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Implementing Evidence in the Detection and Treatment of Post Stroke Depression

Implementation Evidence in the Detection and Treatment of Post-stroke Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00296140
Enrollment
66
Registered
2006-02-24
Start date
2006-12-13
Completion date
2009-12-31
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Services, Mental Health, Neurology

Keywords

post-stroke depression, clinical reminder, self-management

Brief summary

Post Stroke Depression (PSD)is a high volume condition with negative impact on patient recovery after stroke. The primary aim of this study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and started on treatment for PSD. The secondary aim is evaluate whether a patient-based self-management intervention provides any additional benefit compared to usual care.

Detailed description

Objective: The investigators' immediate objective is to test a system intervention to evaluate which aspects of the intervention are critical to improving the quality of care for veterans with PSD, and to refine it to prepare for the investigators' long-term objective: a multi-site study across multiple facilities and Veteran Integrated Service Networks (VISNs). To address the immediate objective, the investigators will evaluate two specific study aims using a quasi-experimental design comparing improvement in depression screening and treatment in veteran stroke survivors receiving care at two facilities receiving the intervention. The primary aim of the study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and treated for PSD. The system intervention is based on extending the use of the current depression performance measure that mandates yearly depression screening in VA primary care clinics to target veteran stroke survivors following-up in Veterans Administration (VA) Primary Care or Neurology clinics within six months of stroke. The primary outcome is the effect of the intervention on depression screening and treatment rates. The secondary aim of the study is to evaluate whether a patient-based self-management intervention provides additional benefit beyond the system intervention alone in improving patient depression symptoms, quality of life, and self-efficacy compared to usual post-stroke care. Subjects for the secondary aim will be recruited from the two intervention sites and will be randomized, stratified by site, to the patient intervention or usual care. Hypotheses/Key Research Questions: Specific Aim 1: To determine whether the system implementation intervention improves a) detection, and b) guideline-adherent treatment of PSD. Aim 1 Hypotheses: Compared to the base rate of PSD screening and treatment at the two intervention facilities, the system intervention will result in at least a 25% increase in: a) The proportion of Veterans screened for PSD in the first six months after stroke, and b) The proportion of Veterans with PSD that receive guideline-adherent depression treatment. Specific Aim 2: To determine the effect of a patient self-management intervention in improving a) guideline-adherent treatment of PSD, and b) patient-centered outcomes after stroke. Aim 2 Hypotheses: Compared to Veterans receiving usual post-stroke care, Veterans receiving the self-management intervention will have: a) fewer depression symptoms, and b) improved quality of life and reduced health-related fears. Research Plan: Specific Aim 1: The investigators developed clinical teams at the two intervention facilities, and worked with these front-line providers to develop two depression reminders: a screening reminder used by clinic intake personnel, and a provider reminder triggered by any positive screen. The reminders were tailored to the clinical system at each site. The investigators are gathering administrative and chart review data on Veterans with ischemic stroke hospitalized at any of the VISN 8 or 11 VA Medical Center (VAMC) facilities during the 18-month cohort enrollment period. These data allow us to identify patients who follow up in either Primary Care or Neurology, identify whether they were screened and the screening result, and identify actions taken in response to a positive screen. Chart review allows us to examine depression screening and treatment that takes place even if the screening reminder is not used. The investigators will compare these data during the study period to chart review data for the 12 months prior to study initiation in both Primary Care and Neurology clinics at each site and to administrative data for all VISN 8 and 11 facilities (estimated number of patients in both VISNs is 822). For Specific Aim 2, the investigators are recruiting hospitalized Veterans for ischemic stroke at the Indianapolis or Gainesville VAMC, age 18 or older, able to speak and understand English, no severe cognitive impairments, access to a telephone, willing to follow-up at VA outpatient care, willing to participate in interviews, and life expectancy of at least six months. For Aim 2, the investigators plan to recruit 75 stroke patients into the Aim 2 self-management cohort. Methodology: Aim 1: All data will be obtained from chart review and from the VA administrative databases that are part of the usual clinic care of the patients. These data include International Classification of Diseases (ICD)-9 codes extracted from Patient Treatment File main as well as basic demographics (i.e., age, gender, race, ethnicity, depression screening results, antidepressants prescribed, and number and type of outpatient follow-up appointments in the six months after stroke). All outcome data for this aim will be collected from electronic medical records Aim 2: Data for the self-management program will be collected via patient interviews during the course of the study. The baseline interview will take place prior to hospital discharge or within two weeks of discharge. Two other interviews for outcome assessment will be done by phone at three and six months post-stroke. Intervention patients will also receive a self-management program over the first six months post-stroke. The program consists of six sessions delivered either in person or by phone and four additional follow-up calls to assess goal-setting, behaviors, and study outcomes. Based upon the investigators' earlier work, patients have expressed an interest in the following topics: expectations after stroke, negative/positive thinking, fears, creating a daily schedule, follow-up care, communication with providers, adapting/coping with disabilities, community resources and communication with caregivers. These topics will be addressed in the six sessions. Control patients will get baseline, three, and six-month interviews with the same outcome assessments. They will be provided American Stroke Association printed literature about stroke risk factors, warning signs, and community resources. They will receive one individual session prior to discharge or within two weeks of discharge focusing on stroke symptoms and risk factor education. They will receive the same number of calls at similar frequency to the intervention patients but the calls will generically cover how they are doing since their stroke and will not address goal setting, post-stroke behaviors, or self-management strategies. The primary outcome for the patient self-management intervention is depression symptoms (Patient Health Questionnaire-9 (PHQ-9) score). Secondary outcomes include depression treatment, quality of life (measured by the Stroke-specific Quality of Life (SS-QOL) scale), self-efficacy, fear of injury, and stroke outcomes (patient-reported modified Rankin scale).

Interventions

BEHAVIORALself management of PSD symptoms
PROCEDUREscreening and treatment of PSD

Sponsors

Richard L. Roudebush VA Medical Center
CollaboratorFED
Malcom Randall VA Medical Center
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Prospective, randomized, outcome-blinded (PROBE) design. Intervention based on the Chronic Care Model

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aim 1 - veterans with ischemic stroke hospitalized at any of the VISN 8 or 11 facilities during the 18th month enrollment period. * Aim 2 - veterans hospitalized at the Indianapolis or Gainesville VAMC's.

Exclusion criteria

* Aim 1 - none * Aim 2 - 18 or younger, unable to speak or understand English, severe cognitive impairments, no access to telephone, not willing to follow-up at VA for outpatient care, unwilling to participate in interviews and/or life expectancy less than 6 months.

Design outcomes

Primary

MeasureTime frameDescription
PHQ-96 monthsPatient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms

Secondary

MeasureTime frameDescription
SS-QOL6 monthsStroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.
Self-efficacy6 monthsPatient-reported self-efficacy for stroke symptom management, range 1.0 - 10.0, higher scores indicate greater self-efficacy for stroke symptom management

Countries

United States

Participant flow

Participants by arm

ArmCount
Self Management of PSD Symptoms
Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.
30
Screening and Treatment of PSD
Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
33
Total63

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDischarge to Nursing Home10
Overall StudyLost to Follow-up10
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicScreening and Treatment of PSDTotalSelf Management of PSD Symptoms
Age, Continuous64.0 years
STANDARD_DEVIATION 8.4
65.6 years
STANDARD_DEVIATION 10.3
67.3 years
STANDARD_DEVIATION 12.4
Caregiver Present
No
21 Participants40 Participants19 Participants
Caregiver Present
Yes
12 Participants23 Participants11 Participants
Living status
Alone
11 Participants18 Participants7 Participants
Living status
With 2 or more others
5 Participants13 Participants8 Participants
Living status
With one other
17 Participants32 Participants15 Participants
National Institute of Health Stroke Scale score2.0 points2.0 points3.0 points
Race/Ethnicity, Customized
Black
7 Participants13 Participants6 Participants
Race/Ethnicity, Customized
Unknown
5 Participants6 Participants1 Participants
Race/Ethnicity, Customized
White
21 Participants44 Participants23 Participants
Region of Enrollment
United States
33 participants63 participants30 participants
Sex: Female, Male
Female
1 Participants1 Participants0 Participants
Sex: Female, Male
Male
32 Participants62 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
7 / 3311 / 33
serious
Total, serious adverse events
2 / 330 / 33

Outcome results

Primary

PHQ-9

Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms

Time frame: 6 months

Population: Comparison of PHQ-9 scores between intervention and control groups

ArmMeasureValue (MEAN)Dispersion
Self Management of PSD SymptomsPHQ-96.4 units on a scaleStandard Deviation 6
Screening and Treatment of PSDPHQ-94.4 units on a scaleStandard Deviation 5.1
Secondary

Self-efficacy

Patient-reported self-efficacy for stroke symptom management, range 1.0 - 10.0, higher scores indicate greater self-efficacy for stroke symptom management

Time frame: 6 months

Population: Comparison of self-rated self efficacy for managing stroke symptoms between intervention and control subjects

ArmMeasureValue (MEAN)Dispersion
Self Management of PSD SymptomsSelf-efficacy8.8 units on a scaleStandard Deviation 3.1
Screening and Treatment of PSDSelf-efficacy8.5 units on a scaleStandard Deviation 3.7
Secondary

SS-QOL

Stroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.

Time frame: 6 months

Population: Comparison of overall SS-QOL scores between intervention and control subjects

ArmMeasureValue (MEAN)Dispersion
Self Management of PSD SymptomsSS-QOL4.0 units on a scaleStandard Deviation 0.9
Screening and Treatment of PSDSS-QOL4.1 units on a scaleStandard Deviation 0.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026