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Michigan Stroke Transitions Trial (MISTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653170
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
University of Michigan
Saint Joseph Mercy Health System
Sparrow Health System
Massachusetts General Hospital
Information provided by (Responsible Party):
Mathew Reeves, Michigan State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Acute Stroke
Interventions Other: SCM
Other: SCM and VSSP
Enrollment 320
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.

Arm/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description 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.

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.

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
Period Title: Overall Study
Started [1] 87 88 90
Completed 70 72 72
Not Completed 17 16 18
Reason Not Completed
Withdrawal by Subject             3             8             3
withdrawn by study team             2             4             5
Lost to Follow-up             12             4             10
[1]
Numbers are reported for patient participants only.
Arm/Group Title Usual Care SWSCM SWSCM and VSSP Website Total
Hide Arm/Group Description 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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 87 88 90 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 88 participants 90 participants 265 participants
65.2  (13.9) 67.5  (13.0) 66.1  (12.7) 66.2  (13.2)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age in years Number Analyzed 87 participants 88 participants 90 participants 265 participants
18-54.9
20
  23.0%
15
  17.0%
17
  18.9%
52
  19.6%
55-74.9
47
  54.0%
44
  50.0%
51
  56.7%
142
  53.6%
75+
20
  23.0%
29
  33.0%
22
  24.4%
71
  26.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
Female
42
  48.3%
48
  54.5%
41
  45.6%
131
  49.4%
Male
45
  51.7%
40
  45.5%
49
  54.4%
134
  50.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 87 participants 88 participants 90 participants 265 participants
White
66
  75.9%
68
  77.3%
75
  83.3%
209
  78.9%
Non-white
21
  24.1%
20
  22.7%
15
  16.7%
56
  21.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Non-Hispanic Number Analyzed 87 participants 88 participants 90 participants 265 participants
74
  85.1%
79
  89.8%
79
  87.8%
232
  87.5%
Recruitment Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
Sparrow Hospital (Lansing)
51
  58.6%
50
  56.8%
52
  57.8%
153
  57.7%
St. Joseph Mercy Hospital System (Ann Arbor)
22
  25.3%
25
  28.4%
26
  28.9%
73
  27.5%
University of Michigan Health System (Ann Arbor)
14
  16.1%
13
  14.8%
12
  13.3%
39
  14.7%
Required Proxy Consent   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
8
   9.2%
13
  14.8%
12
  13.3%
33
  12.5%
[1]
Measure Description: Proxy consent was required if patients failed the Six-Item Cognitive Screen (score of <=4) or had clinically documented cognitive deficits or stroke-related impairments sufficient to impact the consent process:
Stroke type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
Ischemic stroke
74
  85.1%
74
  84.1%
80
  88.9%
228
  86.0%
Hemorrhagic stroke
13
  14.9%
14
  15.9%
10
  11.1%
37
  14.0%
Stroke Severity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
Mild
66
  75.9%
60
  68.2%
64
  71.1%
190
  71.7%
Moderate
12
  13.8%
21
  23.9%
23
  25.6%
56
  21.1%
Severe
9
  10.3%
7
   8.0%
3
   3.3%
19
   7.2%
[1]
Measure Description: Stroke severity was documented at admission using the NIH-Stroke Scale (NIHSSS) or Glasgow Coma Scale (GCS). Severity was categorized as mild (NIHSS=1-5 and GCS=13-15), moderate (NIHSS=6-13 and GCS=5-12), or severe (NIHSS=14-42, GCS=3-4).
Modified Rankin Score (mRS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
Mild (score <=2)
62
  71.3%
62
  70.5%
54
  60.0%
178
  67.2%
Moderate/severe (score >2)
25
  28.7%
26
  29.5%
36
  40.0%
87
  32.8%
[1]
Measure Description: Modified Rankin Score documented at acute hospital discharge. Scores were categorized into mild (<=2) or moderate/severe (>2).
Days Between Stroke Admission and Discharge to Home   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 87 participants 88 participants 90 participants 265 participants
12.4  (11.7) 13.8  (9.7) 14.5  (11.2) 13.6  (10.9)
[1]
Measure Description: Duration of time from stroke admission until discharge to home. This includes acute hospital length of stay in addition to rehabilitation length of stay, if applicable.
Discharge Destination   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
Home
49
  56.3%
32
  36.4%
36
  40.0%
117
  44.2%
Inpatient Rehabilitation (IPR/IRF)
29
  33.3%
47
  53.4%
48
  53.3%
124
  46.8%
Sub-acute Rehabilitation (SAR)
9
  10.3%
9
  10.2%
6
   6.7%
24
   9.1%
[1]
Measure Description: Discharge destination immediately following discharge from acute stroke hospitalization.
History of Prior Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
12
  13.8%
18
  20.5%
11
  12.2%
41
  15.5%
History of Prior Transient Ischemic Attack (TIA)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
4
   4.6%
6
   6.8%
11
  12.2%
21
   7.9%
History of Myocardial Infarction  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
6
   6.9%
7
   8.0%
11
  12.2%
24
   9.1%
Coronary Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
17
  19.5%
16
  18.2%
25
  27.8%
58
  21.9%
Atrial Fibrillation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
12
  13.8%
17
  19.3%
8
   8.9%
37
  14.0%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
31
  35.6%
33
  37.5%
33
  36.7%
97
  36.6%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
60
  69.0%
67
  76.1%
78
  86.7%
205
  77.4%
Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
46
  52.9%
41
  46.6%
43
  47.8%
130
  49.1%
Living Alone Pre-Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
19
  21.8%
27
  30.7%
20
  22.2%
66
  24.9%
Caregiver consented to MISTT  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
58
  66.7%
57
  64.8%
54
  60.0%
169
  63.8%
Relationship to Consented Caregiver  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
spouse
33
  37.9%
33
  37.5%
36
  40.0%
102
  38.5%
Other
25
  28.7%
24
  27.3%
18
  20.0%
67
  25.3%
N/A - no caregiver consented
29
  33.3%
31
  35.2%
36
  40.0%
96
  36.2%
Living with Consented Caregiver  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 90 participants 265 participants
43
  49.4%
41
  46.6%
36
  40.0%
120
  45.3%
1.Primary Outcome
Title Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description:
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.

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.

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 Number of Participants Analyzed 70 72 72
Least Squares Mean (Standard Error)
Unit of Measure: change in T-score
0.293  (0.717) 1.263  (0.704) 3.663  (0.690)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, SWSCM, SWSCM and VSSP Website
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]
Method Mixed Models Analysis
Comments PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term
Method of Estimation Estimation Parameter difference-in-differences (DID) p-value
Estimated Value 0.025
Estimation Comments The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)
2.Primary Outcome
Title Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description:
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.

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.

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 Number of Participants Analyzed 70 72 72
Least Squares Mean (Standard Error)
Unit of Measure: change in T-score
1.187  (0.945) 0.123  (0.926) 1.445  (0.907)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, SWSCM, SWSCM and VSSP Website
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.562
Comments P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]
Method Mixed Models Analysis
Comments PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term
Method of Estimation Estimation Parameter difference-in-differences (DID) p-value
Estimated Value 0.562
Estimation Comments The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)
3.Primary Outcome
Title Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description:
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.

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.

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 Number of Participants Analyzed 44 43 42
Least Squares Mean (Standard Error)
Unit of Measure: change in score
1.934  (1.496) 0.646  (1.561) 1.961  (1.522)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, SWSCM, SWSCM and VSSP Website
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description:
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.

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.

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 Number of Participants Analyzed 70 72 72
Least Squares Mean (Standard Error)
Unit of Measure: change in PAM score
0.874  (2.018) -0.777  (1.958) 5.897  (1.919)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, SWSCM, SWSCM and VSSP Website
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference-in-differences (DID) p-value
Estimated Value 0.042
Estimation Comments The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)
5.Secondary Outcome
Title Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description:
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.

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.

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 Number of Participants Analyzed 44 43 42
Least Squares Mean (Standard Error)
Unit of Measure: change in PHQ-9 score
-0.919  (0.537) -1.0100  (0.560) -0.947  (0.551)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, SWSCM, SWSCM and VSSP Website
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]
Method Mixed Models Analysis
Comments [Not Specified]
6.Other Pre-specified Outcome
Title NeuroQOL Anxiety Scale (Patient)
Hide Description Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).
Time Frame 90 day post discharge
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Depression Symptoms (PHQ-9) (Patient)
Hide Description Validated 9-item questionnaire to identify depressive symptoms.
Time Frame 90 day post discharge
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Hospital Readmission (Patient)
Hide Description Unscheduled hospital admissions
Time Frame 90 day post discharge
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Stroke Recurrence (Patient)
Hide Description New onset acute stroke events requiring hospital admission
Time Frame 90 day post discharge
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Home Time (Patient)
Hide Description Total number of days spent at home since discharge back to home.
Time Frame 90 day post discharge
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Oberst Caregiver Burden Scale (OCBS) (Caregiver)
Hide Description Validated 15-item questionnaire measuring caregiver burden in response to providing care to stroke survivors.
Time Frame 90 day post discharge
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Unhealthy Days (Caregiver)
Hide Description 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
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title PROMIS Emotional Support Scale (Caregiver).
Hide Description 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
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title PROMIS Informational Support Scale (Caregiver).
Hide Description 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
Outcome Measure Data Not Reported
Time Frame 90-day study participation period
Adverse Event Reporting Description

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.

 
Arm/Group Title Usual Care SWSCM SWSCM and VSSP Website
Hide Arm/Group Description 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.

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.

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
All-Cause Mortality
Usual Care SWSCM SWSCM and VSSP Website
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)      2/88 (2.27%)      0/90 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care SWSCM SWSCM and VSSP Website
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/87 (1.15%)      2/88 (2.27%)      5/90 (5.56%)    
General disorders       
Admitted to Nursing Home or Long-term Care Facility * [1]  0/87 (0.00%)  0 1/88 (1.14%)  1 3/90 (3.33%)  3
Admitted to Hospice Care * [2]  1/87 (1.15%)  1 1/88 (1.14%)  1 2/90 (2.22%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Admitted to nursing home or long-term care facility
[2]
Admitted to Hospice Care
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Usual Care SWSCM SWSCM and VSSP Website
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/87 (0.00%)      0/88 (0.00%)      0/90 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mathew Reeves
Organization: Michigan State University
Phone: 517-353-8623
EMail: reevesm@msu.edu
Layout table for additonal information
Responsible Party: Mathew Reeves, Michigan State University
ClinicalTrials.gov Identifier: NCT02653170     History of Changes
Other Study ID Numbers: 135457
HIS-1310-07420-01 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) )
First Submitted: April 9, 2015
First Posted: January 12, 2016
Results First Submitted: May 4, 2018
Results First Posted: August 16, 2019
Last Update Posted: August 16, 2019