NCT05359679

Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?

Completed NA Results posted Last updated 18 May 2025

What this trial tests

NA trial testing Value Champion Training Program in Dementia in 3,300 participants. Completed in 31 October 2023.

Timeline

30 August 2023

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	3,300
Start date	30 August 2023
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Value Champion Training Program
• No Intervention

Conditions studied

• Dementia — all drugs for Dementia →
• Med: Dementia — all drugs for Med: Dementia →

Sponsor

Kaiser Permanente — full company profile →

Who can join

65 and older, any sex, with Dementia or Med: Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Possession Ratio (MPR) for Any Antipsychotics Medication Primary · 21 months

The Medication Possession Ratio is calculated from Medicare Part D claims data as quotients with denominator equal to the length of the quarter and the numerators equal to the days supply for prescriptions within the medication class filled during the quarter, plus excess days-supply from the previous period minus excess days-supply remaining at the end.

Group	Value	95% CI
Value Champion Training Program	0.64	± 0.079
Standard Care	0.56	± 0.073

Medication Possession Ratio (MPR) for Any Benzodiazepine Medication Primary · 21 months

The Medication Possession Ratio is calculated from Medicare Part D claims data as quotients with denominator equal to the length of the quarter and the numerators equal to the days supply for prescriptions within the medication class filled during the quarter, plus excess days-supply from the previous period minus excess days-supply remaining at the end.

Group	Value	95% CI
Value Champion Training Program	0.29	± 0.064
Standard Care	0.28	± 0.074

Medication Possession Ratio (MPR) for Insulin Medication Primary · 21 months

The Medication Possession Ratio is calculated from Medicare Part D claims data as quotients with denominator equal to the length of the quarter and the numerators equal to the days supply for prescriptions within the medication class filled during the quarter, plus excess days-supply from the previous period minus excess days-supply remaining at the end.

Group	Value	95% CI
Value Champion Training Program	0.48	± 0.094
Standard Care	0.43	± 0.078

Medication Possession Ratio (MPR) for Any Sulfonylureas Medications Primary · 21 months

The Medication Possession Ratio is calculated from Medicare Part D claims data as quotients with denominator equal to the length of the quarter and the numerators equal to the days supply for prescriptions within the medication class filled during the quarter, plus excess days-supply from the previous period minus excess days-supply remaining at the end.

Group	Value	95% CI
Value Champion Training Program	0.51	± 0.108
Standard Care	0.46	± 0.065

Percent of Patients With Emergency Department (ED) Visits Secondary · 21 months

Mean percent of patients with Emergency Department (ED) visits in a given study follow up month

Group	Value	95% CI
Value Champion Training Program	8.1	± 0.018
Standard Care	6.0	± 0.016

Percentage of Falls Secondary · 21 months

Mean percentage of falls reported in claims in a given study month

Group	Value	95% CI
Value Champion Training Program	3.85	± 1.5
Standard Care	4.47	± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Value Champion

Serious: 0/1613 (0%)

Deaths: 0/1613

Standard Care

Serious: 0/1668 (0%)

Deaths: 0/1668

Other adverse events (2 terms — click to expand)

Reaction	System	Value Champion	Standard Care
Worsening of diabetes control	Endocrine disorders	—	—
Worsening of anxiety	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT05359679 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Can clinician champions reduce potentially inappropriate medications in people living with dementia? Study protocol for a cluster randomized trial.
   Parchman ML, Perloff J, Ritter G. · · 2022 · cited 3× · PMID 36163181 · DOI 10.1186/s13012-022-01237-0
2. Champion-Led Deprescribing for Persons with Dementia in Primary Care: A Qualitative Study in Accountable Care Organizations.
   Tabata-Kelly M, Palazzo LG, Perloff J, Kiel L, et al · · 2026 · PMID 41629556 · DOI 10.1007/s11606-026-10234-8