Clinical trial NCT05628181: A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)
Official title: A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Dementia
Keywords: Central Nervous System medication
Education
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-28
Enrollment: 146
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be a total of four primary care clinics at University of Michigan Health and Henry Ford Health; potentially more clinics will be engaged if necessary.
Primary purpose: TREATMENT

Brief summary: The goal of this project is to address Central nervous system-active polypharmacy (CNS polyRx) in people with living dementia (PLWD) through focus group and an educational intervention.

This project involves three interconnected Aims and includes engaging clinicians, patients/PLWD, and care partners (CP). AIM 1 will be completed for the development of the educational tool and is not considered a clinical trial. Therefore, this registration includes the clinical trial (Aims 2 and 3) of the project.

The study hypothesizes that the total standardized daily dosage (TSDD) of the medication classes contributing to CNS polyRx will decline from baseline to 4 months in participants receiving the nudge intervention.

Detailed description: The United States (U.S.) health care system is poorly equipped to deal with the growing number of persons living with dementia (PLWD) in the U.S. and their complex medical and psychosocial needs. While memory impairment is the cardinal feature of Alzheimer's disease and related dementias (ADRD), behavioral and psychological symptoms (e.g., apathy, delusions, agitation) are common during all stages of illness and cause significant caregiver distress. CNS polyRx, defined by the American Geriatrics Society Beers Criteria as overlapping use of greater or equal to (≥) 3 medications from any of the following six classes: antidepressants, antipsychotics, anti-epileptics, benzodiazepines, non-benzodiazepine benzodiazepine receptor agonist hypnotics, or opioids. CNS polyRx is common among PLWD with limited evidence to support such prescribing despite significant evidence of harms, an example of routine care provided to PLWD that is potentially harmful in the vast majority of cases.

Minimizing CNS polypharmacy is a critical opportunity to improve safe medication use for PLWD. Direct-to-patient education has been demonstrated as one successful approach to initiate deprescribing in older adults. For this pilot study, after developing the tool (AIM 1), the study team will use the electronic health records (EHR) of the two healthcare systems (UM and Henry Ford) to identify PLWD with CNS polypharmacy and will send the educational tool, with subsequent EHR review to determine the implementation outcome of whether the recipients' clinicians were engaged in a discussion about these specific prescriptions. Finally, in preparation for a pragmatic trial, the study team will then query the EHR to assess change in CNS-active prescribing in the months following receiving the tool. The data generated during this pilot will allow the study team to seek future funding for a pragmatic trial to test this nudge intervention to reduce CNS polypharmacy among PLWD.

This pragmatic trial of a clinic-level intervention received a waiver of informed consent. There is no informed consent document for the intervention.

Eligibility criteria: Inclusion Criteria:

* Individuals who are receiving care at the one of the selected primary care clinics at Michigan Medicine and Henry Ford Health System
* Individuals who have a diagnosis of dementia or mild cognitive impairment (MCI) of any type based on International Classification of Diseases (ICD-10) codes
* Individuals who have been prescribed ≥3 of the medications that contribute to CNS polyRx (e.g., antidepressants, antipsychotics, anti-epileptics, benzodiazepines, non-benzodiazepine benzodiazepine receptor agonist hypnotics, or opioids) based on chart review

Exclusion Criteria:

- primary care clinicians review of participants and determines intervention is not appropriate

Primary outcomes:
measure: Change in the total standardized daily dosage (TSDD) of the medication classes contributing to CNS polyRx as measured in the EHR
timeFrame: baseline, 4 months (after sending the educational tool)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: University of Michigan
name: Donovan Maust, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: