DiabetesWICKEDNCT02200965
Impact of Individualized Structured Information Provision to the Patients, on Diabetes Related Outcomes
A study testing My Diabetes, My Information, My Plan Document in people with Diabetes and Care Delivery, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Care Delivery
- What is being tested?
- My Diabetes, My Information, My Plan Document
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,002 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All People with diabetes aged over 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.
Who cannot join
- All People with diabetes aged less than 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Diabetes Centre, New Cross Hospital
Wolverhampton, WV10 0QP
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Diabetes, Care Delivery
- Being tested
- My Diabetes, My Information, My Plan Document
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Diabetes, My Information, My Plan DocumentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Received a letter on 3 occasions | Active comparator | 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. Receives: Other: My Diabetes, My Information, My Plan Document |
| Received letter on 1 occasion | Active comparator | 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. Receives: Other: My Diabetes, My Information, My Plan Document |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in completion of nine key care processes in diabetes
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.
Measured: 12 months
Secondary outcomes (1)
Assessment of change in surrogate markers that define hard outcomes in diabetes
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- None (open label)
- Enrolment
- 17,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Syed M R Gillani, MRCP, Principal investigator, The Royal Wolverhampton NHS TrustBaldev M Singh, MD, Study director, Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200965
- Sponsor's protocol ID
- UKCRN-14324
- Acronym
- WICKED
- Status last verified
- Mar 2015
- First submitted
- 22 Jul 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillani SM, Nevill A, Singh BM. Provision of structured diabetes information encourages activation amongst people with diabetes as measured by diabetes care process attainment: the WICKED Project. Diabet Med. 2015 Jul;32(7):865-71. doi: 10.1111/dme.12737. Epub 2015 Apr 11.
PubMed 25764229
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02200965
- Acronym / sponsor ID
- WICKED / UKCRN-14324
- Conditions
- Diabetes, Care Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,002 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jul 2014 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received a letter on 3 occasions | Active comparator | Other: My Diabetes, My Information, My Plan DocumentMy 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. |
| Received letter on 1 occasion | Active comparator | Other: My Diabetes, My Information, My Plan DocumentMy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All People with diabetes aged over 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.
Key exclusion criteria (1 listed)
- All People with diabetes aged less than 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.
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 |
|---|---|---|
| My Diabetes, My Information, My Plan DocumentA 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. | Other | Received a letter on 3 occasions, Received letter on 1 occasion |
Primary outcome
Assessment of change in completion of nine key care processes in diabetes
Time frame: 12 months
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.
1 secondary outcome
Assessment of change in surrogate markers that define hard outcomes in diabetes
Time frame: 12 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 17 Mar 2015.
- Derived from this study: PubMed 25764229Gillani SM, Nevill A, Singh BM. Provision of structured diabetes information encourages activation amongst people with diabetes as measured by diabetes care process attainment: the WICKED Project. Diabet Med. 2015 Jul;32(7):865-71. doi: 10.1111/dme.12737. Epub 2015 Apr 11.
- Website for Diabetes Centre contain Information about the Research ProjectLink provided by the sponsor.
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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.
Syed M R Gillani, MRCP principal investigator
The Royal Wolverhampton NHS Trust
Baldev M Singh, MD study director
Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Diabetes, My Information, My Plan Document in people with Diabetes and Care Delivery, run by The Royal Wolverhampton Hospitals NHS Trust 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 1 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 17 Mar 2015. 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?
Assessment of change in completion of nine key care processes in diabetes (time frame: 12 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 NCT02200965, which also lists 1 linked publication.
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 17 Mar 2015.