Hypoglycemia, Polypharmacy, Primary Health Care, Type 2 Diabetes Treated With Insulin
Conditions
Keywords
clinical trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALConversation 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 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.
OTHERAttention Control Educational Handout
Attention control is an existing health education handout that provides some general health advice geared towards older patients.
Sponsors
Patient-Centered Outcomes Research Institute
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
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.)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 75 years * type 2 diabetes with last measured Hemoglobin A1c (HbA1c) ≤ 8.0% * currently prescribed insulin and/or sulfonylureas (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia | Preceding 6 month period (asked 6 months after initial primary care visit) | Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else |
| Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing | 6 months after initial primary care visit | 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: 1. Discontinuation of either insulin or a sulfonylureas (SU) 2. Reduction in dose of insulin or SU, 3. 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hypoglycemic-related Hospitalizations | 6 months following the first study-related visit | Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit. |
| Perceived Efficacy in Patient - Physician Interactions | 6 months following the first study-related visit | 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) |
| RAND Patient Satisfaction Questionnaire | 6 months following the first study-related visit | Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire \[5 item, score 5- 25, higher is worse\] |
| Diabetes Treatment Satisfaction Questionnaire Scores | Asked 6 months after initial primary care visit | Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire \[8 items, scores 0 - 36, higher score is better\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c Level | 1 year following the first study-related visit | HbA1c Change from baseline to study completion, an average of 1 year |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 232 |
| 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. | 218 |
| Total | 450 |
Baseline characteristics
| Characteristic | General Health Education Handout | Pre-Visit Conversation Aid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 218 Participants | 232 Participants | 450 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 80.2 years STANDARD_DEVIATION 4.2 | 79.7 years STANDARD_DEVIATION 3.9 | 79.9 years STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Asian | 34 Participants | 39 Participants | 73 Participants |
| Race/Ethnicity, Customized Black/African-American | 29 Participants | 32 Participants | 61 Participants |
| Race/Ethnicity, Customized Hispanic | 42 Participants | 35 Participants | 77 Participants |
| Race/Ethnicity, Customized Missing/Unknown | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Multi/Other | 11 Participants | 15 Participants | 26 Participants |
| Race/Ethnicity, Customized White | 101 Participants | 110 Participants | 211 Participants |
| Region of Enrollment United States | 218 participants | 232 participants | 450 participants |
| Sex: Female, Male Female | 112 Participants | 111 Participants | 223 Participants |
| Sex: Female, Male Male | 106 Participants | 121 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 232 | 10 / 218 |
| other Total, other adverse events | 0 / 232 | 0 / 218 |
| serious Total, serious adverse events | 0 / 232 | 0 / 218 |
Outcome results
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: 1. Discontinuation of either insulin or a sulfonylureas (SU) 2. Reduction in dose of insulin or SU, 3. 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).
Time frame: 6 months after initial primary care visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Visit Conversation Aid | Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing | 34 Participants |
| General Health Education Handout | Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing | 21 Participants |
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
Time frame: Preceding 6 month period (asked 6 months after initial primary care visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Visit Conversation Aid | Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia | 10 Participants |
| General Health Education Handout | Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia | 13 Participants |
Secondary
Diabetes Treatment Satisfaction Questionnaire Scores
Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire \[8 items, scores 0 - 36, higher score is better\]
Time frame: 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.
Time frame: 6 months following the first study-related visit
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)
Time frame: 6 months following the first study-related visit
Secondary
RAND Patient Satisfaction Questionnaire
Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire \[5 item, score 5- 25, higher is worse\]
Time frame: 6 months following the first study-related visit
Other Pre-specified
Change in HbA1c Level
HbA1c Change from baseline to study completion, an average of 1 year
Time frame: 1 year following the first study-related visit