Preventing Diabetes: Impact of an EMR-Based Intervention for Enhanced Pre-Diabetes Management in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Guideline-concordant prediabetes care
研究概览
简要总结
The goal of this study is to find out if adding electronic medical record (EMR) prompts helps prevent people with pre-diabetes from developing diabetes. It will also look at how these prompts affect doctor and patient behaviors.
The main questions are:
Does it improve follow-up care, such as blood tests, referrals, and medication? Does the EMR prompt reduce the number of patients who progress to diabetes within six months?
Researchers will compare clinics that use EMR prompts with clinics that do not.
Participants will:
Receive usual care for pre-diabetes at their polyclinic In some clinics, doctors will see EMR prompts suggesting tests, referrals, and medication Complete surveys about their health and lifestyle at different time points
详细描述
This is a two-year cluster-randomized controlled trial conducted across eight primary care polyclinics within the National University Polyclinics (NUP) network in Singapore. These clinics provide multidisciplinary family medicine and chronic disease management services to a large and diverse population. All sites use a unified Electronic Medical Record (EMR) system (Epic, National University Health System cluster), which supports standardized clinical workflows, integrates decision-support tools, and enables secure extraction of de-identified data for research.
The study targets adults aged 21-59 years with prediabetes. All clinicians in both intervention and control clinics will receive standardized clinical training on updated prediabetes clinical practice guidelines and patient education materials. The updated workflow emphasizes lifestyle modification and behavioural counselling as the foundation of diabetes prevention. Clinicians are guided to refer patients to a dietitian or structured lifestyle programme if body mass index (BMI) is 23 kg/m² or above, counsel patients on nutrition and physical activity, schedule a six-month follow-up review, order HbA1c testing prior to the next review, and consider metformin initiation if HbA1c exceeds 6.5% after six months of lifestyle intervention, particularly in adults under 60 years with BMI ≥ 23 kg/m². Training will be conducted virtually during protected lunchtime sessions.
The study consists of three sequential phases. Phase 0 (Baseline) involves no workflow intervention, during which baseline EMR and survey data are collected. Phase 1 (Workflow Phase) introduces the standardized prediabetes clinical workflow across all clinics. Phase 2 (Prompt Phase) introduces EMR-based smart-set prompts only in intervention clinics to evaluate whether prompts further increase referrals, follow-up scheduling, HbA1c testing, and metformin prescribing beyond the workflow alone. Control clinics continue to use the standardized workflow without EMR prompts. The smart-set prompts are designed to be non-intrusive and provide decision support without interrupting workflow or overriding clinical judgment. Clinicians retain full autonomy to accept, modify, or dismiss suggested actions.
A sub-sample of approximately 300 patients will complete questionnaires assessing lifestyle behaviours and patient activation using the Consumer Health Activation Index (CHAI) to complement EMR-derived outcomes. Approximately 80-100 clinicians are expected to complete voluntary, anonymous surveys assessing knowledge, confidence, and clinical behaviours using the COM-B framework. Baseline clinical and survey data will be collected prior to intervention implementation, with follow-up data collected at multiple time points to evaluate short- and longer-term outcomes.
Intervention components include standardized workflow implementation and clinician education across all clinics, with additional EMR-based prompts implemented only in intervention clinics. Smart-set prompts integrated within Epic display automated reminders at the point of care, with options to facilitate orders for laboratory tests, referrals, medications, and follow-up scheduling. Prompts are non-mandatory to preserve clinician autonomy. The intervention is informed by the COM-B model to enhance clinician capability (through training and guidelines), opportunity (through EMR-enabled workflows and referral pathways), and motivation (through feedback and reinforcement). The Transtheoretical Model (TTM) will be used to monitor stages of change among both patients and clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 59 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for study population (EMR based analytic cohort):
- •All adults aged 21 to 59 years with prediabetes who attend any of the eight participating polyclinics during the study period will be included in the EMR-based analytic cohort.
- •Prediabetes is defined as impaired fasting glucose or impaired glucose tolerance according to standard clinical criteria, with either diagnosis documented in the EMR problem list or visit diagnosis. Individuals with a prior diagnosis of diabetes will be excluded.
- •Patient surveys:
- •Inclusion criteria Age: 40 to 59 years old Diagnosis: Pre-diabetes Willingness to sign informed consent form
排除标准
- •Diagnosis of diabetes mellitus or gestational diabetes Cognitive impairment Allergy to metformin Severe, acute, or chronic liver or kidney disease Pregnancy Inability to speak English
- •For clinicians: All clinicians that consult patients in National University Polyclinics
- •Additional Notes:
- •Sex: All (not gender-based) Does not accept healthy volunteers No exclusion criteria specified for clinicians
研究组 & 干预措施
EMR-Based Intervention - Practice advisories (OPA) in electronic medical records (EMR)
To implement a non-intrusive OPA in EMR (Epic) to appear in the OPA section of the Visit Navigator in Epic that will be triggered for patients with prediabetes to remind clinicians to fulfil the clinical workflow for managing patients with prediabetes
干预措施: Electronic Medical Record-Based Clinical Decision Support (Behavioral)
Comparison Group
Control clinics continue to use the clinical workflow without EMR-based OPAs, representing usual care.
结局指标
主要结局
Guideline-concordant prediabetes care
时间窗: From enrollment to the end of intervention period at 24 months. collected at baseline, 6 months, 12, months, 18 months and 24 months.
The primary outcome of this study is the proportion of patients receiving guideline-concordant prediabetes care within 6 months of the index consultation, defined as the first prediabetes consultation during the study period at which patient meets eligibility criteria for prediabetes. 1. HbA1c test ordered and recorded in the EMR. 2. Referral to a dietitian or structured lifestyle programme placed and recorded in the EMR. 3. Follow-up visit ordered by the attending clinician. 4. Metformin prescription recorded in the EMR for eligible patients (HbA1c ≥ 6.5%). Scale: Guideline-concordant care is defined as a composite measure in which patients have at least two of the following four clinician-initiated care processes captured in EMR data: Method: EMR data extracted from the Epic system, including laboratory orders, referrals, visit scheduling, and medication prescriptions.
次要结局
- Patient health activation(Baseline, 6 months, and 12 months.)
- Clinician perceptions and satisfaction with the EMR-based intervention(Baseline, 6 months and 12 months)
- Progression to Diabetes(Up to 24 months after index consultation)
- Patient health activation(Baseline, 6 months, and 12 months.)
- Clinician perceptions and satisfaction with the EMR-based intervention(Baseline, 6 months and 12 months)
研究者
Lynette Goh
Senior Principal Dietitian
National University Polyclinics, Singapore
