Diabetes in Primary Care - Improving Classification (DePICtion)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 18
- 主要终点
- Number and Proportion of patients flagged by the tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility criteria for qualitative interviews.
- •Inclusion Criteria:
- •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
- •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)
排除标准
- •Unable to give written informed consent
- •Under 18 years of age
- •No diabetes or diabetes diagnosed over the age of
- •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.
- •Unable to give written informed consent
- •Under 18 years of age
- •General Practice staff not involved with the study procedures.
研究组 & 干预措施
Patients qualitative interviews
- Patients reviewed by their GP as a result of Stage 1 (running of tool) are invited to a qualitative interview.
- Consenting participants interviewed by the research team.
- Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.
干预措施: Qualitative interview (patients) (Other)
Practice staff qualitative interviews
- Practice staff (clinical and administrative) who have been involved in Stage 1 (running of tool) are invited to a qualitative interview.
- Consenting participants interviewed by the research team.
- Information used to assess the impact and potential benefit of using the diabetes classification tool in general practice.
干预措施: Qualitative interview (staff) (Other)
结局指标
主要结局
Number and Proportion of patients flagged by the tool
时间窗: Months 12-18.
Number and Proportion of patients flagged by the tool at each practice. Mean number of patients flagged by the tool across the practices.
次要结局
- Assessment of acceptability of the DePICtion Tool(Interviews to be conducted from 2 weeks to 6 months after implementing the tool in practice.)