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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK128572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary care hypoglycemia prevention program | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Group (Hypoglycemia Prevention Program) | Other | 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. |
| 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 |
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| 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) |
Inclusion criteria for patients:
Exclusion criteria for patients:
Exclusion Criteria for continuous glucose monitoring (not required for study participation):
Inclusion criteria for primary care providers:
Exclusion criteria for primary care providers:
Inclusion criteria for clinic staff:
Exclusion criteria for clinic staff
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| Name | Affiliation | Role |
|---|---|---|
| Scott J Pilla, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Pre/post pilot study
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| Primary Care Physician Group | Other | 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. |
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| Clinic Staff Group | Other | Clinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit. |
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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 |
| Ethicality (primary care providers) | 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 (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 |
| Intervention coherence (clinic staff) | 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 (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 |
| Ethicality (clinic staff) | 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 (clinic staff) | 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 (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 |
| Self-efficacy (clinic staff) | 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 |
| 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) |
| 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 |
| 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 pre-intervention 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 |
| 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 |
| Hemoglobin A1c | Change in hemoglobin A1c level from electronic health record, from before the intervention visit (most recent value within 6 months) to the next value >60 days after the intervention visit. | Pre-intervention up to 220 days post intervention |