Implementing Evidence in the Detection and Treatment of Post Stroke Depression

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).

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.