Study of a Primary Care Hypoglycemia Prevention Program

Pilot Study of a Primary Care Hypoglycemia Prevention Program

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Hypoglycemia
• Intervention / Treatment: Other: Patient Group (Hypoglycemia Prevention Program); Other: Primary Care Physician Group; Other: Clinic Staff Group

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott J Pilla, MD, MHS; Phone Number: 9087680002; Email: spilla1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Scott J Pilla, MD, MHS; Phone Number: 908-768-0002; Email: spilla1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria for continuous glucose monitoring (not required for study participation):

• History of allergic skin reaction to adhesive
• Implantable pacemaker

Inclusion criteria for primary care providers:

• Practicing at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for primary care providers:

• Planning to leave their position prior to end of study
• Not serving as primary care provider for any included patient

Inclusion criteria for clinic staff:

• Participating in check-in at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for clinic staff

• Planning to leave their position prior to end of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient Involvement; Patients who participate in the study will undergo one Baseline Clinic Visit (baseline usual care), and one Intervention clinic visit.	Other: Patient 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.
Other: Primary Care Physician (PCP) Involvement; PCPs will be given access to the Hypoglycemia Prevention toolkit	Other: Primary 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.
Other: Clinic Staff Involvement	Other: Clinic Staff Group; Clinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall acceptability to patients	Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)	Immediately after the intervention
Overall acceptability to primary care providers	Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)	Immediately after the intervention
Overall acceptability to clinic staff	Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)	Immediately after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention coherence (patients)	Mean score for intervention coherence on patient intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)	Immediately after the intervention
Opportunity costs (patients)	Mean score for opportunity costs on patient intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)	Immediately after the intervention
Ethicality (patients)	Mean score for ethicality on patient intervention evaluation survey (developed for this study, range 1-very unfair, to 5-very fair)	Immediately after the intervention
Affective attitude (patients)	Mean score for affective attitude on patient intervention evaluation survey (developed for this study, range 1-very uncomfortable, to 5-very comfortable)	Immediately after the intervention
Burden (patients)	Mean score for burden on patient intervention evaluation survey (developed for this study, range 1-no effort at all, to 5-huge effort)	Immediately after the intervention
Self-efficacy (patients)	Mean score for self-efficacy on patient intervention evaluation survey (developed for this study, range 1-very un-confident, to 5-very confident)	Immediately after the intervention
Perceived effectiveness (primary care providers)	Mean score for perceived effectiveness on primary care provider intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)	Immediately after the intervention
Intervention coherence (primary care providers)	Mean score for intervention coherence on primary care provider intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)	Immediately after the intervention
Opportunity costs (primary care providers)	Mean score for opportunity costs on primary care provider intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)	Immediately after the intervention
Affective attitude (primary care providers)	Mean score for affective attitude on primary care provider intervention evaluation survey (developed for this study, range 1-very uncomfortable, to 5-very comfortable)	Immediately after the intervention
Burden (primary care providers)	Mean score for burden on primary care provider intervention evaluation survey (developed for this study, range 1-no effort at all, to 5-huge effort)	Immediately after the intervention
Self-efficacy (primary care providers)	Mean score for self-efficacy on primary care provider intervention evaluation survey (developed for this study, range 1-Very unconfident, to 5-very confident)	Immediately after the intervention
Burden (clinic staff)	Mean score for burden on clinic staff intervention evaluation survey (developed for this study, range 1-no effort at all, to 5-huge effort)	Immediately after the intervention
Opportunity costs (clinic staff)	Mean score for opportunity costs on clinic staff intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)	Immediately after the intervention
Recruitment rate	% of eligible participants who consented to participate	Immediately after the intervention
Retention rate for second clinic visit	% of participants who completed two clinic visits	Immediately after the intervention
Continuous glucose monitoring (CGM) completion	% of participants who completed CGM measurements	Immediately after the final CGM measurement (4-12 weeks after the intervention)
Continuous glucose monitoring (CGM) wear time	Mean days with complete CGM data	Immediately after the final CGM measurement (4-12 weeks after the intervention)
Patient hypoglycemia burden on continuous glucose monitoring (CGM)	Change from baseline in mean minutes per day with glucose <70 mg/dl and <54 mg/dl	Baseline to post-intervention up to 12 weeks
Patient time below range on continuous glucose monitoring (CGM)	Change from baseline in % time with glucose <70 mg/dl	Baseline to post-intervention up to 12 weeks
Patient time above range on continuous glucose monitoring (CGM)	Change from baseline in % time with glucose >180 mg/dl	Baseline to post-intervention up to 12 weeks
Patient mean glucose on continuous glucose monitoring (CGM)	Change from baseline in mean glucose	Baseline to post-intervention up to 12 weeks
Patient satisfaction with care	Change from baseline in mean score on The Patient Satisfaction Questionnaire Short Form (PSQ-18), range 1 (lowest satisfaction) to 5 (highest satisfaction) in 7 domains	Change from baseline to immediately after the intervention
Patient activation	Change from baseline in mean score on Patient Activation Measure (PAM 10), range 0 (lowest activation) to 100 (highest activation)	Change from baseline to immediately after the intervention
Patient self-reported hypoglycemic events	Change from baseline in frequency of level 1, level 2, and level 3 hypoglycemia events on hypoglycemia history survey	Change from baseline to 4-12 weeks after the intervention
Changes to hypoglycemia-causing medications	% of patients with changes in diabetes medications (dose increase, decrease, stop, switch, initiate)	Change from baseline to immediately after the intervention
Glucagon prescription	% of patients with active glucagon prescription	Change from baseline to immediately after the intervention
Continuous glucose monitoring (CGM) prescription	Change from baseline in frequency of CGM prescription	Change from baseline to immediately after the intervention
Change in Frequency of Referrals to Diabetes Self Management Training (DSMT)	Change from baseline in frequency of DSMT referral	Change from baseline to immediately after the intervention
Frequency of hypoglycemia history discussions	Frequency and content of hypoglycemia history discussion by audio-recording	Change from baseline to immediately after the intervention
Frequency of Hypoglycemia anticipatory guidance discussions	Frequency, content, and accuracy of hypoglycemia anticipatory guidance	Change from baseline to immediately after the intervention
Frequency of Medication adherence discussions	Frequency and content of discussions of adherence to diabetes medications	Change from baseline to immediately after the intervention
Time needed to complete patient hypoglycemia profile	Mean completion time (minutes) for patient hypoglycemia profile	Immediately after completion of intervention clinic visit
Duration of clinical visit	Change from baseline in mean duration of clinic visit (minutes)	Change from baseline to immediately after completion of intervention clinic visit
Patient completion of hypoglycemia assessment	Completion rate overall and for individual items	Immediately after completion of intervention clinic visit
Primary care provider use of provider hypoglycemia toolkit	Rate of toolkit use overall and for individual tools	Immediately after completion of intervention clinic visit

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Scott J Pilla, MD, MHS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): April 14, 2024
• Primary Completion (Estimated): April 14, 2026
• Study Completion (Estimated): April 14, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: IRB00419034; K23DK128572 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No