Drug Reduction in Older Patients: The DROP Trial (DROP)

• ClinicalTrials.gov Identifier: NCT03722017
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Last Update Posted: April 10, 2023
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

Anticipated Impact on Veterans Healthcare: Polypharmacy, defined as more than five medications, and hyperpolypharmacy, defined as more than 10 medications, are both common in older patients discharged to nursing homes for short stays. Several recent studies demonstrate the occurrence and potential inappropriateness of polypharmacy among older patients in both VA and non-VA healthcare settings. Other studies have shown that polypharmacy can lead to many harmful events among older community-dwelling and hospitalized populations including decreased medication taking, increased harm due to medications, and increased health care use and costs. Polypharmacy and a ways to measure drug burden have additionally been found to be associated with the development of the following geriatric syndromes: mild dementia, delirium, falls, loss of urine, and unintentional weight loss. The investigators' innovative, patient-centered Drug Reduction in Older Patients (DROP) procedure has significant potential to impact the health of a large population of older Veterans who are vulnerable to poor health outcomes. It is during hospitalization and nursing home care that older patients often acquire new geriatric syndromes and medications and, thus, when deprescribing actions should be initiated by VA care providers. In addition, the clinical care provided during the hospital and SNF stays allows the effects of medication changes to be more closely monitored for safety relative to when the Veteran is at home.

Project Objectives: The proposed randomized, controlled trial will evaluate the effects of procedures to reduce medications (DROP) among hospitalized older Veterans discharged to nursing homes using an hybrid study design to inform future efforts to spread it across VA.

Project Background/Rationale: Patients discharged to nursing homes for short stays represent the largest group of Medicare beneficiaries discharged to post-hospital services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a VA-funded Quality Improvement Award and a Centers for Medicare and Medicaid Services (CMS) Innovation Award, both of which provide strong results related to the occurrence 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 and pilot-tested a patient-centered deprescribing set of procedures combined with standardized questions for eight geriatric syndromes to be implemented in the hospital and monitored during the nursing home stay.

Project Methods: The investigators propose an innovative hybrid study design that will be conducted in one VA hospital. The goal of the proposed DROP intervention is to safely deprescribe medications, as defined by reducing doses or stopping medications, based on a combination of clinical criteria and Veteran preferences. This randomized, controlled trial conducted over three years will evaluate the effects of this hospital-based intervention on medication use, geriatric syndromes, and health status across Veterans' care transitions from the hospital to nursing home to home to include a 90-day follow-up period after leaving the nursing home. The hypothesis is that reducing medications for older Veterans will favorably impact geriatric syndromes. Additionally, the investigators aim to understand Veteran, both VA and non-VA provider and system-level factors that help or hinder how well the deprescribing procedures are implemented to inform future clinical uptake and dissemination throughout the VA.

Condition or disease	Intervention/treatment	Phase
Geriatric Assessment; Frail Elderly; Skilled Nursing Facilities; Patient-centered Care	Other: Deprescribing intervention	Not Applicable

Detailed Description:

Note: We have resumed face to face enrollment for non-COVID patients as of 8/17/20. COVID+ patients are being approached by phone.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

The investigators will ascertain for each medication: (1) Indication; (2) Deprescribing rationale (i.e., stopping or reducing dose) for each medication.

Deprescribing Recommendations will be specified as: (1) Stop prior to hospital discharge, no monitoring; (2) Stop prior to hospital discharge with monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until stopped; (5) Reduce to lower dose without monitoring; (6) Reduce to lower dose with monitoring. Deprescribing will begin prior to hospital discharge.

The investigators will incorporate Veteran preferences, communicate with all providers involved in prescribing, create final deprescribing actions, and do enhanced hospital discharge communication.

• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The investigators and outcomes assessors (study personnel) will be masked as to which study arm patients below. The participant and providers involved in their care will not be masked to the intervention, as there is participation of both groups in the deprescribing protocol discussions.
• Primary Purpose: Treatment
• Official Title: Drug Reduction in Older Patients: The DROP Trial
• Actual Study Start Date: October 7, 2019
• Actual Primary Completion Date: March 31, 2023
• Actual Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control--usual care; Medication History: All participants / surrogates will receive a structured interview and chart review by the study Pharmacist or Nurse Practitioner at enrollment to determine: Medications: Medications will include ANY medication with the potential for continuation at the time of hospital discharge to include pre-hospital medications, [OTC medications] and active in-hospital medications. Pre-hospital [and OTC] medications will be confirmed by Veteran/surrogate interview and pharmacy refills. If a Veteran is admitted from SNF (short-term stay), the investigators will request a copy of the Medication Administration Record (MAR) for the past 30 days. Current medications will be defined as those taken within 30 days prior to the index (enrollment) hospitalization event.
Experimental: Intervention--deprescribing protocol; In addition to a medication history, a study Pharmacist or Nurse Practitioner will review the reconciled total enrollment medication list. The following information will be ascertained for each medication: (1) Medication Indication; and, (2) Deprescribing rationale: Rationales for deprescribing (i.e., stopping or reducing dose) will be assessed for each medication. Deprescribing Recommendations: For each medication recommended for deprescribing, the deprescribing action will be specified as: (1) Stop prior to hospital discharge without need for monitoring; (2) Stop prior to hospital discharge with symptoms/physiologic monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until medication is stopped; (5) Reduce to lower dose without need for monitoring; (6) Reduce to lower dose with symptoms/physiologic monitoring.	Other: Deprescribing intervention; In addition to a medication history, a study Pharmacist or Nurse Practitioner will review the reconciled total enrollment medication list. The following information will be ascertained for each medication: (1) Medication Indication; and, (2) Deprescribing rationale: Rationales for deprescribing (i.e., stopping or reducing dose) will be assessed for each medication. Deprescribing Recommendations: For each medication recommended for deprescribing, the deprescribing action will be specified as: (1) Stop prior to hospital discharge without need for monitoring; (2) Stop prior to hospital discharge with symptoms/physiologic monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until medication is stopped; (5) Reduce to lower dose without need for monitoring; (6) Reduce to lower dose with symptoms/physiologic monitoring.

Outcome Measures

Primary Outcome Measures :

1. Total number of medications [ Time Frame: baseline ]
   Data sources will include the hospital medical record, Veteran/surrogate interview, pharmacy refill records, and SNF medical record at the point of discharge. The investigators will include oral, intravenous, intramuscular, ophthalmologic and over-the-counter medications. Both routine and as needed medications will be included.
2. Total number of medications [ Time Frame: SNF discharge--within approximately 30 days after enrollment ]
   Data sources will include the hospital medical record, Veteran/surrogate interview, pharmacy refill records, and SNF medical record at the point of discharge. The investigators will include oral, intravenous, intramuscular, ophthalmologic and over-the-counter medications. Both routine and as needed medications will be included.
3. Total number of medications [ Time Frame: post-SNF discharge 7 days ]
   Data sources will include the hospital medical record, Veteran/surrogate interview, pharmacy refill records, and SNF medical record at the point of discharge. The investigators will include oral, intravenous, intramuscular, ophthalmologic and over-the-counter medications. Both routine and as needed medications will be included.
4. Total number of medications [ Time Frame: post-SNF discharge 90 days ]
   Data sources will include the hospital medical record, Veteran/surrogate interview, pharmacy refill records, and SNF medical record at the point of discharge. The investigators will include oral, intravenous, intramuscular, ophthalmologic and over-the-counter medications. Both routine and as needed medications will be included.

Secondary Outcome Measures :

1. Cognitive impairment (BIMS) [ Time Frame: baseline ]
   Cognitive Impairment and Delirium: The Brief Interview for Mental Status (BIMS) is a short, validated assessment of cognitive impairment with a total score range from 0 to 15 (0-7: severe impairment; 8-12: moderate impairment; 13-15: cognitively intact).The BIMS is part of a required assessment for all SNF patients.
2. Functional Health Status (VES-13) [ Time Frame: baseline ]
   Vulnerable Elders Survey (VES-13) is a functional measure of health status employing 13 items that assesses a patient's cognitive, physical and self-care activities and includes an item for self-rated health status. Scores range from 1 (low risk for health deterioration) to 10 (high risk for health deterioration).
3. Delirium (BCAM) [ Time Frame: baseline ]
   The Brief Confusion Assessment Method (BCAM) is a brief screening tool for delirium and has been validated among hospitalized, elderly patients. However, the BCAM is not conducive to a telephone interview so this assessment will only be conducted prior to hospital discharge. The scoring is either positive or negative and depends on whether symptoms had acute onset or fluctuating course, the presence of inattention, an altered level of consciousness, and disorganized thinking. Patients are B-CAM positive, i.e. delirium present, if they have an altered mental status or fluctuating course and inattention, and either altered level of consciousness or disorganized thinking. Those not meeting the criteria are B-CAM negative.
4. Unplanned Healthcare Utilization [ Time Frame: SNF discharge--within approximately 30 days after enrollment ]
   The investigators will contact the patient/surrogate weekly during their SNF stay to track their status and follow-up at 7 and 90 days via telephone after SNF discharge. The presence or absence of unplanned utilization (ED visit or hospitalization) to date will be recorded.
5. Depression (PHQ-9) [ Time Frame: baseline ]
   The Patient Health Questionnaire (PHQ-9) is a validated tool to assess depression symptoms and severity. It is routinely used in the SNF care setting as part of required assessments. Each item is scored from 0 ("not at all") to 3 ("nearly every day") to yield a total score range from 0 (no depressive symptoms) to 27 (severe depression).
6. Adverse Drug Withdrawal Events (composite) [ Time Frame: baseline ]
   Any unplanned healthcare utilization event (i.e. hospitalization, ER or urgent care visit) will be assessed by research staff for ADWEs. Clinician-adjudicators will determine if an unplanned healthcare utilization is potentially related to medication withdrawal (i.e., ADWE). They will review the patient's medical record for each incident using the 10-question Drug Withdrawal Probability Scale, a scale based on the Naranjo algorithm. ADWE will be coded as definite (>8), probable (5-8), possible (1-4), and doubtful (<1). For all ADWEs, the physicians will then determine whether it was avoidable by any change in management. Severity will be judged using two definitions: 1) "serious," "life-threatening," or "fatal," using established definitions; and, 2) serious ADEs as defined by the FDA (i.e., any event due to a drug that causes death, requires or prolongs hospitalization, is permanently disabling, life-threatening, or requires intervention to prevent permanent impairment or damage).
7. Urinary incontinence (ICIQ-UI SF) [ Time Frame: baseline ]
   The International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)consists of four items that assess the symptoms, frequency and impact of urinary incontinence on quality of life. The sum of 3 Likert scale questions determines the overall score, ranging from 0 to 18 with higher scores reflecting more impact on quality of life.
8. Health Status: Long-Term Care, Hospice, or Death [ Time Frame: SNF discharge--within approximately 30 days after enrollment ]
   The investigators will contact the patient/surrogate weekly during their SNF stay to track their status and follow-up at 7 and 90 days via telephone after SNF discharge to ask about entry into long-term care, hospice, or if the patient died. Presence or absence of one of these destinations is recorded.
9. Unintentional weight loss (DETERMINE) [ Time Frame: baseline ]
   The investigators will use a structured interview to assess recent changes in weight and/or appetite and the 10-item "Determine Your Nutritional Health checklist", which yields a total nutritional risk score of: 0-2 ("low"), 3-5 ("moderate"), or > 6 ("high"). The DETERMINE checklist has been validated in a longitudinal study of community-dwelling older adults.
10. Pain (Brief Pain Inventory-short form) [ Time Frame: baseline ]
    Pain will be assessed using the Brief Pain Inventory (BPI) Short-Form, which is a validated instrument for assessing pain location, severity, and interference with daily activities among older adults. Pain severity and impact on debility is based on 11 questions wherein participants use a 0 (no pain) to 10 (worse pain imaginable) scale to rate their pain in the last 24-hours under four conditions: at its worst, at its least, on average, and now. The pain severity score is calculated Pain is measured in the SNF and hospital settings using the same 0-10 scale. Severity and debility scores are averaged and reported on the 0 to 10 scale.
11. Falls [ Time Frame: baseline ]
    Falls in the three months prior to hospitalization (frequency = 0, 1 or 2 or more) will be abstracted from the hospital medical record at baseline and confirmed via direct interview with the Veteran and/or surrogate at baseline followed by telephone interviews at 7 and 90-days post SNF discharge.
12. Pressure ulcers [ Time Frame: baseline ]
    The presence of pressure ulcers (presence or absence) and stage (1 - 4, unstageable) will be abstracted from the hospital medical record at baseline and confirmed via direct interview with the Veteran and/or surrogate at baseline followed by telephone interviews at 7 and 90-days post SNF discharge.
13. Drug Burden Index (DBI) [ Time Frame: time of randomization--within 1 day of baseline ]
    A DBI score will be calculated for each relevant medication. The drug burden is the sum of each individual anticholinergic/sedative prescribed daily dose divided by the sum of the minimum effective dose (as estimated by the FDA minimum recommended dose) and the Veteran's daily dose. The range is 0 to 1 for each medication, with higher scores indicating a higher burden. The DBI includes over-the-counter medications. Importantly, the DBI captures reductions in dose, even when total number of medications may not be reduced.
14. Medication adherence (ARMS) [ Time Frame: baseline ]
    The investigators will administer the 12-item Adherence to Refills and Medication Scale (ARMS) to assess medication adherence at baseline, 7 and 90 days post SNF discharge. Response options are on a 4-point Likert scale ranging from "none of the time" to "all of the time". The scores range from 12 to 34, with lower scores indicating better adherence.
15. Cognitive impairment (BIMS) [ Time Frame: post-SNF discharge 7 days ]
    Cognitive Impairment and Delirium: The Brief Interview for Mental Status (BIMS) is a short, validated assessment of cognitive impairment with a total score range from 0 to 15 (0-7: severe impairment; 8-12: moderate impairment; 13-15: cognitively intact).The BIMS is part of a required assessment for all SNF patients.
16. Cognitive impairment (BIMS) [ Time Frame: post-SNF discharge 90 days ]
    Cognitive Impairment and Delirium: The Brief Interview for Mental Status (BIMS) is a short, validated assessment of cognitive impairment with a total score range from 0 to 15 (0-7: severe impairment; 8-12: moderate impairment; 13-15: cognitively intact).The BIMS is part of a required assessment for all SNF patients.
17. Depression (PHQ-9) [ Time Frame: post-SNF discharge 7 days ]
    The Patient Health Questionnaire (PHQ-9) is a validated tool to assess depression symptoms and severity. It is routinely used in the SNF care setting as part of required assessments. Each of nine questions are scored from 0 ("not at all") to 3 ("nearly every day") to yield a total score range from 0 (no depressive symptoms) to 27 (severe depression).
18. Depression (PHQ-9) [ Time Frame: post-SNF discharge 90 days ]
    The Patient Health Questionnaire (PHQ-9) is a validated tool to assess depression symptoms and severity. It is routinely used in the SNF care setting as part of required assessments. Each of nine questions are scored from 0 ("not at all") to 3 ("nearly every day") to yield a total score range from 0 (no depressive symptoms) to 27 (severe depression).
19. Drug Burden Index (DBI) [ Time Frame: hospital discharge--within approximately 14 days after enrollment ]
    A DBI score will be calculated for each relevant medication. The drug burden is the sum of each individual anticholinergic/sedative prescribed daily dose divided by the sum of the minimum effective dose (as estimated by the FDA minimum recommended dose) and the Veteran's daily dose. The range is 0 to 1 for each medication, with higher scores indicating a higher burden. The DBI includes over-the-counter medications. Importantly, the DBI captures reductions in dose, even when total number of medications may not be reduced.
20. Urinary incontinence (ICIQ-UI SF) [ Time Frame: post-SNF discharge 7 days ]
    The International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)consists of four items that assess the symptoms, frequency and impact of urinary incontinence on quality of life. The sum of 3 Likert scale questions determines the overall score, ranging from 0 to 18 with higher scores reflecting more impact on quality of life.
21. Drug Burden Index (DBI) [ Time Frame: SNF discharge--within approximately 30 days after enrollment ]
    A DBI score will be calculated for each relevant medication. The drug burden is the sum of each individual anticholinergic/sedative prescribed daily dose divided by the sum of the minimum effective dose (as estimated by the FDA minimum recommended dose) and the Veteran's daily dose. The range is 0 to 1 for each medication, with higher scores indicating a higher burden. The DBI includes over-the-counter medications. Importantly, the DBI captures reductions in dose, even when total number of medications may not be reduced.
22. Urinary incontinence (ICIQ-UI SF) [ Time Frame: post-SNF discharge 90 days ]
    The International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)consists of four items that assess the symptoms, frequency and impact of urinary incontinence on quality of life. The sum of 3 Likert scale questions determines the overall score, ranging from 0 to 18 with higher scores reflecting more impact on quality of life.
23. Drug Burden Index (DBI) [ Time Frame: 90-day follow-up ]
    A DBI score will be calculated for each relevant medication. The drug burden is the sum of each individual anticholinergic/sedative prescribed daily dose divided by the sum of the minimum effective dose (as estimated by the FDA minimum recommended dose) and the Veteran's daily dose. The range is 0 to 1 for each medication, with higher scores indicating a higher burden. The DBI includes over-the-counter medications. Importantly, the DBI captures reductions in dose, even when total number of medications may not be reduced.
24. Unintentional weight loss (DETERMINE) [ Time Frame: post-SNF discharge 7 days ]
    The investigators will use a structured interview to assess recent changes in weight and/or appetite and the 10-item "Determine Your Nutritional Health checklist", which yields a total nutritional risk score of: 0-2 ("low"), 3-5 ("moderate"), or > 6 ("high"). The DETERMINE checklist has been validated in a longitudinal study of community-dwelling older adults.
25. Medication adherence (ARMS) [ Time Frame: post-SNF discharge 7 days ]
    The investigators will administer the 12-item Adherence to Refills and Medication Scale (ARMS) to assess medication adherence at baseline, 7 and 90 days post SNF discharge. Example questions include: "How often do you forget to take your medicines?"; "How often do you miss taking your medicines when you feel better?" Response options are on a 4-point Likert scale ranging from "none of the time" to "all of the time". The scores range from 12 to 34, with lower scores indicating better adherence.
26. Unintentional weight loss (DETERMINE) [ Time Frame: post-SNF discharge 90 days ]
    The investigators will use a structured interview to assess recent changes in weight and/or appetite and the 10-item "Determine Your Nutritional Health checklist", which yields a total nutritional risk score of: 0-2 ("low"), 3-5 ("moderate"), or > 6 ("high"). The DETERMINE checklist has been validated in a longitudinal study of community-dwelling older adults.
27. Medication adherence (ARMS) [ Time Frame: post-SNF discharge 90 days ]
    The investigators will administer the 12-item Adherence to Refills and Medication Scale (ARMS) to assess medication adherence at baseline, 7 and 90 days post SNF discharge. Example questions include: "How often do you forget to take your medicines?"; "How often do you miss taking your medicines when you feel better?" Response options are on a 4-point Likert scale ranging from "none of the time" to "all of the time". The scores range from 12 to 34, with lower scores indicating better adherence.
28. Pain (Brief Pain Inventory-short form) [ Time Frame: post-SNF discharge 7 days ]
    Pain will be assessed using the Brief Pain Inventory (BPI) Short-Form, which is a validated instrument for assessing pain location, severity, and interference with daily activities among older adults. Pain severity and impact on debility is based on 11 questions wherein participants use a 0 (no pain) to 10 (worse pain imaginable) scale to rate their pain in the last 24-hours under four conditions: at its worst, at its least, on average, and now. The pain severity score is calculated Pain is measured in the SNF and hospital settings using the same 0-10 scale. Severity and debility scores are averaged and reported on the 0 to 10 scale.
29. Functional Health Status (VES-13) [ Time Frame: post-SNF discharge 7 days ]
    Vulnerable Elders Survey (VES-13) is a functional measure of health status employing 13 items that assesses a patient's cognitive, physical and self-care activities and includes an item for self-rated health status. Scores range from 1 (low risk for health deterioration) to 10 (high risk for health deterioration).
30. Pain (Brief Pain Inventory-short form) [ Time Frame: post-SNF discharge 90 days ]
    Pain will be assessed using the Brief Pain Inventory (BPI) Short-Form, which is a validated instrument for assessing pain location, severity, and interference with daily activities among older adults. Pain severity and impact on debility is based on 11 questions wherein participants use a 0 (no pain) to 10 (worse pain imaginable) scale to rate their pain in the last 24-hours under four conditions: at its worst, at its least, on average, and now. The pain severity score is calculated Pain is measured in the SNF and hospital settings using the same 0-10 scale. Severity and debility scores are averaged and reported on the 0 to 10 scale.
31. Functional Health Status (VES-13) [ Time Frame: post-SNF discharge 90 days ]
    Vulnerable Elders Survey (VES-13) is a functional measure of health status employing 13 items that assesses a patient's cognitive, physical and self-care activities and includes an item for self-rated health status. Scores range from 1 (low risk for health deterioration) to 10 (high risk for health deterioration).
32. Falls [ Time Frame: post-SNF discharge 7 days ]
    Falls in the three months prior to hospitalization (frequency = 0, 1 or 2 or more) will be abstracted from the hospital medical record at baseline and confirmed via direct interview with the Veteran and/or surrogate at baseline followed by telephone interviews at 7 and 90-days post SNF discharge.
33. Unplanned Healthcare Utilization [ Time Frame: post-SNF discharge 7 days ]
    The investigators will contact the patient/surrogate weekly during their SNF stay to track their status and follow-up at 7 and 90 days via telephone after SNF discharge. The presence or absence of unplanned utilization (ED visit or hospitalization) to date will be recorded.
34. Falls [ Time Frame: post-SNF discharge 90 days ]
    Falls in the three months prior to hospitalization (frequency = 0, 1 or 2 or more) will be abstracted from the hospital medical record at baseline and confirmed via direct interview with the Veteran and/or surrogate at baseline followed by telephone interviews at 7 and 90-days post SNF discharge.
35. Unplanned Healthcare Utilization [ Time Frame: post-SNF discharge 90 days ]
    The investigators will contact the patient/surrogate weekly during their SNF stay to track their status and follow-up at 7 and 90 days via telephone after SNF discharge. The presence or absence of unplanned utilization (ED visit or hospitalization) to date will be recorded.
36. Pressure ulcers [ Time Frame: post-SNF discharge 7 days ]
    The presence of pressure ulcers (presence or absence) and stage (1 - 4, unstageable) will be abstracted from the hospital medical record at baseline and confirmed via direct interview with the Veteran and/or surrogate at baseline followed by telephone interviews at 7 and 90-days post SNF discharge.
37. Pressure ulcers [ Time Frame: post-SNF discharge 90 days ]
    The presence of pressure ulcers (presence or absence) and stage (1 - 4, unstageable) will be abstracted from the hospital medical record at baseline and confirmed via direct interview with the Veteran and/or surrogate at baseline followed by telephone interviews at 7 and 90-days post SNF discharge.
38. Adverse Drug Withdrawal Events (composite) [ Time Frame: SNF discharge--within approximately 30 days after enrollment ]
    Any unplanned healthcare utilization event (i.e. hospitalization, ER or urgent care visit) will be assessed by research staff for ADWEs. Clinician-adjudicators will determine if an unplanned healthcare utilization is potentially related to medication withdrawal (i.e., ADWE). They will review the patient's medical record for each incident using the 10-question Drug Withdrawal Probability Scale, a scale based on the Naranjo algorithm. ADWE will be coded as definite (>8), probable (5-8), possible (1-4), and doubtful (<1). For all ADWEs, the physicians will then determine whether it was avoidable by any change in management. Severity will be judged using two definitions: 1) "serious," "life-threatening," or "fatal," using established definitions; and, 2) serious ADEs as defined by the FDA (i.e., any event due to a drug that causes death, requires or prolongs hospitalization, is permanently disabling, life-threatening, or requires intervention to prevent permanent impairment or damage).
39. Adverse Drug Withdrawal Events (composite) [ Time Frame: post-SNF discharge 7 days ]
    Any unplanned healthcare utilization event (i.e. hospitalization, ER or urgent care visit) will be assessed by research staff for ADWEs. Clinician-adjudicators will determine if an unplanned healthcare utilization is potentially related to medication withdrawal (i.e., ADWE). They will review the patient's medical record for each incident using the 10-question Drug Withdrawal Probability Scale, a scale based on the Naranjo algorithm. ADWE will be coded as definite (>8), probable (5-8), possible (1-4), and doubtful (<1). For all ADWEs, the physicians will then determine whether it was avoidable by any change in management. Severity will be judged using two definitions: 1) "serious," "life-threatening," or "fatal," using established definitions; and, 2) serious ADEs as defined by the FDA (i.e., any event due to a drug that causes death, requires or prolongs hospitalization, is permanently disabling, life-threatening, or requires intervention to prevent permanent impairment or damage).
40. Adverse Drug Withdrawal Events (composite) [ Time Frame: post-SNF discharge 90 days ]
    Any unplanned healthcare utilization event (i.e. hospitalization, ER or urgent care visit) will be assessed by research staff for ADWEs. Clinician-adjudicators will determine if an unplanned healthcare utilization is potentially related to medication withdrawal (i.e., ADWE). They will review the patient's medical record for each incident using the 10-question Drug Withdrawal Probability Scale, a scale based on the Naranjo algorithm. ADWE will be coded as definite (>8), probable (5-8), possible (1-4), and doubtful (<1). For all ADWEs, the physicians will then determine whether it was avoidable by any change in management. Severity will be judged using two definitions: 1) "serious," "life-threatening," or "fatal," using established definitions; and, 2) serious ADEs as defined by the FDA (i.e., any event due to a drug that causes death, requires or prolongs hospitalization, is permanently disabling, life-threatening, or requires intervention to prevent permanent impairment or damage).
41. Health Status: Long-Term Care, Hospice, or Death [ Time Frame: post-SNF discharge 7 days ]
    The investigators will contact the patient/surrogate weekly during their SNF stay to track their status and follow-up at 7 and 90 days via telephone after SNF discharge to ask about entry into long-term care, hospice, or if the patient died. Presence or absence of one of these destinations is recorded.
42. Health Status: Long-Term Care, Hospice, or Death [ Time Frame: post-SNF discharge 90 days ]
    The investigators will contact the patient/surrogate weekly during their SNF stay to track their status and follow-up at 7 and 90 days via telephone after SNF discharge to ask about entry into long-term care, hospice, or if the patient died. Presence or absence of one of these destinations is recorded.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Tennessee

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States, 37212-2637

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Amanda S Mixon, MD MSPH MS; Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03722017
• Other Study ID Numbers: IIR 17-033
• First Posted: October 26, 2018
• Last Update Posted: April 10, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The investigators plan to share our protocol and a de-identified anonymized dataset.
• Supporting Materials: Study Protocol
• Time Frame: Data will become available Oct 31, 2021 (study conclusion).
• Access Criteria: A de-identified dataset will be shared upon the finalization of a written agreement between VA Tennessee Valley Healthcare System and the requesting party. This agreement will detail use of the data and prohibit the re-identification of dataset subjects. Our study team will evaluate requests for datasets.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

deprescriptions; polypharmacy; potentially inappropriate medication; medication adherence