reporting symptoms and response time of health professionals to respond.
measure: Equity: Whether the social status of participants affects the size of differences in the other four outcome criteria.
time frame: 6 months
description: The number of participants designated by deprivation score (more or less deprived) using analysis of postcodes.
arm group label: Interventional
arm group type: Active Comparator
description: 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.
arm group label: Observational
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Health reports
description: 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.
arm group label: Interventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: John G Williams, MSc
role: Principal Investigator
affiliation: Professor of Health Services Research
facility: 
country: United Kingdom
citation: 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
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.
PMID: 21172194
citation: 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
citation: 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
citation: 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
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.
PMID: 21172215
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.
PMID: 19208715
responsible party type: Sponsor-Investigator
investigator affiliation: Swansea University
investigator full name: Phedra Dodds
investigator title: Consultant Nurse
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided
ipd description: De-identified individual participant data for the primary and secondary outcomes data will be made available upon completion of reporting of the trial.