Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?

NCT05359679 | Completed Results DMC

• 2 other identifiers: FY21_Demo2_Parchman5U54AG063546-03
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prescribing

Outcome Measures

Primary Outcomes (4)

• Medication Possession Ratio (MPR) for Any Antipsychotics Medication

  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.

  21 months

• Medication Possession Ratio (MPR) for Any Benzodiazepine Medication

  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.

  21 months

• Medication Possession Ratio (MPR) for Insulin Medication

  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.

  21 months

• Medication Possession Ratio (MPR) for Any Sulfonylureas Medications

  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.

  21 months

Secondary Outcomes (2)

• Percent of Patients With Emergency Department (ED) Visits

  21 months

• Percentage of Falls

  21 months

Study Arms (2)

Value Champion Training Program

EXPERIMENTAL

Intervention arm.

Behavioral: Value Champion Training Program

Standard Care

ACTIVE COMPARATOR

Control group.

Other: No Intervention

Interventions

Value Champion Training Program BEHAVIORAL

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.

Value Champion Training Program

No Intervention OTHER

Usual clinical care - no value champion present at this clinical setting

Standard Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Aging (NIA): collaborator
• Brown University: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• Tabata-Kelly M, Palazzo LG, Perloff J, Kiel L, Parchman M, Penfold RB. Champion-Led Deprescribing for Persons with Dementia in Primary Care: A Qualitative Study in Accountable Care Organizations. J Gen Intern Med. 2026 Feb 2. doi: 10.1007/s11606-026-10234-8. Online ahead of print.

  PMID: 41629556 DERIVED

• Parchman ML, Perloff J, Ritter G. Can clinician champions reduce potentially inappropriate medications in people living with dementia? Study protocol for a cluster randomized trial. Implement Sci. 2022 Sep 27;17(1):63. doi: 10.1186/s13012-022-01237-0.

  PMID: 36163181 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Lorella Palazzo PhD
• Organization: Kaiser Permanente Washington

lorella.g.palazzo@kp.org

206-287-2900

Study Officials

• Lorella Palazzo, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pragmatic cluster randomized trial across two Accountable Care Organizations. (ACOs) Within each ACO 15 primary care clinics will be randomized to the intervention arm or control arm of the study. From each intervention clinic, one clinician will participate in a clinical champion training program and subsequently work to decrease the prescribing of potentially inappropriate medications among patients with dementia among their colleagues. 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) among patients with a diagnosis of dementia.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: May 4, 2022
• Study Start: August 30, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-05

Locations

US (1)