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Deprescribing Education for Alzheimer's Disease and Dementia (Optimize Trial)
N/A
Waitlist Available
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age>=65
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post brochure mailing
Awards & highlights
Optimize Trial Summary
This trial will test whether a simple, pragmatic intervention focused on deprescribing can be delivered at the clinic level and improve patient-centered outcomes.
Who is the study for?
This trial is for people aged 65 or older with Alzheimer's, related dementia, or mild cognitive impairment who see a primary care physician in the Denver-Boulder area. They must have at least one other chronic condition and be taking five or more long-term medications. Those in long term care facilities, hospice, or receiving home-based complex care are excluded.Check my eligibility
What is being tested?
The study tests if educational materials can help optimize medication use for patients with Alzheimer's and multiple chronic conditions. It randomly assigns clinics to either start the intervention right away or later on, comparing outcomes between these two groups.See study design
What are the potential side effects?
Since this trial focuses on education rather than medication changes directly administered by researchers, side effects are not a primary concern as they would be in drug trials. However, changes to medication regimens could potentially lead to side effects which will vary based on individual patient responses.
Optimize Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are 65 years old or older.
Select...
You have been diagnosed with Alzheimer's disease, related dementia, or mild cognitive impairment according to your medical records.
Select...
You have one or more of 86 specific long-term health conditions.
Optimize Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post brochure mailing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post brochure mailing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of chronic medications
Number of potentially inappropriate medications
Secondary outcome measures
Activities of daily living as reported in the Medicare Health Risk Assessment (MHRA)
Hospitalization Rate, Skilled Nursing Facility Admissions Rate, Emergency Department Visit Rate
Selected adverse drug event (ADE) rates
+1 moreOptimize Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Patient and ClinicianExperimental Treatment1 Intervention
Intervention educational materials provided to patient and family and clinician
Group II: Delayed InterventionActive Control1 Intervention
Usual care
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Who is running the clinical trial?
Monash UniversityOTHER
187 Previous Clinical Trials
10,479,193 Total Patients Enrolled
5 Trials studying Dementia
21,291 Patients Enrolled for Dementia
Duke UniversityOTHER
2,358 Previous Clinical Trials
3,412,671 Total Patients Enrolled
17 Trials studying Dementia
33,645 Patients Enrolled for Dementia
University of South AustraliaOTHER
17 Previous Clinical Trials
2,781 Total Patients Enrolled
1 Trials studying Dementia
88 Patients Enrolled for Dementia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have one or more of 86 specific long-term health conditions.You live in a nursing home or are receiving hospice care.You are 65 years old or older.You have been diagnosed with Alzheimer's disease, related dementia, or mild cognitive impairment according to your medical records.People who get all their main healthcare from the KPCO Complex Care Home Rounding service at home.
Research Study Groups:
This trial has the following groups:- Group 1: Delayed Intervention
- Group 2: Intervention - Patient and Clinician
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main aims of this research endeavor?
"The main aim of this experiment, lasting for twelve months following the distribution of brochures, is to reduce potentially inappropriate medications. Secondary objectives consist of changes in dose from baseline to outcome measurement for benzodiazepines, opioids and antipsychotics; hospitalization rate; admissions into skilled nursing facilities (and whether these are permanent or temporary); emergency department visit frequency; as well as fall-related incidents, haemorrhagic events, and hypoglycemia episodes amongst diabetes patients."
Answered by AI
Are there any vacancies in this medical trial for prospective participants?
"As detailed on clinicaltrials.gov, this medical study is closed for recruitment; the trial was first posted in March 2019 and most recently updated in February 2022. Nonetheless, there are 768 other trials currently recruiting participants at this time."
Answered by AI
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