Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Total number of medications |
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. |
baseline |
|
| Primary |
Total number of medications |
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. |
SNF discharge--within approximately 30 days after enrollment |
|
| Primary |
Total number of medications |
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. |
post-SNF discharge 7 days |
|
| Primary |
Total number of medications |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Cognitive impairment (BIMS) |
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. |
baseline |
|
| Secondary |
Functional Health Status (VES-13) |
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). |
baseline |
|
| Secondary |
Delirium (BCAM) |
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. |
baseline |
|
| Secondary |
Unplanned Healthcare Utilization |
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. |
SNF discharge--within approximately 30 days after enrollment |
|
| Secondary |
Depression (PHQ-9) |
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). |
baseline |
|
| Secondary |
Adverse Drug Withdrawal Events (composite) |
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). |
baseline |
|
| Secondary |
Urinary incontinence (ICIQ-UI SF) |
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. |
baseline |
|
| Secondary |
Health Status: Long-Term Care, Hospice, or Death |
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. |
SNF discharge--within approximately 30 days after enrollment |
|
| Secondary |
Unintentional weight loss (DETERMINE) |
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. |
baseline |
|
| Secondary |
Pain (Brief Pain Inventory-short form) |
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. |
baseline |
|
| Secondary |
Falls |
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. |
baseline |
|
| Secondary |
Pressure ulcers |
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. |
baseline |
|
| Secondary |
Drug Burden Index (DBI) |
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. |
time of randomization--within 1 day of baseline |
|
| Secondary |
Medication adherence (ARMS) |
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. |
baseline |
|
| Secondary |
Cognitive impairment (BIMS) |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Cognitive impairment (BIMS) |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Depression (PHQ-9) |
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). |
post-SNF discharge 7 days |
|
| Secondary |
Depression (PHQ-9) |
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). |
post-SNF discharge 90 days |
|
| Secondary |
Drug Burden Index (DBI) |
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. |
hospital discharge--within approximately 14 days after enrollment |
|
| Secondary |
Urinary incontinence (ICIQ-UI SF) |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Drug Burden Index (DBI) |
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. |
SNF discharge--within approximately 30 days after enrollment |
|
| Secondary |
Urinary incontinence (ICIQ-UI SF) |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Drug Burden Index (DBI) |
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. |
90-day follow-up |
|
| Secondary |
Unintentional weight loss (DETERMINE) |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Medication adherence (ARMS) |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Unintentional weight loss (DETERMINE) |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Medication adherence (ARMS) |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Pain (Brief Pain Inventory-short form) |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Functional Health Status (VES-13) |
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). |
post-SNF discharge 7 days |
|
| Secondary |
Pain (Brief Pain Inventory-short form) |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Functional Health Status (VES-13) |
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). |
post-SNF discharge 90 days |
|
| Secondary |
Falls |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Unplanned Healthcare Utilization |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Falls |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Unplanned Healthcare Utilization |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Pressure ulcers |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Pressure ulcers |
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. |
post-SNF discharge 90 days |
|
| Secondary |
Adverse Drug Withdrawal Events (composite) |
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). |
SNF discharge--within approximately 30 days after enrollment |
|
| Secondary |
Adverse Drug Withdrawal Events (composite) |
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). |
post-SNF discharge 7 days |
|
| Secondary |
Adverse Drug Withdrawal Events (composite) |
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). |
post-SNF discharge 90 days |
|
| Secondary |
Health Status: Long-Term Care, Hospice, or Death |
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. |
post-SNF discharge 7 days |
|
| Secondary |
Health Status: Long-Term Care, Hospice, or Death |
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. |
post-SNF discharge 90 days |
|
