A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: No educational tool This arm will collect data on total standardized daily dosage of the medication classes contributing to CNS polyRx from the Electronic Medical Record (EMR). |
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| Experimental: Educational nudge intervention Participants will be mailed the educational tool in the form of a brochure. |
Behavioral: Educational nudge intervention
This project will adapt the EMPOWER educational brochure for PLWD receiving CNS polyRx. The educational brochure will be mailed to intervention participants identified through EHR at Michigan Medicine and Henry Ford Health System. The brochure will describe what CNS polyRx is, present information about the associated risks, and suggest that participants speak with the prescribing clinician or pharmacist about ways to potentially simplify the medication regimen. The tool will be adapted through three successive rounds of focus groups (AIM one of this project) of PLWD.
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Outcome Measures
Primary Outcome Measures
- Change in the total standardized daily dosage (TSDD) of the medication classes contributing to CNS polyRx as measured in the EHR [baseline, 4 months (after sending the educational tool)]
The study team will use each active outpatient prescription for a CNS-active medication and convert them to a standardized daily dose using the minimal effective geriatric daily dose, adding the total across all CNS-active medications at the patient level.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals who are receiving care at the one of the selected primary care clinics at Michigan Medicine and Henry Ford Health System
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Individuals who have a diagnosis of dementia or mild cognitive impairment (MCI) of any type based on International Classification of Diseases (ICD-10) codes
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 2 | Henry Ford Health | Detroit | Michigan | United States | 48202 |
Sponsors and Collaborators
- University of Michigan
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Donovan Maust, MD, MS, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00218048
- 3U54AG063546-03