Preventing Diabetes: Impact of an EMR-Based Intervention for Enhanced Pre-Diabetes Management in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-59
SponsorLynette Goh
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Adults aged 40-59 years
Disqualifiers
Prior diagnosis of diabetes mellitus or gestational diabetes
Severe acute or chronic liver or kidney disease
Pregnancy
Cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Electronic Medical Record-Based Clinical Decision Support
BehavioralA 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.
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: EMR-Based Intervention - Practice advisories (OPA) in electronic medical records (EMR)Active comparator 1 intervention
Group B: Comparison GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Guideline-concordant prediabetes care
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.
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.Secondary outcomes
1
Progression to Diabetes
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
Up to 24 months after index consultation2
Patient health activation
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.3
Clinician perceptions and satisfaction with the EMR-based intervention
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.
Time frame
Baseline, 6 months and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lynette Goh
Lead sponsor
National University Polyclinics, Singapore
Sponsor institution
National University Health System, Singapore
Collaborator
National University of Singapore
Collaborator
Source ClinicalTrials.gov