Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJohns Hopkins University
About this trial
The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:
* Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes? * Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes?
Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.
Participants will:
* Complete surveys at the beginning of the study and up to 2 additional surveys * If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
active patient portal account (MyChart)
patient receiving primary care at Johns Hopkins Community Physicians in Frederick
have overweight or obesity (BMI ≥ 25 kg/m2)
Disqualifiers
have diabetes (HbA1c > 6.4% in prior 6 months or on diabetes registry)
have dementia
previously participated in the Diabetes Prevention Program (DPP)
Trial design
Design model
Parallel
Treatments tested in this trial
Risk Informed Shared Decision-Making Strategy (RISE)
Other interventionSingle visit with health care team member to discuss diabetes risk and choosing next steps
Low Touch Messaging Strategy (LTM)
Other interventionSingle message delivered via patient portal system describing diabetes risk and tips to lower risk
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Risk-Informed Shared Decision-Making Engagement StrategyActive comparator 1 intervention
Group B: Low Touch Messaging StrategyActive comparator 1 intervention
Group C: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Presence of a DPP referral or new metformin prescription
Prediabetes treatment uptake - Presence of a DPP referral or new metformin prescription based on electronic health record data
Time frame
From randomization to 3 months after randomizationSecondary outcomes
1
Proportion of patients enrolled in the DPP
DPP enrollment- Proportion of patients enrolled in the DPP -
Time frame
Referral to 6 months after DPP referral2
Proportion of patients who complete ≥ 9 months of the DPP
DPP completion- Proportion of patients who complete ≥ 9 months of the DPP
Time frame
From enrollment to 12 months of follow-up3
Weight change (kg)
Change in body weight
Time frame
From enrollment to 12 months4
Metformin adherence
Proportion of participants with a new metformin prescription who have a proportion-of-days covered (PDC) value of ≥0.80 (calculated as the sum of days' supply of metformin divided by the number of days between the first fill and end of follow-up period).
Time frame
From enrollment to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
American Diabetes Association
Collaborator
Source ClinicalTrials.gov