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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-1197 | Other Identifier | IRB Number | |
| R01AG050504 | U.S. NIH Grant/Contract | View source | |
| A534100 | Other Identifier | UW Madison | |
| SMPH\EMERG MED | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The emergency department (ED) is a common source of acute illness care for older adults. Many older adults who are discharged home from the ED return within 30 days due to numerous challenges faced during the ED-to-home transition. Unless programs to improve the ED-to-home transition are identified, the health and financial costs will only increase as the older adult population doubles by 2040. This study will apply Coleman's Care Transitions Intervention to the ED-to-home transition by adapting the program to account for the unique aspects of the ED setting. The research will evaluate the process, ED use, and cost outcomes of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion, this study will provide empiric evidence regarding this innovative approach to help the rapidly growing older adult population remain healthy and independent after an ED visit.
Older adults use the emergency department (ED) as an important source of acute care, making 20 million ED visits annually. Most older adults who visit the ED do not have conditions of sufficient severity to warrant hospital admission; thus, they are treated and discharged home. Unfortunately, older adults do poorly after being discharged home from the ED, with 20% having repeat ED visits within 30 days. The ED-to-home transition has been identified as a cause for these avoidable poor outcomes, but ED-focused interventions to improve this transition have had inconclusive outcomes and have suffered from feasibility, sustainability and scalability problems.
Coleman's Care Transition Intervention (CTI) has been validated to improve the hospital-to-home transition, decreasing both hospital readmissions and costs. The CTI uses coaches, usually nurses or social workers, to support patients being discharged home by transferring skills to activate patients. Applying the CTI to the ED-to-home transition is a natural extension, but it has not been evaluated in this unique and demanding setting.
In this study, the investigators will test the hypothesis that the community-based, paramedic-coordinated ED-to-home CTI will improve community-dwelling older adults' post-ED health outcomes and reduce costs. The investigators will evaluate CTI process outcomes by testing if participants randomized to the CTI demonstrate better understanding of red flags that indicate a worsening of their condition, implement medication changes more frequently, and follow up with their primary care physicians more rapidly after ED discharge, as compared to the control group. The investigators will also evaluate the effectiveness and cost-effectiveness of the CTI by testing if participants randomized to the CTI have improved Patient Activation Measure scores 30 days after discharge, have decreased frequency of ED use, and decreased health care costs within 30 days of ED discharge. Additionally, the investigators recognize that the CTI will not eliminate all repeat ED visits. Thus, they will identify factors independently associated with repeat ED visits among CTI recipients such that future programs can ensure their needs are adequately addressed.
This research will provide critical empiric evidence regarding the significant problem of poor ED-to-home transitions. By leveraging the CTI, a widely available and efficient intervention and paramedics, a highly-skilled and respected health care provider present in all communities, the investigators will apply an innovative approach to improve older adults' health following an ED visit. Through rigorous research, they will test the effectiveness and cost-effectiveness of this approach, with a specific focus on ultimate sustainability and dissemination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Older adults discharged from an ED to home who receive the usual processes and services. | |
| Care Transitions Intervention | Active Comparator | Older adults discharged from an ED to home who receive the Care Transitions Intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Transitions Intervention | Behavioral | The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | The investigators included all unplanned ED use, regardless of reason, during the 30 days after discharge as abstracted from electronic medical records (with out-of-system ED use identified during participant phone surveys). The investigators constructed dichotomous variables measuring whether or not any ED visits occurred within 14 and 30 days after discharge, with the 30-day interval being the primary prespecified outcome. Control vs Intent-to-Treat vs Per Protocol population reported. | 30 days after emergency department discharge |
| Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Follow-up visits, abstracted from participant medical records, included office visits with primary or specialty providers, telephone calls, and online patient portal messaging (excluding automated reminder messages, electronic messages that did not receive a patient response, laboratory testing, and previously scheduled outpatient procedures). Outpatient follow-up was dichotomized by whether or not any contact with outpatient providers occurred within either 7 or 30 days of discharge. This approach allowed us to differentiate follow-up occurring soon after discharge (consistent with most ED discharge instructions) from less-timely contact with outpatient clinics. To conduct a preplanned subanalysis, we also categorized all follow-up as either "in-person" or "electronic." Dichotomous variables were created for each modality at each time point as well as a combined variable representing all forms of contact. Control vs Intent-To-Treat vs Per Protocol population reported. | Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits |
| Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Control vs Intent-to-Treat vs Per Protocol Population reported | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Medication Changes Implemented | The investigators asked participants to self-report any medication changes (starts, stops, or modifications) they had made since discharge during the 4-day survey. They had to provide the name, classification, or purpose of each medication. Medically trained researchers compared self-reported medication changes to those listed on participants' AVS discharge instructions, excluding those with "as needed" instructions. The dichotomized variable indicates whether or not the participant reported making all recommended medication changes. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Satisfaction Survey Score | Participants and Caregivers were surveyed for their satisfaction with the intervention, on a scale of 0-10 where 0 is the worst experience and 10 is the best experience. | day 1, day 30 |
| Family Caregiver Activation in Transitions (FCAT) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manish N Shah, MD, MPH | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States | ||
| University of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29724172 | Derived | Mi R, Hollander MM, Jones CMC, DuGoff EH, Caprio TV, Cushman JT, Kind AJH, Lohmeier M, Shah MN. A randomized controlled trial testing the effectiveness of a paramedic-delivered care transitions intervention to reduce emergency department revisits. BMC Geriatr. 2018 May 3;18(1):104. doi: 10.1186/s12877-018-0792-5. |
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6,102 (11.3 percent) of 53,801 patients greater than or equal to 60 years old presenting during recruitment hours were approached for the study. Primary reasons for exclusion were inpatient admission from ED, not having a primary care provider in the health system, and living in a long-term care/assisted-living facility. After additional eligibility checks and refusals, 1,979 patients (32.4 percent) were consented and randomized into the study.
A single-blind randomized controlled trial conducted at three university-affiliated hospital Emergency Departments: one in Madison, Wisconsin, and two in Rochester, New York. The study was approved by institutional review boards at the University of Wisconsin and University of Rochester with written informed consent. Enrollment and data collection occurred between January 2016 and July 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Older adults discharged from an ED to home who receive the usual processes and services. |
| FG001 | Care Transitions Intervention | Older adults discharged from an ED to home who receive the Care Transitions Intervention. Care Transitions Intervention: The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
223 enrolled participants were removed following randomization, see Participant Flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care: Control Group | Older adults discharged from an ED to home who receive the usual processes and services. |
| BG001 | Care Transitions Intervention (ITT) | Older adults discharged from an ED to home, intended to receive the Care Transitions Intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Returning to the ED Within 30 Days of the Original ED Visit | The investigators included all unplanned ED use, regardless of reason, during the 30 days after discharge as abstracted from electronic medical records (with out-of-system ED use identified during participant phone surveys). The investigators constructed dichotomous variables measuring whether or not any ED visits occurred within 14 and 30 days after discharge, with the 30-day interval being the primary prespecified outcome. Control vs Intent-to-Treat vs Per Protocol population reported. | Posted | Count of Participants | Participants | 30 days after emergency department discharge |
|
up to 30 days
Adverse Events data reported for all participants who were randomized for study. MedDRA System Order Class (SOC) reported for all adverse events and serious adverse events.
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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 | Usual Care | Older adults discharged from an ED to home who receive the usual processes and services. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and Lymphatic Disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manish N. Shah, MD, MPH | UW School of Medicine and Public Health | 608-263-6690 | mnshah@medicine.wisc.edu |
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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 10, 2016 | May 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| day 4 |
| Number of Participants Who Could Recall Any Specific Red Flag | The discharge instructions from the ED will be abstracted for key red flags. Participants will be asked to list the red flags for which they are monitoring their condition. | day 4 |
| Level of Participant Activation as Measured by the Perceived Health Competence Survey | Perceived Health Competence Score (PHCS) has a total possible range of scores from 8-40 where higher scores indicate a stronger perception of health competency. This is also known as the Wallston score. | 30 days after emergency department discharge |
| Median Cost of Healthcare Services Within 30 Days of the Original ED Visit | 30 days after emergency department discharge |
The Family Caregiver Activation in Transitions survey is a series of statements about challenges commonly faced by those caring for a loved one. It is scored on a 6 point likert scale for a total possible range between 10-60, where higher scores indicate fewer challenges to care. |
| day 1, day 30 |
| Number of Participants Who Died Within 30 Days of Discharge | up to 30 days |
| Madison |
| Wisconsin |
| 53705 |
| United States |
| ED greater than 24 hours |
|
| other ineligibility |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Number of Participants with some college or less | Count of Participants | Participants |
|
| Marital Status | Number of Participants who are not married | Count of Participants | Participants |
|
| Number of Charlson Comorbidities | Charlson Comorbidities are nineteen conditions included in an index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Extracted from participant medical records. | Mean | Standard Deviation | Charlson Comorbidities |
|
| Number of Participants with Deficiencies in One or more ADL | Activities of Daily Living (ADL) are a list of fundamental skills required for independent living such as walking, feeding, dressing, personal hygiene, toileting, or continence. | Count of Participants | Participants |
|
| Number of Participants with Cognitive Impairment | The investigators considered participants cognitively impaired if they met any of the following conditions: (1) score > 10 on the Blessed Orientation Memory Concentration Test (BOMC); (2) self-reported a diagnosis of dementia or cognitive impairment; or (3) had medical record documentation of a memory-related condition (e.g., dementia). | Count of Participants | Participants |
|
| Number of Participants with Inadequate Health Literacy | Inadequate health literacy was measured with the Brief Health Literacy Screening Tool. Total scores range from 2-20, inadequate health literacy is considered a score between 2-12. | Count of Participants | Participants |
|
| Number of Participants with Anxiety per GAD-2 | The Generalized Anxiety Disorder-2 (GAD-2) scale has a total possible range of scores from 0-6, a score of 3 or higher indicates generalized anxiety. | Count of Participants | Participants |
|
| Number of Participants with Moderate to Severe Depression per PHQ-9 | The Patient Health Questionnaire-9 (PHQ-9) scale is a measure of depression with a total possible range of scores from 0-27. A score of greater than 10 indicates moderate or greater depression. | Count of Participants | Participants |
|
| Perceived Health Competence Score | Perceived Health Competence Score (PHCS) has a total possible range of score from 8-40 where higher scores indicate a stronger perception of health competency. | Mean | Standard Deviation | score on a scale |
|
| Number of Participants with Fair or Poor Overall Health per SF-12 | The Short Form-12 (SF-12) general health item. Participants select either Excellent, Very Good, Good, Fair, Poor, or no answer. | Count of Participants | Participants |
|
| Number of Participants Hospitalized in 30 days prior to Emergency Department (ED) study visit | Count of Participants | Participants |
|
| Number of ED visits in 30 days prior to index ED visit | Mean | Standard Deviation | ED visits |
|
Older adults discharged from an ED to home intended to receive the Care Transitions Intervention. |
| OG002 | Care Transitions Intervention (PP) | Older adults discharged from an ED to home receive the Care Transitions Intervention per protocol. |
|
|
|
| Primary | Time to Any Follow up (in Person or Phone) With PCP, Specialists, or Urgent Care | Follow-up visits, abstracted from participant medical records, included office visits with primary or specialty providers, telephone calls, and online patient portal messaging (excluding automated reminder messages, electronic messages that did not receive a patient response, laboratory testing, and previously scheduled outpatient procedures). Outpatient follow-up was dichotomized by whether or not any contact with outpatient providers occurred within either 7 or 30 days of discharge. This approach allowed us to differentiate follow-up occurring soon after discharge (consistent with most ED discharge instructions) from less-timely contact with outpatient clinics. To conduct a preplanned subanalysis, we also categorized all follow-up as either "in-person" or "electronic." Dichotomous variables were created for each modality at each time point as well as a combined variable representing all forms of contact. Control vs Intent-To-Treat vs Per Protocol population reported. | Posted | Count of Participants | Participants | Medical records reviewed for number of participants who followed up within 7 and 30 days, augmented by participant surveys at day 4 and 30 to learn about non-University of Wisconsin hospital visits |
|
|
|
| Primary | Number of Participants With Urgent Care or Unplanned Hospitalizations Within 30 Days of ED Discharge | Control vs Intent-to-Treat vs Per Protocol Population reported | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| Secondary | Number of Participants With Medication Changes Implemented | The investigators asked participants to self-report any medication changes (starts, stops, or modifications) they had made since discharge during the 4-day survey. They had to provide the name, classification, or purpose of each medication. Medically trained researchers compared self-reported medication changes to those listed on participants' AVS discharge instructions, excluding those with "as needed" instructions. The dichotomized variable indicates whether or not the participant reported making all recommended medication changes. | Only participants with medication-related changes on their AVS instructions were included in this analysis | Posted | Count of Participants | Participants | day 4 |
|
|
|
| Secondary | Number of Participants Who Could Recall Any Specific Red Flag | The discharge instructions from the ED will be abstracted for key red flags. Participants will be asked to list the red flags for which they are monitoring their condition. | Only patients with specific red flags listed on their discharge instructions were included in this analysis (n = 1207). | Posted | Count of Participants | Participants | day 4 |
|
|
|
| Secondary | Level of Participant Activation as Measured by the Perceived Health Competence Survey | Perceived Health Competence Score (PHCS) has a total possible range of scores from 8-40 where higher scores indicate a stronger perception of health competency. This is also known as the Wallston score. | Posted | Mean | Standard Deviation | score on a scale | 30 days after emergency department discharge |
|
|
|
| Secondary | Median Cost of Healthcare Services Within 30 Days of the Original ED Visit | The investigators made an informed decision not to collect cost data. | Posted | 30 days after emergency department discharge |
|
|
| Other Pre-specified | Program Satisfaction Survey Score | Participants and Caregivers were surveyed for their satisfaction with the intervention, on a scale of 0-10 where 0 is the worst experience and 10 is the best experience. | Not Posted | day 1, day 30 | Participants |
| Other Pre-specified | Family Caregiver Activation in Transitions (FCAT) | The Family Caregiver Activation in Transitions survey is a series of statements about challenges commonly faced by those caring for a loved one. It is scored on a 6 point likert scale for a total possible range between 10-60, where higher scores indicate fewer challenges to care. | Investigators did not analyze the FCAT because of reliability issues with the instrument that led them to lack confidence in the instrument. | Posted | day 1, day 30 |
|
|
|
| Other Pre-specified | Number of Participants Who Died Within 30 Days of Discharge | Posted | Count of Participants | Participants | up to 30 days |
|
|
|
| 5 |
| 992 |
| 51 |
| 992 |
| 93 |
| 992 |
| EG001 | Care Transitions Intervention | Older adults discharged from an ED to home who receive the Care Transitions Intervention. | 2 | 987 | 51 | 987 | 76 | 987 |
| Cardiac Disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| General Disorders | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Surgical and Medical Procedures | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Endocrine Disorders | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| General Disorders | General disorders | MedDRA (Unspecified) | Systematic Assessment | There is one 'unknown' event counted in this category. |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal and connective tissues disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Surgical and Medical procedures | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Vascular Disorders | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| In-Person Follow-Up within 7 days |
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| In-Person Follow-Up within 30 days |
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| Electronic Follow-Up within 7 Days |
|
| Electronic Follow-Up within 30 Days |
|
|