Trial Outcomes & Findings for Michigan Stroke Transitions Trial (NCT NCT02653170)
NCT ID: NCT02653170
Last Updated: 2019-08-16
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
320 participants
Primary outcome timeframe
7 days and 90 days post discharge
Results posted on
2019-08-16
Participant Flow
Patients and their caregivers were recruited from three mid-Michigan hospital stroke units. MISTT recruitment started in January 2016 and concluded in July 2017.
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.
Participant milestones
| Measure |
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.
|
SWSCM
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
87
|
88
|
90
|
|
Overall Study
COMPLETED
|
70
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
18
|
Reasons for withdrawal
| Measure |
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.
|
SWSCM
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
3
|
|
Overall Study
withdrawn by study team
|
2
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
10
|
Baseline Characteristics
Michigan Stroke Transitions Trial
Baseline characteristics by cohort
| Measure |
Usual Care
n=87 Participants
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.
|
SWSCM
n=88 Participants
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.
|
SWSCM and VSSP Website
n=90 Participants
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.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
|
Age, Customized
Age in years · 18-54.9
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Age, Customized
Age in years · 55-74.9
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
142 Participants
n=4 Participants
|
|
Age, Customized
Age in years · 75+
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Non-white
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
74 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Recruitment Site
Sparrow Hospital (Lansing)
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
|
Recruitment Site
St. Joseph Mercy Hospital System (Ann Arbor)
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Recruitment Site
University of Michigan Health System (Ann Arbor)
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Required Proxy Consent
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Stroke type
Ischemic stroke
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
|
Stroke type
Hemorrhagic stroke
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Stroke Severity
Mild
|
66 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Stroke Severity
Moderate
|
12 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Stroke Severity
Severe
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Modified Rankin Score (mRS)
Mild (score <=2)
|
62 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Modified Rankin Score (mRS)
Moderate/severe (score >2)
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Days Between Stroke Admission and Discharge to Home
|
12.4 days
STANDARD_DEVIATION 11.7 • n=5 Participants
|
13.8 days
STANDARD_DEVIATION 9.7 • n=7 Participants
|
14.5 days
STANDARD_DEVIATION 11.2 • n=5 Participants
|
13.6 days
STANDARD_DEVIATION 10.9 • n=4 Participants
|
|
Discharge Destination
Home
|
49 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Discharge Destination
Inpatient Rehabilitation (IPR/IRF)
|
29 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Discharge Destination
Sub-acute Rehabilitation (SAR)
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
History of Prior Stroke
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
History of Prior Transient Ischemic Attack (TIA)
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
History of Myocardial Infarction
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Coronary Artery Disease
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Atrial Fibrillation
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Diabetes
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Hypertension
|
60 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
|
Hyperlipidemia
|
46 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Living Alone Pre-Stroke
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Caregiver consented to MISTT
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
|
Relationship to Consented Caregiver
spouse
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Relationship to Consented Caregiver
Other
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Relationship to Consented Caregiver
N/A - no caregiver consented
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Living with Consented Caregiver
|
43 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days and 90 days post dischargePopulation: 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)
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).
Outcome measures
| Measure |
Usual Care
n=70 Participants
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.
|
SWSCM
n=72 Participants
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
SWSCM and VSSP Website
n=72 Participants
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
|
|---|---|---|---|
|
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
|
1.263 change in T-score
Standard Error 0.704
|
3.663 change in T-score
Standard Error 0.690
|
PRIMARY outcome
Timeframe: 7 days and 90 days post dischargePopulation: 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)
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).
Outcome measures
| Measure |
Usual Care
n=70 Participants
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.
|
SWSCM
n=72 Participants
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
SWSCM and VSSP Website
n=72 Participants
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
|
|---|---|---|---|
|
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
|
0.123 change in T-score
Standard Error 0.926
|
1.445 change in T-score
Standard Error 0.907
|
PRIMARY outcome
Timeframe: 7 days and 90 days post dischargePopulation: 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)
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.
Outcome measures
| Measure |
Usual Care
n=44 Participants
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.
|
SWSCM
n=43 Participants
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
SWSCM and VSSP Website
n=42 Participants
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
|
|---|---|---|---|
|
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
|
0.646 change in score
Standard Error 1.561
|
1.961 change in score
Standard Error 1.522
|
SECONDARY outcome
Timeframe: 7 days and 90 days post dischargePopulation: 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)
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.
Outcome measures
| Measure |
Usual Care
n=70 Participants
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.
|
SWSCM
n=72 Participants
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
SWSCM and VSSP Website
n=72 Participants
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
|
|---|---|---|---|
|
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
|
-0.777 change in PAM score
Standard Error 1.958
|
5.897 change in PAM score
Standard Error 1.919
|
SECONDARY outcome
Timeframe: 7 days and 90 days post dischargePopulation: 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)
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.
Outcome measures
| Measure |
Usual Care
n=44 Participants
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.
|
SWSCM
n=43 Participants
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
SWSCM and VSSP Website
n=42 Participants
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
|
|---|---|---|---|
|
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
|
-1.0100 change in PHQ-9 score
Standard Error 0.560
|
-0.947 change in PHQ-9 score
Standard Error 0.551
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 day post dischargeValidated QOL scale measuring patient anxiety (administered by computer adaptive testing).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 day post dischargeValidated 9-item questionnaire to identify depressive symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 day post dischargeUnscheduled hospital admissions
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 day post dischargeNew onset acute stroke events requiring hospital admission
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 day post dischargeTotal number of days spent at home since discharge back to home.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 day post dischargeValidated 15-item questionnaire measuring caregiver burden in response to providing care to stroke survivors.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-days post dischargeNumber of days in the past 30 days that the caregiver reported that their own physical or mental health had not been good.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-days post dischargeA validated 4-item questionnaire measuring emotional support. Emotional support is defined as the perceived feeling of being cared for and valued as a person.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90-days post dischargeA validated 4-item questionnaire measuring informational support. Informational support is defined as the perceived availability of helpful information or advice.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
SWSCM
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
SWSCM and VSSP Website
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=87 participants at risk
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.
|
SWSCM
n=88 participants at risk
One intervention is provided:
1\. SWSCM (Social Work Case Management) program: a trained social worker provides in-home case management services.
SWSCM: 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 as 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 and activation.
5. Facilitate patient and caregiver engagement and activation.
6. Facilitate access to social and community services.
|
SWSCM and VSSP Website
n=90 participants at risk
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
|
|---|---|---|---|
|
General disorders
Admitted to Nursing Home or Long-term Care Facility
|
0.00%
0/87 • 90-day study participation period
Serious Adverse Event: reported if admitted to Hospice Care or a Nursing Home/Long-term Care Facility Other Adverse Event: not collected NOTE: hospital readmissions were collected as a secondary outcome measure and were not included in the Adverse Event reporting.
|
1.1%
1/88 • Number of events 1 • 90-day study participation period
Serious Adverse Event: reported if admitted to Hospice Care or a Nursing Home/Long-term Care Facility Other Adverse Event: not collected NOTE: hospital readmissions were collected as a secondary outcome measure and were not included in the Adverse Event reporting.
|
3.3%
3/90 • Number of events 3 • 90-day study participation period
Serious Adverse Event: reported if admitted to Hospice Care or a Nursing Home/Long-term Care Facility Other Adverse Event: not collected NOTE: hospital readmissions were collected as a secondary outcome measure and were not included in the Adverse Event reporting.
|
|
General disorders
Admitted to Hospice Care
|
1.1%
1/87 • Number of events 1 • 90-day study participation period
Serious Adverse Event: reported if admitted to Hospice Care or a Nursing Home/Long-term Care Facility Other Adverse Event: not collected NOTE: hospital readmissions were collected as a secondary outcome measure and were not included in the Adverse Event reporting.
|
1.1%
1/88 • Number of events 1 • 90-day study participation period
Serious Adverse Event: reported if admitted to Hospice Care or a Nursing Home/Long-term Care Facility Other Adverse Event: not collected NOTE: hospital readmissions were collected as a secondary outcome measure and were not included in the Adverse Event reporting.
|
2.2%
2/90 • Number of events 2 • 90-day study participation period
Serious Adverse Event: reported if admitted to Hospice Care or a Nursing Home/Long-term Care Facility Other Adverse Event: not collected NOTE: hospital readmissions were collected as a secondary outcome measure and were not included in the Adverse Event reporting.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place