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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG053264 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. The investigators will evaluate the effects of the intervention on the total number of medications prescribed to patients at hospital and SNF discharge and at home 90-days after SNF discharge along with the prevalence of eight geriatric syndromes, medication adherence, and health status.
This randomized, controlled trial will evaluate the effects of an intervention to reduce exposure to medications among hospitalized older adults discharged to skilled nursing facilities (SNFs). This study will be conducted in one university-affiliated hospital and 14 area SNFs to enroll approximately 1,300 total participants across five project years. Patients discharged to SNF represent the largest segment of Medicare beneficiaries discharged to post-acute care services and are a particularly high risk group for loss of independence and other poor clinical outcomes. This investigative team recently completed a Centers for Medicare and Medicaid Services (CMS) Innovation Award, which provides strong preliminary data related to the prevalence of polypharmacy and the relationship between polypharmacy and geriatric syndromes (e.g., medications associated with falls) in this patient population. Based on these data, the investigators developed a structured deprescribing intervention protocol ("Shed-Meds") coupled with standardized screening assessments for eight geriatric syndromes to be implemented in the hospital and continued during the SNF stay. The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. This trial will evaluate the effects of this intervention on medication exposure, medication adherence, geriatric syndromes, and health status across the care transitions from hospital to SNF to home to include a 90-day follow-up period after SNF discharge. The overarching hypothesis is that reducing medications for older patients across the continuum of care will favorably impact geriatric syndromes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Experimental | Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. |
|
| Control Group | No Intervention | Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shed-Meds: A Patient-Centered Deprescribing Intervention | Behavioral | The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Medications | The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications. | Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC |
| Measure | Description | Time Frame |
|---|---|---|
| Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic & Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic & Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra F Simmons, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36745422 | Background | Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Kripalani S, Mixon AS, Simmons SF. Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial. JAMA Intern Med. 2023 Mar 1;183(3):223-231. doi: 10.1001/jamainternmed.2022.6545. | |
| 35881109 | Background | Kim JL, Lewallen KM, Hollingsworth EK, Shah AS, Simmons SF, Vasilevskis EE. Patient-Reported Barriers and Enablers to Deprescribing Recommendations During a Clinical Trial (Shed-MEDS). Gerontologist. 2023 Mar 21;63(3):523-533. doi: 10.1093/geront/gnac100. |
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Deidentified data may be shared, per written request and completion of formal data sharing agreement approved by the institution
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| ID | Title | Description |
|---|---|---|
| FG000 | Shed-Meds: A Patient-Centered Deprescribing Intervention | Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. |
| FG001 | Control Group | Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Shed-Meds: A Patient-Centered Deprescribing Intervention | Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Medications | The number of medications a participant is taking. This includes all prescribed and over-the-counter medications and both scheduled and as-needed (PRN) medications. | Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The "number analyzed" below for each time point reflects the number of participants who completed that particular study time point. | Posted | Median | Inter-Quartile Range | Medications | Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC |
|
All adverse events including all-cause mortality and serious adverse events were continuously monitored from participant enrollment through final follow-up timepoint at 90-days following post-acute care discharge, up to 295 days.
The study used NIH/NIA definitions for adverse and serious adverse events. Serious adverse events included escalation of care to the intensive care unit (during baseline hospitalization), rehospitalization (after baseline), and death. Data for all unplanned healthcare utilizations and death are reported here regardless of cause or study-relatedness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shed-Meds: A Patient-Centered Deprescribing Intervention | Participants assigned to the intervention group will receive a clinical review of their prescribed medications by a research clinician (Pharmacist, Physician, and/or Nurse Practitioner) followed by a patient interview to assess their willingness to discontinue or reduce some of their medicines based on the clinical recommendations of the team. Hospital and out-patient providers also will be part of the deprescribing decision process. Deprescribing actions will be initiated in the hospital prior to discharge and continue through the skilled nursing facility stay. Shed-Meds: A Patient-Centered Deprescribing Intervention: The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra F Simmons, PhD, Principle Investigator | Vanderbilt University Medical Center | 615-343-6729 | sandra.simmons@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2022 | Mar 20, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2020 | Jul 8, 2021 | ICF_000.pdf |
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| Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC |
| 35164584 | Background | Hollingsworth EK, Shah AS, Shotwell MS, Simmons SF, Vasilevskis EE. Older Patient and Surrogate Attitudes Toward Deprescribing During the Transition From Acute to Post-Acute Care. J Appl Gerontol. 2022 Mar;41(3):788-797. doi: 10.1177/07334648211015756. |
| 34967444 | Background | Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Simmons SF, Vasilevskis EE. Sources of medication omissions among hospitalized older adults with polypharmacy. J Am Geriatr Soc. 2022 Apr;70(4):1180-1189. doi: 10.1111/jgs.17629. Epub 2021 Dec 30. |
| 30871561 | Result | Vasilevskis EE, Shah AS, Hollingsworth EK, Shotwell MS, Mixon AS, Bell SP, Kripalani S, Schnelle JF, Simmons SF; Shed-MEDS Team. A patient-centered deprescribing intervention for hospitalized older patients with polypharmacy: rationale and design of the Shed-MEDS randomized controlled trial. BMC Health Serv Res. 2019 Mar 14;19(1):165. doi: 10.1186/s12913-019-3995-3. |
| 38725307 | Derived | Lee JW, Hollingsworth EK, Shah AS, Szanton SL, Perrin N, Mixon AS, Vasilevskis EE, Boyd CM, Han HR, Green AR, Taylor JL, Simmons SF. Emergency department visits and hospital readmissions after a deprescribing intervention among hospitalized older adults. J Am Geriatr Soc. 2024 Jul;72(7):2038-2047. doi: 10.1111/jgs.18945. Epub 2024 May 9. |
| Death |
|
| Transfer to Hospice Care |
|
| Lost to Follow-up |
|
| BG001 | Control Group | Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Number of Medications at Enrollment | Median | Inter-Quartile Range | Medications |
|
| Anticholinergic and Sedative Drug Burden Index | A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic & Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic & Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome). | Median | Inter-Quartile Range | score on a scale |
|
| Vulnerable Elders Survey 13 (VES-13) | The Vulnerable Elders Survey 13 (VES-13) is a self-rating of functional health status, and it consists of 4 groups of questions: age, self-perceived health, difficulties to perform 6 specific activities, and difficulties to perform daily living tasks due to health concerns. The total score ranges from 0 to 10. A score >=3 was considered to show impairment (i.e., worse outcome). | The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure. | Median | Inter-Quartile Range | score on a scale |
|
| Adherence to Refills and Medications Scale (ARMS) | Trained research staff administered the Adherence to Refills and Medication Scale (ARMS). Participants indicate the extent of their adherence on a 4-point Likert-like scale. Responses range from 1="none of the time" to 4="all of the time," and are summed to produce an overall adherence score ranging from 12-48, with lower values indicating better adherence (better outcome). | The number analyzed differs from the overall group N due to missing or incomplete participant assessment data for this measure. | Median | Inter-Quartile Range | score on a scale |
|
| OG001 | Control Group | Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. |
|
|
|
| Secondary | Total Drug Burden Index (DBI): Anticholinergic and Sedative Drug | A Drug Burden Index (DBI) score is calculated for each anticholinergic and sedative medication by dividing the individual medication's prescribed daily dose by the sum of the minimum effective dose (per FDA minimum recommended dose) and the patient's daily dose. The score range for each individual medication is 0 to 1, and the Anticholinergic & Sedative DBI reported is the sum of the individual medication scores. The Anticholinergic & Sedative DBI has a minimum score of 0 and no maximum. Higher scores indicate a higher drug burden (i.e., lower score is a better outcome). | Outcomes are reported for three different study time points (Hospital Discharge, Post-Acute Care Discharge, and 90-Day Follow Up After PAC Discharge). Both the Intervention and Control groups experienced attrition at each time point. The "number analyzed" below for each time point reflects the number of participants who completed that particular study time point. | Posted | Median | Inter-Quartile Range | score on a scale | Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from PAC |
|
|
|
|
| 10 |
| 186 |
| 59 |
| 186 |
| 12 |
| 186 |
| EG001 | Control Group | Participants assigned to the control group will receive usual care as it is normally provided by the hospital and skilled nursing facility treatment teams. Research staff will monitor their prescribed medications in both care settings but not make any recommendations or changes, unless a safety issue is identified. | 11 | 186 | 76 | 186 | 7 | 186 |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Cardiac Arrhythmias | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Respiratory Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Urinary Tract Infections | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Infections - Pathogen Unspecified | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Bacterial Infections Disorders | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Renal Disorders | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Vascular Hypotensive Disorders | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Sepsis - Pathogen unspecified | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Bone & Joint Fractures | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Central Nervous System Vascular Disorders | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| General System Disorders (NEC) | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Coronary Artery Disorder | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastrointestinal Motility and Defecation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Seizures | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Bronchial Disorders (excludes neoplasms) | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Electrolyte and Fluid Balance Conditions | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Mental Disorders | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Cerebral Injuries | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Depressive Disorders | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Exocrine Pancreas Conditions | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastrointestinal Signs & Symptoms | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastrointestinal Stenosis & Obstructions | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Glucose Metabolism Disorder | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Vascular Hypertensive Disorders | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Anaemias (NEC) | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Anxiety Disorders & Symptoms | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Calcium Metabolic Disorders | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Delusion Symptoms | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Device Issues | General disorders | MedDRA (12.0) | Systematic Assessment |
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| Embolism & Thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Fungal Infection Disorders | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Gallbladder Disorders | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
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| Haematology Investigations | Investigations | MedDRA (12.0) | Systematic Assessment |
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| Joint Disorders | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
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| Lower Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Male Reproductive Tract Infections & Inflammations | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
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| Peripheral Neuropathies | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Phosphorous Metabolism Disorders | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Plasma Cell Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
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| Pleural Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Poisoning & Toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
|
| Procedural Related Injuries & Complications | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
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| Pulmonary Hypertensions | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Spleen Disorders | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Urinary Tract Signs & Symptoms | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
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| Vascular Haemorrhagic Disorders | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Viral Infectious Disorders | Infections and infestations | MedDRA (12.0) | Systematic Assessment | COVID-19 |
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| White Blood Cell Disorders | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Post-Acute Care Discharge (approximately 31 days after study enrollment) |
|
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| 90-Day Follow-Up After PAC Discharge (approximately 122 days after study enrollment) |
|
|
| Regression, Linear |
| <0.00001 |
| Mean Difference (Net) |
| -0.59 |
| 2-Sided |
| 95 |
| Superiority |
| Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment). | Regression, Linear | 0.01 | Mean Difference (Net) | -0.35 | 2-Sided | 95 | Superiority |