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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 17,002
- Locations
- 1
- Primary Endpoint
- Assessment of change in completion of nine key care processes in diabetes
Study Overview
Brief 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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All People with diabetes aged over 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.
Exclusion Criteria
- •All People with diabetes aged less than 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.
Arms & Interventions
Received a letter on 3 occasions
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: My Diabetes, My Information, My Plan Document (Other)
Received letter on 1 occasion
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: My Diabetes, My Information, My Plan Document (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Assessment of change in surrogate markers that define hard outcomes in diabetes(12 months)