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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA202699 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of California, San Diego | OTHER |
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Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Further, even the recent small decline in smoking rates that has been reported in the general population in the past decade has not occurred among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US are by individuals with a psychiatric disorder and the primary cause of death among Americans with an SMI is a tobacco-related disease.
This cluster randomized trial will be conducted in 14 Philadelphia community mental health clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of adherence to guidelines for treating TUD will be greater among clinic personnel that receive the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention and at a 3-month follow-up, rates of client smoking cessation will be significantly greater in clinics that receive the ATTOC intervention than among clients treated with usual care; and 3) using non-inferiority testing, at the end of the intervention and at a 3-month follow-up, there will be no significant degradation in mental health functioning or QOL among clients who receive care at clinics that received the ATTOC intervention than among clients treated with usual care.
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Transforming the mental healthcare system to integrate and adhere to evidence-based guidelines for the provision of tobacco use disorder (TUD) treatment is a priority of the National Institute of Mental Health and is a critical component of a national effort to meet Healthy People 2020 target goals for tobacco use (www.healthypeople.gov).
The Addressing Tobacco Through Organizational Change (ATTOC) model is a systems-level intervention to address systemic and cultural barriers that undermine assessment and treatment of TUD. In this innovative way, ATTOC assumes that effective organizational change requires more than clinic personnel training; it also requires the application of organizational theory to address attitudinal and system barriers and promote a culture in which tobacco use is not accepted or supported and that TUD treatment is integrated into standard practice. Consistent with organizational theory, ATTOC is implemented in 3 phases: preparing for, implementing, and sustaining change. By addressing cultural barriers and strengthening the care system (e.g., integrated treatment), ATTOC intends to have sustained benefits beyond the intervention.
This cluster-randomized trial will be conducted with 14 Philadelphia CMHCs, 7 randomized to ATTOC and 7 to usual care (UC). Following randomization, study staff will visit sites to recruit clinic personnel and clients over a 4 to 6 week period. Those eligible will complete informed consent and HIPAA forms and a baseline assessment to establish pre-intervention levels on all measures (baseline). After 4-6 weeks, the ATTOC intervention will be implemented over 9 months, from Week 1 to Week 36 (with UC at the control sites). Two mid-intervention assessments (Weeks 12 and 24) will allow for performance feedback and mediational analyses. Week 36 (end-of-treatment; EOT) and 52 (3-months post-EOT) assessments will allow for evaluation of changes on outcomes between groups over time. All measures will be conducted at the respective CMHC (or over the phone if necessary) and 7-day point prevalence smoking cessation will be verified using a breath carbon monoxide (CO) monitor (abstinence = < 8ppm).
This will be the first controlled, randomized trial to evaluate the effects of the ATTOC model on clinician adherence to treatment guidelines, client smoking, and client mental health and QOL. If this approach is shown to be effective and safe, it can serve as a model for the nation's community mental healthcare infrastructure, representing a powerful initiative to address tobacco use in an under-served sub-group of smokers, and support efforts to attain the Healthy People 2020 goals regarding tobacco use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTOC | Experimental | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence |
|
| Usual Care | Other | Usual Care is the typical guideline based smoking cessation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTOC Intervention | Behavioral | ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Reported Tobacco Medications | Client-reported use of tobacco treatment for nicotine dependence measured via self-report | Week 36 & Week 52 |
| Rate of Medication to Treat Nicotine Dependence - EHR | Frequency of provision of medications for nicotine dependence measured via electronic health record (EHR) data for clients. | Week 36 & Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation Rate | Change in proportion of smoking from baseline to follow-up time-points for clients | Week 36 & Week 52 |
| Mental Health Functioning | Mental health functioning was measured using the Revised Behavior and Symptom Identification Scale (BASIS-R), a 24-item assessment of mental health functioning that yields a total score and subscale scores for: depression, interpersonal relationships, self-harm, emotional liability, psychosis, and substance abuse. The total overall score was used. The 24 questions are scored on a 5-pointscale (from 0 to 4) with higher numbers indicating greater symptom/problem frequency or severity. The overall score can range from a 0 to a 96. |
| Measure | Description | Time Frame |
|---|---|---|
| S-KAP: Staff-Reported Tobacco Treatment Treatment | The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26. | Week 36 and Week 52 |
Inclusion Criteria (clinic client participants):
Exclusion Criteria (clinic client participants):
Inclusion Criteria (Clinic personnel participants):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Schnoll, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Once the final analyses are conducted to address the specific aims of this project, study data will be made available to other qualified researchers. The investigators plan to create a mechanism to allow such researchers to apply for access to these data.
Final analyses will be conducted after all participant activities have been completed, approximately 9/2021. Once the final analyses are conducted to address the specific aims of this project, study data will be made available.
Study data will be made available to other qualified researchers. The investigators plan to create a mechanism to allow such researchers to apply for access to these data.
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| ID | Title | Description |
|---|---|---|
| FG000 | ATTOC Clients | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. |
| FG001 | ATTOC Staff | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. Staff from community mental healthcare clinics. |
| FG002 | Usual Care Clients | Usual Care is the typical guideline based smoking cessation intervention UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. |
| FG003 | UC Staff | Usual Care is the typical guideline based smoking cessation intervention UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. Staff from community mental healthcare clinics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Descriptive statistics characterized the sample; chi-square for categorical variables (e.g., race) and ANOVA for continuous variables (e.g., age) compared the study arms. Variables that were significantly different across arms were included as covariates in modeling of outcomes.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Clients | Usual Care is the typical guideline based smoking cessation intervention UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Client Reported Tobacco Medications | Client-reported use of tobacco treatment for nicotine dependence measured via self-report | Below is it specified the number of participants were analyzed at each timepoint for this outcome. | Posted | Count of Participants | Participants | Week 36 & Week 52 |
|
Adverse events were assessed at their week 36 and week 52 visit. Adverse events were monitored through from enrollment through study completion, up to 60 weeks.
The definition of an adverse event matches the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ATTOC Clients | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ORG0010 | Psychiatric disorders | Systematic Assessment | On 3/15/2017, ORG0010 was reportedly hospitalized for a duration of 30 days due to a psychotic episode and hearing voices. We were informed of this information from the participant on 6/5/2017, during their Week 36 visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Schnoll | University of Pennsylvania | 2157467143 | schnoll@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2022 | Dec 7, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2021 | Oct 24, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| UC Intervention | Behavioral | Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. |
|
| Week 36 & Week 52 |
| Short-Form Health Survey Emotional | The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the emotional section of questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 8-30. | Week 36 & Week 52 |
| Short-Form Health Survey Physical | The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the physical functioning section of the questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 5-15. | Week 36 and Week 52 |
| S-KAP: Staff-Reported Barriers to Treat Tobacco | The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more barriers to tobacco treatment with the range of scores being 0-13. | Week 36 and Week 52 |
| S-KAS: Client Reported Tobacco Treatment Treatment From Staff | The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items. Higher scores mean more tobacco treatment and the range of scores is 7-35. | Week 36 and Week 52 |
| S-KAP: Staff-Reported Skills to Treat Tobacco Treat Tobacco | The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective).The scores are from the summed items. Higher scores equal more skills and the range of scores is: 0-26. | Week 36 and Week 52 |
| S-KAS: Client Reported Tobacco Services and Policies Services and Policies | The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items Higher scores equal more tobacco services. The range of scores is: 1-14. | Week 36 and Week 52 |
| Withdrawal by Subject |
|
| BG001 | ATTOC Clients | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. |
| BG002 | Usual Care Staff | Usual Care is the typical guideline based smoking cessation intervention UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. |
| BG003 | ATTOC Staff | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Usual Care is the typical guideline based smoking cessation intervention
UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
|
|
| Primary | Rate of Medication to Treat Nicotine Dependence - EHR | Frequency of provision of medications for nicotine dependence measured via electronic health record (EHR) data for clients. | Below is it specified the number of participants were analyzed at each timepoint for this outcome | Posted | Count of Participants | Participants | Week 36 & Week 52 |
|
|
|
| Secondary | Smoking Cessation Rate | Change in proportion of smoking from baseline to follow-up time-points for clients | Below is it specified the number of participants were analyzed at each timepoint for this outcome | Posted | Count of Participants | Participants | Week 36 & Week 52 |
|
|
|
| Secondary | Mental Health Functioning | Mental health functioning was measured using the Revised Behavior and Symptom Identification Scale (BASIS-R), a 24-item assessment of mental health functioning that yields a total score and subscale scores for: depression, interpersonal relationships, self-harm, emotional liability, psychosis, and substance abuse. The total overall score was used. The 24 questions are scored on a 5-pointscale (from 0 to 4) with higher numbers indicating greater symptom/problem frequency or severity. The overall score can range from a 0 to a 96. | Below is it specified the number of participants were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Scores on a scale | Week 36 & Week 52 |
|
|
|
| Secondary | Short-Form Health Survey Emotional | The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the emotional section of questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 8-30. | Below is it specified the number of participants were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from SF-12 (emotion questions) | Week 36 & Week 52 |
|
|
|
| Secondary | Short-Form Health Survey Physical | The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the physical functioning section of the questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 5-15. | Below is it specified the number of participants were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from SF-12 (physical questions) | Week 36 and Week 52 |
|
|
|
| Other Pre-specified | S-KAP: Staff-Reported Tobacco Treatment Treatment | The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26. | Below it is specified the number of participants that were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from S-KAP | Week 36 and Week 52 |
|
|
|
| Other Pre-specified | S-KAP: Staff-Reported Barriers to Treat Tobacco | The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more barriers to tobacco treatment with the range of scores being 0-13. | Below it is specified the number of participants that were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from S-KAP | Week 36 and Week 52 |
|
|
|
| Other Pre-specified | S-KAS: Client Reported Tobacco Treatment Treatment From Staff | The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items. Higher scores mean more tobacco treatment and the range of scores is 7-35. | Below it is specified the number of participants that were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from S-KAS | Week 36 and Week 52 |
|
|
|
| Other Pre-specified | S-KAP: Staff-Reported Skills to Treat Tobacco Treat Tobacco | The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective).The scores are from the summed items. Higher scores equal more skills and the range of scores is: 0-26. | Below it is specified the number of participants that were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from S-KAP | Week 36 and Week 52 |
|
|
|
| Other Pre-specified | S-KAS: Client Reported Tobacco Services and Policies Services and Policies | The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items Higher scores equal more tobacco services. The range of scores is: 1-14. | Below it is specified the number of participants that were analyzed at each timepoint for this outcome | Posted | Mean | Standard Deviation | Score from S-KAS | Week 36 and Week 52 |
|
|
|
| 8 |
| 344 |
| 34 |
| 344 |
| 0 |
| 344 |
| EG001 | Usual Care Clients | Usual Care is the typical guideline based smoking cessation intervention UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. | 6 | 266 | 15 | 266 | 0 | 266 |
| EG002 | ATTOC Personnel | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence ATTOC Intervention: ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. Staff from community mental healthcare clinics. | 2 | 131 | 0 | 131 | 0 | 131 |
| EG003 | Usual Care Personnel | Usual Care is the typical guideline based smoking cessation intervention UC Intervention: Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. Staff from community mental healthcare clinics. | 0 | 91 | 0 | 91 | 0 | 91 |
|
| ORG0008 | Psychiatric disorders | Systematic Assessment | On 4/13/2017, ORG0008 was reportedly hospitalized for a duration of 5 days due to a psychotic episode. We were informed of this information from the participant on 6/8/2017, during their Week 36 visit. |
|
| ORG0029 | Psychiatric disorders | Systematic Assessment | On 5/10/2017, ORG0029 was reportedly hospitalized for a duration of 1 day due to a psychotic episode. We were informed of this information from the participant on 6/8/2017, during their Week 36 visit. |
|
| ORG0079 | Psychiatric disorders | Systematic Assessment | On 5/29/2017, ORG0079 was reportedly hospitalized for a duration of 19 days due to a psychotic episode. We were informed of this information from the participant on 6/22/2017, during their Week 36 visit. |
|
| ORG0098 | Psychiatric disorders | Systematic Assessment | On 11/25/2016, ORG0098 was reportedly hospitalized for a duration of 12 days due to suicidal thoughts or behaviors. On 3/15/2017, ORG0098 was reportedly hospitalized for a duration of 7 days due to suicidal thoughts or behaviors. |
|
| ORG0084 | Psychiatric disorders | Systematic Assessment | On 1/15/2017, ORG0084 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/13/2017, during their Week 36 visit. |
|
| ORG0093 | Psychiatric disorders | Systematic Assessment | On 2/4/2017, ORG0093 was reportedly hospitalized for a duration of 10 days due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/18/2017, during their Week 36 visit. |
|
| ORG0087 | Psychiatric disorders | Systematic Assessment | On 4/4/2017, ORG0087 was reportedly hospitalized for a duration of 9 days due to a psychotic episode. We were informed of this information from the participant on 7/19/2017, during their Week 36 visit. |
|
| ORG101 | Psychiatric disorders | Systematic Assessment | On 6/15/2017, ORG0101 was reportedly hospitalized for a duration of 1 day due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/18/2017, during their Week 36 visit. |
|
| ORG0012 | Psychiatric disorders | Systematic Assessment | On 6/22/2017, ORG0012 was reportedly hospitalized for a duration of 7 days due to a psychotic episode. We were informed of this information from the participant on 10/4/2017, during their Week 52 visit. |
|
| ORG0019 | Psychiatric disorders | Systematic Assessment | On 9/1/2017, ORG0019 was reportedly hospitalized for a duration of 30 days due to a psychotic episode. We were informed of this information from the participant on 10/3/2017, during their Week 52 visit. |
|
| ORG0022 | Psychiatric disorders | Systematic Assessment | On 9/8/2017, ORG0022 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behaviors. We were informed of this information from the participant on 10/9/2017, during their Week 52 visit. |
|
| ORG0013 | Psychiatric disorders | Systematic Assessment | On 9/10/2017, ORG0013 was reportedly hospitalized for a duration of 4 days due to "a high anxiety level". We were informed of this information from the participant on 10/5/2017, during their Week 52 visit. |
|
| ORG0246 | Psychiatric disorders | Systematic Assessment | On 9/15/2017, ORG0246 was reportedly hospitalized for a duration of 5 days due to suicidal thoughts or behavior. We were informed of this information from the participant on 3/19/2018, during their Week 36 visit. |
|
| ORG0327 | General disorders | Systematic Assessment | On 9/15/2017, ORG0327 was reportedly hospitalized for a duration of 7 days due to a drug or alcohol overdose. We were informed of this information from the participant on 5/22/2018, during their Week 36 visit. |
|
| ORG0346 | Psychiatric disorders | Systematic Assessment | On 10/25/2017, ORG0346 was reportedly hospitalized for a duration of 11 days due to a psychotic episode. On 6/5/2018, ORG0346 was reportedly hospitalized for a duration of 21 days for "drug rehab and depression". |
|
| ORG0198 | Psychiatric disorders | Systematic Assessment | On 10/28/2017, ORG0198 was reportedly hospitalized for a duration of 2 days due to a psychotic episode. We were informed of this information from the participant on 11/14/2017, during their Week 36 visit. |
|
| ORG0299 | General disorders | Systematic Assessment | On 1/16/2018, ORG0299 was reportedly hospitalized for a duration of 28 days due to alcohol use. We were informed of this information from the participant on 5/21/2018, during their Week 36 visit. |
|
| ORG0162 | Psychiatric disorders | Systematic Assessment | On 2/2/2018, ORG0162 was reportedly hospitalized for a duration of 7 days due to homicidal or aggressive behavior. We were informed of this information from the participant on 2/12/2018, during their Week 52 visit. |
|
| ORG0203 | Psychiatric disorders | Systematic Assessment | On 4/11/2018, ORG0203 was reportedly hospitalized for a duration of 8 days due to suicidal thoughts or behavior. We were informed of this information from the participant on 6/26/2018, during their Week 52 visit. |
|
| ORG0305 | Psychiatric disorders | Systematic Assessment | On 1/15/2018, ORG0305 was reportedly hospitalized for a duration of 21 days due to a psychotic episode. We were informed of this information from the participant on 9/17/2018, during their Week 52 visit. |
|
| ORG0415 | General disorders | Systematic Assessment | On 5/21/2018, ORG0415 was reportedly hospitalized for a duration of 30 days due to an unknown reason. On 5/21/2018, ORG0415 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behavior. |
|
| ORG0374 | Psychiatric disorders | Systematic Assessment | On 2/15/2018, ORG0374 was reportedly hospitalized for a duration of 6 days due to self-harm. On 9/15/2018, ORG0374 was reportedly hospitalized for a duration of 6 days due to suicidal thoughts or behavior. |
|
| ORG0348 | Psychiatric disorders | Systematic Assessment | On 4/15/2018, ORG0348 was reportedly hospitalized for a duration of 28 days due suicidal thoughts or behavior. On 9/24/2018, ORG0348 was reportedly hospitalized for a duration of 21 day due to a psychotic episode. |
|
| ORG0390 | Psychiatric disorders | Systematic Assessment | On 4/26/2018, ORG0390 was reportedly hospitalized for a duration of 14 days due to suicidal thoughts or behavior. On 6/29/2018, ORG0390 was reportedly hospitalized for a duration of 7 days due to an unknown reason |
|
| ORG0426 | General disorders | Systematic Assessment | On 6/13/2018, ORG0426 was reportedly hospitalized for a duration of 1 day due to "medication change". We were informed of this information from the participant on 10/23/2018, during their Week 36 visit. |
|
| ORG0362 | General disorders | Systematic Assessment | On 7/15/2018, ORG0362 was reportedly hospitalized for a duration of 21 days due to an unknown reason. We were informed of this information from the participant on 10/16/2018, during their Week 36 visit. |
|
| ORG0367 | Psychiatric disorders | Systematic Assessment | On 8/5/2018, ORG0367 was reportedly hospitalized for a duration of 30 days due to suicidal thoughts or behavior. We were informed of this information from the participant on 2/14/2019, during their Week 52 visit. |
|
| ORG0380 | Psychiatric disorders | Systematic Assessment | On 8/16/2018, ORG0380 was reportedly hospitalized for a duration of 33 days due to a psychotic episode. We were informed of this information from the participant on 10/15/2018, during their Week 36 visit. |
|
| ORG0487 | General disorders | Systematic Assessment | On 9/1/2018, ORG0487 was reportedly hospitalized for a duration of 14 days due to a drug or alcohol overdose. We were informed of this information from the participant on 1/8/2019, during their Week 36 visit. |
|
| ORG0364 | Psychiatric disorders | Systematic Assessment | On 9/8/2018, ORG0364 was reportedly hospitalized for a duration of 6 days due to homicidal or aggressive behavior. We were informed of this information from the participant on 10/15/2018, during their Week 36 visit. |
|
| ORG0372 | Psychiatric disorders | Systematic Assessment | On 10/2/2018, ORG0372 was reportedly hospitalized for a duration of 7 days due to suicidal thoughts or behaviors. On 1/15/2019, ORG0372 was reportedly hospitalized for a duration of 7 days due to suicidal thoughts or behaviors. |
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| ORG0421 | Psychiatric disorders | Systematic Assessment | On 10/10/2018, ORG0421 was reportedly hospitalized for a duration of 5 days due to a psychotic episode. On 11/7/2018, ORG0421 was reportedly hospitalized for a duration of 23 days "to be put on medication". |
|
| ORG0389 | Psychiatric disorders | Systematic Assessment | On 12/25/2018, ORG0389 was reportedly hospitalized for a duration of 5 days due to a psychotic episode. We were informed of this information from the participant on 2/13/2019, during their Week 52 visit. |
|
| ORG0425 | General disorders | Systematic Assessment | On 2/6/2019, ORG0425 was reportedly hospitalized for a duration of 7 days due to "drug rehab". We were informed of this information from the participant on 2/13/2019, during their Week 52 visit. |
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| ORG0475 | General disorders | Systematic Assessment | On 2/27/2019, ORG0475 was reportedly hospitalized for a duration of 28 days due to an unknown reason. We were informed of this information from the participant on 4/17/2019, during their Week 52 visit. |
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| ORG0479 | Psychiatric disorders | Systematic Assessment | On 4/6/2019, ORG0479 was reportedly hospitalized for a duration of 13 days due to a psychotic episode. We were informed of this information from the participant on 4/18/2019, during their Week 52 visit. |
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| ORG0620 | Psychiatric disorders | Systematic Assessment | they reported they were hospitalized on 12/10/2019 for 30 days for a psychotic episode. they reported they were hospitalized on 9/15/2019 for 2 days for a medication adjustment. They were also hospitalized on 6/15/2019 for 7 days for the same reason. |
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| ORG0705 | Psychiatric disorders | Systematic Assessment | During ORG0705 Week 36 session, they reported they were hospitalized on 9/26/2019 for 9 days for self-harm. |
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| ORG0759 | Psychiatric disorders | Systematic Assessment | During ORG0759 Week 36 session, they reported they were hospitalized on 1/15/2020 for 14 days for a psychotic episode. |
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| ORG0619 | General disorders | Systematic Assessment | On 3/26/2020, we were informed that ORG0619 is in rehab for an unknown duration. |
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| ORG0740 | General disorders | Systematic Assessment | During ORG0740 Week 36 session, they reported they were hospitalized on 7/25/2019 for 16 days for an unknown reason |
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| ORG0727 | Psychiatric disorders | Systematic Assessment | During ORG0727 Week 36 session, they reported they were hospitalized on 12/3/2019 for 14 days for a psychotic episode. |
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| ORG0772 | General disorders | Systematic Assessment | On 05/14/2020, we were informed that ORG0772 was in the hospital due to COVID-19 complications. |
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| ORG0922 | Gastrointestinal disorders | Systematic Assessment | On 11/23/2020, during the ORG0922 baseline session ppt expressed that he had been in the hospital for 12 days problems going to the bathroom. |
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| ORG0881 | General disorders | Systematic Assessment | On 3/18/2021 during the Week 12 session, ORG0881 informed a research team member that they were in the hospital from 2/18/2021-3/10/2021 due to being "302'd" (involuntarily admitted) by their sister and for having Covid-19. |
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| ORG0920 | Social circumstances | Systematic Assessment | On 5/26/2021 during the Week 24 session, ORG0920 reported that she'd been in a car accident on 5/17/21. As of 5/26 she is still in the hospital and cannot walk, but she is getting physical therapy. |
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| ORG0880 | Renal and urinary disorders | Systematic Assessment | On 8/18/2021 ORG0880 reported that she had been hospitalized on 7/24/2021 for a kidney infection. She spent 5 days at the hospital before being transferred to Immaculate Mary for inpatient rehab, which ended on 8/12/2021. |
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| ORG0101 | Psychiatric disorders | Systematic Assessment | On 6/15/2017, ORG0101 was reportedly hospitalized for a duration of 1 day due to suicidal thoughts or behaviors. We were informed of this information from the participant on 7/18/2017, during their Week 36 visit. |
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