Implementing Evidence in the Detection and Treatment of Post Stroke Depression

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296140
• Other study ID #: IMV 04-096
• Status: Completed
• Phase: N/A
• Start date: December 13, 2006
• Est. completion date: December 31, 2009

Study information

• Verified date: August 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2009
• Est. primary completion date: June 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Health Services
• Mental Health
• Neurology

Intervention

Behavioral:
• self management of PSD symptoms

Procedure:
• screening and treatment of PSD

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Malcom Randall VA Medical Center, Richard L. Roudebush VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Damush TM, Jackson GL, Powers BJ, Bosworth HB, Cheng E, Anderson J, Guihan M, LaVela S, Rajan S, Plue L. Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerati — View Citation

Damush TM, Plue L, Bakas T, Schmid A, Williams LS. Barriers and facilitators to exercise among stroke survivors. Rehabil Nurs. 2007 Nov-Dec;32(6):253-60, 262. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PHQ-9	Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms	6 months
Secondary	SS-QOL	Stroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.	6 months
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	6 months