Kaiser Permanente
Aurora, Colorado, 80014, United States
NCT Number: NCT03984396
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Aurora, Colorado, 80014, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Clinician Inclusion Criteria:
Clinician Exclusion Criterion:
deprescribing information for patient & clinician
Time frame: 6 months post brochure mailing
Number of chronic medications defined as those with at least a 28 days supply
Time frame: 12 months post brochure mailing
Number of chronic medications defined as those with at least a 28 days supply
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.
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.
Time frame: 12 months post initial brochure mailing
Change in dose from baseline to outcome measurement for selected medications: benzodiazepines, opioids, antipsychotics
Time frame: 12 months post brochure mailing
Three types of ADEs: falls; hemorrhagic events; and episodes of hypoglycemia in individuals with diabetes.
Time frame: 12 months post brochure mailing
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.)
Time frame: 3 days to 365 days after a participant's study index date
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.
Kaiser Permanente
Other
Acronym: Optimize
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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