N/A
Completed N=3,281
Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
Dementia · Med: Dementia
Source: ClinicalTrials.gov NCT05359679 ↗
Enrolled (actual)
3,281
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Medication Possession Ratio (MPR) for Any Antipsychotics Medication — 0.64; 0.56 Medication possession ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Possession Ratio (MPR) for Any Antipsychotics Medication |
0.64; 0.56 | — |
| PRIMARY Medication Possession Ratio (MPR) for Any Benzodiazepine Medication |
0.29; 0.28 | — |
| PRIMARY Medication Possession Ratio (MPR) for Insulin Medication |
0.48; 0.43 | — |
| PRIMARY Medication Possession Ratio (MPR) for Any Sulfonylureas Medications |
0.51; 0.46 | — |
| SECONDARY Percent of Patients With Emergency Department (ED) Visits |
8.1; 6.0 | — |
| SECONDARY Percentage of Falls |
3.85; 4.47 | — |
Eligibility Criteria
Inclusion Criteria - clinician practices:
- Clinical practices with 3 or more primary care providers (defined as a primary care physician (specialty code of 08 or 11), nurse practitioner (specialty code = 50) or physician's assistant (specialty code = 97), and
- Clinical practices with clinical encounters with 10 or more Medicare beneficiaries with Alzheimer's or Alzheimer's related dementia in the base years (2019-2020).
Inclusion Criteria - Medicare beneficiaries:
- Seen by a clinician at a participating practice as evidenced by one or more evaluation and management claim,
- Continuous coverage in Medicare Parts A, B and D and no months of Part C (Medicare Advantage),
- Two or more claims with an International Statistical Classification of Diseases (ICD-10) diagnosis for Alzheimer's or Alzheimer's related dementia 30 days apart or 1 inpatient stay with a principal diagnosis of Alzheimer's.
Exclusion Criteria- Medicare beneficiaries:
- Medicare beneficiaries with a diagnosis of metastatic cancer or
- Medicare beneficiaries enrolled in hospice any time in the 6 months before the start of the intervention
Data sourced from ClinicalTrials.gov (NCT05359679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.