DementiaNCT05359679
Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
A study testing Value Champion Training Program in people with Dementia and Med: Dementia, run by Kaiser Permanente at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Med: Dementia
- What is being tested?
- Value Champion Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Impact Collaboratory Transforming Dementia Care - Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
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.
Read more
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.
Read the 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
- Being tested
- Value Champion Training Program, No Intervention
- Keywords
- Prescribing
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Value Champion Training ProgramBehavioural
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.
No InterventionOther
Usual clinical care - no value champion present at this clinical setting
| Study group | Role | What they receive |
|---|---|---|
| Value Champion Training Program | Experimental | Intervention arm. Receives: Behavioral: Value Champion Training Program |
| Standard Care | Active comparator | Control group. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 months
Secondary outcomes (2)
Percent of Patients With Emergency Department (ED) Visits
Mean percent of patients with Emergency Department (ED) visits in a given study follow up month
Measured: 21 months
Percentage of Falls
Mean percentage of falls reported in claims in a given study month
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start30 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brown University
- Responsible party
- Sponsor
- Investigators
- Lorella Palazzo, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359679
- Sponsor's protocol ID
- FY21_Demo2_Parchman
- Other IDs
- 5U54AG063546-03
- Status last verified
- May 2025
- First submitted
- 14 Mar 2022
- Last updated
- 18 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Aug;41(10):2844-2855. doi: 10.1007/s11606-026-10234-8. Epub 2026 Feb 2.
PubMed 41629556Parchman 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.
PubMed 36163181
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Collaboratory Transforming Dementia Care - Can Value Champions Reduce Inappropriate Prescribing for People With Dementia?
- ClinicalTrials.gov ID
- NCT05359679
- Acronym / sponsor ID
- FY21_Demo2_Parchman
- Conditions
- Dementia, Med: Dementia
- Keywords
- Prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brown University
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Posted 18 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Value Champion Training Program | Experimental | Behavioral: Value Champion Training ProgramIntervention arm. |
| Standard Care | Active comparator | Other: No InterventionControl group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Value Champion Training ProgramClinicians 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. | Behavioural | Value Champion Training Program |
| No InterventionUsual clinical care - no value champion present at this clinical setting | Other | Standard Care |
Primary outcome
Medication Possession Ratio (MPR) for Any Antipsychotics Medication
Time frame: 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.
Medication Possession Ratio (MPR) for Any Benzodiazepine Medication
Time frame: 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.
Medication Possession Ratio (MPR) for Insulin Medication
Time frame: 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.
Medication Possession Ratio (MPR) for Any Sulfonylureas Medications
Time frame: 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.
2 secondary outcomes
Percent of Patients With Emergency Department (ED) Visits
Time frame: 21 months
Percentage of Falls
Time frame: 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41629556Tabata-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 Aug;41(10):2844-2855. doi: 10.1007/s11606-026-10234-8. Epub 2026 Feb 2.
- Derived from this study: PubMed 36163181Parchman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorella Palazzo, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Value Champion Training Program in people with Dementia and Med: Dementia, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Possession Ratio (MPR) for Any Antipsychotics Medication (time frame: 21 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359679, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.