Dementia, Polypharmacy, Quality of Life
Conditions
Keywords
Deprescribing
Brief summary
This single-arm pilot study will evaluate the effects of an intervention to reduce exposure to unnecessary or potentially harmful medications among residents with dementia living in an assisted living facility. The goal of the intervention is to safely deprescribe medications (defined by dose reductions and stopped medications), based on a combination of clinical criteria and resident/surrogate preferences. The investigators will evaluate the effects of the intervention on the total number of medications deprescribed from enrollment at 30, 60, and 90 days along with resident/surrogate reports of quality of life at enrollment and 90 days.
Detailed description
This single-arm pilot trial will evaluate an evidence-based, patient-centered deprescribing intervention with assisted living facility (ALF) residents age 65+ who have a diagnosis of dementia. This deprescribing intervention was demonstrated to be safe and effective in reducing medication burden during the Shed-MEDS randomized clinical trial that enrolled hospitalized older adults discharging to post-acute care facilities. The intervention includes a comprehensive review of a participant's medications by the study's clinician and deprescribing recommendations using evidence-based guidelines. Deprescribing recommendations will be shared with residents/surrogate decision makers (i.e., respective family member/s) to determine their willingness to stop or reduce the dose of the targeted medications. If the resident/surrogate-decision maker agrees, deprescribing recommendations will then be communicated with the routine ALF medical providers for consideration and final deprescribing decisions.
Interventions
BEHAVIORALShed-MEDS deprescribing intervention
See single arm description
Sponsors
National Institute on Aging (NIA)
Vanderbilt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
All participants will receive a clinical review of their prescribed medications by a research clinician, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the research clinician. The facility's medical providers will also be part of the deprescribing decision process and will initiate any agreed upon deprescribing
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Resident of assisted living facility * Speaks English (due to interview-based assessments) * Diagnosis of dementia * Taking a total of 5 medications or at least one potentially inappropriate medication (defined by the Beers criteria, STOPP criteria, and the Rationalization of home medication by an Adjusted STOPP in older Patients \[RASP\]) * Able self-consent or has a proxy (surrogate)
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Medications That Have Been Deprescribed Since Enrollment | 30 days | The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication. |
| Resident Quality of Life | Enrollment | The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better). |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from memory care units at two assisted living facilities in Nashville, TN.
Participants by arm
| Arm | Count |
|---|---|
| ShedMEDS Intervention ShedMEDS is a patient-centered intervention to safely deprescribe medicines, as defined by dose reductions and stopping, based on a combination of clinical criteria and patient/surrogate preference.
All participants received a clinical review of their medications by a research nurse practitioner, followed by a resident/surrogate interview to assess their willingness to discontinue or reduce some of their medicines based on the research clinician's clinical recommendations. The deprescribing recommendations were discussed with the assisted living facility's medical providers, who initiated the agreed upon deprescribing.
Shed-MEDS deprescribing intervention: See single arm description | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ShedMEDS Intervention |
|---|---|
| Age, Continuous | 82 years |
| Anticholinergic & Sedative Drug Burden Index | 2.3 units on a scale |
| Brief Interview for Mental Status (BIMS) | 2.5 units on a scale |
| Charlson Comorbidity Index (CCI) | 5.0 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 17 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 6 Participants |
| Total Number of Medications | 13 Medications |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 18 |
| other Total, other adverse events | 7 / 18 |
| serious Total, serious adverse events | 3 / 18 |
Outcome results
Primary
Resident Quality of Life
The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better).
Time frame: Enrollment
Population: All participants who completed the entire intervention protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ShedMEDS Intervention | Resident Quality of Life | 94 score on a scale |
Primary
Resident Quality of Life
The Dementia Quality of Life Instrument-Proxy Version (DEMQOL-Proxy) is used to evaluate health-related quality of life in participants with severe dementia as rated by their caregivers. The DEMQOL-Proxy has 31 items which are reported on a four-point Likert scale (a lot/ quite a bit/ a little/ not at all) with a total score range from 31 to 124. Higher scores indicate a better health-related quality of life (i.e., higher scores are better).
Time frame: 90 days
Population: All participants who completed the intervention protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ShedMEDS Intervention | Resident Quality of Life | 104.5 score on a scale |
Primary
Total Number of Medications That Have Been Deprescribed Since Enrollment
The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.
Time frame: 30 days
Population: All participants who completed the intervention protocol (medication review, surrogate interview, and provider conversation).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ShedMEDS Intervention | Total Number of Medications That Have Been Deprescribed Since Enrollment | 4 Medications |
Primary
Total Number of Medications That Have Been Deprescribed Since Enrollment
The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.
Time frame: 60 days
Population: All participants who completed and the entire intervention protocol (medication review, surrogate interview, and provider conversation).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ShedMEDS Intervention | Total Number of Medications That Have Been Deprescribed Since Enrollment | 4 Medications |
Primary
Total Number of Medications That Have Been Deprescribed Since Enrollment
The number of medications (including all prescribed and over-the-counter medications and both scheduled and as-needed medications) that have been deprescribed since enrollment. Deprescribed is defined as either stopping or reducing the dose/frequency of a medication.
Time frame: 90 days
Population: All participants who completed the entire intervention protocol (medication review, surrogate interview, and provider conversation).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ShedMEDS Intervention | Total Number of Medications That Have Been Deprescribed Since Enrollment | 4 Medications |