A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)

Dementia Clinical Trial

Official title:

A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628181
• Other study ID #: HUM00218048
• Secondary ID: 3U54AG063546-03
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: January 19, 2024

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Henry Ford Health	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the total standardized daily dosage (TSDD) of the medication classes contributing to CNS polyRx as measured in the EHR	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.	baseline, 4 months (after sending the educational tool)