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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ShedMEDS Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shed-MEDS deprescribing intervention | Behavioral | See single arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| 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. | 60 days |
| 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. | 90 days |
| 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). | Enrollment |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
- None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abe's Garden Community | Nashville | Tennessee | 37027 | United States | ||
| NHC At The Trace |
Deidentified data may be shared, per written request, upon study completion and all final analyses
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Study participants were recruited from memory care units at two assisted living facilities in Nashville, TN.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant withdrew consent prior to completing baseline data collection and is therefore excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed the intervention protocol (medication review, surrogate interview, and provider conversation). | Posted | Median | Inter-Quartile Range | Medications | 30 days |
|
All adverse events including serious adverse events and all-cause mortality were continuously monitored from participant enrollment through final follow-up 90-days after intervention completion.
The study used NIH/NIA definition for adverse and serious adverse events. Serious adverse events included hospitalization and death. Non-serious adverse events were defined as emergency room visits, which did not lead to a subsequent hospitalization. Data for all unplanned healthcare utilization and death are reported here regardless of cause or study-relatedness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kim, DNP, GNP-BC | Vanderbilt University School of Nursing | 615-936-0739 | jennifer.kim@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2024 | Sep 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2024 | Aug 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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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
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| 90 days |
| Nashville |
| Tennessee |
| 37221 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Brief Interview for Mental Status (BIMS) | The BIMS is a standardized assessment to screen for cognitive impairment with a score range of 0-15. A total score of 0-7 represents severe impairment, 8-12 moderate impairment, and 13-15 cognitively intact. | Median | Inter-Quartile Range | units on a scale |
|
| Charlson Comorbidity Index (CCI) | The Charlson Comorbidity Index is calculated by summing the weights of all comorbid conditions documented in the participant's medical record. There is an additional 1 point increase in score for every decade starting at age 50. The age adjusted score ranges from 0-31 with higher scores indicating more comorbid illness. | Median | Inter-Quartile Range | units on a scale |
|
| Total Number of Medications | The number of medications a participant takes. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications. | Median | Inter-Quartile Range | Medications |
|
| Anticholinergic & Sedative Drug Burden Index | A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic & Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic & Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome). | Median | Inter-Quartile Range | units 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. | All participants who completed and the entire intervention protocol (medication review, surrogate interview, and provider conversation). | Posted | Median | Inter-Quartile Range | Medications | 60 days |
|
|
|
| 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. | All participants who completed the entire intervention protocol (medication review, surrogate interview, and provider conversation). | Posted | Median | Inter-Quartile Range | Medications | 90 days |
|
|
|
| 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). | All participants who completed the entire intervention protocol | Posted | Median | Inter-Quartile Range | score on a scale | Enrollment |
|
|
|
| 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). | All participants who completed the intervention protocol | Posted | Median | Inter-Quartile Range | score on a scale | 90 days |
|
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|
| 1 |
| 18 |
| 3 |
| 18 |
| 7 |
| 18 |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Mental Status Change | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D001523 | Mental Disorders |