Impact of Individualized Structured Information Provision to the Patients, on Diabetes Related Outcomes

NCT02200965 | Completed

• 1 other identifier: UKCRN-14324
• Study Type: interventional
• Target: 17,002
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Care Delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Assessment of change in surrogate markers that define hard outcomes in diabetes

  12 months

Study Arms (2)

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.

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.

Other: My Diabetes, My Information, My Plan Document

Interventions

My Diabetes, My Information, My Plan Document OTHER

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.

Received a letter on 3 occasions; Received letter on 1 occasion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All People with diabetes aged over 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.

You may not qualify if:

• All People with diabetes aged less than 18 registered in local health economy under Wolverhampton City Clinical Commissioning Group.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

Diabetes Centre, New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25764229 DERIVED

Related Links

• Website for Diabetes Centre contain Information about the Research Project

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Syed M R Gillani, MRCP

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

• Baldev M Singh, MD

  Royal Wolverhampton NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 25, 2014
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

GB (1)