Stroke, Transient Ischemic Attack
Conditions
Keywords
Early Supported Discharge, Transitional Care, Post-acute Stroke Care, Pragmatic Trial, Recovery and Rehabilitation, Secondary Prevention
Brief summary
The purpose of this pragmatic study is to investigate whether implementation of a comprehensive post-acute stroke service model that integrates Early Supported Discharge (ESD) and Transitional Care Management (TCM) for stroke survivors discharged home improves functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.
Detailed description
Stroke mortality is 20-40% higher in North Carolina (NC) than in the overall United States. After discharge, stroke patients are at high risk for complications. Although a model of stroke post-care (early supported discharge) exists in Europe and Canada, it has not been adapted for and tested in the US, although patients and stakeholders attest that post-acute care does not meet their needs. Transitional care services from hospital to home are now reimbursed by Centers for Medicaid and Medicare Services (CMS), but only for 30 days after discharge. The study team proposed a pragmatic, cluster randomized trial of 41 NC hospitals to determine the effectiveness of COMprehensive Post-Acute Stroke Services (COMPASS), a patient-centered intervention uniting transitional care management services and elements of early supported discharge in stroke patients discharged directly home. The study team will build on the successful North Carolina Stroke Care Collaborative (NCSCC) registry, a prospective stroke database in which 51 (of 113) hospitals in NC enroll patients. In preparation for COMPASS, the study team engaged these hospitals via webinars. Over 80% of NCSCC hospitals demonstrated an interest in participation and provided letters of support. The main question of this pragmatic trial is: Does implementation of COMPASS for all stroke patients discharged directly home improve functional outcomes as measured by the Stroke Impact Scale-16 (SIS-16) at 90 days post-stroke? The primary aim is to: compare the COMPASS model versus usual care on stroke survivors' self-reported functional status at 90 days post-stroke. The secondary aims are to determine if the COMPASS model affects: (1) caregiver strain (Modified Caregiver Strain Index); (2) self-reported general health; (3) disability (Modified Rankin Score); (4) self-reported physical activity; (5) depression (PHQ-2); (6) cognition (MoCA 5-min protocol); (7) medication adherence (Morisky Green Levine Scale-4); (8) self-reported falls; (9) self-reported fatigue (PROMIS Fatigue Instrument); (10) satisfaction with care; (11) secondary prevention - home blood pressure monitoring; (12) self-reported blood pressure; (13-15) all-cause hospital readmissions at 30-days, at 90-days and at 1 year after index discharge; (16-17) mortality at 90-days and at 1 year after index discharge; (18-20) healthcare utilization (emergency department visits, admissions to skilled nursing facilities/inpatient rehabilitation facilities); and (21) use of transitional care management billing codes. This study will also evaluate the effectiveness of the COMPASS Intervention in key patient subgroups based on race, sex, age, diagnosis (stroke versus TIA), stroke severity, and type of health insurance. English and Spanish-speaking patients ages 18 and older who are admitted to a participating hospital with a diagnosis of ischemic or hemorrhagic stroke or transient ischemic attack and discharged from acute care hospitalization to home will be included (about 6,000 patients/year). Participating hospitals will be randomized (stratified by stroke volume and primary stroke center status) to receive COMPASS or usual care (control group) in Phase 1. In Phase 2, usual care hospitals will cross over to COMPASS, while the early intervention hospitals sustain the intervention using hospital-based resources. The trial has three integrated intervention components: (1) COMPASS, which combines transitional care services provided by advanced practice providers (APPs) and early supported discharge services coordinated by the Post-Acute Coordinators (PAC); (2) COMPASS-funded post-acute care coordinators who will engage patient and stakeholder communities to improve post-acute stroke comprehensive stroke services; and (3) development of a stroke metrics scorecard for participating sites. Well-trained APPs and coordinators will have access to online learning and ongoing support/consultation from WFBH personnel and board-certified vascular neurologists. The study team will assess 90-day and 1-year outcomes. Outcomes at 90-days will be assessed by telephone surveyors blinded to patient's group assignment. Patients will be informed about COMPASS in the hospital and can opt out of 90-day phone follow-up at any time. Those who agree to be surveyed will be asked to provide informed consent at the 90-day phone call to collect outcomes data. This proposal is led by three highly experienced researchers as co-principal investigators. The team includes expertise in stroke care, large clinical trials, biostatistics, managing clinical registries, survey and acquisition of patient or proxy-reported outcomes, community-based practice improvement, building community coalitions to reduce readmissions, claims analyses, registry management, translating evidence into practice with large multi-site collaboratives, and engaging patients and stakeholders in research. The planning phase of this project has been guided by patients and stakeholders. Each community will form a community resource network to advise and support the implementation of COMPASS, provide feedback to the team, and help create sustainability. If the COMPASS model shows effectiveness, engaged patients and stakeholders will be key partners to disseminate and implement COMPASS throughout the state and beyond.
Interventions
OTHERCOMPASS Intervention
* A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. * Patient will receive a follow-up telephone call two days after having been discharged. * 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. * Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.
Sponsors
University of North Carolina, Chapel Hill
Duke University
East Carolina University
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English and Spanish speaking stroke patients with diagnosis of ischemic stroke, hemorrhagic stroke or TIA who are discharged home from participating hospitals * Must be 18 years of age and older at the time of the stroke
Exclusion criteria
* Excludes subdural or aneurysmal subarachnoid hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (SIS-16) | post-stroke day 90 | 16-item survey to assess the difficulty level of performing basic physical activities; scores range from 0-100; higher scores correspond to more favorable outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence (Morisky Green Levine Scale-4) | post-stroke day 90 | 4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence |
| Number of Subjects With Claims-based All-cause Hospital Readmissions | post-stroke day 30 | — |
| Number of Subjects With All-cause Mortality Using NC State Death Index | post-stroke day 90 | Deaths within 90 days of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death. |
| Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | post-discharge year 1 | Deaths within 1 year of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death. |
| Number of Subjects With Claims-based Emergency Department Visits | post-discharge year 1 | — |
| Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) | post-discharge year 1 | — |
| Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes | post-discharge day 14 | — |
| Modified Caregiver Strain Index | post-stroke day 90 | 13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden |
| Self-reported General Health | post-stroke day 90 | Self-reported general health is a single question to rate their general health. Responses on a 5-point Likert Scale (Excellent, Very Good, Good, Fair, or Poor) will be analyzed as a continuous variable. Scores range from 95-15 with a higher score indicating better health. |
| Modified Rankin Score | post-stroke day 90 | to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes |
| Number of Participants Physically Active and Not Physically Active | post-stroke day 90 | Participants are asked whether they walked continuously for at least 10 minutes on any of the last seven days, how many of those days they walked continuously for at least 10 minutes and how many minutes they walked, on average, each day. The physical activity endpoint will be self-reported total number of minutes walked during the past seven days. |
| Number of Participants With or Without Depression | post-stroke day 90 | Based on answers to Patient Health Questionnaire 2-Item (PHQ-2) which is a 2-item questionnaire to determine the frequency of depressed mood; scores range from 0-6; higher scores correspond to less favorable outcomes |
| Cognition (MoCA 5-min Protocol) | post-stroke day 90 | 4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable |
| Number of Participants With or Without Falls | post-stroke day 90 | Participants are asked 4 questions to determine whether they have fallen (yes versus no) since hospital discharge, whether or not the fall resulted in a doctor/emergency room visit, whether they have fallen multiple times since discharge, and how many times they have fallen since discharge. Analysis of falls will be based on incidence of any fall since hospital discharge (no falls versus at least one fall). |
| Self-reported Fatigue (PROMIS Fatigue Instrument) | post-stroke day 90 | 4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes; The total raw score is obtained by summing individual question scores and has a range of 4-20. For analysis, raw scores are translated into T-scores which range from 33.7 - 75.8. The T-score rescales the raw score into a standardized score with a mean of 50 and a SD of 10. |
| Satisfaction With Care | post-stroke day 90 | 6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care |
| Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | post-stroke day 90 | Participants are asked 2 questions to determine whether they monitor their blood pressure at home (yes or no) and, if they answer in the affirmative, how frequently (daily, weekly, and monthly). Home blood pressure monitoring was analyzed as a dichotomous endpoint (monitoring with any frequency versus no monitoring). |
| Self-reported Blood Pressure | post-stroke day 90 | 1 question to determine self-reported blood pressure. Self-reported systolic and diastolic BP will each be analyzed as a continuous endpoint. In addition, self-reported systolic and diastolic BP will be used to create a dichotomous hypertension endpoint (systolic BP \>= 140 versus systolic BP \< 140). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis: Age | measured 90 days post-stroke | Analyze the main endpoint of the study in \<45; 45-\<55; 55-\<65; 65-\<75; \>=75 individuals |
| Subgroup Analysis: Diagnosis (Stroke Versus TIA) | measured 90 days post-stroke | Analyze the main endpoint of the study in stroke versus TIA individuals |
| Subgroup Analysis: Stroke Severity | measured 90 days post-stroke | Analyze the main endpoint of the study in NIHSS=0, NIHSS=1-4, NIHSS\>4 individuals |
| Subgroup Analysis: Type of Health Insurance | measured 90 days post-stroke | Analyze the main endpoint of the study in insured and uninsured individuals |
| Subgroup Analysis: Race | post-stroke day 90 | Analyze the main endpoint of the study in white and non-white individuals |
| Subgroup Analysis: Sex | measured 90 days post-stroke | Analyze the main endpoint of the study in female and male individuals |
Countries
United States
Participant flow
Pre-assignment details
Excluded subsequent stroke (or TIA) events within the study period (N=142)
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. | 3,193 |
| COMPASS Intervention Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.
COMPASS Intervention: \*A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital.
* Patient will receive a follow-up telephone call two days after having been discharged.
* 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving.
* Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services. | 2,689 |
| Total | 5,882 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 56 | 55 |
| Overall Study | Lost to Follow-up | 1,305 | 990 |
Baseline characteristics
| Characteristic | Total | Usual Care | COMPASS Intervention |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 13.9 | 66.3 years STANDARD_DEVIATION 13.9 | 68.0 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 114 Participants | 71 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5517 Participants | 3017 Participants | 2500 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 251 Participants | 105 Participants | 146 Participants |
| Health Insurance Insured | 5263 Participants | 2823 Participants | 2440 Participants |
| Health Insurance Missing Insurance Status | 96 Participants | 77 Participants | 19 Participants |
| Health Insurance Uninsured | 523 Participants | 293 Participants | 230 Participants |
| NIH Stroke Scale (NIHSS) | 1 units on a scale | 1 units on a scale | 1 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 38 Participants | 18 Participants | 20 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 18 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 1431 Participants | 942 Participants | 489 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 132 Participants | 86 Participants | 46 Participants |
| Race (NIH/OMB) White | 4234 Participants | 2122 Participants | 2112 Participants |
| Region of Enrollment United States | 5882 participants | 3193 participants | 2689 participants |
| Sex: Female, Male Female | 2957 Participants | 1657 Participants | 1300 Participants |
| Sex: Female, Male Male | 2925 Participants | 1536 Participants | 1389 Participants |
| Stroke Diagnosis Intracerebral Hemorrhage | 167 Participants | 107 Participants | 60 Participants |
| Stroke Diagnosis Ischemic Stroke | 3392 Participants | 1829 Participants | 1563 Participants |
| Stroke Diagnosis Stroke, not otherwise specified | 188 Participants | 108 Participants | 80 Participants |
| Stroke Diagnosis Transient Ischemic Attack (TIA) | 2135 Participants | 1149 Participants | 986 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 56 / 3,193 | 55 / 2,689 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3,137 | 0 / 2,689 |
Outcome results
Primary
Stroke Impact Scale (SIS-16)
16-item survey to assess the difficulty level of performing basic physical activities; scores range from 0-100; higher scores correspond to more favorable outcomes
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 3476 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Stroke Impact Scale (SIS-16) | 79.9 score on a scale | Standard Deviation 21.4 |
| COMPASS Intervention | Stroke Impact Scale (SIS-16) | 80.6 score on a scale | Standard Deviation 21.1 |
Secondary
Cognition (MoCA 5-min Protocol)
4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 2,728 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Cognition (MoCA 5-min Protocol) | 24.3 score on a scale | Standard Deviation 4.5 |
| COMPASS Intervention | Cognition (MoCA 5-min Protocol) | 24.3 score on a scale | Standard Deviation 4.7 |
Secondary
Medication Adherence (Morisky Green Levine Scale-4)
4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 2,730 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Medication Adherence (Morisky Green Levine Scale-4) | 0 score on a scale |
| COMPASS Intervention | Medication Adherence (Morisky Green Levine Scale-4) | 0 score on a scale |
Secondary
Modified Caregiver Strain Index
13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden
Time frame: post-stroke day 90
Population: Each enrolled patient was asked to identify a caregiver. A total of 4208 caregivers were identified and asked to complete the Caregiver Questionnaire. A total of 1228 caregivers completed the Caregiver Survey. However, to account for missing data, we utilized inverse probability weight to perform the analysis so the final analysis included was 4208 for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Modified Caregiver Strain Index | 21.9 score on a scale | Standard Deviation 23.1 |
| COMPASS Intervention | Modified Caregiver Strain Index | 21.9 score on a scale | Standard Deviation 23.5 |
Secondary
Modified Rankin Score
to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 3209 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Modified Rankin Score | 1 score on a scale |
| COMPASS Intervention | Modified Rankin Score | 1 score on a scale |
Secondary
Number of Participants Physically Active and Not Physically Active
Participants are asked whether they walked continuously for at least 10 minutes on any of the last seven days, how many of those days they walked continuously for at least 10 minutes and how many minutes they walked, on average, each day. The physical activity endpoint will be self-reported total number of minutes walked during the past seven days.
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 2968 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants Physically Active and Not Physically Active | Yes Physically Active (150 min/week of physical activity or more) | 488 Participants |
| Usual Care | Number of Participants Physically Active and Not Physically Active | Not Physically Active (Less than 150 min/week of physical activity) | 1064 Participants |
| COMPASS Intervention | Number of Participants Physically Active and Not Physically Active | Yes Physically Active (150 min/week of physical activity or more) | 431 Participants |
| COMPASS Intervention | Number of Participants Physically Active and Not Physically Active | Not Physically Active (Less than 150 min/week of physical activity) | 985 Participants |
Secondary
Number of Participants Who Do or Do Not Monitor Blood Pressure at Home
Participants are asked 2 questions to determine whether they monitor their blood pressure at home (yes or no) and, if they answer in the affirmative, how frequently (daily, weekly, and monthly). Home blood pressure monitoring was analyzed as a dichotomous endpoint (monitoring with any frequency versus no monitoring).
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 3,033 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | Yes - Home BP Monitoring (at least monthly) | 1013 Participants |
| Usual Care | Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | No - Home BP Monitoring (at least monthly) | 573 Participants |
| COMPASS Intervention | Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | Yes - Home BP Monitoring (at least monthly) | 1040 Participants |
| COMPASS Intervention | Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | No - Home BP Monitoring (at least monthly) | 407 Participants |
Secondary
Number of Participants With or Without Depression
Based on answers to Patient Health Questionnaire 2-Item (PHQ-2) which is a 2-item questionnaire to determine the frequency of depressed mood; scores range from 0-6; higher scores correspond to less favorable outcomes
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 2,774 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With or Without Depression | Not Depressed (or a score of 2 or less on PHQ-2) | 1122 Participants |
| Usual Care | Number of Participants With or Without Depression | Yes Depressed (or a score of 3 or higher on PHQ-2) | 343 Participants |
| COMPASS Intervention | Number of Participants With or Without Depression | Not Depressed (or a score of 2 or less on PHQ-2) | 1025 Participants |
| COMPASS Intervention | Number of Participants With or Without Depression | Yes Depressed (or a score of 3 or higher on PHQ-2) | 284 Participants |
Secondary
Number of Participants With or Without Falls
Participants are asked 4 questions to determine whether they have fallen (yes versus no) since hospital discharge, whether or not the fall resulted in a doctor/emergency room visit, whether they have fallen multiple times since discharge, and how many times they have fallen since discharge. Analysis of falls will be based on incidence of any fall since hospital discharge (no falls versus at least one fall).
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 3,055 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Participants With or Without Falls | Yes - reported at least 1 fall | 334 Participants |
| Usual Care | Number of Participants With or Without Falls | No - No falls reported | 1264 Participants |
| COMPASS Intervention | Number of Participants With or Without Falls | Yes - reported at least 1 fall | 299 Participants |
| COMPASS Intervention | Number of Participants With or Without Falls | No - No falls reported | 1158 Participants |
Secondary
Number of Subjects With All-cause Mortality Using NC State Death Index
Deaths within 90 days of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death.
Time frame: post-stroke day 90
Population: Mortality by 90-days post-stroke according to the NC State Death Index was collected on all 5,882 enrolled patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Subjects With All-cause Mortality Using NC State Death Index | Yes - Did Die | 56 Participants |
| Usual Care | Number of Subjects With All-cause Mortality Using NC State Death Index | No - Did Not Die | 3137 Participants |
| COMPASS Intervention | Number of Subjects With All-cause Mortality Using NC State Death Index | Yes - Did Die | 55 Participants |
| COMPASS Intervention | Number of Subjects With All-cause Mortality Using NC State Death Index | No - Did Not Die | 2634 Participants |
Secondary
Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare
Deaths within 1 year of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death.
Time frame: post-discharge year 1
Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | Yes - Did Die | 105 Participants |
| Usual Care | Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | No - Did not Die | 1088 Participants |
| COMPASS Intervention | Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | Yes - Did Die | 91 Participants |
| COMPASS Intervention | Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | No - Did not Die | 978 Participants |
Secondary
Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)
Time frame: post-discharge year 1
Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) | 142 Participants |
| COMPASS Intervention | Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) | 150 Participants |
Secondary
Number of Subjects With Claims-based All-cause Hospital Readmissions
Time frame: post-stroke day 30
Population: Of the enrolled patients, 2,262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Subjects With Claims-based All-cause Hospital Readmissions | 103 Participants |
| COMPASS Intervention | Number of Subjects With Claims-based All-cause Hospital Readmissions | 105 Participants |
Secondary
Number of Subjects With Claims-based All-cause Hospital Readmissions
Time frame: post-stroke day 90
Population: Of the enrolled patients, 2,262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Subjects With Claims-based All-cause Hospital Readmissions | 222 Participants |
| COMPASS Intervention | Number of Subjects With Claims-based All-cause Hospital Readmissions | 210 Participants |
Secondary
Number of Subjects With Claims-based All-cause Hospital Readmissions
Time frame: post-discharge year 1
Population: Of the enrolled patients, 2,262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Subjects With Claims-based All-cause Hospital Readmissions | 516 Participants |
| COMPASS Intervention | Number of Subjects With Claims-based All-cause Hospital Readmissions | 485 Participants |
Secondary
Number of Subjects With Claims-based Emergency Department Visits
Time frame: post-discharge year 1
Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Subjects With Claims-based Emergency Department Visits | 691 Participants |
| COMPASS Intervention | Number of Subjects With Claims-based Emergency Department Visits | 626 Participants |
Secondary
Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes
Time frame: post-discharge day 14
Population: Of the enrolled patients, 2262 were linked to Fee-For-Service (FFS) Medicare claims and included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes | 239 Participants |
| COMPASS Intervention | Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes | 345 Participants |
Secondary
Satisfaction With Care
6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 2,929 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Satisfaction With Care | 6.9 score on a scale | Standard Deviation 1.5 |
| COMPASS Intervention | Satisfaction With Care | 7.0 score on a scale | Standard Deviation 1.4 |
Secondary
Self-reported Blood Pressure
1 question to determine self-reported blood pressure. Self-reported systolic and diastolic BP will each be analyzed as a continuous endpoint. In addition, self-reported systolic and diastolic BP will be used to create a dichotomous hypertension endpoint (systolic BP \>= 140 versus systolic BP \< 140).
Time frame: post-stroke day 90
Population: Data was not considered reliable and was therefore not used for analysis. Responses to blood pressure was frequently 120 over 80. This response was so frequent that investigative team did not think the data was a valid measured blood pressure.
Secondary
Self-reported Fatigue (PROMIS Fatigue Instrument)
4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes; The total raw score is obtained by summing individual question scores and has a range of 4-20. For analysis, raw scores are translated into T-scores which range from 33.7 - 75.8. The T-score rescales the raw score into a standardized score with a mean of 50 and a SD of 10.
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 2,721 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Self-reported Fatigue (PROMIS Fatigue Instrument) | 51.5 score on a scale | Standard Deviation 10.7 |
| COMPASS Intervention | Self-reported Fatigue (PROMIS Fatigue Instrument) | 51.0 score on a scale | Standard Deviation 10.9 |
Secondary
Self-reported General Health
Self-reported general health is a single question to rate their general health. Responses on a 5-point Likert Scale (Excellent, Very Good, Good, Fair, or Poor) will be analyzed as a continuous variable. Scores range from 95-15 with a higher score indicating better health.
Time frame: post-stroke day 90
Population: Of the 5,882 that were enrolled in the study, 3169 provided a response to the survey question. However, we utilized inverse probability weight to perform the analysis in a way to account for missing data. The final analysis included 5,882 for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Self-reported General Health | 65.4 score on a scale | Standard Deviation 28.8 |
| COMPASS Intervention | Self-reported General Health | 66.2 score on a scale | Standard Deviation 28.8 |
Other Pre-specified
Subgroup Analysis: Age
Analyze the main endpoint of the study in \<45; 45-\<55; 55-\<65; 65-\<75; \>=75 individuals
Time frame: measured 90 days post-stroke
Population: Subgroup Analysis: Age
Other Pre-specified
Subgroup Analysis: Diagnosis (Stroke Versus TIA)
Analyze the main endpoint of the study in stroke versus TIA individuals
Time frame: measured 90 days post-stroke
Population: Subgroup analysis: diagnosis (stroke versus TIA)
Other Pre-specified
Subgroup Analysis: Race
Analyze the main endpoint of the study in white and non-white individuals
Time frame: post-stroke day 90
Population: This was a Subgroup Analysis: Race
Other Pre-specified
Subgroup Analysis: Sex
Analyze the main endpoint of the study in female and male individuals
Time frame: measured 90 days post-stroke
Population: Subgroup Analysis: sex
Other Pre-specified
Subgroup Analysis: Stroke Severity
Analyze the main endpoint of the study in NIHSS=0, NIHSS=1-4, NIHSS\>4 individuals
Time frame: measured 90 days post-stroke
Population: Subgroup analysis: stroke severity
Other Pre-specified
Subgroup Analysis: Type of Health Insurance
Analyze the main endpoint of the study in insured and uninsured individuals
Time frame: measured 90 days post-stroke
Population: Subgroup analysis: type of health insurance