Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
NCT05359679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3300
Last updated 2025-05-18
Summary
The primary objective is to assess the effectiveness of training a clinician to be a 'value champion' within clinical settings to decrease the use of three classes of potentially inappropriate prescription medications (PIMs) among people living with dementia (PLWD). Secondary objectives include determining if the intervention is associated with a reduction in emergency department (ED) visits or hospitalizations due to a fall, and examining five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity.
This study is a pragmatic cluster-randomized trial to test the effectiveness of a primary care clinician value champion for de-implementing PIMs among patients 65 years of age and older with a diagnosis of dementia. Medicare Part D pharmacy claims data will be analyzed at the end of the 12-month intervention for the primary outcome, the medication possession rates (MPR) for three groups of potentially inappropriate medications: antipsychotic medications, benzodiazepines, and hypoglycemic medications (sulfonylureas and insulin). In a similar fashion, a hospital admission, or an emergency department visit for a fall will be assessed at the end of the intervention using Medicare claims data. Finally, the five implementation outcomes will be evaluated at the end of the intervention from notes entered by the value champions in project workbooks.
Primary care clinics within each of the two participating ACOs will be randomized to either the intervention or control arms of the study. Prior to random assignment, the investigators will stratify practices based on high versus low historic prescribing rates. A primary care clinician from each clinic selected for the trial in the intervention arm (n=30 across the two ACOs) will be recruited as a clinician value champion for each intervention clinic. The clinician value champion will participate in twice monthly value champion web-based training sessions for six months and then launch a 12-month initiative within the clinician value champions' clinics to reduce PIM prescribing among PLWD. Study outcomes will be assessed 12 months after the clinician value champions launch the initiative.
The hypothesis is that for each medication class, the intervention will produce clinically relevant decreases in mean possession rates of 10% of a standard deviation in patients seen in intervention clinics compared to those who are seen in control group clinics.
Conditions
- Dementia
- Med: Dementia
Interventions
- BEHAVIORAL
-
Value Champion Training Program
Clinicians from primary care clinic sites randomized to the intervention arm of the study will complete a 6-month clinician value champion training program by participating in a series of 12 web-based training sessions. No intervention will be conducted at clinics in the control arm.
- OTHER
-
No Intervention
Usual clinical care - no value champion present at this clinical setting
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
Brown University
collaborator OTHER -
Kaiser Permanente
lead OTHER
Principal Investigators
-
Lorella Palazzo, PhD · Kaiser Permanente
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-30
- Primary Completion
- 2023-10-31
- Completion
- 2023-10-31
Countries
- United States
Study Locations
More Related Trials
-
A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease
NCT05147428 ·Status: COMPLETED ·Phase: NA
-
A Simulation Training Program for Person-Centered In-Home Dementia Care
NCT06850883 ·Status: COMPLETED ·Phase: NA
-
Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
NCT01459783 ·Status: COMPLETED ·Phase: NA
-
Improving How People Living With Dementia Are Selected for Care Coordination
NCT05651308 ·Status: COMPLETED ·Phase: NA
-
Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0
NCT05950607 ·Status: RECRUITING ·Phase: NA
-
Comprehensive Dementia Management : From Translational Medicine to Innovative Care
NCT06214962 ·Status: RECRUITING
-
A Home-based Training Program for Elderly Patients With Dementia
NCT02667951 ·Status: COMPLETED ·Phase: NA
-
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
NCT05949047 ·Status: RECRUITING ·Phase: NA
-
Telephone Support for Dementia Caregivers
NCT00735800 ·Status: COMPLETED ·Phase: PHASE2
-
Patient-Centered Dementia Care Practice Coaching Intervention
NCT06249204 ·Status: COMPLETED ·Phase: NA
-
A Pilot Study to Reduce Inappropriate Anticholinergic Prescribing in the Elderly
NCT02172612 ·Status: COMPLETED ·Phase: NA
-
Behavioral Interventions to Prevent or Delay Dementia
NCT02265757 ·Status: COMPLETED ·Phase: NA
-
Cohort Study on Cognitive Decline in Elderly
NCT07093892 ·Status: NOT_YET_RECRUITING
-
Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia
NCT06273917 ·Status: COMPLETED ·Phase: NA
-
Dementia Symptom Management at Home Program
NCT03255967 ·Status: COMPLETED ·Phase: NA
-
Preventing Alzheimer's With Cognitive Training
NCT03848312 ·Status: RECRUITING ·Phase: PHASE3
-
Community Paramedic Coaching Program for Caregivers and People With Dementia
NCT04239924 ·Status: COMPLETED ·Phase: NA
-
Systematic Care for Informal Caregivers of Dementia Patients: An Efficient Approach?
NCT00147693 ·Status: COMPLETED ·Phase: NA
-
Preventing Cognitive and Functional Decline Among Seniors at Risk
NCT03495037 ·Status: COMPLETED ·Phase: NA
-
Digital Reminiscence for People With Dementia
NCT03429686 ·Status: COMPLETED ·Phase: NA
-
Families Affected by Dementia: A Survey of Caregivers
NCT02095327 ·Status: COMPLETED
-
Implementation Study of Dementia Guidelines in Primary Care
NCT00459784 ·Status: UNKNOWN ·Phase: NA
-
Deprescribing to Reduce Injurious Falls Among Older Adults With Dementia
NCT05777772 ·Status: COMPLETED ·Phase: NA
-
Environmental Design for Behavioral Regulation in People With Dementia
NCT04555616 ·Status: COMPLETED ·Phase: NA
-
Sharing the Outcome of a Memory Assessment
NCT04935060 ·Status: COMPLETED ·Phase: NA