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| ID | Type | Description | Link |
|---|---|---|---|
| A534100 | Other Identifier | UW Madison | |
| SMPH/EMERG MED | Other Identifier | UW Madison | |
| K24AG054560 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 1/20/2021 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This pilot study is designed to evaluate the potential effectiveness of the implementation strategy and intervention delivery model of a community paramedic coaching program for caregivers of persons with dementia, in direct coordination with the participant and caregiver's primary health care team. Specifically, the acceptability, appropriateness, and feasibility of the program will be assessed, collecting data from all implementation stakeholders at baseline, 13 weeks, 25 weeks, and post-intervention (~50 weeks) using quantitative survey instruments and qualitative interviews.
The intervention is an adaptation of the evidence-based REACH program (Resources Enhancing Alzheimer's Caregiver Health), designed for and validated in multiple settings to give education, tools, and support to informal caregivers of people with dementia, delivered through a series of at-home visits (minimum of 9 in-person and 3 phone sessions) conducted by trained and certified coaches over 6-12 months. The content of the coaching visits will follow the REACH program protocol, with materials customized with information about local community resources (e.g., Dane County).
Coach/administrator training for delivery of the REACH intervention will be conducted by master trainers from the Rosalynn Carter Institute (RCI) for Caregiving, a department of Georgia Southwestern State University, who administers, certifies, and provides oversight for REACH sites nationally (https://www.rosalynncarter.org/programs/rci-reach/). For the purposes of this pilot study, the investigators have coordinated with RCI to extend delivery of REACH content over a 12-month period, with home visits occurring more frequently at the beginning and spreading further apart towards the end, and additional phone "REVIEW" sessions between home-visits.
Each home visit covers specific coaching content, building on strategies and behaviors covered in prior sessions. The program includes flexibility to allow coaches to adapt the timing/delivery of content to attend to the needs of the caregiver (e.g., answering questions about previously-covered topics, covering topics from a future visit to help coach a caregiver through an emergent dementia-related issue). Sessions typically last 1-2 hours. Following each visit, the coach completes a fidelity checklist and writes client progress notes as per the REACH protocol.
This pilot adapts prior REACH implementations in two main ways: (1) intervention coaches will be community paramedics with advanced medical training, rather than social workers (or other non-medical social service personnel), and (2) the program will be formally coordinated with the participant and caregiver's primary care practice, allowing for care coordination and information sharing between participants, coaches, and clinic staff/providers. Participants will also have the ability to share information about their use of community dementia care resources (e.g., social services, transportation, senior center case management, dementia caregiver support groups, dementia-related educational programming, respite) with coaches so they can communicate necessary information to the clinic for possible inclusion in the participant's Electronic Health Record (EHR) (as per the clinic's determination), facilitate care coordination, and help keep the participant's care plan up to date. Paramedic coaches will be utilizing their medical knowledge, but not providing any direct medical care.
This pilot study also differs from prior REACH trials in that outcome measures include health care and emergency services utilization, particularly related to the occurrence of acute medical and behavioral problems, as well as perceptions of health care quality, in addition to caregiver psycho-socio-emotional measures (already included in the standard REACH assessment package).
The study will employ a stepped design using a rapid-cycle evaluation approach. Three cohorts of 4-5 patient-caregiver dyads each will start the intervention at staggered intervals. Within each cohort, a new dyad will begin the program approximately every two weeks, with an approximate four week gap between each cohort for feedback collection and program iteration. Real-time feedback obtained from multiple intervention stakeholders (caregivers, persons with dementia, coaches, clinical staff/providers - up to 10 enrolled) will be used to iteratively improve intervention delivery and program implementation for the next, all while the first group continues the pilot. In this way, problems can be identified and solutions generated, with enough time to adapt the program and evaluate revisions. Staggering participant start dates allows for multiple rapid-cycle iterations within a single pilot study.
NOTE: While COVID-19 restrictions are in place, all feedback interviews will take place by telephone or WebEx videoconferencing, beginning 17 March 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paramedic Coaching | Experimental | The intervention is an adaptation of the evidence-based REACH program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paramedic Coaching | Behavioral | The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits to the Emergency Department by the Person With Dementia | As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for persons with dementia. | up to 24 months |
| Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia | As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for average older adults. | up to 24 months |
| Feasibility: Proportion of Coaching Phone Calls Completed | The intervention will be deemed feasible if at least 75% of the intended coaching phone calls are completed. The minimum number of coaching calls is 3, additional calls will be scheduled opposite weeks of home visits as needed. | up to 12 months |
| Feasibility: Proportion of Coaching Home Visits Completed | The intervention will be deemed feasible if at least 75% of the intended home visits are completed. The minimum number of intended home visits is 9. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Zarit Burden Interview (ZBI-12) Score | The Zarit Burden Interview measures caregiver burden. This is a 12-item survey with a total possible range of scores from 0-48, where higher scores indicate increased burden. The investigators hypothesize the score will decrease as a result of the intervention. | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
Stakeholder Inclusion 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 Wisconsin | Madison | Wisconsin | 53705 | United States |
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20 participant enrolled are 10 caregivers and 10 patients with dementia
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| ID | Title | Description |
|---|---|---|
| FG000 | Paramedic Coaching of Caregivers | The intervention is an adaptation of the evidence-based REACH program Paramedic Coaching: The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paramedic Coaching | The intervention is an adaptation of the evidence-based REACH program Paramedic Coaching: The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Visits to the Emergency Department by the Person With Dementia | As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for persons with dementia. | Posted | Number | visits to the Emergency Department | up to 24 months |
|
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Adverse events were collected from the time a participant was enrolled to 6 months after the completion of their participation. Typically, 1 year and 6 months.
Adverse events for caregivers and for patients with dementia were not monitored/assessed separately.
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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 | Paramedic Coaching | The intervention is an adaptation of the evidence-based REACH program Paramedic Coaching: The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Events | Vascular disorders | Systematic Assessment | Pt presented w/ stroke symptoms of LE weakness. MRI showed acute right thalamic infarct & vascular imaging showed no flow limiting stenosis of carotids. Pt given aspirin, statin, antihypertensives. Pt d/c to f/u w/ stroke clinic, & rec'd home health |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED Use | Renal and urinary disorders | Systematic Assessment | 3 visits to ED for Urinary Catheter Problem within 1 week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manish Shah | BerbeeWalsh Department of Emergency Medicine | 608-263-9174 | 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 | Jan 20, 2021 | Jun 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Caregiver Informed Consent Form | Feb 12, 2020 | Jun 6, 2023 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient with Dementia Informed Consent Form | Feb 12, 2020 | Jun 6, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Change in Generalized Anxiety Disorder (GAD-7) Score | The GAD-7 is a 7-item survey that measures anxiety symptom severity. The total possible range of scores is 0-21, where higher scores indicate increased symptom severity. The investigators hypothesize the score will decrease as a result of the intervention. | Baseline, week 13, week 25, week 50 |
| Change in Center for Epidemiologic Studies Depression Scale (CESD-10) | The CESD-10 is a general measure of depression frequently used in caregiver studies. It is a 10-item survey with a total possible range of scores of 0-30 where higher scores indicate increased depression. The investigators hypothesize the score will decrease as a result of the intervention. | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) |
| Change in Revised Caregiving Satisfaction Scale (RCSS) | The RCSS is a 6-item survey used to measure the positive aspects of caring. The range of total possible scores is 6-30 where higher scores indicate increased caregiver satisfaction. The investigators hypothesize the score will increase as a result of the intervention. | Baseline, week 13, week 25, week 50 |
| Change in Revised Scale for Caregiving Self-Efficacy | The revised scale for caregiving self-efficacy measures three domains: obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts. It is a 15-item scale with a total possible range of scores between 0-100, where higher scores are better. The investigators hypothesize the score will increase as a result of the intervention. | First home visit (~ week 1) and last home visit (~up to week 50) |
| Change in Work-Family Conflict Scale (WFC) | WFC is measured for the caregiver. It is a 6-item survey with a total possible range of scores between 6-30 with higher scores indicating lesser work-family conflict. The investigators hypothesize the score will increase as a result of the intervention. | First home visit (~ week 1) and last home visit (~up to week 50) |
| Change in Caregiver Quality of Life (C-DEMQOL) Score | C-DEMQOL is measured for the caregiver. The investigators will be asking 18 of the questions from the scale to understand the quality of life the caregivers experience. Scores can range from 18-90, with a higher score reflecting a higher quality of life. | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) |
| Change in Knowledge of Dementia (DKAS) Score | DKAS is measured for the caregiver. It is a 25 item true-false survey of facts about dementia. Scoring is by measuring the proportion of questions answered correctly. The range for score values is 0 to 50, the higher the score the better the outcome (a.k.a. the more knowledgeable about dementia). | First home visit (~ week 1) and week 13 |
| Clinic Utilization by Persons With Dementia | As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia. | up to 24 months |
| Clinic Utilization by Caregivers of Persons With Dementia | As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia. | up to 24 months |
| Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure | Assesses caregivers perception of communication with health care team and extent to which the team considers their capacity and preferences in decision making. This measure consists of 12 questions, with scores ranging from 12-60, where higher scores indicate increased communication with the health care team. | First home visit (~ week 1) and week 13 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Number of Visits to the Emergency Department by the Caregiver of the Person With Dementia | As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for average older adults. | Posted | Number | visits to the Emergency Department | up to 24 months |
|
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| Primary | Feasibility: Proportion of Coaching Phone Calls Completed | The intervention will be deemed feasible if at least 75% of the intended coaching phone calls are completed. The minimum number of coaching calls is 3, additional calls will be scheduled opposite weeks of home visits as needed. | The coaching phone calls are relevant to and only conducted with caregivers, which makes up for 10 of our 20 participants. | Posted | Number | Number of Phone Calls Completed | up to 12 months | Number of Phone Calls Made | Number of Phone Calls Made |
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| Primary | Feasibility: Proportion of Coaching Home Visits Completed | The intervention will be deemed feasible if at least 75% of the intended home visits are completed. The minimum number of intended home visits is 9. | The coaching phone calls are relevant to and only conducted with caregivers, which makes up for 10 of our 20 participants. | Posted | Number | number of completed coaching visits | up to 12 months | Number of Home Visits Planned | Number of Home Visits Planned |
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| Secondary | Change in Zarit Burden Interview (ZBI-12) Score | The Zarit Burden Interview measures caregiver burden. This is a 12-item survey with a total possible range of scores from 0-48, where higher scores indicate increased burden. The investigators hypothesize the score will decrease as a result of the intervention. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Deviation | score on a scale | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) |
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| Secondary | Change in Generalized Anxiety Disorder (GAD-7) Score | The GAD-7 is a 7-item survey that measures anxiety symptom severity. The total possible range of scores is 0-21, where higher scores indicate increased symptom severity. The investigators hypothesize the score will decrease as a result of the intervention. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 13, week 25, week 50 |
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| Secondary | Change in Center for Epidemiologic Studies Depression Scale (CESD-10) | The CESD-10 is a general measure of depression frequently used in caregiver studies. It is a 10-item survey with a total possible range of scores of 0-30 where higher scores indicate increased depression. The investigators hypothesize the score will decrease as a result of the intervention. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Deviation | score on a scale | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) |
|
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| Secondary | Change in Revised Caregiving Satisfaction Scale (RCSS) | The RCSS is a 6-item survey used to measure the positive aspects of caring. The range of total possible scores is 6-30 where higher scores indicate increased caregiver satisfaction. The investigators hypothesize the score will increase as a result of the intervention. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 13, week 25, week 50 |
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| Secondary | Change in Revised Scale for Caregiving Self-Efficacy | The revised scale for caregiving self-efficacy measures three domains: obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts. It is a 15-item scale with a total possible range of scores between 0-100, where higher scores are better. The investigators hypothesize the score will increase as a result of the intervention. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Deviation | score on a scale | First home visit (~ week 1) and last home visit (~up to week 50) |
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| Secondary | Change in Work-Family Conflict Scale (WFC) | WFC is measured for the caregiver. It is a 6-item survey with a total possible range of scores between 6-30 with higher scores indicating lesser work-family conflict. The investigators hypothesize the score will increase as a result of the intervention. | Survey only relevant to caregivers who are working. Unable to obtain participant feedback for last home visit. | Posted | Mean | Standard Deviation | score on a scale | First home visit (~ week 1) and last home visit (~up to week 50) |
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| Secondary | Change in Caregiver Quality of Life (C-DEMQOL) Score | C-DEMQOL is measured for the caregiver. The investigators will be asking 18 of the questions from the scale to understand the quality of life the caregivers experience. Scores can range from 18-90, with a higher score reflecting a higher quality of life. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Deviation | score on a scale | First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50) |
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| Secondary | Change in Knowledge of Dementia (DKAS) Score | DKAS is measured for the caregiver. It is a 25 item true-false survey of facts about dementia. Scoring is by measuring the proportion of questions answered correctly. The range for score values is 0 to 50, the higher the score the better the outcome (a.k.a. the more knowledgeable about dementia). | This interview is relevant to and only conducted on caregivers | Posted | Mean | Standard Deviation | score on a scale | First home visit (~ week 1) and week 13 |
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| Secondary | Clinic Utilization by Persons With Dementia | As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia. | No data was collected. As the outcomes were not relevant to the primary goal of the project, medical records were not abstracted for this data due to study staff changes and time constraints. | Posted | up to 24 months |
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| Secondary | Clinic Utilization by Caregivers of Persons With Dementia | As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia. | No data was collected. As the outcomes were not relevant to the primary goal of the project, medical records were not abstracted for this data due to study staff changes and time constraints. | Posted | up to 24 months |
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| Secondary | Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure | Assesses caregivers perception of communication with health care team and extent to which the team considers their capacity and preferences in decision making. This measure consists of 12 questions, with scores ranging from 12-60, where higher scores indicate increased communication with the health care team. | This interview is relevant to and only conducted on caregivers, which makes up for 10 of our 20 participants. | Posted | Mean | Standard Error | score on a scale | First home visit (~ week 1) and week 13 |
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| 0 |
| 20 |
| 3 |
| 20 |
| 7 |
| 20 |
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| Serious Adverse Event | Vascular disorders | Systematic Assessment | Pt presented to ED c/o 2 weeks worsening chest pain w/ SOB. Pt HTN in ED. CXR, Trops and ECG WNL. CT shows no PE. After admission pt able to complete walking desaturation test, HTN decreased. Pt d/c w/ instructions to f/u w/ PCP. |
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| Serious Adverse Event | General disorders | Systematic Assessment | Pt presented to ED c/o worsening LE weakness. Pt admitted after elevated trop-NSTEMI type 2 demand. Cardiology placed pt on heparin infusion for 48 hrs. Pt stable, LLL pneumonia resolved with IV abx. D/c to SNF for PT/OT therapy & f/u w/ PCP & Cardio |
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| ED Use | Vascular disorders | Systematic Assessment | Pt presented to ED with Dizziness |
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| ED Use | Nervous system disorders | Systematic Assessment | Pt presented to ED with Altered Mental Status |
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| ED Use | Vascular disorders | Systematic Assessment | Pt presented to ED with Hypertension |
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| ED Use | Vascular disorders | Systematic Assessment | Pt presented to ED with Chest Pain |
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| ED Use | Gastrointestinal disorders | Systematic Assessment | Pt presented to ED with Abdominal Pain twice in one week |
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| ED Use | Injury, poisoning and procedural complications | Systematic Assessment | Pt presented to ED with Fall |
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| ED Use | Vascular disorders | Systematic Assessment | Pt presented to ED with Weakness |
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| ED Use | General disorders | Systematic Assessment | Pt presented to ED with Leg Problem |
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| D001523 | Mental Disorders |
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| Responding to Disruptive Behavior - last home visit |
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| Controlling Upsetting Thoughts - first home visit |
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| Controlling Upsetting Thoughts - last home visit |
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