Diabetes Mellitus, Hypoglycemia
Conditions
Brief summary
This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.
Interventions
OTHERPatient Group (Hypoglycemia Prevention Program)
The Hypoglycemia Prevention Program: The patient hypoglycemia profile - this is a set of survey questions about hypoglycemia and related aspects of diabetes care. The questions will be administered as an Epic MyChart message sent to the patient in the week prior to the clinic visit, and in the clinic waiting room on a tablet immediately prior to the patient's primary care provider visit.
OTHERPrimary Care Physician Group
The provider hypoglycemia toolkit - this is the report from the patient hypoglycemia profile, which triggers a set of hypoglycemia prevention tools and patient education materials as appropriate. Primary Care Providers will not be exposed to the intervention until all of their patients have completed the Baseline Clinic Visit.
OTHERClinic Staff Group
Clinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit.
Sponsors
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Pre/post pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for patients: * Age 18 years or older * Diabetes mellitus by electronic health record review * Treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides * Community dwelling (not residing in long-term care or a skilled nursing facility) * Receiving primary care from a participating primary care provider at Johns Hopkins Internal Medicine at Green Spring Station * The patient's primary care provider approves their participation
Exclusion criteria
for patients: * Significant cognitive impairment or dementia * Receiving hospice or end of life care * Any other serious illness or condition not compatible with participation as determined by the investigators * Planning to leave area prior to end of study * Investigator discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall acceptability to patients | Immediately after the intervention | Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable) |
| Overall acceptability to primary care providers | Immediately after the intervention | Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable) |
| Overall acceptability to clinic staff | Immediately after the intervention | Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott J Pilla, MD, MHS
Johns Hopkins University
Outcome results
None listed