CompletedNCT02653170MISTTUpdated Aug 16, 2019Results posted

Michigan Stroke Transitions Trial

An interventional study of SCM and SCM and VSSP in Acute Stroke, sponsored by Michigan State University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-16.

Sponsored by Michigan State University · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 320
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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:

Usual care
Stroke Case Manager (SCM): trained social workers who provide home based case management services
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.

Conditions studied

Acute Stroke

Browse trials for

Stroke 7,286

Keywords

acute stroke
care transitions
patient engagement
patient education
caregivers
social workers

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 320 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Michigan State University is the lead sponsor of 139 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility 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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 320 participants (actual)

Study arms

No intervention
Usual Care
Patients in this group will receive the hospitals' usual transitional care approach.
Experimental
SCM
One intervention is provided: 1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services.
Other: SCM
Experimental
SCM and VSSP
Two interventions are provided: 1. SCM (Stroke Case manager): a trained social worker who provides in-home case management services. Plus: 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.
Other: SCM and VSSP

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.

What researchers measure

Primary outcomes

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
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
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

Secondary outcomes

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
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

Other outcomes

NeuroQOL Anxiety Scale (Patient)
Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).
Time frame: 90 day post discharge
Depression Symptoms (PHQ-9) (Patient)
Validated 9-item questionnaire to identify depressive symptoms.
Time frame: 90 day post discharge
Hospital Readmission (Patient)
Unscheduled hospital admissions
Time frame: 90 day post discharge
Stroke Recurrence (Patient)
New onset acute stroke events requiring hospital admission
Time frame: 90 day post discharge
Home Time (Patient)
Total number of days spent at home since discharge back to home.
Time frame: 90 day post discharge
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
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
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
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

Results

Posted Aug 16, 2019

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.

Participant flow — Overall Study
Milestone	Usual Care	SWSCM	SWSCM and VSSP Website
Started	87	88	90
Completed	70	72	72
Not completed	17	16	18
Withdrew: Withdrawal by subject	3	8	3
Withdrew: Withdrawn by study team	2	4	5
Withdrew: Lost to follow-up	12	4	10

Outcome measures

PrimaryChange 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
Reported as:: Least squares mean · change in T-score

Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)
change in T-score	Usual Care	SWSCM	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)	0.293 ± 0.717	1.263 ± 0.704	3.663 ± 0.690

Statistical analysis

Usual Care vs SWSCM vs SWSCM and VSSP Website · Mixed Models Analysis · p = 0.025 (P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]) · Difference-in-differences (did) p-value: 0.025The 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)

PrimaryChange 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
Reported as:: Least squares mean · change in T-score

Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)
change in T-score	Usual Care	SWSCM	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)	1.187 ± 0.945	0.123 ± 0.926	1.445 ± 0.907

Statistical analysis

Usual Care vs SWSCM vs SWSCM and VSSP Website · Mixed Models Analysis · p = 0.562 (P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]) · Difference-in-differences (did) p-value: 0.562The 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)

PrimaryChange 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
Reported as:: Least squares mean · change in score

Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)
change in score	Usual Care	SWSCM	SWSCM and VSSP Website
Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)	1.934 ± 1.496	0.646 ± 1.561	1.961 ± 1.522

Statistical analysis

Usual Care vs SWSCM vs SWSCM and VSSP Website · Mixed Models Analysis · p = 0.789 (P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\])

SecondaryChange 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
Reported as:: Least squares mean · change in PAM score

Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)
change in PAM score	Usual Care	SWSCM	SWSCM and VSSP Website
Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)	0.874 ± 2.018	-0.777 ± 1.958	5.897 ± 1.919

Statistical analysis

Usual Care vs SWSCM vs SWSCM and VSSP Website · Mixed Models Analysis · p = 0.042 (P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]) · Difference-in-differences (did) p-value: 0.042The 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)

SecondaryChange 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
Reported as:: Least squares mean · change in PHQ-9 score

Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)
change in PHQ-9 score	Usual Care	SWSCM	SWSCM and VSSP Website
Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)	-0.919 ± 0.537	-1.0100 ± 0.560	-0.947 ± 0.551

Statistical analysis

Usual Care vs SWSCM vs SWSCM and VSSP Website · Mixed Models Analysis · p = 0.993 (P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\])

Other pre-specifiedNeuroQOL Anxiety Scale (Patient)

Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).

Time frame:: 90 day post discharge