Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?

NCT ID: NCT05359679

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2023-10-31

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.

Detailed Description

Background on Condition, Disease, or Other Primary Study Focus:

For people living with dementia (PLWD) the overuse of Potentially Inappropriate Medications (PIMs), those for which the potential for harm outweighs benefit, remains a persistent problem despite evidence-based guidelines supporting de-adoption. A group of geriatric experts convened by the Choosing Wisely initiative identified three classes of PIMs for PLWD: antipsychotics, benzodiazepines, and hypoglycemics (sulfonylureas and insulin) with adequate glycemic control. In a systematic review the prevalence of PIMs when cognitive impairment was reported ranged from 20.6% to 80.5%. Approximately 14.3% of Medicare Part D enrollees with dementia residing in the general community are prescribed an antipsychotic. The prevalence of potentially inappropriate benzodiazepine prescriptions has been reported to be as high as 20% among elderly persons with dementia living in the community. The proportion of elderly patients with an A1c < 7% who received a prescription for sulfonylurea, insulin or combined insulin and sulfonylurea therapies was 35.2%, 24.2% and 16.3% respectively and was as prevalent in those with dementia as in those without. Park and colleagues compared rates of prescribing low-value medications in the elderly from 2006-2015 in both traditional Medicare and Medicare Advantage. Not only was there no difference in rates between the two groups, there was also no evidence of any decline in rates of prescribing over time, including use of benzodiazepines in PLWD.

Study Rationale:

The rationale for decreasing the use of PIMs is that use in this population of patients results in a greater likelihood of harm than benefit. Documented harms in the medical literature includes falls, worsening cognitive impairment, hospital admission, functional impairment, and death.

Name and Description of the Intervention:

One clinician value champion from each clinic randomized to the intervention arm will complete a value champion training program led by the P.I. and then implement care redesign activities in the clinical practice setting to reduce the use of low value prescribing in older adults with dementia. The 6-month training phase will consist of twice monthly web-based training sessions. A recently completed Robert Wood Johnson Foundation (RWJF)-funded Value Champion Fellowship program resulted in the development of a training curriculum comprised of 10 learning modules for the training phase of the intervention and a project workbook to guide clinician value champions during the 12-month project phase. Following the 6 months of training, clinician value champions will participate in a monthly 1-hour shared learning sessions via video conference to share successes, challenges, and brainstorm solutions for 12 months (months 10-22 of the study). The investigators will invite former value champion fellows and faculty from the RWJF fellowship to participate in these meetings to support this new cohort of value champions.

Conditions

Dementia; Med: Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Value Champion Training Program

Intervention arm.

Group Type: EXPERIMENTAL

Value Champion Training Program

Intervention Type: 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.

Standard Care

Control group.

Group Type: ACTIVE_COMPARATOR

No Intervention

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

No Intervention

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorella Palazzo, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36163181 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5U54AG063546-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FY21_Demo2_Parchman

Identifier Type: -

Identifier Source: org_study_id