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

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ClinicalTrials.gov Identifier: NCT03722017
Recruitment Status : Not yet recruiting
First Posted : October 26, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

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.





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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722017


Contacts
Layout table for location contacts
Contact: Amanda S Mixon, MD (615) 936-3710 amanda.mixon@va.gov
Contact: Sandra F Simmons, BA MA PhD (615) 343-6729 Sandra.Simmons@Vanderbilt.edu

Locations
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United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Not yet recruiting
Nashville, Tennessee, United States, 37212-2637
Contact: Donald H Rubin, MD    615-873-6977    donald.rubin@va.gov   
Principal Investigator: Amanda S Mixon, MD         
Sub-Investigator: Sandra F Simmons, BA MA PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Amanda S Mixon, MD Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03722017     History of Changes
Other Study ID Numbers: IIR 17-033
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
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.

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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