Trial Outcomes & Findings for Can Value Champions Reduce Inappropriate Prescribing for People With Dementia? (NCT NCT05359679)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3300 participants

Primary outcome timeframe

21 months

Results posted on

2025-05-18

Participant Flow

Primary care clinics were randomized to intervention or control arms, stratified by high versus low historic prescribing rates of potentially inappropriate medications (PIMs). Patients accrued to the study according to the intervention arm clinic or control arm clinic where they were prescribed PIMs.

Value Champion clinicians (VCs) were enrolled and consented for the purpose of training activities, and for qualitative data collection only. No baseline or outcome data was collected for the VCs.

Unit of analysis: clinics

Participant milestones

Participant milestones
Measure	Value Champion Intervention arm Primary care clinic sites were randomized to the intervention arm of the study. One clinician from each intervention site completed a 6-month clinician Value Champion training program by participating in a series of 12 web-based training sessions. Value Champions engaged with other clinicians at their site regarding deprescribing PIMs.	Standard Care Control arm No Intervention: Usual clinical care - no Value Champion present at this clinical setting
Overall Study STARTED	1613 18	1668 17
Overall Study Value Champion Clinicians	19 18	0 0
Overall Study COMPLETED	1613 18	1668 17
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting	Total n=3182 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	1570 Participants n=93 Participants	1612 Participants n=4 Participants	3182 Participants n=27 Participants
Sex: Female, Male Female	1055 Participants n=93 Participants	1182 Participants n=4 Participants	2237 Participants n=27 Participants
Sex: Female, Male Male	515 Participants n=93 Participants	430 Participants n=4 Participants	945 Participants n=27 Participants
Race/Ethnicity, Customized American Indian/ Alaskan Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	21 Participants n=93 Participants	51 Participants n=4 Participants	72 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	305 Participants n=93 Participants	372 Participants n=4 Participants	677 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	37 Participants n=93 Participants	46 Participants n=4 Participants	83 Participants n=27 Participants
Race/Ethnicity, Customized Non-Hispanic White	1171 Participants n=93 Participants	1091 Participants n=4 Participants	2262 Participants n=27 Participants
Race/Ethnicity, Customized Other/Unknown	36 Participants n=93 Participants	52 Participants n=4 Participants	88 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
Medication Possession Ratio (MPR) for Any Antipsychotics Medication	0.64 Medication possession ratio Standard Deviation 0.079	0.56 Medication possession ratio Standard Deviation 0.073

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
Medication Possession Ratio (MPR) for Any Benzodiazepine Medication	0.29 Medication possession ratio Standard Deviation 0.064	0.28 Medication possession ratio Standard Deviation 0.074

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
Medication Possession Ratio (MPR) for Insulin Medication	0.48 Medication possession ratio Standard Deviation 0.094	0.43 Medication possession ratio Standard Deviation 0.078

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
Medication Possession Ratio (MPR) for Any Sulfonylureas Medications	0.51 Medication possession ratio Standard Deviation 0.108	0.46 Medication possession ratio Standard Deviation 0.065

SECONDARY outcome

Timeframe: 21 months

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

Outcome measures

Outcome measures
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
Percent of Patients With Emergency Department (ED) Visits	8.1 percentage of participants per month Standard Deviation 0.018	6.0 percentage of participants per month Standard Deviation 0.016

SECONDARY outcome

Timeframe: 21 months

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

Outcome measures

Outcome measures
Measure	Value Champion Training Program n=1570 Participants Intervention arm. 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.	Standard Care n=1612 Participants Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
Percentage of Falls	3.85 percent of falls per month Standard Deviation 1.5	4.47 percent of falls per month Standard Deviation 1.7

Adverse Events

Value Champion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Value Champion n=1613 participants at risk Intervention arm: Primary care clinic sites were randomized to the intervention arm of the study. One clinician from each intervention site completed a 6-month clinician Value Champion training program by participating in a series of 12 web-based training sessions. Value Champions engaged with other clinicians at their site regarding deprescribing potentially inappropriate medications (PIMs).	Standard Care n=1668 participants at risk Control group. No Intervention: Usual clinical care - no Value Champion present at this clinical setting
Endocrine disorders Worsening of diabetes control	0.06% 1/1613 • Number of events 1 • 10 months We surveyed clinical Value Champions administering the intervention monthly on whether any adverse events occurred with their patients receiving the intervention. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed in clinicians	0.00% 0/1668 • 10 months We surveyed clinical Value Champions administering the intervention monthly on whether any adverse events occurred with their patients receiving the intervention. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed in clinicians
Psychiatric disorders Worsening of anxiety	0.06% 1/1613 • Number of events 1 • 10 months We surveyed clinical Value Champions administering the intervention monthly on whether any adverse events occurred with their patients receiving the intervention. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed in clinicians	0.00% 0/1668 • 10 months We surveyed clinical Value Champions administering the intervention monthly on whether any adverse events occurred with their patients receiving the intervention. All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed in clinicians

Additional Information

Lorella Palazzo PhD

Kaiser Permanente Washington

Phone: 206-287-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place