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Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?

Impact Collaboratory Transforming Dementia Care - Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05359679
Enrollment
3300
Registered
2022-05-04
Start date
2023-08-30
Completion date
2023-10-31
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Med: Dementia

Keywords

Prescribing

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.

Interventions

BEHAVIORALValue 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.

OTHERNo Intervention

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Brown University
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- clinician practices: * 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). Inclusion Criteria - Medicare beneficiaries: * 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: * 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

Design outcomes

Primary

MeasureTime frameDescription
Medication Possession Ratio (MPR) for Any Antipsychotics Medication21 monthsThe 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.
Medication Possession Ratio (MPR) for Any Benzodiazepine Medication21 monthsThe 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.
Medication Possession Ratio (MPR) for Insulin Medication21 monthsThe 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.
Medication Possession Ratio (MPR) for Any Sulfonylureas Medications21 monthsThe 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.

Secondary

MeasureTime frameDescription
Percent of Patients With Emergency Department (ED) Visits21 monthsMean percent of patients with Emergency Department (ED) visits in a given study follow up month
Percentage of Falls21 monthsMean percentage of falls reported in claims in a given study month

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Value Champion Training Program
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.
1,570
Standard Care
Control group. No Intervention: Usual clinical care - no value champion present at this clinical setting
1,612
Total3,182

Baseline characteristics

CharacteristicValue Champion Training ProgramStandard CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1570 Participants1612 Participants3182 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian/ Alaskan Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
21 Participants51 Participants72 Participants
Race/Ethnicity, Customized
Black or African American
305 Participants372 Participants677 Participants
Race/Ethnicity, Customized
Hispanic
37 Participants46 Participants83 Participants
Race/Ethnicity, Customized
Non-Hispanic White
1171 Participants1091 Participants2262 Participants
Race/Ethnicity, Customized
Other/Unknown
36 Participants52 Participants88 Participants
Sex: Female, Male
Female
1055 Participants1182 Participants2237 Participants
Sex: Female, Male
Male
515 Participants430 Participants945 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,6130 / 1,668
other
Total, other adverse events
2 / 1,6130 / 1,668
serious
Total, serious adverse events
0 / 1,6130 / 1,668

Outcome results

Primary

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.

Time frame: 21 months

ArmMeasureValue (MEAN)Dispersion
Value Champion Training ProgramMedication Possession Ratio (MPR) for Any Antipsychotics Medication0.64 Medication possession ratioStandard Deviation 0.079
Standard CareMedication Possession Ratio (MPR) for Any Antipsychotics Medication0.56 Medication possession ratioStandard Deviation 0.073
Primary

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.

Time frame: 21 months

ArmMeasureValue (MEAN)Dispersion
Value Champion Training ProgramMedication Possession Ratio (MPR) for Any Benzodiazepine Medication0.29 Medication possession ratioStandard Deviation 0.064
Standard CareMedication Possession Ratio (MPR) for Any Benzodiazepine Medication0.28 Medication possession ratioStandard Deviation 0.074
Primary

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.

Time frame: 21 months

ArmMeasureValue (MEAN)Dispersion
Value Champion Training ProgramMedication Possession Ratio (MPR) for Any Sulfonylureas Medications0.51 Medication possession ratioStandard Deviation 0.108
Standard CareMedication Possession Ratio (MPR) for Any Sulfonylureas Medications0.46 Medication possession ratioStandard Deviation 0.065
Primary

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.

Time frame: 21 months

ArmMeasureValue (MEAN)Dispersion
Value Champion Training ProgramMedication Possession Ratio (MPR) for Insulin Medication0.48 Medication possession ratioStandard Deviation 0.094
Standard CareMedication Possession Ratio (MPR) for Insulin Medication0.43 Medication possession ratioStandard Deviation 0.078
Secondary

Percentage of Falls

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

Time frame: 21 months

ArmMeasureValue (MEAN)Dispersion
Value Champion Training ProgramPercentage of Falls3.85 percent of falls per monthStandard Deviation 1.5
Standard CarePercentage of Falls4.47 percent of falls per monthStandard Deviation 1.7
Secondary

Percent of Patients With Emergency Department (ED) Visits

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

Time frame: 21 months

ArmMeasureValue (MEAN)Dispersion
Value Champion Training ProgramPercent of Patients With Emergency Department (ED) Visits8.1 percentage of participants per monthStandard Deviation 0.018
Standard CarePercent of Patients With Emergency Department (ED) Visits6.0 percentage of participants per monthStandard Deviation 0.016

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026