Mental HealthNCT00296140
Implementing Evidence in the Detection and Treatment of Post Stroke Depression
A study testing self management of PSD symptoms and screening and treatment of PSD in people with Mental Health and Neurology, run by VA Office of Research and Development at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Neurology, Health Services
- What is being tested?
- self management of PSD symptoms and screening and treatment of PSD
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Dec 2006to 31 Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: Implementation Evidence in the Detection and Treatment of Post-stroke Depression
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.
Read the 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).
- Conditions
- Mental Health, Neurology, Health Services
- Being tested
- self management of PSD symptoms, screening and treatment of PSD
- Keywords
- post-stroke depression, clinical reminder, self-management
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self management of PSD symptomsBehavioural
screening and treatment of PSDProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| self management of PSD symptoms | Other | Not described Receives: Behavioral: self management of PSD symptoms |
| screening and treatment of PSD | Other | Not described Receives: Procedure: screening and treatment of PSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9
Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms
Measured: 6 months
Secondary outcomes (2)
SS-QOL
Stroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study start13 Dec 2006
- Primary completion30 Jun 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, outcome-blinded (PROBE) design. Intervention based on the Chronic Care Model
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Richard L. Roudebush VA Medical Center, Malcom Randall VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Linda S. Williams, MD, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296140
- Sponsor's protocol ID
- IMV 04-096
- Status last verified
- Aug 2018
- First submitted
- 22 Feb 2006
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1002/j.2048-7940.2007.tb00183.x.
PubMed 18065147Damush 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 considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):68-71. doi: 10.1007/s11606-009-1123-5.
PubMed 20077155
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Evidence in the Detection and Treatment of Post-stroke Depression
- ClinicalTrials.gov ID
- NCT00296140
- Acronym / sponsor ID
- IMV 04-096
- Conditions
- Mental Health, Neurology, Health Services
- Keywords
- post-stroke depression, clinical reminder, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Richard L. Roudebush VA Medical Center, Malcom Randall VA Medical Center
- Study start
- 13 Dec 2006 (actual)
- Primary completion
- 30 Jun 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, outcome-blinded (PROBE) design. Intervention based on the Chronic Care Model
| Arm | Type | Receives |
|---|---|---|
| self management of PSD symptoms | Other | Behavioral: self management of PSD symptoms |
| screening and treatment of PSD | Other | Procedure: screening and treatment of PSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self management of PSD symptoms | Behavioural | self management of PSD symptoms |
| screening and treatment of PSD | Procedure or surgery | screening and treatment of PSD |
Primary outcome
PHQ-9
Time frame: 6 months
Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms
2 secondary outcomes
SS-QOL
Time frame: 6 months
Self-efficacy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18065147Damush 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. doi: 10.1002/j.2048-7940.2007.tb00183.x.
- Results publication: PubMed 20077155Damush 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 considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):68-71. doi: 10.1007/s11606-009-1123-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda S. Williams, MD principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self management of PSD symptoms and screening and treatment of PSD in people with Mental Health and Neurology, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.