Care Transitions, Geriatric Syndromes, Polypharmacy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALShed-Meds: A Patient-Centered Deprescribing Intervention
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.
Sponsors
National Institute on Aging (NIA)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Medications | Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC | The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shed-Meds: A Patient-Centered Deprescribing Intervention Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay.
Shed-Meds: A Patient-Centered Deprescribing Intervention: 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. | 186 |
| Control Group Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. | 186 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 11 |
| Overall Study | Hospital Discharge to Non-Partner PAC or Non- PAC Location | 24 | 29 |
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | Transfer to Hospice Care | 19 | 14 |
| Overall Study | Withdrawal by Subject | 16 | 12 |
Baseline characteristics
| Characteristic | Total | Control Group | Shed-Meds: A Patient-Centered Deprescribing Intervention |
|---|---|---|---|
| Adherence to Refills and Medications Scale (ARMS) | 15 score on a scale | 15 score on a scale | 14 score on a scale |
| Age, Continuous | 76.8 years | 76.9 years | 76.4 years |
| Anticholinergic and Sedative Drug Burden Index | 4.2 score on a scale | 4.5 score on a scale | 4.1 score on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 368 Participants | 182 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants | 30 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 313 Participants | 155 Participants | 158 Participants |
| Region of Enrollment United States | 372 participants | 186 participants | 186 participants |
| Sex: Female, Male Female | 229 Participants | 112 Participants | 117 Participants |
| Sex: Female, Male Male | 143 Participants | 74 Participants | 69 Participants |
| Total Number of Medications at Enrollment | 23.0 Medications | 23.0 Medications | 24.0 Medications |
| Vulnerable Elders Survey 13 (VES-13) | 7 score on a scale | 7 score on a scale | 7 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 186 | 11 / 186 |
| other Total, other adverse events | 12 / 186 | 7 / 186 |
| serious Total, serious adverse events | 59 / 186 | 76 / 186 |
Outcome results
Primary
Total Number of Medications
The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications.
Time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC
Population: Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The number analyzed below for each time point reflects the number of participants who completed that particular study time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Total Number of Medications | 90 Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment) | 12 Medications |
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Total Number of Medications | Hospital Discharge (approximately 3 days after study enrollment) | 15 Medications |
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Total Number of Medications | Post-Acute Care Discharge (approximately 31 days after study enrollment) | 13 Medications |
| Control Group | Total Number of Medications | Hospital Discharge (approximately 3 days after study enrollment) | 16 Medications |
| Control Group | Total Number of Medications | Post-Acute Care Discharge (approximately 31 days after study enrollment) | 15 Medications |
| Control Group | Total Number of Medications | 90 Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment) | 14 Medications |
Comparison: Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)p-value: 0.017Mixed Models Analysis
Comparison: Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)p-value: <0.0001Mixed Models Analysis
Comparison: Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)p-value: <0.0001Mixed Models Analysis
Secondary
Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug
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).
Time frame: Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC
Population: Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The number analyzed below for each time point reflects the number of participants who completed that particular study time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | Hospital Discharge (approximately 3 days after study enrollment) | 2.4 score on a scale |
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | Post-Acute Care Discharge (approximately 31 days after study enrollment) | 2.2 score on a scale |
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | 90-Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment) | 2.0 score on a scale |
| Control Group | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | Hospital Discharge (approximately 3 days after study enrollment) | 2.9 score on a scale |
| Control Group | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | Post-Acute Care Discharge (approximately 31 days after study enrollment) | 2.7 score on a scale |
| Control Group | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | 90-Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment) | 2.3 score on a scale |
Comparison: Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)p-value: 0.02Regression, Linear
Comparison: Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).p-value: <0.00001Regression, Linear
Comparison: Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).p-value: 0.01Regression, Linear