<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/NCT02200965</url>
  </required_header>
  <id_info>
    <org_study_id>UKCRN-14324</org_study_id>
    <nct_id>NCT02200965</nct_id>
  </id_info>
  <brief_title>Impact of Individualized Structured Information Provision to the Patients, on Diabetes Related Outcomes</brief_title>
  <acronym>WICKED</acronym>
  <official_title>The National Health Service (NHS) Choice and Information Revolution - Exploring the Utilization of High Quality Clinical Data Governance Processes to Promote Informed Patient Driven Care in a Locally Integrated English Diabetes Health Economy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Royal Wolverhampton Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Royal Wolverhampton Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Health professionals usually lead in the management of long term conditions such as Diabetes.&#xD;
      In a conventional professionally driven compliance model of care, patients may be placed in a&#xD;
      secondary role. National audits show components of systematic diabetes care consistently fail&#xD;
      despite several years of heavy expenditure in the service focused Diabetes Quality and&#xD;
      Outcome Framework. To what extent is this due to the nature of that process which may not&#xD;
      engage patients nor be focused on informed patient centred concerns? The aim of this research&#xD;
      is to determine the effectiveness of a healthcare delivery approach in which patients,&#xD;
      empowered with structured guidance and specific information about their diabetes, take&#xD;
      decisions to get involved in their diabetes care as determined in hard measures of engagement&#xD;
      and outcomes. The methodology will be by a whole population cluster randomised controlled&#xD;
      study of an intervention the delivery of an individualised diabetes specific structured&#xD;
      report, and we will look at its impact on measured key diabetes access and process outcomes.&#xD;
      The contention is that the patients, guided in their understanding of empowerment and&#xD;
      enablement, equipped with highly person specific risk stratified outcome based information,&#xD;
      and informed regarding which actions they may accordingly take, will be enabled to make a&#xD;
      significant and impactful contribution in improvement in their own care . This large scale&#xD;
      project can deliver on that research question in a tested , efficient and cost effective&#xD;
      manner.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis &amp; Aim:&#xD;
&#xD;
      The central aim is to determine whether communication of data structured against key diabetes&#xD;
      process and outcomes directly to people with diabetes, with an emphasis on enabling,&#xD;
      informing and empowering their engagement with service provision will drive improvement in&#xD;
      the key parameters of structured diabetes care access, process and outcomes.&#xD;
&#xD;
      Thus we hypothesise that the communicating letter, which is proven to be readable,&#xD;
      informative, valuable and desired in user acceptance analysis can be evidenced to drive&#xD;
      engagement of users as demonstrated by measures of access and process and that subsequently&#xD;
      attainment of access and process permit the achievement of diabetes clinical outcomes.&#xD;
&#xD;
      Project Design&#xD;
&#xD;
      The trial is designed as a prospective cluster randomised controlled trial of an intervention&#xD;
      (structured reporting to patients) on key outcomes (as defined below). All patients with&#xD;
      diabetes in Wolverhampton will be randomly allocated to receiving 3 mailings at 0, 3 and 6&#xD;
      months (Active Group) or 1 mailing at 3 months (Control Group) of their structured diabetes&#xD;
      report (My Diabetes, My Information, My Plan). Using our pan district integrated diabetes&#xD;
      information system, data parameters will be observed at 0, 3, 6 and 12 monthly intervals over&#xD;
      the 12 months following the delivery of the report.&#xD;
&#xD;
      The objective will be to determine whether the repeated provision of structured, specific and&#xD;
      annotated process and outcome information promotes patients to improve their own health care&#xD;
      whether by their own actions and /or by seeking support, advice and help and this will be&#xD;
      measured using a Process Score and an Outcome Score - emplacing that it is known that&#xD;
      surrogate markers for clinical outcomes in diabetes (eg HbA1c) cannot be improved without&#xD;
      service Access and completion of process.&#xD;
&#xD;
      The project will run for 2 years - 6 months set up, 1 year active implementation, 6 months&#xD;
      analysis, publication, dissemination and closure. Throughout, evidenced effective methodology&#xD;
      will be transitioned into standard NHS process.&#xD;
&#xD;
      Project Feasibility:&#xD;
&#xD;
      The Wolverhampton diabetes service is well integrated across primary and secondary care. A&#xD;
      centralized pan district register is established. Data linkage between multiple systems is in&#xD;
      place, including direct links between the local GP data warehouse (Graphnet) and all&#xD;
      specialist / secondary care systems. Data management and governance systems are in place.&#xD;
      Data quality is subject to rolling audit and is consistently at &gt;97% accuracy. Effective use&#xD;
      of such data has been demonstrated in care pathways - e.g. the diabetes retinal screening&#xD;
      programme (national EQA) and the innovative foot care pathway where Wolverhampton amputation&#xD;
      rates are amongst the lowest in the country. The local service has a good track record in&#xD;
      clinical research. The project has full support of all key NHS groupings including the local&#xD;
      Diabetes GP Commissioning Lead (Dr M Sidhu) and the specialist services Clinical Director.&#xD;
      All relevant significant others have been engaged in our local Diabetes Implementation Group&#xD;
      - including our large local user group (Wolverhampton Action 4 Diabetes) and the regional&#xD;
      office of Diabetes UK. We have run a pilot to test the feasibility and effectiveness of our&#xD;
      key intervention (structured diabetes information report). This involved consultation with a&#xD;
      diverse diabetes user group and conducting a questionnaire survey with 50 patients attending&#xD;
      hospital diabetes clinics. Following translation of learning from that pilot into further NHS&#xD;
      process, the project is now fully achievable as proposed.&#xD;
&#xD;
      Data Analysis:&#xD;
&#xD;
      Data will be analysed in SPSS for with and between group (paired and unpaired) effects of the&#xD;
      individual process and outcome parameters and the summary scores. Thus access process and&#xD;
      outcome scores (as defined) will be calculated at baseline and at 3 monthly intervals over 1&#xD;
      year and analysed to determine within and between group effects by 2 way analysis of variance&#xD;
      (a group-by-time repeated measures ANOVA) Significance is set at the 5 % level. Professorial&#xD;
      level academic statistical advice is available within the local diabetes research group. A&#xD;
      power calculation to predict sample size is not warranted since the entire population (not a&#xD;
      sample) is to be studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of change in completion of nine key care processes in diabetes</measure>
    <time_frame>12 months</time_frame>
    <description>Completion of nine key care processes; HbA1C, Serum Creatinine, Urine Albumin Creatinine Ratio, Body Mass Index, Serum Cholesterol, Retinal Screening, Foot Screening, Smoking Status and Blood Pressure in people with diabetes are taken as a standard of structured diabetes care delivery. Failure to complete each process over last 15 months (Failed Process Score (FPS)) will be scored as 1. Therefore an individual can have a FPS from 0-9 based on how many parameters were not completed. A change in the FPS score will be compared between the active and control at the end of 12 months period to assess the impact of provision of individualised patient information on the completion of these key care processes that is taken as a marker of Access and Process. This data will be captured in our electronic centralised district diabetes register that captures these nine key care processes and is updated on monthly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of change in surrogate markers that define hard outcomes in diabetes</measure>
    <time_frame>12 months</time_frame>
    <description>Only with access and completion of process can intervention be made that results in improvement of all associated diabetes care outcome measures - surrogates for hard endpoints e. g. HbA1C, blood pressure, lipid and Coronary Heart Disease (CHD) risk parameters, smoking cessation, renal markers, and eye and foot outcomes emphasising that over this time frame it is not the expectation that hard endpoints (retinopathy, nephropathy, macro vascular outcome and death) will be influenced but that data will be captured and an assessment of change will be made at the end of 12 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17002</enrollment>
  <condition>Diabetes</condition>
  <condition>Care Delivery</condition>
  <arm_group>
    <arm_group_label>Received a letter on 3 occasions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>My Diabetes, My Information, My Plan Document:&#xD;
To deliver a structured, understandable, well designed, user friendly, user developed and approved document / letter to all people with diabetes that contains all information about their key care processes in diabetes to promote self-awareness, patient activation and process completion of their own diabetes outcomes.&#xD;
This communication (3 mailings per patient (at 0 and 3 and 6 months) will be distributed to the 50% of the whole epidemiological base of people with diabetes (n=&gt;16,000) with the non-interventional group (that will receive the same document once at 3 months) acting as control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Received letter on 1 occasion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>My Diabetes, My Information, My Plan Document:&#xD;
To deliver a structured, understandable, well designed, user friendly, user developed and approved document / letter to all people with diabetes that contains all information about their key care processes in diabetes to promote self-awareness, patient activation and process completion of their own diabetes outcomes.&#xD;
This communication (3 mailings per patient (at 0 and 3 and 6 months) will be distributed to the 50% of the whole epidemiological base of people with diabetes (n=&gt;16,000) with the non-interventional group (that will receive the same document once at 3 months) acting as control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>My Diabetes, My Information, My Plan Document</intervention_name>
    <description>A structured, understandable, well designed, user friendly, user developed and approved letter has been developed and undergone user acceptability testing for this purpose. It succinctly contains all information mapping to core diabetes care processes, is simple and easy to digest and effective in encouraging self-understanding and prompting self-care and empowering informative engagement with services and care providers. The satisfaction of users with the communicating letter both in a developmental pilot phase has been assessed by user group feedback and patient questionnaire.</description>
    <arm_group_label>Received a letter on 3 occasions</arm_group_label>
    <arm_group_label>Received letter on 1 occasion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All People with diabetes aged over 18 registered in local health economy under&#xD;
             Wolverhampton City Clinical Commissioning Group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All People with diabetes aged less than 18 registered in local health economy under&#xD;
             Wolverhampton City Clinical Commissioning Group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Syed M R Gillani, MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Royal Wolverhampton NHS Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Baldev M Singh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Royal Wolverhampton NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes Centre, New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>March 16, 2015</last_update_submitted>
  <last_update_submitted_qc>March 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200965
org study id: UKCRN-14324
nct id: NCT02200965
lead sponsor: 
has dmc: No
Health professionals usually lead in the management of long term conditions such as Diabetes.
      In a conventional professionally driven compliance model of care, patients may be placed in a
      secondary role. National audits show components of systematic diabetes care consistently fail
      despite several years of heavy expenditure in the service focused Diabetes Quality and
      Outcome Framework. To what extent is this due to the nature of that process which may not
      engage patients nor be focused on informed patient centred concerns? The aim of this research
      is to determine the effectiveness of a healthcare delivery approach in which patients,
      empowered with structured guidance and specific information about their diabetes, take
      decisions to get involved in their diabetes care as determined in hard measures of engagement
      and outcomes. The methodology will be by a whole population cluster randomised controlled
      study of an intervention the delivery of an individualised diabetes specific structured
      report, and we will look at its impact on measured key diabetes access and process outcomes.
      The contention is that the patients, guided in their understanding of empowerment and
      enablement, equipped with highly person specific risk stratified outcome based information,
      and informed regarding which actions they may accordingly take, will be enabled to make a
      significant and impactful contribution in improvement in their own care . This large scale
      project can deliver on that research question in a tested , efficient and cost effective
      manner.
Hypothesis & Aim:

      The central aim is to determine whether communication of data structured against key diabetes
      process and outcomes directly to people with diabetes, with an emphasis on enabling,
      informing and empowering their engagement with service provision will drive improvement in
      the key parameters of structured diabetes care access, process and outcomes.

      Thus we hypothesise that the communicating letter, which is proven to be readable,
      informative, valuable and desired in user acceptance analysis can be evidenced to drive
      engagement of users as demonstrated by measures of access and process and that subsequently
      attainment of access and process permit the achievement of diabetes clinical outcomes.

      Project Design

      The trial is designed as a prospective cluster randomised controlled trial of an intervention
      (structured reporting to patients) on key outcomes (as defined below). All patients with
      diabetes in Wolverhampton will be randomly allocated to receiving 3 mailings at 0, 3 and 6
      months (Active Group) or 1 mailing at 3 months (Control Group) of their structured diabetes
      report (My Diabetes, My Information, My Plan). Using our pan district integrated diabetes
      information system, data parameters will be observed at 0, 3, 6 and 12 monthly intervals over
      the 12 months following the delivery of the report.

      The objective will be to determine whether the repeated provision of structured, specific and
      annotated process and outcome information promotes patients to improve their own health care
      whether by their own actions and /or by seeking support, advice and help and this will be
      measured using a Process Score and an Outcome Score - emplacing that it is known that
      surrogate markers for clinical outcomes in diabetes (eg HbA1c) cannot be improved without
      service Access and completion of process.

      The project will run for 2 years - 6 months set up, 1 year active implementation, 6 months
      analysis, publication, dissemination and closure. Throughout, evidenced effective methodology
      will be transitioned into standard NHS process.

      Project Feasibility:

      The Wolverhampton diabetes service is well integrated across primary and secondary care. A
      centralized pan district register is established. Data linkage between multiple systems is in
      place, including direct links between the local GP data warehouse (Graphnet) and all
      specialist / secondary care systems. Data management and governance systems are in place.
      Data quality is subject to rolling audit and is consistently at >97% accuracy. Effective use
      of such data has been demonstrated in care pathways - e.g. the diabetes retinal screening
      programme (national EQA) and the innovative foot care pathway where Wolverhampton amputation
      rates are amongst the lowest in the country. The local service has a good track record in
      clinical research. The project has full support of all key NHS groupings including the local
      Diabetes GP Commissioning Lead (Dr M Sidhu) and the specialist services Clinical Director.
      All relevant significant others have been engaged in our local Diabetes Implementation Group
      - including our large local user group (Wolverhampton Action 4 Diabetes) and the regional
      office of Diabetes UK. We have run a pilot to test the feasibility and effectiveness of our
      key intervention (structured diabetes information report). This involved consultation with a
      diverse diabetes user group and conducting a questionnaire survey with 50 patients attending
      hospital diabetes clinics. Following translation of learning from that pilot into further NHS
      process, the project is now fully achievable as proposed.

      Data Analysis:

      Data will be analysed in SPSS for with and between group (paired and unpaired) effects of the
      individual process and outcome parameters and the summary scores. Thus access process and
      outcome scores (as defined) will be calculated at baseline and at 3 monthly intervals over 1
      year and analysed to determine within and between group effects by 2 way analysis of variance
      (a group-by-time repeated measures ANOVA) Significance is set at the 5 % level. Professorial
      level academic statistical advice is available within the local diabetes research group. A
      power calculation to predict sample size is not warranted since the entire population (not a
      sample) is to be studied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assessment of change in completion of nine key care processes in diabetes
time frame: 12 months
description: Completion of nine key care processes; HbA1C, Serum Creatinine, Urine Albumin Creatinine Ratio, Body Mass Index, Serum Cholesterol, Retinal Screening, Foot Screening, Smoking Status and Blood Pressure in people with diabetes are taken as a standard of structured diabetes care delivery. Failure to complete each process over last 15 months (Failed Process Score (FPS)) will be scored as 1. Therefore an individual can have a FPS from 0-9 based on how many parameters were not completed. A change in the FPS score will be compared between the active and control at the end of 12 months period to assess the impact of provision of individualised patient information on the completion of these key care processes that is taken as a marker of Access and Process. This data will be captured in our electronic centralised district diabetes register that captures these nine key care processes and is updated on monthly.
measure: Assessment of change in surrogate markers that define hard outcomes in diabetes
time frame: 12 months
description: Only with access and completion of process can intervention be made that results in improvement of all associated diabetes care outcome measures - surrogates for hard endpoints e. g. HbA1C, blood pressure, lipid and Coronary Heart Disease (CHD) risk parameters, smoking cessation, renal markers, and eye and foot outcomes emphasising that over this time frame it is not the expectation that hard endpoints (retinopathy, nephropathy, macro vascular outcome and death) will be influenced but that data will be captured and an assessment of change will be made at the end of 12 months.
arm group label: Received a letter on 3 occasions
arm group type: Active Comparator
description: My Diabetes, My Information, My Plan Document:
To deliver a structured, understandable, well designed, user friendly, user developed and approved document / letter to all people with diabetes that contains all information about their key care processes in diabetes to promote self-awareness, patient activation and process completion of their own diabetes outcomes.
This communication (3 mailings per patient (at 0 and 3 and 6 months) will be distributed to the 50% of the whole epidemiological base of people with diabetes (n=>16,000) with the non-interventional group (that will receive the same document once at 3 months) acting as control.
arm group label: Received letter on 1 occasion
arm group type: Active Comparator
description: My Diabetes, My Information, My Plan Document:
To deliver a structured, understandable, well designed, user friendly, user developed and approved document / letter to all people with diabetes that contains all information about their key care processes in diabetes to promote self-awareness, patient activation and process completion of their own diabetes outcomes.
This communication (3 mailings per patient (at 0 and 3 and 6 months) will be distributed to the 50% of the whole epidemiological base of people with diabetes (n=>16,000) with the non-interventional group (that will receive the same document once at 3 months) acting as control.
intervention type: Other
intervention name: My Diabetes, My Information, My Plan Document
description: A structured, understandable, well designed, user friendly, user developed and approved letter has been developed and undergone user acceptability testing for this purpose. It succinctly contains all information mapping to core diabetes care processes, is simple and easy to digest and effective in encouraging self-understanding and prompting self-care and empowering informative engagement with services and care providers. The satisfaction of users with the communicating letter both in a developmental pilot phase has been assessed by user group feedback and patient questionnaire.
arm group label: Received a letter on 3 occasions
arm group label: Received letter on 1 occasion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Syed M R Gillani, MRCP
role: Principal Investigator
affiliation: The Royal Wolverhampton NHS Trust
last name: Baldev M Singh, MD
role: Study Director
affiliation: Royal Wolverhampton NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus