PreDiabetes, Prediabetic State
Conditions
Keywords
Diabetes prevention, Primary care, Clinical pathway, Pragmatic intervention
Brief summary
Prediabetes is a significant public health problem affecting 88 million U.S. adults. Evidence suggest that the vast majority of people with prediabetes are unaware of having this condition and many are not receiving appropriate care for prediabetes, including referral to evidence-based programs like the Diabetes Prevention Programs (DPP). In the investigator's retrospective cohort study of patients with prediabetes from Johns Hopkins Health Systems, the investigators found that the rates of prediabetes clinical care activities are low. In the investigators' qualitative studies, the investigators found that primary care physician (PCP) barriers include low knowledge about Diabetes Prevention Programs and misperceptions of insurance coverage of these programs and inadequate clinical staff to address prediabetes. Common patient barriers to taking action to prevent diabetes include lack of motivation, time and resources. Based on prior research, comprehensive strategies are urgently needed to improve prediabetes care. Using these findings, the investigators have designed and plan to implement a diabetes prevention clinical pathway which seeks to address some of these common clinician and patient barriers. The investigators hypothesize that the clinical pathway will result in increased clinician screening and intervention and improve patient engagement in diabetes prevention. The investigators will compare results from the intervention clinic compared to a control clinic. If successful, the investigators plan to implement and test the effectiveness of this clinical pathway across the entire health system.
Interventions
OTHERSTART diabetes prevention clinical pathway
The diabetes prevention clinical pathway will focus on the following steps: 1. Screen/test - testing of eligible patients for prediabetes/diabetes 2. Education - PCPs will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit 3. Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit 4. Referral - patients may be referred to DPPs and/or medical nutrition therapy (MNT) 5. Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prediabetes based on prediabetes registry * Age ≥ 18 years * PCP visit during intervention period * Patient of Johns Hopkins Green Spring Station (GSS) General Internal Medicine or Johns Hopkins Community Physicians (JHCP) Internal Medicine clinic.
Exclusion criteria
* Visit with clinician who's not their Primary Care Physician (PCP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit | 12 months | Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period |
| Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days | 12 months | — |
| Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period | 12 months | Fasting glucose or Hemoglobin A1c |
| Achieve 5% or Greater Reduction in Weight Compared to Baseline | Baseline and 12 months | Proportion achieving 5% or greater weight reduction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Clinic START diabetes prevention clinical pathway | 873 |
| Control Clinic Routine usual care | 1,037 |
| Total | 1,910 |
Baseline characteristics
| Characteristic | Intervention Clinic | Control Clinic | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 13.6 | 60.7 years STANDARD_DEVIATION 14.6 | 61.6 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 26 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 825 Participants | 977 Participants | 1802 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 29 Participants | 34 Participants | 63 Participants |
| Race/Ethnicity, Customized Asian | 62 Participants | 93 Participants | 155 Participants |
| Race/Ethnicity, Customized Black/African American | 220 Participants | 280 Participants | 500 Participants |
| Race/Ethnicity, Customized Other | 33 Participants | 49 Participants | 82 Participants |
| Race/Ethnicity, Customized Unknown/Declined to Answer | 14 Participants | 11 Participants | 25 Participants |
| Race/Ethnicity, Customized White | 544 Participants | 604 Participants | 1148 Participants |
| Sex/Gender, Customized Female | 545 Participants | 617 Participants | 1162 Participants |
| Sex/Gender, Customized Male | 327 Participants | 420 Participants | 747 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Clinic | Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days | 58 pcp visits |
| Control Clinic | Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days | 39 pcp visits |
Primary
Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit
Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Clinic | Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit | 47 pcp visits |
| Control Clinic | Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit | 10 pcp visits |
Primary
Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Clinic | Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days | 3 pcp visits |
| Control Clinic | Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days | 37 pcp visits |
Secondary
Achieve 5% or Greater Reduction in Weight Compared to Baseline
Proportion achieving 5% or greater weight reduction
Time frame: Baseline and 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Clinic | Achieve 5% or Greater Reduction in Weight Compared to Baseline | 49 Participants |
| Control Clinic | Achieve 5% or Greater Reduction in Weight Compared to Baseline | 43 Participants |
Secondary
Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period
Fasting glucose or Hemoglobin A1c
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Clinic | Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period | 800 Participants |
| Control Clinic | Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period | 906 Participants |