Treatment as Usual Site Training

Treatment as Usual Site Training
Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) Treatment as Usual Site Training 1

Outline of Presentation
Phase overview Inclusion/exclusion criteria Case identification and enrollment Forms

Data Collection Phases
Treatment as Usual Screening Alone Intervention Phase Slide 4 4

Data Collection Phases
In all phases: Patient enrollment in ED 5 follow-up phone calls In the Intervention Phase, subjects will receive additional telephone counseling Slide 5 5

Treatment as Usual Clinically, patients will be screened for self-harm and treated according to the usual care at the site We will use lessons learned from sites as we move into the next phases Slide 7 7

Treatment as Usual RAs will screen ED documentation (charts, electronic information systems) in “real time” to identify patients RAs will further screen anyone with evidence of any intentional self-harm ideation or behavior in the past week, including the current visit This will involve asking the clinicians for permission to approach the patient Slide 8 8

Treatment as Usual While clinical staff’s cooperation is vital, we do not want to introduce treatment contamination Emphasize that we don’t want clinical staff to do anything different than they ordinarily would The clinical staff should not be told to let the RAs know when a suicidal patient is present (i.e., referral) Slide 9 9

Phase Overview Inclusion/exclusion criteria Case identification and enrollment Forms

Inclusion Criteria Age ≥18 years
Suicidal ideation or behavior in the past week, including current visit Able to consent (alert, fully oriented, not intoxicated, able to paraphrase the study requirements) Willing to complete telephone follow-up assessments at 6, 12, 24, 36, 52 weeks Slide 11 11

Exclusion Criteria Medically/cognitively unable to participate
Currently dwelling in a non-community setting (e.g., acute psychiatric facility) Currently in state custody Pending legal action Lack of permanent residence Lack of reliable telephone service Insurmountable language barrier Already enrolled into ED-SAFE Slide 12 12

Site Enrollment Goal 60 subjects
30 subjects with suicidal ideation only in past week 30 subjects with suicidal attempt in past week 60 / 50 weeks = 1.2 / week Slide 14 14

Case Identification RA will screen in “real time” all charts for ED patients ≥18 years old who are triaged during their shift Use the ED triage log (tracking system) to monitor patients triaged during shift Slide 15 15

ED Coverage 40 hours/week required Shift days and hours flexible
Recommendations: coverage between noon and 10 pm one weekend day per month, minimum Target: screen ~50 charts/8-10 hr shift Slide 16 16

Case Identification (cont'd)
Will need to order patients chronologically by triage time Start screening chart of the first patient triaged after the start of the RA’s shift RAs may approach patients with documented self-harm if the patient is present in the ED when the shift starts even if the patient was triaged prior to the start of the RA’s shift. Slide 17 17

Screen all consecutive charts of patients ≥18 y.o. for any intentional self-harm thoughts or behaviors Approach patients who have documented self-harm thoughts/behaviors and who otherwise seem to meet eligibility criteria Slide 18 18

If chart or MD clearly identifies stable exclusion criteria, such as mental retardation, brain damage, homelessness, or insurmountable language barrier, then the patient does not have to be approached Slide 19 19

If chart or MD identifies transient exclusion criteria (e.g., intoxication) the patient should be “pending” or “warm” and approached later Pending patients should be “resolved” at the end of every shift Stable exclusion criteria Left ED before RA approach End of RA shift Slide 20 20

Eligibility If deemed “approachable,” RA completes the eligibility screening interview at the bedside If eligible, RA initiates consent process Should emphasize the importance of the study in helping us to understand how to better help people who are suicidal Should be a thorough discussion of responsibilities Allow patient a little time to think about it Slide 21 21

Eligibility Some may be eligible and interested, but the time may not be opportune (e.g., too distracted to participate during ED visit, busy with tests, being transferred to inpatient setting) May consent admitted or “boarded” patient within 48 hours of ED discharge “Warm” transfer Slide 22 22

04/15/10 Slide 23 23

Enrollment After consent, patient should be enrolled
Locator form – in ED Baseline assessment – in ED Chart review – after ED visit Utilization Summary – after ED visit Healthcare Utilization Forms – after ED visit Slide 24 24

Follow-up Assessments
6 and 12 months Utilization Summary Healthcare Utilization Form(s) Vital Statistics Form Slide 25 25

04/15/10

Forms Recommendation during shift: Paper-based Screening Log
REDCap (computer-based) forms for all other enrollment tasks (eligibility screening, locator form, baseline assessment)

Screening Log All charts screened in “real time” should be documented on the paper Screening Log during the shift All Screening Log data must be entered at least weekly into REDCap Shift screening summary Screening log ID #s automatically assigned in each database Slide 29 29

Screening Log (cont'd) Completeness of Screening Log (paper and REDCap) is a crucial part of the entire data collection process Helps RA to keep track of people in “real time” (paper) Will provide information for describing the representativeness of the sample and reasons for exclusion Will provide information for Quality Assurance efforts Slide 30 30

Screening Log (cont'd) Review all documentation available in the ED
At minimum, review the triage nursing notes Stop the review once you identify any self-harm and approach the patient When possible, review charts in order, but do not miss people with SI/SA. Screening ID # automatically assigned in REDCap; not necessary to include on paper version Slide 31 31

Screening Log (cont'd) Data collected include:
Shift start time, end time RA initials Order of presentation Triage time Age Sex Ethnicity and race Presence of self-harm thoughts or behavior Whether or not the patient was approached Name, MRN, bed – for site RA use only Slide 32 32

Screening Log (cont'd) Screening Log Order of Presentation
Patient’s Chart Reviewed Answer “no” if there was no chart available for review (e.g., pt registered and “in the system,” but left before any triage notes documented) or ED became too busy for you to keep up with screening Stop screening Self-harm Thoughts or behaviors Suicidal or non-suicidal Slide 33 33

Ethnicity and Race On Screening Log, record as it is documented in the chart / administrative databases Two distinct concepts, but some hospital systems treat them as the same Example 1 “Race” documented as Hispanic Record ethnicity as Hispanic; race as not documented Slide 34 34

Ethnicity and Race (cont'd)
Example 2 Race documented as Puerto Rican Record ethnicity as Hispanic; race as not documented Example 3 Ethnicity and race both documented as Hispanic Example 4 Documentation on the chart reads “white male” Record ethnicity as not documented; race as white * See the MOP for definitions Slide 35 35

Screening Log (cont'd) Requires Follow-up Patient Approached
Use to flag patients that require follow-up the next day For patients admitted with evidence of SI or SA with a potentially transient state that kept them from being enrolled in the ED (e.g., intoxication) Patient Approached Continue to Eligibility Screening Slide 36 36

Screening Log (cont'd) Quality Assurance
Regular review of REDCap by EMNet staff to compare against estimates/projections Cross-validation of screening logs against ED logs in a random sample of 5% of enrollment days Helps to ensure that the consecutive screening nature of the protocol is being applied with fidelity to avoid selection bias Slide 37 37

Eligibility All potentially eligible patients should be entered in real time into the REDCap Screening Log Enter the eligibility screening questions in the REDCap Screening Log Slide 38 38

Screening Log (cont'd) Shift Screening Summary Shift Date
Shift Start Time Shift End Time Slide 39 39

Eligibility Considerations
Ask to speak one-on-one with the patient if others are in the room Ask about self-harm and suicidal behavior even if the patient does not report self-harm or suicidal ideation Slide 40 40

Eligibility Screening
Assesses the following items: Self-harm and suicidal behavior and ideation If no suicidal behavior or ideation Characteristics that facilitate follow-up Phone always in service Wiling to participate in follow-up calls Permanent address and plan to stay there for 12 months If “no” to any of these characteristics Slide 41 41

Eligibility Screening (cont'd)
Self-harm and suicidal behavior and ideation Thoughts of self-harm in past week Thoughts of ending life in past week Tried to hurt self in past week Tried to kill self in past week Slide 42 42

Wallet Card All patients approached – regardless of whether or not they are enrolled – receive a wallet card with a national hotline phone # Slide 43 43

Patient Resources Give all patients who decline to participate or meet exclusion criteria site-specific resources used by the ED for patients with psychiatric issues For example: a list with local mental health providers and services Slide 44 44

Consent Forms Separate consent for each phase
Use color coded paper to easily identify TAU: Light blue Screening Alone: Light yellow Intervention: Light green Received a Certificate of Confidentiality (as stated on consent forms) Slide 45 45

Enrollment If an individual consents:
2 data collection “forms” need to be completed in the ED Locator form Baseline assessment Must record Subject ID # in the Screening Log. Slide 46 46

Subject ID# Each enrolled subject will have a unique Subject ID#
Assign a 6-digit ID#: First 3 digits will be your site # Second 3 digits will be the consecutive # assigned to each subject No dashes Subject ID # is only for enrolled subjects Important: record Subject ID # on the eligibility “form” (i.e., enter it into the REDCap Screening Log) Slide 47 47

Locator Form Complete the Locator Form before the baseline assessment
Record the subject’s preferred language (English or Spanish) Very important for all subjects to provide alternate contacts Emergency contact Non-cohabiting contact Slide 48 48

Locator Form (cont'd) However, subjects who are unable or unwilling to provide alternate contacts may still participate if they have a stable telephone and address Slide 49 49

Locator Form (cont'd) Ensure the subject has a working phone:
After interview, call the subject’s primary number to confirm that it rings If phone not in service, re-approach the patient and fix the problem If the problem cannot be resolved, the subject cannot continue (protocol violation; report by filling out questions at end of baseline assessment) Slide 50 50

Locator Form (cont'd) Any changes made to the locator data in REDCap after enrollment must be communicated to Ashley This is necessary so that the call center updates their records accordingly. Slide 51 51

Baseline Assessment Main constructs: Demographic information
Suicidal ideation and behavior – past week and lifetime Non-suicidal self-injury Lethal means restriction Drug and alcohol use Medical and psychological problems Quality of life Healthcare utilization Slide 52 52

Baseline Assessment (cont'd)
Use bedside computer and enter data directly into REDCap (REDCap will navigate the skip patterns for you) Estimated time to complete assessment Median = 30 minutes IQR = 20 to 40 minutes Slide 53 53

General Concepts If a patient refuses to answer a question, leave it blank in REDCap For questions that ask for exact numbers (e.g., # of suicide attempts) enter whole numbers. If a subject gives a range, take the average. Slide 54 54

Placard to help provide anchors for questions with multiple response options May be completed after the subject leaves the ED if the subject: already signed the written consent form is willing to finish the assessment in person or by phone within 48 hours Slide 55 55

Demographic information Fill in subject’s sex before starting interview Ethnicity and race Self-identified If a subject says that he/she is of Latino/Hispanic origin and their race is "other: Hispanic" or “other: Latino” ask follow-up questions to determine race. Slide 56 56

Suicidal Ideation and Behavior Adapted the Columbia Suicide Severity Rating Scale (C-SSRS) Separate C-SSRS training Will assess past week, including today AND lifetime (time he/she felt most suicidal) Read questions as written; many sound similar, but are slightly different Have subjects provide an answer in their own words Slide 57 57

Suicidal Ideation and Behavior Extensive branching logic built into REDCap # of suicide attempts: if subject unable to give exact #, ask for best estimate Possible that subject reports SI or SA during eligibility screen, but when asked details does not report these thoughts or behaviors Subject cannot participate Protocol violation (discussed later in presentation) Slide 58 58

Non-suicidal self-injury Lethal means restriction Brief Symptom Inventory Drug and alcohol use Slide 59 59

# of drinks per day “Not sure” or “loses count” ask for estimated range, and take the average Example: “3 to 5 drinks” would be entered as 4 “As much as possible”  follow up with, “OK, I’m trying to get a number. Would you say it was 10 or more?” If the subject says “yes” to the follow-up question, but still refused to quantify it exactly, then record “10” Slide 60 60

Smoking status “smoked in the last 30 days:” if the patient currently smokes cigarettes every day or some days, or if the patient quit smoking cigarettes within the last 30 days. If the person has tried a couple of cigarettes, ask the follow-up question: have you smoked a total of more than 5 packs, which is 100 cigarettes? If yes, and they no longer smoke regularly, they are a “former smoker.” If no, they are a “never smoker.” Slide 61 61

Quality of life Healthcare utilization Outpatient (includes urgent care) ED Hospitalizations Military service Slide 62 62

Subjects are paid for follow-up calls completed after they leave the ED (not for baseline assessment) $30 for calls at 6, 12, & 24 weeks $40 for calls at 36 & 52 weeks EMNet will tell sites who should be paid We therefore ask about SSN during the baseline assessment Slide 63 63

Options if a SSN is required for payment and the subject refuses to give it: Subject may participate without payment Withdraw from study (protocol violation) if subject refuses to participate without pay Slide 64 64

Wallet Card All patients approached – regardless of whether or not they are enrolled – receive a wallet card with a national hotline phone # Slide 65 65

Brochure All patients enrolled also receive a brochure that describes the study and expectations of participants. Enrolled subjects do NOT receive the list of patient resources. Slide 66 66

Chart Review In each phase, 2 groups have chart reviews:
Enrolled subjects (performed after index ED visit) Randomly selected ED patients from the period in which the site enrolled patients Note: For TAU, the retro chart review serves as #2 Slide 67 67

Chart Review (cont’d) Same form for all ED chart reviews
Use any documentation that occurred while the patient was in the ED If a patient has both a current and past history of an item, document the most recent time period in which the indicator was present Slide 68 68

Utilization Forms Completed for all enrolled subjects
Covers 6 month period prior to index ED visit Utilization Summary Healthcare Encounter Form

Utilization Summary Primary Purpose
Provides a retrospective count and date listing of ED visits and hospitalizations a subject has made over the past six months This information is used for calculating the number of separate Healthcare Encounter Forms that need to be completed

Utilization Summary (cont’d)
Data Sources Electronic records from ED/Hospital of subject enrollment Electronic records for the larger healthcare system affiliated with the ED/Hospital Total Visit Calculation ED visit (with discharge) + ED visit (with admission) + Direct hospital admits = Total Visits = # of Healthcare Encounter Forms to be completed

Utilization Summary (cont’d)
Dates of Review Baseline  Start date: 6 months prior to the index visit date End date: index visit date 6-mo  Start date: day after index visit (index date +1 day) End date: 6 mo after index visit 12 mo review  Start date: 6 mo after index visit + 1 day End date: 12 mo after index visit Example: index visit was on January 1, 2010 Baseline dates: June 1, 2009 – Jan 1, 2010 6-mo review dates: Jan 2 – June 1 12-mo review dates: June 2 – Jan 1, 2011

Healthcare Encounter Form
Primary Purpose Provide a detailed retrospective summary of individual ED visits and hospitalizations made by a subject, with an emphasis on intentional self-injury Used for measuring utilization outcomes, documentation and reporting of adverse events, and economic data analysis

Healthcare Encounter Form (cont’d)
Data Sources Electronic records from ED/Hospital of subject enrollment Paper-based charts from ED/Hospital of subject enrollment Electronic records for the larger healthcare system affiliated with the ED/Hospital

Multiple Form Completion The number of forms completed for the six-month interval will be determined by the Utilization Summary Form One form should be completed for each separate health encounter (ED visit or hospitalization), regardless of the reason for the encounter

Visit Type ED visit not resulting in hospital admission ED visit resulting in hospital admission Direct admission or transfer from another facility Slide 76 76

Visit Location If the visit did NOT occur at the index hospital, you may not have documentation available Fill out a healthcare encounter form, but record that documentation is not available REDCap will prompt you to stop the review Slide 77 77

If hospital admission (any type), select: a. medical admission and discharge; b. psychiatric admission (no medical hospital admission); or c. medical admission and transfer to a psychiatric admission Slide 78 78

Evidence of Intentional Self-injury
No, clearly not intentional  no evidence of intentional self-injury e.g., subject died of natural causes, subject stated injury was accidental Unsure or not documented in sufficient detail to determine  unable to determine from the documentation available Slide 79 79

Evidence of Intentional Self-injury (cont’d)
Probable, but inconclusive  supporting, but inconclusive evidence of intentional self-injury e.g., apparent intentional overdose but not witnessed, no self-reported self-injury, or no suicide note Yes, clear evidence  evidence of intentional self-injury e.g., there is a witness, a suicide note, or self-injury is self-reported to healthcare provider prior to death Slide 80 80

Evidence of Suicidal Ideation
No, clearly no intent to die  documentation that demonstrates no intent to die. e.g., subject denied suicidal ideation, stated that he/she was just trying to get attention, or state that it was accidental Unsure or not documented in sufficient detail to determine  documentation available is insufficient to make a determination Slide 81 81

Evidence of Suicidal Ideation (cont’d)
Probable, but inconclusive  apparent ideation, but the documentation is inconsistent or vague Yes, clear evidence  documentation of positive suicidal ideation or the subject stated they wanted to kill him/herself Slide 82 82

Event Narrative Crucial for AE reports Use the prompts in REDCap as a guide Include specific dates and times of the events as well as tests/interventions performed, diagnoses and outcomes. Extract from transcription reports, discharge summaries, etc. Slide 83 83

Special considerations Sites will be responsible for obtaining ICD9 codes, E and V codes, and CPT codes for each health encounter. May need to coordinate with hospital IT or billing/coding personnel

Outcome Assessment Forms
Utilization Summary Healthcare Encounter Form(s) Vital Statistics Review Slide 85 85

Outcome Assessment Forms
Frequency of Completion Six months post-enrollment Twelve months post-enrollment (covering only the last six months) Same process as at enrollment Slide 86 86

Healthcare Encounter Form
Completion of the healthcare encounter form will act as an electronic “prompt” for the EMNet Coordinating center to complete a separate form for the purpose of reporting adverse events and creating DSMB reports Slide 87 87

Vital Statistics Form Primary Purpose: Summarize the nature of the death of any subject who dies during project enrollment, regardless of cause of death.

Vital Statistics Form (cont’d)
Frequency of Completion To be completed immediately upon any knowledge of death of subject Death identified through chart review or notification by EMNet Also completed for subjects lost to follow-up (3 consecutive missed calls) Sites will be notified by EMNet of subjects lost to follow-up Slide 89 89

Data Sources Completed death certificate on record through state vital records programs Special Considerations Sites will need to establish local protocols and relationships with state vital records programs for conducting routine death certificate reviews Slide 90 90

“Not documented”  information missing on the death certificate “Not collected”  question not present on the death certificate Slide 91 91

REDCap Slide 92 92

Protocol Violations Violation  results in subject being terminated from the study Examples: Patient withdrawals from study mid-way through baseline assessment Patient enrolled, but ineligible Slide 93 93

Protocol Violations Violations captured on baseline assessment form
No separate reporting required Answer queries as needed Slide 94 94

Adverse Events We expect serious adverse events (SAEs), including suicide attempts or completion However, none of the SAEs can logically be related to the study procedures Most AE reporting is automated through REDCap Slide 95 95

Adverse Event Categorization, Identification and Reporting
Type Examples Ascertainment & Identification Reporting to EMNet Adverse Events Evidence of coercion to participate Distress during the assessment* Access of confidential information by a non-authorized person Non-suicidal self-injury* Site RA observation during subject enrollment Via Serious Adverse Events Death for any reason Suicide attempt Inpatient hospitalization ED Visit Suicidal Crisis Site RA chart review of subject medical history as part of 6 and 12 month outcome assessments + vital stats review UMass Call Center Butler Counseling Center Lifeline Crisis Center Embedded in REDCap Forms  NO ACTION REQUIRED BY RA CATI Interview Form Counseling Call Form Lifeline Form * Distress and non-suicidal self-injury are ascertained/identified and reported to EMNet like a SAE

Adverse Event Reporting
Report coersion and non-authorized access to confidential information to Ashley via Must report: Subject ID# Date of event Description of event Description of action(s) taken as a result of AE Slide 97 97

AE and SAE Review and Reporting
EMNet Coordinating Center Reviews all AE and SAE data received via , REDCap, follow-up assessments and counseling calls. Obtains additional information from reporting sources Completes AE forms

AE and SAE Review and Reporting
SAEs reported to NIMH, ED-SAFE Steering Committee, and site PI within 72 hours EMNet completes and distributes Monthly AE and SAEs reports to NIMH, Steering Committee and site PIs Comprehensive review of AEs and SAEs conducted 3 times/year by DSMB and Steering Committee

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