Value Champion Training Program for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Washington Health Research Institute, Seattle, WA
Dementia+2 More
Value Champion Training Program - Behavioral
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Dementia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 1 year

1 year
Medication Possession Ratio for any medication in these three classes: antipsychotics, benzodiazepines, or hypoglycemic medication (sulfonylureas or insulin).
12 months
Number of equity related milestones achieved by each clinician champion during their project. Recorded in the Value Champions Project Workbook.
Number of milestones completed by the clinician champions during the "design and implement" phase of their improvement project- recorded in the Value Champions Project Workbook
Proportion of stakeholders identified by clinician champions as opponents of their improvement project - recoded in Stakeholder log.
Total Number of Milestones achieved by each clinician champion during their improvement project. - Recorded in Value Champions Project Workbook.
Total number of stakeholders engaged by each clinician champion within their clinic. - recorded in Stakeholder Log.
Month 18
Number of Emergency Department or Hospitalizations attributed to a fall.

Trial Safety

Trial Design

2 Treatment Groups

Standard Care
1 of 2
Value Champion Training Program
1 of 2
Active Control
Experimental Treatment

5000 Total Participants · 2 Treatment Groups

Primary Treatment: Value Champion Training Program · No Placebo Group · N/A

Value Champion Training Program
Behavioral
Experimental Group · 1 Intervention: Value Champion Training Program · Intervention Types: Behavioral
Standard Care
Other
ActiveComparator Group · 1 Intervention: No Intervention · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Kaiser Permanente Washington Health Research Institute · Seattle, WA
Photo of Seattle 1Photo of Seattle 2Photo of Seattle 3
2019First Recorded Clinical Trial
3 TrialsResearching Dementia
17 CompletedClinical Trials

Who is running the clinical trial?

Brown UniversityOTHER
406 Previous Clinical Trials
510,181 Total Patients Enrolled
14 Trials studying Dementia
203,420 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,348 Previous Clinical Trials
3,256,897 Total Patients Enrolled
200 Trials studying Dementia
886,087 Patients Enrolled for Dementia
Kaiser PermanenteLead Sponsor
496 Previous Clinical Trials
22,181,187 Total Patients Enrolled
8 Trials studying Dementia
15,150 Patients Enrolled for Dementia
Michael Parchman, MDPrincipal InvestigatorKaiser Permanente

Eligibility Criteria

Age 65+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.