Hypoglycemia Clinical Trial
— RETRO-DMOfficial title:
Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation
Verified date | April 2024 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.
Status | Active, not recruiting |
Enrollment | 450 |
Est. completion date | September 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - age = 75 - type 2 diabetes with last measured HbA1c = 8.0% - currently prescribed insulin and/or SUs - Kaiser Permanente Northern California member Exclusion Criteria: - Given the requirements of this funding mechanism, we will not be able to develop new patient materials in languages other than English, and patients unable to communicate in English will be excluded. - Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded. - Excluded by their primary care provider |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente South San Francisco | San Francisco | California |
United States | Kaiser Permanente Northern California | San Leandro | California |
United States | Kaiser Permanente Union City | Union City | California |
United States | Kaiser Permanente Vallejo | Vallejo | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | HbA1c Change from baseline to study completion, an average of 1 year | Change in HbA1c level between baseline and follow-up | 1 year following the first study-related visit | |
Primary | Clinical Outcome: Number of Participants with glycemic regimen de-prescribing | Aggregate measure of diabetes medication deprescribing between baseline and 6-month follow-up, defined as any combination of:
Discontinuation of either insulin or SU, Reduction in dose of insulin or SU, Switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin) and/or higher risk to lower risk oral medicine (e.g. switching from SU to other oral medicine less associated with hypoglycemia). |
6 months after initial primary care visit | |
Primary | Patient-Reported Outcome: Number of Participants with Self-Reported Hypoglycemia | Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else | Preceding 6 month period (asked 6 months after initial primary care visit) | |
Secondary | Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire | Diabetes Treatment Satisfaction Questionnaire scores | Asked 6 months after initial primary care visit | |
Secondary | Number of Participants with Hypoglycemic-related hospitalizations | Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit. | 6 months following the first study-related visit | |
Secondary | Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire | RAND Patient Satisfaction Questionnaire | 6 months following the first study-related visit | |
Secondary | Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions | Perceived Efficacy in Patient - Physician Interactions 5 - Item Survey | 6 months following the first study-related visit |
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