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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
In this comparative effectiveness clinical trial, primary care physicians (PCPs) will receive 2 academic detailing sessions 6 months apart. Eligible patients (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%) of these PCPs will be randomized to receive either a pre-visit conversation aid/communication tool that elicits values and preferences regarding safe insulin/SU deprescribing [Intervention] or a general health education handout ("Embracing Life as You Age") [Attention Control]. Patient-reported outcomes (e.g., self-reported hypoglycemia episodes) and clinical outcomes (e.g., changes in glycemic regimen) will be compared between study arms. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Visit Conversation Aid | Experimental | Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" prior to a scheduled appointment with their primary care physician (PCP). This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. |
|
| General Health Education Handout | Active Comparator | Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conversation Aid | Behavioral | Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their primary care physician (PCP). This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing | Aggregate binary measure of diabetes medication deprescribing between baseline and 6-month follow-up. Greater de-prescribing is better. De-prescribing defined as any combination of:
| 6 months after initial primary care visit |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Treatment Satisfaction Questionnaire Scores | Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [8 items, scores 0 - 36, higher score is better] | Asked 6 months after initial primary care visit |
| Number of Participants With Hypoglycemic-related Hospitalizations |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c Level | HbA1c Change from baseline to study completion, an average of 1 year | 1 year following the first study-related visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W Grant, MD MPH | Division of Research, Kaiser Permanente Northern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente South San Francisco | San Francisco | California | 94080 | United States | ||
| Kaiser Permanente Northern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40549370 | Derived | Grant RW, Peterson I, McCloskey JM, Lipska KJ, Nugent J, Karter AJ, Gilliam LK. Diabetes Deprescribing in Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):926-935. doi: 10.1001/jamainternmed.2025.2015. |
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Among primary care physicians (PCPs) who attended the academic detailing sessions, their study eligible patients provided informed consent, were enrolled in the study, and are the subject of all outcome analyses. PCPs assented to participate but were not asked to provide informed consent and are therefore not considered the primary subjects of this RCT.
Patients provided informed consent and were enrolled into the study. All study outcomes are measured at the patient level, with clustering within primary care physician panel accounted for in all outcome analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Visit Conversation Aid | Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. Conversation Aid: Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. |
| FG001 | General Health Education Handout | Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Visit Conversation Aid | Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. Conversation Aid: Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing | Aggregate binary measure of diabetes medication deprescribing between baseline and 6-month follow-up. Greater de-prescribing is better. De-prescribing defined as any combination of:
| Posted | Count of Participants | Participants | 6 months after initial primary care visit |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Visit Conversation Aid | Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. Conversation Aid: Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Grant | Division of Research, Kaiser Permanente Northern California | 5108213969 | Richard.W.Grant@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2025 | Mar 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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There are two arms within the Comparative Effectiveness Randomized Clinical Trial (CE-RCT). All eligible primary care physicians (PCPs) will receive academic detailing. Eligible and consenting patients of these PCPs will be randomly allocated to intervention vs attention control arms grouped by PCP. (There will be a secondary, parallel comparison group to measure temporal trends in care for similar patients at other facilities in our care system not involved in the clinical trial.)
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|
| Attention Control Educational Handout | Other | Attention control is an existing health education handout that provides some general health advice geared towards older patients. |
|
Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit. |
| 6 months following the first study-related visit |
| RAND Patient Satisfaction Questionnaire | Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [5 item, score 5- 25, higher is worse] | 6 months following the first study-related visit |
| Perceived Efficacy in Patient - Physician Interactions | Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions (5 - Item Survey, score 5-25, higher is better) | 6 months following the first study-related visit |
| San Leandro |
| California |
| 94577 |
| United States |
| Kaiser Permanente Union City | Union City | California | 94587 | United States |
| Kaiser Permanente Vallejo | Vallejo | California | 94589 | United States |
| BG001 | General Health Education Handout | Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | General Health Education Handout | Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients. |
|
|
| 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 | Posted | Count of Participants | Participants | Preceding 6 month period (asked 6 months after initial primary care visit) |
|
|
|
| Secondary | Diabetes Treatment Satisfaction Questionnaire Scores | Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [8 items, scores 0 - 36, higher score is better] | Not Posted | May 2025 | Asked 6 months after initial primary care visit | Participants |
| Secondary | Number of Participants With Hypoglycemic-related Hospitalizations | Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit. | Not Posted | 6 months following the first study-related visit | Participants |
| Secondary | RAND Patient Satisfaction Questionnaire | Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [5 item, score 5- 25, higher is worse] | Not Posted | May 2025 | 6 months following the first study-related visit | Participants |
| Secondary | Perceived Efficacy in Patient - Physician Interactions | Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions (5 - Item Survey, score 5-25, higher is better) | Not Posted | May 2025 | 6 months following the first study-related visit | Participants |
| Other Pre-specified | Change in HbA1c Level | HbA1c Change from baseline to study completion, an average of 1 year | Not Posted | May 2025 | 1 year following the first study-related visit | Participants |
| 7 |
| 232 |
| 0 |
| 232 |
| 0 |
| 232 |
| EG001 | General Health Education Handout | Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well. Attention Control Educational Handout: Attention control is an existing health education handout that provides some general health advice geared towards older patients. | 10 | 218 | 0 | 218 | 0 | 218 |
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