Ignite Creation Date:
2024-05-06 @ 1:17 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03984396
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2019-05-24
Brief Title:
Optimal Medication Management in Alzheimers Disease and Dementia
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Optimal Medication Management in Alzheimers Disease and Dementia
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Optimize
Brief Summary:
The study objective is to conduct a pragmatic deprescribing intervention for people with Alzheimers 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 inclusionexclusion criteria and be implemented across the Kaiser Permanente Colorado KPCO system The intervention will have two components a patientcare 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
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 inclusionexclusion criteria and be implemented across the Kaiser Permanente Colorado KPCO system The intervention will have two components a patientcare 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 Alzheimers 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 Patientcare 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
There are two components to the intervention Patient care partner education and clinician education Patientcare 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None