Diabetes in Primary Care - Improving Classification

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-25

Study Completion Date

2026-03-31

Brief Summary

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This study aims to evaluate the clinical utility and acceptability to patients and practitioners of running diabetes classification algorithms on primary care data to help improve diagnosis of diabetes subtypes in adults diagnosed with diabetes under the age of 50. The outputs from this research will help provide initial data on how best to use these algorithms in primary care and the optimal design of a decision support tool that could be taken forward to a full trial.

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Detailed Description

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Part 1:

Using a successful approach from previous research, and experience from existing online diabetes classification calculators, we will test the feasibility of developing a decision support tool that would run the algorithms in these calculators on electronic healthcare record data at participating GP sites. We will work with a company that will develop a decision support tool that will search and extract relevant healthcare data in GP systems, run our algorithms on these data, and produce a display, highlighting patient records where there is a potential misclassification of diabetes and/or records where there are potential data quality issues (e.g. mis-coding or missing information). The decision support tool will only run on extracted data (rather than being embedded in the GP system).

Participating GP sites will be offered an introductory education session on classification of diabetes subtypes and identification of MODY (Maturity Onset Diabetes of the Young) and training on running and interpreting the decision tool.

On receipt of the outputs from the decision support tool, practice staff will be advised to review the records of potentially misclassified patients to explore any mis-codings and to consider further testing/referrals as relevant and in line with the standard clinical care pathway for diabetes.

At the end of the study, the data extraction/decision support tool may be re-run to determine whether there have been changes and whether additional testing (eg C-peptide or islet autoantibody) or referral to a diabetes specialist team has been carried out.

Part 2:

To assess the acceptability of the diabetes classification tools to potential users, and to consider how best to implement them in clinical practice long term for maximum benefit, we will explore the views and experiences of general practice teams and people with diabetes on the use of the diabetes classification tools.

A sample of clinical and admin staff at participating GP sites, and diabetes patients flagged by the tool as misclassified, will be invited to take part in a semi-structured interview about their views \& experience.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients qualitative interviews

1. Patients reviewed by their GP as a result of Stage 1 (running of tool) are invited to a qualitative interview.
2. Consenting participants interviewed by the research team.
3. Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.

Qualitative interview (patients)

Intervention Type OTHER

Qualitative interviews to be carried out by an experienced researcher with patients who have had their diabetes diagnosis reviewed as a result of the running of the tool.

Practice staff qualitative interviews

1. Practice staff (clinical and administrative) who have been involved in Stage 1 (running of tool) are invited to a qualitative interview.
2. Consenting participants interviewed by the research team.
3. Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.

Qualitative interview (staff)

Intervention Type OTHER

Qualitative interviews to be carried out by an experienced researcher with practice staff who have run the tool and reviewed patients flagged by the tool.

Interventions

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Qualitative interview (patients)

Qualitative interviews to be carried out by an experienced researcher with patients who have had their diabetes diagnosis reviewed as a result of the running of the tool.

Intervention Type OTHER

Qualitative interview (staff)

Qualitative interviews to be carried out by an experienced researcher with practice staff who have run the tool and reviewed patients flagged by the tool.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients

* Able to give written informed consent
* 18 years of age or over at the time of study participation
* Diabetes diagnosed at or under the age of 50
* Registered with a participating GP practice
* Sufficient understanding of the English Language to enable completion of the interview

Staff

* Able to give written informed consent
* 18 years of age or over
* Working at a participating General Practice and directly involved with the study procedures (eg running the decision support tool, responsibility for clinical care of diabetes patients)

Exclusion Criteria

Patients

* Unable to give written informed consent
* Under 18 years of age
* No diabetes or diabetes diagnosed over the age of 50.
* Not registered with a participating GP practice
* Insufficient understanding of the English Language to enable interview completion
* Have an opt-out code where patient has declined electronic medical records examined
* Considered by their General Practitioner(s) to be inappropriate to recruit due to psycho-social reasons, participating in another related clinical trial or significant health reasons, e.g. terminal illness/diagnosis.

Staff

* Unable to give written informed consent
* Under 18 years of age
* General Practice staff not involved with the study procedures.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverley Shields, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

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Tamar Valley Health

Plymouth, Cornwall, United Kingdom

Site Status RECRUITING