Acute Stroke
Conditions
Keywords
acute stroke, care transitions, patient engagement, patient education, caregivers, social workers
Brief summary
The Michigan Stroke Transitions Trial (MISTT) is a patient-centered randomized control trial that aims to improve the experience of stroke patients after they return home. The MISTT study will test the effect of two complementary interventions against usual care. The two interventions include: a) Stroke Case Managers (SCMs) who are trained social workers, and b) an online informational website or portal. The 12 week intervention period begins when the stroke patient returns home from the hospital or rehab facility. The SCMs will conduct at least 2 home visits with the patient (one within 3-4 days and one around 30 days) along with weekly follow-up telephone calls. Supplemental home visits will be used as necessary over the 12 week period. At the first home visit the social workers will conduct a comprehensive in-home assessment and link patients and caregivers to local resources as necessary. Patients also assigned to the website will have access to a patient-centered online information and support resource called the Virtual Stroke Support Portal (VSSP). The investigators hypothesize that this personalized case management program will reduce patient and caregiver needs, improve quality of life, and decrease caregiver stress. The MISTT study will enroll 315 acute stroke patients discharged from 3 Michigan hospitals and will be completed by the end of 2017.
Detailed description
To improve care transitions for acute stroke patients this pragmatic, community-based, randomized, open clinical trial will test the efficacy of two separate but complementary interventions against usual care. The parallel group design will compare the following 3 groups: 1. Usual care 2. Stroke Case Manager (SCM): trained social workers who provide home based case management services 3. SCM services plus access to the Virtual Stroke Support Portal (VSSP) an online information and support resource. This patient-level randomized trial will be conducted at 3 Michigan hospitals and will enroll a total of 315 acute stroke patients (105 per intervention group). Each hospital will enroll cases over an 18 month period. Randomization will be balanced within each hospital to ensure that an equal number of patients are assigned to the 3 groups. If the patient identifies a primary caregivers they will be contacted and enrollment accordingly. The trial interventions begin once the patient returns home (= Day 1) and end 3 months later (= Day 90). Outcomes data will be collected by telephone at baseline (= Day 7) and at Day 90. Subjects who are enrolled but do not go home within 1 month (because they remain in a rehabilitation or Skilled Nursing Facility) will be dropped and replaced by new patients. Two primary patient-level outcome measures include the Patient Activation Measure (PAM), a measure of self-efficacy, and the PROMIS-10, a global quality of life scale. Two primary caregiver-level outcome measures include the Bakas Caregiving Outcomes Scale (BCOS) and depression (PHQ-9). By adhering to the principles of pragmatic trials, this trial is designed to inform typical U.S. clinical practice, with outcomes that are directly relevant to patients and caregivers. Specifically, this trial is designed to answer the practical question of whether the transitional care experience of stroke patients and caregivers can be improved by social workers who visit the home, and whether their effectiveness can be enhanced by a comprehensive patient-centered online resource.
Interventions
OTHERSCM
One intervention (SCM) is provided. Stroke Case Managers (SCMs) will conduct 2 home visits; the first within 72-96 hours and the other after 30-days of returning home. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if needed. Home visit activities include: 1. Biopsychosocial assessment of patient and caregiver needs. 2. Set up appointments. 3. Assist scheduling appointments with primary care physician and other medical providers. 4. Promote medication adherence through medication tool kits, pill organizers and other aids. 5. Facilitate patient and caregiver engagement and activation. 6. Facilitate access to social and community services.
OTHERSCM and VSSP
SCM: Stroke Case Managers (SCMs) will conduct home visits at 72-96 hours and after 30-days. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Activities include: 1. Biopsychosocial assessment of patient and caregiver needs. 2. Set up appointments. 3. Assist scheduling appointments with primary care physician and other medical providers. 4. Promote medication adherence through medication tool kits, pill organizers and other aids. 5. Facilitate patient and caregiver engagement and activation. 6. Facilitate access to social and community services. VSSP: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes: 1. Contact list of care team members. 2. Access to hospital patient portal. 3. Stroke education materials, resources, and guidelines. 4. Access to Michigan 2-1-1 services. 5. Medication information and adherence tools. 6. Patient and Caregiver support networks.
Sponsors
University of Michigan
Trinity Health Michigan
Sparrow Health System
Massachusetts General Hospital
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * A final confirmed hospital diagnosis of acute stroke (ischemic or hemorrhagic). * Patient living at home pre-stroke. * Presence of stroke-related deficits at admission (defined as a National Institute of Health Stroke Severity score of \>=1). * Presence of at least mild functional limitations at discharge (defined as a modified Rankin score \[mRS\] score of \>=1), or therapy ordered. * Discharged directly home (includes patient's residence or that of a family member). * Discharged to a rehabilitation facility (IRF or SNF) with the expectation of return to home within 4 weeks. Patient
Exclusion criteria
* Patients who live more than 50 miles from the hospital (for reasons related to the home visits). * Patients discharged to nursing home, hospice care or LTCH (Long term care hospital). * Patients who have clinically documented cognitive deficits or stroke-related impairments including aphasia sufficient to impact the consent process and for whom a proxy respondent is not available. * Patients who fail the 6-item cognitive screening (SIS-6) for cognitive impairment (score \<=4) and for whom a proxy respondent is not available * Patients enrolled in another acute stroke intervention trial that has a significant impact on the post-acute period (i.e., intensive data collection required of patient during follow-up). * Limited life expectancy (\< 6 months) or significant medical comorbidity likely to impact completion of the study (e.g., severe mental illness, drug or alcohol use or dependence, metastatic cancer). * Neither the patient nor caregiver speaks English. Caregiver Inclusion Criteria: * Age 18 or over. * Are identified by the stroke patient as the primary caregiver (individual who has primary responsibility for assisting with the patient's care). * Speaks English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) | 7 days and 90 days post discharge | Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Physical Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100). |
| Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) | 7 days and 90 days post discharge | Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Mental Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100). |
| Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) | 7 days and 90 days post discharge | Instrument designed to measure perceived caregiver life changes in response to providing care to stroke survivors. Bakas is a 15-item measure using a rating scale with 7 points ranging from -3 (changed for the worse) to +3 (changed for the best); responses are converted to a 1-7 scale and summed (range 15-105). Higher scores indicate more positive changes resulting from caregiving experience whereas lower scores indicate negative changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient) | 7 days and 90 days post discharge | Patient questionnaire to assess knowledge, skills, and self-efficacy for managing one's own healthcare. Patient Activation Measure is a 13-item survey using a five-point Likert scale (strongly disagree, disagree, agree, strongly agree, NA) whose response items are summed and converted to an activation score ranging from 0-100. Higher scores indicate a higher level of activation. |
| Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver) | 7 days and 90 days post discharge | The Patient Health Questionnaire (PHQ-9) measures severity of depression symptoms. PHQ-9 is a 9-item measure using a four-point Likert scale (not at all, several days, more than half the days, nearly every day). Response items are summed (range 0-27) with higher scores indicating the respondent is experiencing more symptoms of depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Oberst Caregiver Burden Scale (OCBS) (Caregiver) | 90 day post discharge | Validated 15-item questionnaire measuring caregiver burden in response to providing care to stroke survivors. |
| Unhealthy Days (Caregiver) | 90-days post discharge | Number of days in the past 30 days that the caregiver reported that their own physical or mental health had not been good. |
| NeuroQOL Anxiety Scale (Patient) | 90 day post discharge | Validated QOL scale measuring patient anxiety (administered by computer adaptive testing). |
| PROMIS Informational Support Scale (Caregiver). | 90-days post discharge | A validated 4-item questionnaire measuring informational support. Informational support is defined as the perceived availability of helpful information or advice. |
| PROMIS Emotional Support Scale (Caregiver). | 90-days post discharge | A validated 4-item questionnaire measuring emotional support. Emotional support is defined as the perceived feeling of being cared for and valued as a person. |
| Depression Symptoms (PHQ-9) (Patient) | 90 day post discharge | Validated 9-item questionnaire to identify depressive symptoms. |
| Hospital Readmission (Patient) | 90 day post discharge | Unscheduled hospital admissions |
| Stroke Recurrence (Patient) | 90 day post discharge | New onset acute stroke events requiring hospital admission |
| Home Time (Patient) | 90 day post discharge | Total number of days spent at home since discharge back to home. |
Countries
United States
Participant flow
Recruitment details
Patients and their caregivers were recruited from three mid-Michigan hospital stroke units. MISTT recruitment started in January 2016 and concluded in July 2017.
Pre-assignment details
Of 320 enrolled patients, 55 were excluded prior to randomization due to extended rehab stays lasting \>4 weeks (n=36), health reasons preventing participation (n=7), and other reasons that contributed to ineligibility (n=12). Of 210 enrolled caregivers, 41 were excluded prior to randomization due to exclusion of their patient.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients in this group will receive the hospitals' usual transitional care approach along with mailings of stroke and health-related brochures to help promote study retention. | 87 |
| SWSCM One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM program: Stroke Case Managers (SWSCMs) will conduct 2 home visits; one within 72-96 hours and another after 30-days of returning home. SWSCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if as needed.
1. Biopsychosocial assessment of patient and caregiver needs.
2. Set up appointments.
3. Assist scheduling appointments with primary care physician and other medical providers.
4. Promote medication adherence through medication tool kits, pill organizers and other aids.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services. | 88 |
| SWSCM and VSSP Website Two interventions are provided:
1. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
2. VSSP (Virtual Stroke Support Portal): Access and training in the use of the VSSP, a purpose-built, online, patient-centered information and support resource intended to complement the SWSCM program.
SWSCM and VSSP:
SWSCM activities as described in the SWSCM group.
VSSP website: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:
1. Care team contact list
2. Hospital patient portal access
3. Stroke education materials and resources
4. Access to Michigan 2-1-1 services
5. Medication information and adherence tools
6. Patient and Caregiver support networks. | 90 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 4 | 10 |
| Overall Study | Withdrawal by Subject | 3 | 8 | 3 |
| Overall Study | withdrawn by study team | 2 | 4 | 5 |
Baseline characteristics
| Characteristic | SWSCM and VSSP Website | SWSCM | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 12.7 | 67.5 years STANDARD_DEVIATION 13 | 65.2 years STANDARD_DEVIATION 13.9 | 66.2 years STANDARD_DEVIATION 13.2 |
| Age, Customized Age in years 18-54.9 | 17 Participants | 15 Participants | 20 Participants | 52 Participants |
| Age, Customized Age in years 55-74.9 | 51 Participants | 44 Participants | 47 Participants | 142 Participants |
| Age, Customized Age in years 75+ | 22 Participants | 29 Participants | 20 Participants | 71 Participants |
| Atrial Fibrillation | 8 Participants | 17 Participants | 12 Participants | 37 Participants |
| Caregiver consented to MISTT | 54 Participants | 57 Participants | 58 Participants | 169 Participants |
| Coronary Artery Disease | 25 Participants | 16 Participants | 17 Participants | 58 Participants |
| Days Between Stroke Admission and Discharge to Home | 14.5 days STANDARD_DEVIATION 11.2 | 13.8 days STANDARD_DEVIATION 9.7 | 12.4 days STANDARD_DEVIATION 11.7 | 13.6 days STANDARD_DEVIATION 10.9 |
| Diabetes | 33 Participants | 33 Participants | 31 Participants | 97 Participants |
| Discharge Destination Home | 36 Participants | 32 Participants | 49 Participants | 117 Participants |
| Discharge Destination Inpatient Rehabilitation (IPR/IRF) | 48 Participants | 47 Participants | 29 Participants | 124 Participants |
| Discharge Destination Sub-acute Rehabilitation (SAR) | 6 Participants | 9 Participants | 9 Participants | 24 Participants |
| History of Myocardial Infarction | 11 Participants | 7 Participants | 6 Participants | 24 Participants |
| History of Prior Stroke | 11 Participants | 18 Participants | 12 Participants | 41 Participants |
| History of Prior Transient Ischemic Attack (TIA) | 11 Participants | 6 Participants | 4 Participants | 21 Participants |
| Hyperlipidemia | 43 Participants | 41 Participants | 46 Participants | 130 Participants |
| Hypertension | 78 Participants | 67 Participants | 60 Participants | 205 Participants |
| Living Alone Pre-Stroke | 20 Participants | 27 Participants | 19 Participants | 66 Participants |
| Living with Consented Caregiver | 36 Participants | 41 Participants | 43 Participants | 120 Participants |
| Modified Rankin Score (mRS) Mild (score <=2) | 54 Participants | 62 Participants | 62 Participants | 178 Participants |
| Modified Rankin Score (mRS) Moderate/severe (score >2) | 36 Participants | 26 Participants | 25 Participants | 87 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 79 Participants | 79 Participants | 74 Participants | 232 Participants |
| Race/Ethnicity, Customized Race Non-white | 15 Participants | 20 Participants | 21 Participants | 56 Participants |
| Race/Ethnicity, Customized Race White | 75 Participants | 68 Participants | 66 Participants | 209 Participants |
| Recruitment Site Sparrow Hospital (Lansing) | 52 Participants | 50 Participants | 51 Participants | 153 Participants |
| Recruitment Site St. Joseph Mercy Hospital System (Ann Arbor) | 26 Participants | 25 Participants | 22 Participants | 73 Participants |
| Recruitment Site University of Michigan Health System (Ann Arbor) | 12 Participants | 13 Participants | 14 Participants | 39 Participants |
| Relationship to Consented Caregiver N/A - no caregiver consented | 36 Participants | 31 Participants | 29 Participants | 96 Participants |
| Relationship to Consented Caregiver Other | 18 Participants | 24 Participants | 25 Participants | 67 Participants |
| Relationship to Consented Caregiver spouse | 36 Participants | 33 Participants | 33 Participants | 102 Participants |
| Required Proxy Consent | 12 Participants | 13 Participants | 8 Participants | 33 Participants |
| Sex: Female, Male Female | 41 Participants | 48 Participants | 42 Participants | 131 Participants |
| Sex: Female, Male Male | 49 Participants | 40 Participants | 45 Participants | 134 Participants |
| Stroke Severity Mild | 64 Participants | 60 Participants | 66 Participants | 190 Participants |
| Stroke Severity Moderate | 23 Participants | 21 Participants | 12 Participants | 56 Participants |
| Stroke Severity Severe | 3 Participants | 7 Participants | 9 Participants | 19 Participants |
| Stroke type Hemorrhagic stroke | 10 Participants | 14 Participants | 13 Participants | 37 Participants |
| Stroke type Ischemic stroke | 80 Participants | 74 Participants | 74 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 2 / 88 | 0 / 90 |
| other Total, other adverse events | 0 / 87 | 0 / 88 | 0 / 90 |
| serious Total, serious adverse events | 1 / 87 | 2 / 88 | 5 / 90 |
Outcome results
Primary
Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)
Instrument designed to measure perceived caregiver life changes in response to providing care to stroke survivors. Bakas is a 15-item measure using a rating scale with 7 points ranging from -3 (changed for the worse) to +3 (changed for the best); responses are converted to a 1-7 scale and summed (range 15-105). Higher scores indicate more positive changes resulting from caregiving experience whereas lower scores indicate negative changes.
Time frame: 7 days and 90 days post discharge
Population: Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=263)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) | 1.934 change in score | Standard Error 1.496 |
| SWSCM | Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) | 0.646 change in score | Standard Error 1.561 |
| SWSCM and VSSP Website | Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver) | 1.961 change in score | Standard Error 1.522 |
Comparison: Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.p-value: 0.789Mixed Models Analysis
Primary
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)
Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Mental Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).
Time frame: 7 days and 90 days post discharge
Population: Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=434)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) | 1.187 change in T-score | Standard Error 0.945 |
| SWSCM | Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) | 0.123 change in T-score | Standard Error 0.926 |
| SWSCM and VSSP Website | Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient) | 1.445 change in T-score | Standard Error 0.907 |
Comparison: Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.p-value: 0.562Mixed Models Analysis
Primary
Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)
Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Physical Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).
Time frame: 7 days and 90 days post discharge
Population: Number of observations used in the analysis are larger than indicated above since both available 7-day and 90-day values were utilized (n=434)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) | 0.293 change in T-score | Standard Error 0.717 |
| SWSCM | Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) | 1.263 change in T-score | Standard Error 0.704 |
| SWSCM and VSSP Website | Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient) | 3.663 change in T-score | Standard Error 0.69 |
Comparison: Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.p-value: 0.025Mixed Models Analysis
Secondary
Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)
The Patient Health Questionnaire (PHQ-9) measures severity of depression symptoms. PHQ-9 is a 9-item measure using a four-point Likert scale (not at all, several days, more than half the days, nearly every day). Response items are summed (range 0-27) with higher scores indicating the respondent is experiencing more symptoms of depression.
Time frame: 7 days and 90 days post discharge
Population: Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=265)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver) | -0.919 change in PHQ-9 score | Standard Error 0.537 |
| SWSCM | Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver) | -1.0100 change in PHQ-9 score | Standard Error 0.56 |
| SWSCM and VSSP Website | Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver) | -0.947 change in PHQ-9 score | Standard Error 0.551 |
Comparison: Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.p-value: 0.993Mixed Models Analysis
Secondary
Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)
Patient questionnaire to assess knowledge, skills, and self-efficacy for managing one's own healthcare. Patient Activation Measure is a 13-item survey using a five-point Likert scale (strongly disagree, disagree, agree, strongly agree, NA) whose response items are summed and converted to an activation score ranging from 0-100. Higher scores indicate a higher level of activation.
Time frame: 7 days and 90 days post discharge
Population: Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=413)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient) | 0.874 change in PAM score | Standard Error 2.018 |
| SWSCM | Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient) | -0.777 change in PAM score | Standard Error 1.958 |
| SWSCM and VSSP Website | Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient) | 5.897 change in PAM score | Standard Error 1.919 |
Comparison: Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.p-value: 0.042Mixed Models Analysis
Other Pre-specified
Depression Symptoms (PHQ-9) (Patient)
Validated 9-item questionnaire to identify depressive symptoms.
Time frame: 90 day post discharge
Other Pre-specified
Home Time (Patient)
Total number of days spent at home since discharge back to home.
Time frame: 90 day post discharge
Other Pre-specified
Hospital Readmission (Patient)
Unscheduled hospital admissions
Time frame: 90 day post discharge
Other Pre-specified
NeuroQOL Anxiety Scale (Patient)
Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).
Time frame: 90 day post discharge
Other Pre-specified
Oberst Caregiver Burden Scale (OCBS) (Caregiver)
Validated 15-item questionnaire measuring caregiver burden in response to providing care to stroke survivors.
Time frame: 90 day post discharge
Other Pre-specified
PROMIS Emotional Support Scale (Caregiver).
A validated 4-item questionnaire measuring emotional support. Emotional support is defined as the perceived feeling of being cared for and valued as a person.
Time frame: 90-days post discharge
Other Pre-specified
PROMIS Informational Support Scale (Caregiver).
A validated 4-item questionnaire measuring informational support. Informational support is defined as the perceived availability of helpful information or advice.
Time frame: 90-days post discharge
Other Pre-specified
Stroke Recurrence (Patient)
New onset acute stroke events requiring hospital admission
Time frame: 90 day post discharge
Other Pre-specified
Unhealthy Days (Caregiver)
Number of days in the past 30 days that the caregiver reported that their own physical or mental health had not been good.
Time frame: 90-days post discharge