Drug Reduction in Older Patients: The DROP Trial

Overview and Specific Aims Polypharmacy, defined as five or more medications, is common in
older patients discharged to skilled nursing facilities (SNFs) and is associated with adverse
health outcomes. As part of a recent VA project, the investigators prospectively collected
medication data for 134 hospitalized, older Veterans. These data showed that, on average,
14.2 medications were ordered for Veterans discharged to SNF, which included 2.5 medications
newly prescribed in the hospital that met criteria for being potentially inappropriate
medications (PIMs). Moreover, 75% of these Veterans had two or more geriatric syndromes.
Geriatric syndromes are clinical conditions common in older adults such as cognitive
impairment, unintentional weight loss and falls. The co-occurrence of multiple syndromes is
associated with loss of independence and higher healthcare utilization.8 All Veterans with
polypharmacy also had one or more medications associated with geriatric syndromes. The
prevalence of polypharmacy and multiple geriatric syndromes may partially explain why these
patients often have poor health outcomes after SNF discharge. Recent data suggests that only
28% of patients discharged from SNF are living at home 100 days later, and 35% experience an
adverse drug event.

There is a dearth of evidence related to the management of multiple co-existing geriatric
syndromes, and few interventions have been implemented to reduce medications while also
monitoring health outcomes. The relationship between polypharmacy, adverse drug events and
geriatric syndromes in the VA population supports the rationale for an intervention focused
on deprescribing medications before hospital discharge. The investigators have pilot-tested a
multifaceted intervention (Drug Reduction in Older Patients, DROP) to engage patients and
providers to reduce the number and/or dose of medications prior to hospital discharge. The
proposed randomized, controlled trial is powered to evaluate the effect of this intervention
on a reduction in medications as defined by the total number of prescribed medications, the
number of PIMs, anticholinergic and sedative drug burden and the number of medications
associated with geriatric syndromes. In addition, the investigators will collect relevant
data on the prevalence and severity of geriatric syndromes and other clinical outcomes. The
investigators also will use a hybrid research design to evaluate both effectiveness and
implementation issues to better inform future adoption and sustainability. Our overarching
hypothesis is that a hospital-based intervention to safely reduce the total number of
medications represents the most feasible way to impact multiple health-related outcomes among
older Veterans. Our Specific Aims reflect the primary outcomes that are the focus of the
analyses, although the investigators also will measure secondary outcomes related to VA
healthcare utilization and patient safety:

Specific Aim 1: Implement a patient-centered deprescribing intervention (DROP) in the
hospital to reduce the total number of medications Veterans are prescribed at hospital
discharge.

Hypothesis 1a: DROP will result in a significant reduction in total medication exposure due
to discontinuations and dose reductions at hospital discharge, SNF discharge and 90-days
after SNF discharge.

Hypothesis 1b: DROP will result in a significant reduction in the number of potentially
inappropriate medications (PIMs) at hospital discharge, SNF discharge and 90-days after SNF
discharge.

Hypothesis 1c: DROP will result in a significant reduction in the anticholinergic and
sedative drug burden at hospital discharge, SNF discharge and 90-days after SNF discharge.

Hypothesis 1d: DROP will result in significantly fewer medications associated with geriatric
syndromes at hospital discharge, SNF discharge and 90-days after SNF discharge.

Specific Aim 2: Document the effects of a Veteran-centered deprescribing intervention (DROP)
on medication adherence, health status, and geriatric syndromes.

Hypothesis 2a: DROP will result in a significant improvement in medication adherence and
self-rated health status at 7 and 90 days after SNF discharge.

Hypothesis 2b: DROP will result in a lower prevalence and severity of geriatric syndromes at
7 and 90 days after SNF discharge.

Specific Aim 3: Evaluate intervention implementation to inform future adoption and
sustainability.

Aim 3a: Identify patient-level barriers and facilitators of DROP. Aim 3b: Identify VA and
Non-VA provider-level barriers and facilitators of DROP.

Aim 3c: Identify system-level factors that influence sustainability after hospital discharge.

Potential for Impact: The DROP intervention has significant potential to impact the health of
older hospitalized Veterans vulnerable to poor health outcomes. During hospitalization and
SNF care, older Veterans often acquire new geriatric syndromes and medications, exactly when
deprescribing actions should be initiated by care providers in the context of clinical
oversight. Lastly, the application of an innovative hybrid research design will allow us to
collect critical data related to both intervention effectiveness and implementation to better
inform future adoption and sustainability across the VA.

Innovation: Our study is advancing science in multiple ways:

1. The proposed study reflects one of the first controlled intervention trials designed to
improve post discharge outcomes for the high-risk population of older Veterans
transitioning from hospital to SNF to home. Healthcare costs are increasing for this
patient population, and they are at high risk for medication-associated complications
and newly acquired geriatric syndromes.

2. Although the number of medications is strongly associated with increases in geriatric
syndromes, it is unknown whether reducing medications will improve geriatric syndromes.
This trial will generate data to evaluate the impact of medication reduction on Veteran
health outcomes.

3. To date, there have been no controlled intervention trials focused on reducing the
number of medications prescribed for hospitalized patients discharged to SNF, and the
proposed intervention is one of the first to explicitly incorporate Veteran preferences
into deprescribing efforts, which is consistent with Veteran-centered care initiatives.
Moreover, our preliminary data show that incorporating patient preferences in the
intervention protocol significantly changes these clinical decisions.

4. The proposed trial will evaluate both clinical effectiveness and implementation to
inform the potential for DROP to be adopted into VA clinical practice.

Rationale for VA Study: Dr. Simmons was recently awarded an National Institute on Aging (NIA)
R01 focused on polypharmacy in hospitalized non-Veterans. The investigators summarize below
the primary differences between the two studies and our rationale for the importance of the
proposed VA study:

The Need for More Evidence: Our NIA study focuses on non-Veterans hospitalized at Vanderbilt
University Medical Center (VUMC) and discharged to a select group of SNFs that have partnered
with VUMC for post-acute care services. Unfortunately, the scope of the NIA study does not
allow us to evaluate the intervention in two separate healthcare systems with two unique
patient populations and a larger number of SNFs, to include VA Community Living Centers and
VA contract community nursing homes.

Uniqueness of the Veteran population: Our preliminary data demonstrates important differences
in older hospitalized Veterans and non-Veterans discharged to SNF. Beyond being predominately
male, older Veterans in the investigators' prior study had a higher overall prevalence of
geriatrics syndromes and were prescribed more medications at hospital discharge than
non-Veterans, particularly antidepressants and antipsychotics. Data also suggests that
Veterans may be more willing to reduce their medicines; thus, the magnitude of the
intervention effects may differ in the VA. Finally, hospitalized Veterans are discharged to a
diverse group of SNFs, many of which are located in rural communities. Unlike the
investigators' NIA study, which only includes a select group of partner SNFs predominately
located in an urban area close to Vanderbilt, the proposed study will follow Veterans from
hospital to SNF to home, irrespective of which SNF they utilize. The VA study, therefore,
will more closely mimic real-world practice. The innovative application of an
effectiveness-implementation hybrid design will further inform unique aspects of the VA
healthcare system critical to adoption.

Uniqueness of VA healthcare system: The VA healthcare system differs significantly from other
hospital systems, to include medication prescribing practices and how patients access and pay
for medications. Thus, the investigators do not expect the results of the NIA study at VUMC
to be directly translatable into the VA healthcare system. The proposed study also will yield
an understanding of Veteran and VA provider attitudes toward deprescribing and other system
factors unique to the VA that may influence intervention implementation.

Inclusion Criteria:

- Referred to SNF (per Physical Therapy and/or Social Work notes)

- Being discharged from the Nashville VA hospital from a medicine or orthopedics team

- Age > or = 50

- Have polypharmacy, as defined by > 5 medications based on pre-hospital and in-hospital
medications

- Able to self-consent or has a surrogate

Exclusion Criteria:

- Resides in long-term care

- On hospice

- Not expected to discharge within 48 hours of referral