National University Polyclinics, Singapore
Singapore, 643664
Location status: Recruiting
Location contact
Lynette Goh, BNutrDiet
CONTACT
Lynette Goh, BNutrDiet
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07252700
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
Interested in participating?
Request Info21 year–59 year
All sexes
Interventional
Not applicable
Singapore, 643664
Location status: Recruiting
Lynette Goh, BNutrDiet
CONTACT
Lynette Goh, BNutrDiet
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Survey data will be collected electronically using FormSG, a secure, government-hosted platform approved for research use. All study data will be stored on institution-approved, PDPA-compliant servers with access restricted to authorized study personnel. Identifiable and de-identified datasets will be stored separately. De-identified datasets will be transferred to analysts using encrypted, password-protected channels. Only the Principal Investigator will have access to the linkage file containing study identifiers and personal identifiers. Hard-copy consent forms will be stored in locked cabinets accessible only to the Principal Investigator. Study data will be retained for six years following study completion in accordance with institutional policy, after which electronic data will be securely deleted and physical records destroyed.
Analyses will follow the intention-to-treat principle, with participants analysed according to their assigned clinic groups. Baseline characteristics will be summarized descriptively. Changes over time and differences between intervention and control clinics will be examined using regression models appropriate to outcome type, including mixed-effects logistic regression to account for clustering at the clinic level. Time-to-event analyses using Cox proportional hazards regression will be used to assess progression to diabetes while accounting for variable follow-up durations. Missing data will be addressed using multiple imputation, and sensitivity analyses will be conducted to assess robustness of findings. All analyses will use two-sided tests with a significance level of 0.05.
Outcome data will be collected at baseline, 6 months, 12 months, and at 18 and 24 months to assess short- and longer-term effects of workflow and EMR-based decision-support implementation.
This study will contribute evidence on the effectiveness of a non-intrusive, EMR-embedded clinical decision-support system for improving guideline-concordant prediabetes care in primary care and inform scalable strategies for diabetes prevention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for study population (EMR based analytic cohort):
Inclusion criteria
for patient surveys:
Exclusion criteria
for patient surveys:
Inclusion criteria
for clinician surveys:
A non-intrusive OurPractice Advisories (OPA) will be implemented in the Epic EMR system. The OPA will appear in the Visit Navigator and will be automatically triggered for patients with pre-diabetes. It will provide clinicians with reminders and decision-support options to complete the recommended clinical workflow for pre-diabetes management, including referrals, follow-up scheduling, HbA1c testing, and medication initiation when indicated.
Time frame: 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.
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.
Time frame: Up to 24 months after index consultation
Progression from prediabetes to diabetes at 6, 12, 18 and 24 months. Diabetes will be defined according to the Agency for Care Effectiveness (ACE) Appropriate Care Guide as fasting plasma glucose ≥7.0 mmol/L, HbA1c ≥7.0%, or 2-hour plasma glucose ≥11.1 mmol/L during an oral glucose tolerance test, as recorded in the EMR.
Scale: Progression to diabetes, defined as the occurrence of diabetes during follow-up among patients with prediabetes at baseline.
Method: Data extraction from EMR records
Time frame: Baseline, 6 months, and 12 months.
Measured using the Consumer Health Activation Index (CHAI) questionnaire. Scores reflect patients' knowledge, skills, and confidence in managing their health. Minimum value: 10 Maximum value: 60. This will then be transformed into a 0 to 100 scale.
Interpretation: Higher scores indicate greater activation. Method: Surveys administered to a sub-sample of approximately 300 patients
Time frame: Baseline, 6 months and 12 months
Clinician perceptions and satisfaction with the EMR-based intervention will be assessed through an anonymous survey.
Description: Survey assessing clinician confidence, familiarity with guidelines, current practices, use of EMR tools, and satisfaction with intervention. Includes multiple-choice and Likert-scale questions (4-point confidence/familiarity scales, 5-point frequency scales, 4-point agreement scales).
Key areas:
Clinician capability (knowledge, skills, confidence) Current practices in pre-diabetes management Use and integration of EMR tools Perceived barriers Impact of EMR tools on care delivery Overall satisfaction
Interpretation: Responses will be analyzed individually and in aggregate to assess changes in clinician perceptions, practices, and satisfaction over time. Higher scores on agreement scales generally indicate more positive perceptions or greater satisfaction.
Contact information is provided by the study sponsor or research team.
Lynette Goh
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07155993
Behavior, Body Weight
Überlingen, Baden-Wurttemberg, Germany
View Trial DetailsNCT07713030
Behavior, Diabetes Mellitus
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT06426277
Diabetes Mellitus, Endocrine System Diseases
Goiânia, Goiás, Brazil
View Trial DetailsNCT07111026
Behavior, Behavioral Symptoms
Ellenton, Georgia, United States
View Trial Details