DementiaOptimizeNCT03984396
Optimal Medication Management in Alzheimer's Disease and Dementia
A study testing Educational Materials - Patient & Clinician in people with Dementia, run by Kaiser Permanente at 1 site in United States.
Trial summary
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer's Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on 'just right' medication regimens. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Educational Materials - Patient & Clinician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,398 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Patient Inclusion Criteria:
- Age>=65
- Bonded to a primary care physician (PCP) in the Kaiser Permanente Colorado (KPCO) - Denver-Boulder service area
- Diagnosis of Alzheimer's Dementia or Related Dementia or Mild Cognitive Impairment (MCI) from ICD-9 or ICD-10 visit codes or from the problem list in the Electronic Health Record (EHR)
- One or more additional chronic conditions from a list of 86 chronic medical conditions
- Be taking 5 or more chronic medications (defined as a 28+ days' supply of medication on the eligibility date; excluding non-indicated medications such as vaccines and anesthetics based on 2-digit GPI codes
- Of this eligible population, those who have at least one visit with a PCP during the intervention period will receive the patient portion of the intervention.
Patient Exclusion Criteria:
- Individuals residing in long term care facilities or enrolled in hospice care at baseline
- Individuals residing at home but receiving all their primary care through the KPCO Complex Care Home Rounding service which replaces primary care delivery
Clinician Inclusion Criteria:
- PCP for adult patients in the KPCO Denver-Boulder service area.
Clinician Exclusion Criterion:
- PCP for adult patients at the Longmont Medical Office since Longmont was the pilot study site.
Trial locations and contacts
1 site in 1 country.
About this study
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer's Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on 'just right' medication regimens.
The intervention will be a pragmatic, cluster randomized trial of medication optimization through increased awareness of deprescribing for the ADRD-MCC population. It will be delivered in primary care at the clinic level with a wait-list control design. As a pragmatic intervention it is designed to be relatively simple, have broad inclusion/exclusion criteria, and be implemented across the Kaiser Permanente Colorado (KPCO) system. The intervention will have two components: a patient/care partner component focused on education and activation about potential deprescribing including sending out a brochure, and a clinician component focused on increasing clinician awareness through monthly Tip Sheets about options and processes for deprescribing in the ADRD-MCC population linked to upcoming visits. The intervention will take place at 18 primary care offices in the Denver-Boulder service delivery area with 9 as initial intervention sites and 9 as delayed intervention sites.
Read the detailed description
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer's Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on 'just right' medication regimens.
There are two components to the intervention: Patient/ care partner education and clinician education. Patient/care partner educational materials about medication optimization will be mailed to eligible members who have upcoming appointments with primary care physicians (PCPs) within 2 weeks of scheduled visits. The initial intervention period will run for 12 months and the delayed intervention period will run for 12 months. Primary care clinicians at the intervention clinics who care for adults (Internal Medicine [IM] and Family Medicine [FM]) will receive education on medication optimization and options for deprescribing through an initial presentation at a monthly team meeting at the beginning of the intervention period, as well as periodic Tip Sheet updates on managing deprescribing in specific situations. Primary care clinicians will receive notification via staff message when materials have been sent to patients with an upcoming appointment.
The intervention has two aims:
Aim 1: In a cluster randomized pragmatic trial, test the effectiveness of a primary care based, clinic level deprescribing intervention on two primary outcomes: number of chronic medications and number of potentially inappropriate medications (PIMs) among older adults with ADRD-MCC.
Aim 2: Evaluate the effect of the intervention on secondary outcomes of adverse drug events (falls, bleeding episodes, hypoglycemic episodes), reductions in dosage for selected PIMs (benzodiazepines, opioids, anti-psychotics), hospital, emergency department and skilled nursing facility utilization, and activities of daily living.
- Conditions
- Dementia
- Being tested
- Educational Materials - Patient & Clinician
- Keywords
- dementia, cognitive impairment, multimorbidity/comorbidity, polypharmacy, deprescriptions, patient education, deprescribe
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Materials - Patient & ClinicianOther
deprescribing information for patient \& clinician
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Patient and Clinician | Experimental | Intervention educational materials provided to patient and family and clinician Receives: Other: Educational Materials - Patient & Clinician |
| Delayed Intervention | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of chronic medications
Number of chronic medications defined as those with at least a 28 days supply
Measured: 6 months post brochure mailing
Number of chronic medications
Number of chronic medications defined as those with at least a 28 days supply
Measured: 12 months post brochure mailing
Number of potentially inappropriate medications
Number of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.
Measured: 6 months post brochure mailing
Number of potentially inappropriate medications
Number of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.
Measured: 12 months post brochure mailing
Secondary outcomes (4)
Treatment change
Change in dose from baseline to outcome measurement for selected medications: benzodiazepines, opioids, antipsychotics
Measured: 12 months post initial brochure mailing
Selected adverse drug event (ADE) rates
Three types of ADEs: falls; hemorrhagic events; and episodes of hypoglycemia in individuals with diabetes.
Measured: 12 months post brochure mailing
Hospitalization Rate, Skilled Nursing Facility Admissions Rate, Emergency Department Visit Rate
Presence/ absence of a one of these admissions over the year prior to baseline and post intervention. (We will distinguish between temporary and permanent admissions to skilled nursing facilities.)
Measured: 12 months post brochure mailing
Activities of daily living as reported in the Medicare Health Risk Assessment (MHRA)
Activities of Daily Living are reported by patients/ proxy responders as part of the annual MHRA. These data will be available on the subset of participants who have completed the MHRA. Data from the most recent MHRA will be used.
Measured: 3 days to 365 days after a participant's study index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start6 Mar 2019
- Primary completion1 Apr 2021
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- A pragmatic cluster randomized educational intervention with a delayed control.
- Masking
- None (open label)
- Enrolment
- 7,398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Duke University, Monash University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984396
- Sponsor's protocol ID
- R33AG057289
- Acronym
- Optimize
- Status last verified
- Jan 2024
- First submitted
- 24 May 2019
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reeve E, Bayliss EA, Shetterly S, Maiyani M, Gleason KS, Norton JD, Sheehan OC, Green AR, Maciejewski ML, Drace M, Sawyer J, Boyd CM. Willingness of older people living with dementia and mild cognitive impairment and their caregivers to have medications deprescribed. Age Ageing. 2023 Jan 8;52(1):afac335. doi: 10.1093/ageing/afac335.
PubMed 36702513Bayliss EA, Shetterly SM, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Weffald LA, Green AR, Reeve E, Maciejewski ML, Sheehan OC, Wolff JL, Kraus C, Boyd CM. Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2022 May 1;182(5):534-542. doi: 10.1001/jamainternmed.2022.0502.
PubMed 35343999Green AR, Boyd CM, Gleason KS, Wright L, Kraus CR, Bedoy R, Sanchez B, Norton J, Sheehan OC, Wolff JL, Reeve E, Maciejewski ML, Weffald LA, Bayliss EA. Designing a Primary Care-Based Deprescribing Intervention for Patients with Dementia and Multiple Chronic Conditions: a Qualitative Study. J Gen Intern Med. 2020 Dec;35(12):3556-3563. doi: 10.1007/s11606-020-06063-y. Epub 2020 Jul 29.
PubMed 32728959Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0.
PubMed 32552857Sheehan OC, Gleason KS, Bayliss EA, Green AR, Drace ML, Norton J, Reeve E, Shetterly SM, Weffald LA, Sawyer JK, Maciejewski ML, Kraus C, Maiyani M, Wolff J, Boyd CM. Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial. J Am Geriatr Soc. 2023 Mar;71(3):774-784. doi: 10.1111/jgs.18148. Epub 2022 Dec 12.
PubMed 36508725Orla Sheehan and others, Intervention Design With Cognitively Impaired Populations: The Optimize Deprescribing Intervention, Innovation in Aging, Volume 5, Issue Supplement_1, 2021, Page 401, https://doi.org/10.1093/geroni/igab046.1558
Green AR, Weffald LA, Powers JD, Drace ML, Norton JD, Boyd CM, Bayliss EA. Assessing medication appropriateness as a deprescribing outcome. J Am Geriatr Soc. 2023 Dec;71(12):3918-3920. doi: 10.1111/jgs.18562. Epub 2023 Aug 26. No abstract available.
PubMed 37632424Boyd CM, Shetterly SM, Powers JD, Weffald LA, Green AR, Sheehan OC, Reeve E, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Maciejewski ML, Wolff JL, Kraus C, Bayliss EA. Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial. Drugs Aging. 2024 Jan;41(1):45-54. doi: 10.1007/s40266-023-01080-y. Epub 2023 Nov 20.
PubMed 37982982
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Medication Management in Alzheimer's Disease and Dementia
- ClinicalTrials.gov ID
- NCT03984396
- Acronym / sponsor ID
- Optimize / R33AG057289
- Conditions
- Dementia
- Keywords
- dementia, cognitive impairment, multimorbidity/comorbidity, polypharmacy, deprescriptions, patient education, deprescribe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,398 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Duke University, Monash University
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer's Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on 'just right' medication regimens.
The intervention will be a pragmatic, cluster randomized trial of medication optimization through increased awareness of deprescribing for the ADRD-MCC population. It will be delivered in primary care at the clinic level with a wait-list control design. As a pragmatic intervention it is designed to be relatively simple, have broad inclusion/exclusion criteria, and be implemented across the Kaiser Permanente Colorado (KPCO) system. The intervention will have two components: a patient/care partner component focused on education and activation about potential deprescribing including sending out a brochure, and a clinician component focused on increasing clinician awareness through monthly Tip Sheets about options and processes for deprescribing in the ADRD-MCC population linked to upcoming visits. The intervention will take place at 18 primary care offices in the Denver-Boulder service delivery area with 9 as initial intervention sites and 9 as delayed intervention sites.
Detailed description
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimer's Disease or Related Dementia with Multiple Chronic Conditions (ADRD-MCC) so that these patients are on 'just right' medication regimens.
There are two components to the intervention: Patient/ care partner education and clinician education. Patient/care partner educational materials about medication optimization will be mailed to eligible members who have upcoming appointments with primary care physicians (PCPs) within 2 weeks of scheduled visits. The initial intervention period will run for 12 months and the delayed intervention period will run for 12 months. Primary care clinicians at the intervention clinics who care for adults (Internal Medicine [IM] and Family Medicine [FM]) will receive education on medication optimization and options for deprescribing through an initial presentation at a monthly team meeting at the beginning of the intervention period, as well as periodic Tip Sheet updates on managing deprescribing in specific situations. Primary care clinicians will receive notification via staff message when materials have been sent to patients with an upcoming appointment.
The intervention has two aims:
Aim 1: In a cluster randomized pragmatic trial, test the effectiveness of a primary care based, clinic level deprescribing intervention on two primary outcomes: number of chronic medications and number of potentially inappropriate medications (PIMs) among older adults with ADRD-MCC.
Aim 2: Evaluate the effect of the intervention on secondary outcomes of adverse drug events (falls, bleeding episodes, hypoglycemic episodes), reductions in dosage for selected PIMs (benzodiazepines, opioids, anti-psychotics), hospital, emergency department and skilled nursing facility utilization, and activities of daily living.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic cluster randomized educational intervention with a delayed control.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Patient and Clinician | Experimental | Other: Educational Materials - Patient & ClinicianIntervention educational materials provided to patient and family and clinician |
| Delayed Intervention | No intervention | –Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Educational Materials - Patient & Cliniciandeprescribing information for patient \& clinician | Other | Intervention - Patient and Clinician |
Primary outcome
Number of chronic medications
Time frame: 6 months post brochure mailing
Number of chronic medications defined as those with at least a 28 days supply
Number of chronic medications
Time frame: 12 months post brochure mailing
Number of chronic medications defined as those with at least a 28 days supply
Number of potentially inappropriate medications
Time frame: 6 months post brochure mailing
Number of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.
Number of potentially inappropriate medications
Time frame: 12 months post brochure mailing
Number of chronic medications that are listed as potentially inappropriate for older adults based on the Beers list.
4 secondary outcomes
Treatment change
Time frame: 12 months post initial brochure mailing
Selected adverse drug event (ADE) rates
Time frame: 12 months post brochure mailing
Hospitalization Rate, Skilled Nursing Facility Admissions Rate, Emergency Department Visit Rate
Time frame: 12 months post brochure mailing
Activities of daily living as reported in the Medicare Health Risk Assessment (MHRA)
Time frame: 3 days to 365 days after a participant's study index date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 36702513Reeve E, Bayliss EA, Shetterly S, Maiyani M, Gleason KS, Norton JD, Sheehan OC, Green AR, Maciejewski ML, Drace M, Sawyer J, Boyd CM. Willingness of older people living with dementia and mild cognitive impairment and their caregivers to have medications deprescribed. Age Ageing. 2023 Jan 8;52(1):afac335. doi: 10.1093/ageing/afac335.
- Background: PubMed 35343999Bayliss EA, Shetterly SM, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Weffald LA, Green AR, Reeve E, Maciejewski ML, Sheehan OC, Wolff JL, Kraus C, Boyd CM. Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2022 May 1;182(5):534-542. doi: 10.1001/jamainternmed.2022.0502.
- Background: PubMed 32728959Green AR, Boyd CM, Gleason KS, Wright L, Kraus CR, Bedoy R, Sanchez B, Norton J, Sheehan OC, Wolff JL, Reeve E, Maciejewski ML, Weffald LA, Bayliss EA. Designing a Primary Care-Based Deprescribing Intervention for Patients with Dementia and Multiple Chronic Conditions: a Qualitative Study. J Gen Intern Med. 2020 Dec;35(12):3556-3563. doi: 10.1007/s11606-020-06063-y. Epub 2020 Jul 29.
- Background: PubMed 32552857Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0.
- Background: PubMed 36508725Sheehan OC, Gleason KS, Bayliss EA, Green AR, Drace ML, Norton J, Reeve E, Shetterly SM, Weffald LA, Sawyer JK, Maciejewski ML, Kraus C, Maiyani M, Wolff J, Boyd CM. Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial. J Am Geriatr Soc. 2023 Mar;71(3):774-784. doi: 10.1111/jgs.18148. Epub 2022 Dec 12.
- BackgroundOrla Sheehan and others, Intervention Design With Cognitively Impaired Populations: The Optimize Deprescribing Intervention, Innovation in Aging, Volume 5, Issue Supplement_1, 2021, Page 401, https://doi.org/10.1093/geroni/igab046.1558
- Background: PubMed 37632424Green AR, Weffald LA, Powers JD, Drace ML, Norton JD, Boyd CM, Bayliss EA. Assessing medication appropriateness as a deprescribing outcome. J Am Geriatr Soc. 2023 Dec;71(12):3918-3920. doi: 10.1111/jgs.18562. Epub 2023 Aug 26. No abstract available.
- Background: PubMed 37982982Boyd CM, Shetterly SM, Powers JD, Weffald LA, Green AR, Sheehan OC, Reeve E, Drace ML, Norton JD, Maiyani M, Gleason KS, Sawyer JK, Maciejewski ML, Wolff JL, Kraus C, Bayliss EA. Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial. Drugs Aging. 2024 Jan;41(1):45-54. doi: 10.1007/s40266-023-01080-y. Epub 2023 Nov 20.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials - Patient & Clinician in people with 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?
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 1 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of chronic medications (time frame: 6 months post brochure mailing). 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 NCT03984396, which also lists 8 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 1 Feb 2024.