A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/14/2018 |
| Start Date: | March 6, 2017 |
| End Date: | April 2021 |
| Contact: | Sandra F Simmons, PhD |
| Email: | Sandra.Simmons@Vanderbilt.edu |
| Phone: | 615-343-6729 |
A Randomized Controlled Trial to Deprescribe for Older Patients With Polypharmacy Transferred From the Hospital to Skilled Nursing Facilities
This randomized, controlled trial will evaluate the effects of an intervention to reduce
exposure to medications among hospitalized older adults discharged to skilled nursing
facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as
defined by dose reductions and stopped medications, based on a combination of clinical
criteria and patient preferences. The investigators will evaluate the effects of the
intervention on the total number of medications prescribed to patients at hospital and SNF
discharge and at home 90-days after SNF discharge along with the prevalence of eight
geriatric syndromes, medication adherence, and health status.
exposure to medications among hospitalized older adults discharged to skilled nursing
facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as
defined by dose reductions and stopped medications, based on a combination of clinical
criteria and patient preferences. The investigators will evaluate the effects of the
intervention on the total number of medications prescribed to patients at hospital and SNF
discharge and at home 90-days after SNF discharge along with the prevalence of eight
geriatric syndromes, medication adherence, and health status.
This randomized, controlled trial will evaluate the effects of an intervention to reduce
exposure to medications among hospitalized older adults discharged to skilled nursing
facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14
area SNFs to enroll approximately 1,300 total participants across five project years.
Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged
to post-acute care services and are a particularly high risk group for loss of independence
and other poor clinical outcomes. This investigative team recently completed a Centers for
Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data
related to the prevalence of polypharmacy and the relationship between polypharmacy and
geriatric syndromes (e.g., medications associated with falls) in this patient population.
Based on these data, the investigators developed a structured deprescribing intervention
protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric
syndromes to be implemented in the hospital and continued during the SNF stay. The goal of
the intervention is to safely deprescribe medications, as defined by dose reductions and
stopped medications, based on a combination of clinical criteria and patient preferences.
This trial will evaluate the effects of this intervention on medication exposure, medication
adherence, geriatric syndromes, and health status across the care transitions from hospital
to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching
hypothesis is that reducing medications for older patients across the continuum of care will
favorably impact geriatric syndromes.
exposure to medications among hospitalized older adults discharged to skilled nursing
facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14
area SNFs to enroll approximately 1,300 total participants across five project years.
Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged
to post-acute care services and are a particularly high risk group for loss of independence
and other poor clinical outcomes. This investigative team recently completed a Centers for
Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data
related to the prevalence of polypharmacy and the relationship between polypharmacy and
geriatric syndromes (e.g., medications associated with falls) in this patient population.
Based on these data, the investigators developed a structured deprescribing intervention
protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric
syndromes to be implemented in the hospital and continued during the SNF stay. The goal of
the intervention is to safely deprescribe medications, as defined by dose reductions and
stopped medications, based on a combination of clinical criteria and patient preferences.
This trial will evaluate the effects of this intervention on medication exposure, medication
adherence, geriatric syndromes, and health status across the care transitions from hospital
to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching
hypothesis is that reducing medications for older patients across the continuum of care will
favorably impact geriatric syndromes.
Inclusion Criteria:
- Hospitalized at Vanderbilt University Medical Center
- Medicare-eligible
- Discharged from VUMC to a post acute care facility
- Has polypharmacy as defined by > 5 medications
- Able to self-consent or has a proxy (surrogate)
- Speaks English (due to interview-based assessments)
- Primary home residence within one of 9 surrounding counties (due to home visit during
follow-up phase)
Exclusion Criteria:
- Resides in long-term care
- Is currently on hospice or otherwise has a limited life expectancy (< 6 months).
- Enrolled in a clinical drug trial
- Has Stage IV Cancer Diagnosis
- Incarcerated or homeless
- Unable to self-consent and does not have a surrogate
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sandra F Simmons, PhD
Phone: 615-343-6729
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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