Clinical trial NCT04585191: Reducing Treatment Risk in Older Adults With Diabetes
Official title: Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Hypoglycemia
Primary Health Care
Polypharmacy
Keywords: clinical trial
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-10-14
Enrollment: 450
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing
timeFrame: 6 months after initial primary care visit
measure: Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia
timeFrame: Preceding 6 month period (asked 6 months after initial primary care visit)
Secondary outcomes:
measure: Diabetes Treatment Satisfaction Questionnaire Scores
timeFrame: Asked 6 months after initial primary care visit
measure: Number of Participants With Hypoglycemic-related Hospitalizations
timeFrame: 6 months following the first study-related visit
measure: RAND Patient Satisfaction Questionnaire
timeFrame: 6 months following the first study-related visit
measure: Perceived Efficacy in Patient - Physician Interactions
timeFrame: 6 months following the first study-related visit
Other outcomes:
measure: Change in HbA1c Level
timeFrame: 1 year following the first study-related visit
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente South San Francisco
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Union City
country: United States
facility: Kaiser Permanente Union City
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Vallejo
state: California
Study officials:
affiliation: Division of Research, Kaiser Permanente Northern California
name: Richard W Grant, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: