Implementation Evidence in the Detection and Treatment of Post-stroke Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- PHQ-9
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
self management of PSD symptoms
Intervention: self management of PSD symptoms (Behavioral)
screening and treatment of PSD
Intervention: screening and treatment of PSD (Procedure)
Outcomes
Primary Outcomes
PHQ-9
Time Frame: 6 months
Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms
Secondary Outcomes
- SS-QOL(6 months)
- Self-efficacy(6 months)