A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)
Phase: NA
Conditions: Opioid-use Disorder, Emergency Department
Sponsor: University of Washington

I. STUDY IDENTIFICATION INFORMATION 
TITLE OF PROTOCOL: Emergency Department Longitudinal Integrated Care 2.0 (ED-LINC 
2.0) 
 
PRINCIPAL INVESTIGATOR: Lauren Whiteside MD MS 
 
FUNDER OF PROTOCOL: National Institute of Drug Abuse (NIDA) 
 
CLINICALTRIALS.GOV: A description of this clinical trial will be available on 
http://www.clinicaltrials.gov, as required by U.S. Law. NCT03699085 
 
Protocol Version date: November 12, 2018 
 
 

 
 
II. STUDY OVERVIEW 
A. Background and Rationale 
The overarching goal of this investigation is to develop and determine the feasibility of a 
multi-component intervention adapted from a collaborative care framework initiated in 
the ED for patients at risk for opioid use disorder.  According to the 2015 national survey 
on drug use and health, an estimated 3.8 million individuals over 12 years of age were 
currently misusing opioid pain relievers.  An additional 329,000 people use heroin.  The 
Emergency Department (ED) is currently at the forefront of this public health emergency 
and often a place where patients come for treatment of overdose and for treatment of 
medical problems related to illicit opioid use or prescription opioid misuse (POM).  
Additionally, patients with substance use disorders use the ED more than patients 
without substance use disorders and the ED can often be a place where patients with 
opioid use disorder (OUD) can present for any type of medical care and may be a place 
where patients with OUD seek treatment.  There is a growing body of evidence that 
patients with OUD who are started on treatment in the ED with buprenorphine are more 
likely to be engaged in substance use treatment at 30 days.1  Additionally, other ED-
based interventions such as take-home naloxone2 and brief intervention utilizing 
principles of motivational interviewing3,4 have a growing body of evidence.  Additionally 
previous work has been done evaluating care coordination programs from the ED 
showing decreases in ED utilization and opioid prescriptions5,6.  However, to date, there 
has been no study which has aimed to combine these elements into a single 
intervention. 
 
Collaborative care is a comprehensive patient-centered model of healthcare delivery 
targeting behavioral health or substance use that stems from the chronic disease 
management framework.  While collaborative care interventions have been tested in 
primary care, substance use treatment centers and inpatient settings, the feasibility of a 
collaborative care intervention aimed at patients in the ED at-risk for OUD has not been 
established.  This investigation aims to establish the feasibility of the ‘Emergency 
Department Longitudinal Integrated Care 2.0’ intervention or ED-LINC for patients at risk 
for OUD from the ED.  Elements of ED-LINC are based on evidence based treatments 
and are central components of collaborative care.  ED-LINC will be supported by a novel 
Emergency Department Information Exchange (EDIE) technology platform that allows 
for the creation of ED care plans and electronic alerts and will assist in care coordination 
of this complex population.  Overall, this study will provide important feasibility 
information for future studies of ED-LINC.   
 
B. Method and Design 
Patients in the ED ≥ 18 years of age will undergo pre-screening via the electronic 
medical record (EMR) screening for increased risk for opioid use disorder. Patients who 
are at risk based on the EMR pre-screen will be approached for additional screening 
procedures. After verbal consent is obtained, patients will be asked questions regarding 
risk behaviors including questions about lifetime heroin use and prescription opioid 
misuse.  Patients who endorse lifetime heroin use will be administered the NIDA 
mASSIST for heroin or illicit opioids.  Patients who endorse lifetime prescription opioid 
misuse will be administered the NIDA mASSIST for misuse of prescription opioids.  
Patients who endorse chronic opioid therapy prescribed by a provider for a pain 
condition that is chronic will be excluded.  If patients receive a NIDA m-ASSIST score of 
four or higher for heroin or illicit opioids or for prescription opioids will be assessed 

further for eligibility using the participant eligibility summary (PES).  Eligible participants 
will undergo informed consent procedures and a total of 60 participants will be 
randomized to the collaborative care intervention (n = 30) or care as usual (n =30) 
condition. Intervention activity will continue for three months after the ED visit, while 
follow-up continues for six months after the ED visit.  Primary outcomes include 
feasibility.  Secondary outcomes include substance use measured by days of use of 
opioids as well as utilization of healthcare services including ED visits, primary care 
visits, mental health visits and substance use treatment visits. 
 
1. Aims and Hypotheses 
1) The primary aim of the investigation is to determine the feasibility of the 
collaborative care intervention initiated from the ED and delivered longitudinally.  
Taken together, all elements of the intervention are referred to as ED-LINC.  
Feasibility measures include enrollment rates, retention rates at each outcome and 
follow-up assessment, intervention completion rates and number and types of 
contacts made by the interventionist.  Feasibility of implementation will also be 
assessed.  Guided by Proctor’s taxonomy of implementation outcomes7, 
acceptability, feasibility and fidelity to ED-LINC will be measured. 
 
2) The secondary aims of the study are to determine differences in substance use 
and health care utilization between the two arms.  While the study is not powered 
to detect a difference as this is a feasibility pilot study, substance use and health 
care utilization will be measured.  Specifically, substance use will be measured 
utilizing a time-line follow back calendar administered by the research assistant to 
determine days of heroin or illicit opioid use and days of prescription opioid misuse.  
Additionally, EDIE will be utilized to determine ED utilization and inpatient 
admissions across Washington, Oregon, Alaska and other areas that EDIE is 
active.  Participants will provide self-report information on primary care visits, 
mental health and substance use treatment visits.  Engagement in substance use 
treatment will be confirmed via phone by study staff at all periods of assessment. 
 
2. Participants 
a. Inclusion Criteria: 
• Aged 18-65 
• Patients with at least one risk factor for opioid use disorder via the EMR pre-screen 
• Patients with score of ≥ 4 on the NIDA modified ASSIST for illicit opioids (e.g. 
heroin) OR a score of ≥ 4 on the NIDA modified ASSIST for prescription opioids  
• Currently have a phone 
• Able to provide a phone number and one additional piece of contact information 
 
b. Exclusion Criteria: 
• They are incarcerated or under arrest 
• Non-English speaking 
• Live beyond a 50 mile radius of HMC 
• Require active resuscitation in the ED or other clinical area at the time of RA 
approach 
• Are receiving palliative care services or hospice care for a chronic illness such as 
metastatic cancer 
• Are in the ED or hospital for a primary psychiatric emergency such as suicidal 
ideation or attempt 

• Receiving chronic opioid therapy (COT) defined as prescription opioids for most 
days out of the last 90 days for a chronic pain condition 
• In the ED for sexual assault 
 
3. Recruitment and Retention Estimates 
Estimates for the recruitment plan are based on literature related to feasibility 
studies.  Specifically, the sample size of this pilot is related to the pragmatics of 
recruitment and a sample of n=30 for each group is related to the necessity for 
examining feasibility including rates of refusal for each group as well as retention in 
both arms.8  Previous work by the research team delivering collaborative care from 
the ED for patients with injury and prescription drug misuse (ED-LINC 1.0) described 
excellent recruitment and retention rates of > 80% over six months for subjects 
getting the intervention.9  Therefore the study intends to recruit at least 30 
participants per arm with retention rates at each assessment and/or follow-up time 
point of 80%. 
 
III. STUDY PROCEDURES 
A. EMR pre-screen OR staff referral 
The study team will be accessing and obtaining PHI from the HMC electronic medical 
record (EMR) to determine if patients have risk for opioid problems or opioid use 
disorder.  Specifically, each morning a member of the study team will review the current 
census of patients in the ED and first determine if they are eligible based on criteria 
listed above easily obtainable (e.g. age, chief complaint) by looking at the track shell 
using FirstNet.  Next, the study team member will look at the EMR for possible eligible 
participants to see if one of the following items exists in the EMR which are associated 
with an increased risk of opioid use disorder based on literature: 
 
• 
Previous overdose 
• 
Diagnosis of OUD in the problem list 
• 
Previous healthcare visit related to substance use 
• 
Chief complaint for the current ED visit suggestive of injection drug use 
o Skin/soft tissue complaint 
o Request for detox or concern for withdrawal 
o Overdose 
• 
Any EDIE criteria which includes: 
▪ 
5 ED visits in 12 months 
▪ 
PMP criteria  
• 
More than three (3) prescribers within 12 months 
• 
 More than 4 controlled substance II-V prescriptions within 12 
months 
• 
More than 2 controlled substance II-V prescriptions within last 40 
days 
• 
Any prescription for Methadone, Suboxone, fentanyl transdermal, 
LA morphine, and LA oxycodone within last 6 months 
• 
Any overlapping prescriptions for narcotics (controlled substance 
II-V) and benzodiazepines within last 6 months 
• 
More than 100 average MED/day prescribed within last 40 days 
▪ 
Care Plan 
• 
From HMC 
• 
From other hospital 

▪ 
Patient Requiring Coordination (PRC) program 
 
 
In addition to using the EMR pre-screen, the study team will take referrals from staff 
working with patients in the ED.  Specifically, structured assessments are often provided 
to patients while in the ED and if a patient is known to be at-risk for OUD, the study team 
can be notified to perform further self-report screening (see below). 
 
If the study team has approached all possible eligible patients in the ED based on EMR 
pre-screen criteria and have exhausted staff referrals for the time being, they can 
continue to approach possible eligible participants based on eligibility criteria listed in 
Section 2 with the self-report screening questions (e.g. universal screening). 
 
B. Approach and verbal consent for verbal screen and additional eligibility criteria 
After reviewing eligibility criteria as described above, a study team member will go to the 
Emergency Department (ED) at HMC.  First, appropriateness of the study for the 
participant will be determined by discussing with a member of the care team if possible 
(e.g. physician or nurse) and determining if the patient has an appropriate mental status 
for screening.  The study team member will then introduce themselves to the patient and 
gauge interest in hearing more about the screen.  Specifically, the study team member 
will let the patient know that they are here with ‘ED-LINC, a project being conducted out 
of the Emergency Department at Harborview and can I ask you a few questions to see if 
you are a good fit for our project’.  Once verbal consent is obtained, the study team 
member will proceed with self-report screening which includes the NIDA m-ASSIST for 
illicit opioids and prescription opioid misuse.10  Participants who endorse any use of illicit 
opioids and/or misuse of prescription opioids in the past 3 months AND have a score of 
≥ 4 on the ASSIST are eligible for enrollment. 
 
A member of the research team will then complete the patient eligibility summary (PES) 
that includes the following:  
 
• 
NIDA modified-ASSIST for illicit opioids or prescription opioid misuse is ≥ 4 
(yes/no) 
• 
Between 18-65 years old (yes/no) 
• 
English speaking (yes/no) 
• 
Medical or injury complaint (e.g. not psych) (yes/no) 
• 
Current address is within 50 miles of HMC and valid for six months (yes/no) 
• 
Has a cell phone or phone number (yes/no) 
• 
Can provide one additional contact (yes/no) 
• 
Not currently receiving hospice or palliative care (yes/no) 
• 
Currently receiving prescribed opioids from a physician for most days out of 90 
(yes/no). 
 
If all answers in the PES confirm eligibility, the potential participant will be offered the 
opportunity to hear more about the study.  If the patient has a NIDA m-ASSIST score for 
illicit opioids or prescription opioid misuse  ≥ 4 but is otherwise ineligible, they will be 
provided a resources list (see Resources Hand Out).  More information on informed 
consent can be found in Section IV Human Subjects Protocol. 
 

C. Obtaining written Informed Consent for those with positive OUD screen and 
confirmed eligibility on the PES 
 
The study team member will provide an overview of the study and provide an unsigned 
copy of the informed consent to the potential participant, allowing ample time to read.  If 
the patient is interested in participating, the study team member will review the informed 
consent verbally with the participant, answer any questions and obtain a signature on 
the consent form located in RedCap.  If a patient does not want to consent to the study, 
the study team member will politely inquire rationale behind the refusal and this will be 
tracked as part of the main outcome related to feasibility.  In previous studies, reasons 
for refusal at this point have included ‘too much pain’, ‘not interested’, ‘do not want to do 
follow-up surveys and/or other study procedures’ and ‘discharged and don’t want to 
wait’. 
 
D. Randomization 
After participants have undergone informed consent, the randomization procedure will 
take place.  The investigation will employ a blocked randomization strategy with random 
assignment of block size of either 4 or 6 participants.  Randomization will also be 
stratified by inclusion for prescription opioid misuse based on a NIDA m-ASSIST score 
of ≥ 4 for prescription opioid misuse.  It is hypothesized that the majority of participants 
will screen in for illicit opioid use and stratified randomization will be used to ensure 
balance of participants with prescription opioid misuse given this is an important but 
likely small population of participants.  Participants will be randomized to the following 
conditions: 
 
a. Usual Care control condition 
b. ED-LINC 2.0 
 
Study condition will be assigned using the RedCap randomization module which will be 
programmed prior to study start by a data analyst.  After the study team member obtains 
informed consent, randomization of condition will be performed using RedCap and the 
participant will be notified of their random assignment. 
 
E. Baseline Interview  
The study team member will next administer the baseline assessment.  The additional 
survey items will be administered via RedCap by the study team member and is 
anticipated to take an additional 20-30 minutes.  Specifically, the study team member 
administering the survey will enter the responses directly into RedCap or assist the 
participant with direct data entry.  The RedCap application is sponsored by the 
University of Washington ITHS and is encrypted.  The application will be run on an 
encrypted I-pad using the University of Washington wi-fi network.  Participants can 
complete the baseline survey in the ED during their clinical evaluation or in any inpatient 
area.  The study team members will not delay or interrupt clinical care and the baseline 
assessment can be stopped and restarted to allow for continuity of clinical care.  If the 
participant is discharged before the assessment is complete, the participant will be 
offered the chance to continue after discharge outside of clinical space.  Importantly, if 
there are issues with data entry for RedCap (e.g. wi-fi connection, application 
malfunction) the study team member will be ready to administer the survey using paper 
and pen and this hard copy of the survey response will be kept as a source file in a 
locked file cabinet in a locked office per confidentiality procedures.  These responses will 
later be entered into RedCap. 

 
F. Usual Care Condition 
Previous investigations at HMC suggest that patients with substance use comorbidity 
may receive a spectrum of consulting services visits including social work services, 
psychiatric consultation, inpatient psychiatry consult, rehabilitation psychology 
consultation, addiction intervention services, pain team consultation services that 
include MD psychiatric and PhD psychologist providers, spiritual care or other 
consulting services. Some of these services social work routinely visit patients with 
substance use concerns. Other services must be generated by a consult request 
from the clinical team, such as psychiatry consultation.  The services provided to 
participants in the Usual Care condition will be abstracted form the EMR and tracked 
in RedCap.  There is no cost to patients for interacting with the study team members. 
However, services received from other hospital staff may incur cost to patients as 
these services will be billed to patients and their insurance per usual billing 
procedures.  
 
G. ED-LINC Intervention Condition 
Participants randomized to the Intervention Condition will receive ‘ED-LINC’ which is a 
multi-component intervention based on the collaborative care framework  It is 
hypothesized that patients with risk for OUD have fragmented healthcare, might receive 
opioids from many sources and use the ED for episodic acute healthcare needs and 
often as an entry point for seeking treatment for OUD.  The intervention is built on the 
hypothesis that patients with risk for opioid use disorder (OUD) from illicit opioid use or 
prescription opioid use will benefit from coordinated care.  There is no cost to patients for 
interacting with the study team members. However, services received from other 
hospital staff may incur cost to patients as these services will be billed to patients and 
their insurance per usual billing procedures.   Therefore all components of ED-LINC aim 
to improve coordination of care and decrease care fragmentation.  Consistent with other 
ED-based interventions, there is an emphasis on initiating services and then linking to 
outpatient service providers.  ED-LINC will include 1) A brief negotiated interview at the 
bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including 
a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from 
the ED for participants that are interested and eligible; 3) Longitudinal care management 
which will proceed for 3-months; and 4) Care plan in the Emergency Department 
Information Exchange (EDIE) system.  Linking all these elements will be weekly 
supervision and case conferences attended by the research assistant, study PI and 
study psychiatrist along with other relevant team members as required in addition to a 
study cell phone which will be used by study team members to provide care 
management.  The study cell phone will be answered as soon as possible by study team 
members with messages/texts returned within 1-2 hours during 9-5 M-F and 
messages/tetxs returned within 12-24 hours overnight and on weekends.  All elements 
of ED-LINC will be discussed in further detail below. 
 
Brief Negotiated Interview 
The study research coordinator (RC) will be trained in delivering evidence-based 
Motivational Interviewing (MI).  There is a large body of evidence that supports the use 
effectiveness of motivational interviewing from the ED for patients with substance use 
3,11-14 using the Screening Brief Intervention and Referral to Treatment (SBIRT) 
framework.  However, SBIRT is not effective in decreasing problematic drug use when 
used alone.15  During ED-LINC, the research coordinator will perform a brief negotiated 
interview (BNI) with a goal of increasing motivation to link to outpatient services including 

primary care and/or outpatient substance use services.  It is expected that the BNI will 
last 10-15 minutes and the RC will record the length in minutes of each session in 
RedCap.  Important steps to the BNI include; 1) raising the subject 2) providing 
information and feedback 3) enhancing motivation 4) development of an action plan.  
The RC will build rapport through non-judgmental active listening and affirming patient 
strengths and values through complex reflections.  
 
1) Raising the subject/Building Rapport 
• 
Establish rapport through non-judgmental active listening  
• 
Ask permission to discuss substance use  
 
2) Providing feedback 
• 
Ask about the patient’s frequency and pattern of drug use  
• 
Review screening results  
• 
Ask about connection between substance use and health (if applicable) 
• 
Provide information about substance use treatments and referrals  
 
3) Enhancing motivation  
• 
Evoke change talk with MI techniques such: the readiness ruler, assessing 
pros and cons 
• 
Use opened ended questions, affirmations, reflections, and summaries 
(OARS).  
• 
Emphasize personal autonomy and responsibility  
 
4) Negotiate a plan  
• 
Negotiate a goal for use and/or treatment engagement  
• 
Provide thoughts with permission  
• 
Discuss details for a follow up meeting  
 
 
 A procedural checklist will be used by the RC to document process fidelity to the BNI. 
(See Appendix A). 
 
Pharmacotherapy 
Medications and pharmacotherapy is an important part of collaborative care.  It is 
hypothesized that many patients will not have primary care and might be experiencing 
fragmented health care delivery.  The pharmacotherapy element will be guided by the 
principle of ultimately linking to care.  First, the RC will address the need for coordinated 
care.  After conducting the BNI (above) The RC will step away from the patient and have 
a conference with one of the supervisory physicians of the study team.  In-line with 
published HMC protocols, the RC will have a conversation with the participant about 
take-home naloxone.  This conversation will be tailored to participant risk for overdose 
based on their use of illicit opioids, misuse of prescription opioids or both.  Naloxone is 
distributed in many locations around Seattle without a prescription based on pharmacy 
collaborative agreements.  If the participant desires a prescription, the RC will talk with 
the treating clinical team or the study physicians.   
 
Next, for participants with prescription opioids, the RC will discuss safely storing 
prescription opioids and safe disposal of prescription opioids.  This conversation will be 

guided by resources published on stopoverdose.org and med-project.org which are 
publically available materials.   
 
Lastly, the study physicians in coordination with the RC will discuss medication assisted 
treatment for participants with risk for opioid use disorder secondary to illicit opioids.  It is 
recognized that opioid agonist treatment improves outcomes for patients with opioid use 
disorder (OUD)16 and patients with OUD that initiated buprenorphine in the ED had 
improved engagement in treatment at 30 days compared to those that received only BNI 
or standard care.1  Therefore study participants will be assessed for willingness for 
opioid agonist treatment.  If participants are interested in opioid agonist treatment, the 
RC will discuss this with both the treating clinical team and study physicians.  Based on 
the patients clinical course, this can be managed by the treating clinical team (e.g. 
patient is getting care inpatient, patient is in the ED) or the study physicians (e.g. patient 
is already discharged) or the study physician will offer to coordinate with the treating 
clinical team (e.g. patient is in the ED).  Initiating buprenorphine from the ED for patients 
with opioid use disorder is an evidence-based treatment1 with recently published 
guidelines.17  Specifically, participants will be screened for opioid withdrawal using the 
clinical opioid withdrawal scale (COWS)18 and if they are in moderate or severe opioid 
withdrawal the RC and study physicians will communicate this with the treating clinical 
team and the treating clinical team can offer one dose of buprenorphine dispensed from 
the ED to treat withdrawal if this is clinically appropriate.  If the participant is not in 
moderate or severe withdrawal, or if the participant has already discharged from the ED, 
the study physician can determine appropriateness for a home induction of 
buprenorphine with appropriate transition to an outpatient based opioid treatment 
(OBOT) clinic.  We anticipate that many patients that do not have a PCP will be 
appropriate for the HMC After Care clinic or the Adult Medicine Clinic although there are 
several community clinics around Seattle which will offer continued buprenorphine and 
there are several local places that will dispense buprenorphine or initiate buprenorphine 
with low barrier or same-day service.  A list of clinics offering buprenorphine for OUD 
has been compiled.  While all efforts will be made to link to an outpatient buprenorphine 
provider as described above, it is a known risk of initiating any medication including 
buprenorphine from the ED that some patients will fail to link to care.  This risk is part of 
the standard of care of initiating treatment from the ED for any condition.  Specifically, 
failing to link to care after initiation of buprenorphine could result in opioid withdrawal.  
Some participants will be interested in other types of opioid agonist treatment such as 
methadone or naltrexone and the RC will discuss this request with the treating clinical 
team if appropriate (e.g. inpatient) and provide coordination to a opioid treatment 
provider that can provide this service after the ED visit as part of the ‘longitudinal care 
management’ element.  Participants in the ED-LINC condition that are already linked to 
opioid agonist treatment will work with the RC to strengthen these connections.  It is 
anticipated that eligible participants that report engagement in opioid agonist treatment 
will require strengthened linkages and potential dose adjustments.  These dose 
adjustments will likely occur by the prescribing provider. 
 
Longitudinal Care Management 
Participants will be followed by the study team for care management for three months.  
During the initial recruitment interview, the RC will ask the participant about preferences 
and schedule ongoing times to communicate based on participant preferences.  All 
participants will be contacted by the RC within 3-4 days of enrollment by the preferred 
method of contact (e.g. text, call) to check-in.  Participants who received buprenorphine 
will receive a phone call within 24 hours by a member of the study team.  The RC will 

work with the study participant to establish with a new primary care provider, or schedule 
and attend a follow-up appointment with their existing primary care provider.  
Additionally, tailored to each participant, the RC will work to actively connect participants 
to substance use treatment and community mental health providers.  Previously care 
management tasks included coordinating care with existing providers, providing referral 
and information for housing, managing care for substance use, meeting participants 
during subsequent HMC ED or outpatient visits to check-in and accompany participants 
to HMC appointments as needed.9  Care management tasks will be logged and tracked 
in RedCap by the RC and other members of the study team. 
 
Care Plan 
During the initial recruitment, participants will be notified that a Care Plan will be placed 
in the Emergency Department Information Exchange (EDIE).  The Emergency 
Department Information Exchange (EDIE) system allows team members to implement 
electronic health care record innovations, such as the creation of care plan notifications 
that provide the care team contact information for the study team which can be viewed 
across emergency department sites utilizing the system.  EDIE also provides real-time 
work-flow integrated electronic alerts that allow collaborative team providers to be 
notified when patients make recurrent visits to an emergency department in the state of 
Washington and Oregon.  Care Plans in EDIE are used as standard of care at HMC and 
the care plan for ED-LINC was adapted from exiting projects (See Appendix B) 
 
Weekly Supervision and Case Conference 
Consistent with the guidelines of collaborative care, the RC will receive supervision from 
the study physicians.  The study PI, Dr. Lauren Whiteside and study psychiatrist, Dr. 
Doug Zatzick will be available to discuss all new ED-LINC participants at the time of 
enrollment and regularly scheduled supervisory meetings will be held with all study team 
members weekly to every-other week depending on case load and availability.  During 
these meetings, the RC will lead a discussion of all newly enrolled participants as well as 
any active participants.  A discussion of relevant assessments will take place for all 
discussed participants to tailor further care management and linkage to services.  
Content of these discussions will be documented in RedCap.  All members of the team 
attending the supervision and case conference meetings will have obtained human 
subjects training prior to participating.  
 
Cell Phone 
The study cell phone number (206-636-8372) will be provided to all participants in the 
ED-LINC intervention.  Specifically, after the baseline interview participants randomized 
to ED-LINC will be provided with the cell phone number and notified that they can call or 
text this number with any concerns during the course of their intervention time.  The cell 
phone will be covered by the study RA/RC or study PI from 9a-5p M-F and by one of the 
study physicians on evenings, nights and all day weekends and holidays.  All efforts will 
be made to answer the call during business hours and response to calls and text during 
business hours will be within 1-2 hours.  Efforts will be made to be timely after hours as 
well.  Participants will be notified that calls and texts that occur after hours, on weekends 
and on holidays can be anticipated to be answered within 24 hours.  All interactions with 
participants on the study cell will be tracked in research logs and notes captured in 
RedCap. 
 
H. Intervention Training and Supervision 
1. Training 

The study research assistant will receive training in Motivational Interviewing in order 
to perform the Brief Negotiated Interview (BNI) with fidelity.  Specifically the RA will 
attend a 1-day workshop specific to Motivational Interviewing techniques in 
substance use and will complete practice sessions (e.g. standardized patients) and 
receive feedback on the core principles of BNI.  The RA will receive at least 16 hours 
of training which is consistent with other studies conducting similar interventions. 
 
2. Supervision 
The study research assistant will receive direct supervision daily by the study PI (Dr. 
Lauren Whiteside).  As part of the mentorship process for the grant, Dr. Whiteside 
will receive at least weekly supervision from Dr. Doug Zatzick.  As part of the ED-
LINC Collaborative Care intervention, the study RA will receive supervision during a 
weekly case conference.  This regular caseload supervision will be facilitated by the 
study intervention data management tool (e.g., REDCap). This computerized data 
management system will be password protected and accessible only to study team 
members.  Access will be available 24 hours a day 7 days a week. As information is 
available in real time, the system can be used by intervention team supervisors to 
monitor and support RA and ED-LINC. 
 
I. Patient Tracking and Scheduling 
At the time of recruitment, the study team will ask subjects for at least two pieces of 
contact information (the absence of sufficient contact information is exclusion criteria). 
One piece will need to be a phone number, while the second piece of contact 
information could include the patient’s address, email address, social media (e.g., 
Facebook page) or any of the aforementioned pieces of contact information for a relative 
or friend (referred to as alternate contacts). In the event that the subject’s contact 
information changes (a common event in this population); the follow-up team may reach 
out to these alternate contacts in an effort to get back in touch with the subject. Over the 
6 months after the ED visit, the follow-up team may perform scheduling or check-in 
phone calls with subjects to ensure that the contact information on file is up to date. 
During these check-in calls or while scheduling upcoming interviews, study staff will 
confirm all contact information on file and ask for any new information relevant to the 
subject. 
 
Previous studies have demonstrated instability of phone numbers and phones in general 
in this population. Therefore, in addition to contacting patient subjects through the 
information they initially provide at the baseline interview, the follow-up team may utilize 
several other approaches to try and stay in touch with subjects throughout the duration 
of the study. These approaches are: 
 
1. Harborview Medical Center EHR or EDIE Records  
If the follow-up team is unable to reach a patient subject after repeatedly trying to 
contact them through the information provided, the study team may utilize the 
Harborview EHR or EDIE records for any updated contact or appointment 
information that may help to reach the subject. 
 
2. Public Records Search  
The follow-up team may also conduct a public records search to find new contact 
information. Examples of public records searches the study team may utilize include 
Google, the White Pages, public jail records, or other paid public record searches. 

The follow-up team will search for records or information on forums that are open to 
the public either for free or at a cost.  
 
3. Social Media  
If the follow-up team is given or finds a URL or a social media website (e.g., 
Myspace, Facebook, Google+, etc.) for the subject, they may view the profile 
information and status updates posted publicly. They may also attempt to contact a 
subject through these websites via private message from TSOS. They will only send 
this message if they are able to match at least two identifiers with information from 
public records or provided by the subject or their alternate contacts. This information 
may include: name, date of birth, email, phone number, links to other personal social 
media sites with two pieces of information (e.g., GoFundMe), injury event, or picture. 
Given that this is a local trial, there will likely be too much overlap to utilize 
information such as location or friends as one of the two required identifiers, so this 
would be considered supplemental information to ascertain a subject’s social media 
page. Any messages will be sent to the subject’s private inbox and will not be 
viewable to the public. The study team will not browse subjects’ social media posts 
except to confirm the patient’s identity to be able to send a private message to the 
subject. 
 
A. Follow-up Interviews 
Patient-reported outcomes will be assessed at 1, 3 and 6 months after the ED visit. 
Length of the follow-up interviews varies and is estimated that the shortest interview may 
take about 15 minutes to complete and up to 60 minutes to complete the longest follow-
up assessment depending on subject answers. Subjects will be remunerated for their 
time. The study team will be flexible with regard to completion method of the follow-up 
interviews. The study team intends to complete follow-up interviews with subjects 
primarily in-person at Harborview Medical Center or other convenient public location or 
over the phone.  Responses will entered into REDCap. If scheduling time with an 
interviewer is difficult, a subject may also have the option of completing the follow-up 
assessment through the encrypted REDCap app or web-based platform, or by another 
preferred method (e.g., faxed interview, hardcopy mailed to their residence).   If a 
subject is completing the assessment on their own, the interview form (e.g., PDF, 
hardcopy, REDCap) would not include their name or any directly identifying information.  
Subjects will be given explicit instructions on certain assessments such as the timeline 
follow back (TLFB) in order to complete this with accuracy and without RA/RC 
assistance. Subjects will be reminded they should complete the interview in a private 
space where no one else can have access or see the interview.  
 
Some subjects will have difficulty completing the entire interview, such as due to fatigue. 
The study team will allow for patients who are unable to tolerate a full-length interview 
the option of completing an interview over multiple sessions 
 
Prior observations from the study team’s effectiveness implementation spectrum 
investigations suggest flexibility is also required with regards to the timing of outcome 
assessments. Biostatistical considerations related to power encourage obtaining follow-
up assessments, even if the actual assessment date deviates from the planned outcome 
assessment point. The study team will attempt follow-up on the appropriate date (e.g., 
within 30 days for the one month follow-up interview) but understand that flexibility on 
timing of followup interviews are needed. 
 

Additionally, the study team anticipates about 20% attrition for follow-up interviews in this 
population. Missing or being unable to complete a follow-up interview is a common event 
and will not be counted and/or reported as a protocol deviation. This information will be 
documented and reported. If a subject misses a particular assessment, they are still able 
to complete subsequent assessments. This may occur if a subject is unreachable for 
several months or becomes incarcerated during the follow-up portion of the study. 
 
At baseline, being a prisoner (i.e., incarcerated or taken in to custody immediately after 
discharge) falls under the exclusionary criteria for study participation. However, a subject 
may become incidentally incarcerated during the follow-up period. Study team members 
may become aware of a subject’s change in incarceration status via public records 
search or from alternate contacts. The study team does not directly contact or collect 
any information from subjects while they are incarcerated. However, in accordance with 
the UW Prisoner SOP, section 8.3.2.4, the study may resume follow-up (and 
intervention, if applicable) activities with subjects who have incidentally become 
prisoners during the course of their trial participation once they have been released. The 
study team intends to search public jail records to track if patients have become 
incarcerated and when they are released in order to facilitate contacting them for 
subsequent study interviews.  
 
B. End of Study Participation 
While final UC and intervention patient subject follow-up interviews take place 
approximately 6 months post-consent, intervention activities with intervention patients 
are anticipated to conclude approximately 3 months after subjects consent into the trial. 
The team may need to exercise flexibility in the duration of the intervention as specific 
situations may arise where intervention activities extend beyond the 3-month planned 
intervention period (e.g., crisis intervention needed at two months). The ED-LINC 
intervention will attempt to have a final intervention contact with all intervention patients. 
The objective of the final ED-LINC intervention contact is to negotiate a specific plan for 
ongoing care beyond the study. The study team will discuss strategies for maintaining 
treatment gains with each intervention patient. This means proper handoff of medication 
prescription management to a subject’s preferred primary care or other medical provider, 
linkage to community resources, and any referrals. Treatment maintenance may also 
include ongoing relationships with the subject’s social support (e.g., family, friends, and 
other community support groups). UC activities are expected to conclude when a patient 
leaves the ED or hospital. 
 
 
IV. HUMAN SUBJECTS PROTECTIONS 
A. Informed Consent Procedures  
After potential patients have been deemed eligible using the eligibility criteria and self-
report screen a study team member will introduce the study and continue to assess the 
patient’s level of consciousness and cognition.  Prior to engaging in the informed 
consent process, the recruiting study team member will review the Glasgow Coma Scale 
(GCS) which provides best response to ‘eye opening’, ‘verbal’ and ‘motor’ and is on a 
scale from 3-15.  Patients with a score of 8 or less often require emergent procedures 
and resuscitation and will not be eligible.  Patients with a score of 9-13 will be monitored 
for improvement of mental status.  Patients with a score of 14 or 15 will be eligible for 
approach.  The GCS is often calculated as part of routine care by the bedside RN in the 
ED and will be reviewed prior to approach by the research team.  At approach, the first 
two questions of the Mini Mental Status Exam (MMSE) which include ‘what is the year’ 

and ‘where are we now’ will be asked.  These are standard questions within emergency 
medicine to determine if a patient has capacity for decision making. Patients who are 
disoriented or delirious will not be able to undergo informed consent procedures. The 
study team member will return at a later time to check if the patient is ready and able to 
participate in research related activities including informed consent procedures. If the 
patient is appropriate and cognizant, a study team member will provide the patient with 
an unsigned consent form to review. The study team member will provide ample time for 
patients to read the consent form; however, once the patient indicates that they are 
willing and able to proceed, the team member will verbally go through the written 
consent form item by item with each participant and will emphasize the following points:  
 
• Participants may choose not to answer any question at any point during the 
study. They may also choose to drop out of the study at any time.  
• Information told to the study team will be kept confidential and will not be shared 
in identifiable form in study team publications or at public conferences, with 
exception only for maintaining the safety of the patient or others (e.g., suicidality; 
child abuse).  
• The data will be kept in locked offices and drawers or electronically on a secure 
server and only the study team members will have keys or access to the server 
via password and designated login.  
• The link between identifiers and the research data will be destroyed after the 
records retention period required by state and/or federal law, in this case 
7/1/2024.  
 
Once everything has been explained and all questions have been answered, the 
participant will sign and date an electronic version of the consent form utilizing 
RedCap.  Specifically, the research team member will have accessed RedCap utilizing a 
secure log-in.  If RedCap is not available (e.g. wi-fi not available in the hospital, problem 
with the RedCap application) at the time the research assistant is ready to obtain a 
signature on the e-consent form, a standard paper copy of the consent form can be 
used.  The participant will be able to view the consent form and sign the form using 
features standard in RedCap as provided by the University of Washington ITHS.  At the 
bottom of the page they will need to select “I certify that all the information in the 
document above is correct, and I understand that signing this form electronically is the 
equivalent of signing a physical document.”   The participant will provide a signature 
which will be witnessed by study staff.  The participant will be given a paper copy of the 
electronic consent form for themselves.  This e-consent will be stored in RedCap as a 
PDF in the file repository accessible only to study staff. 
 
Participants will be informed during the consent process that they may choose not to 
answer any question, to stop and take a break, or to drop out of the study at any time. 
They will be reminded of this before beginning each interview. 
 
If a patient is unable to read and/or sign the consent form due to physical limitations 
(e.g., injured hand or eyes), the study team member will provide the patient and/or a 3rd 
party witness who is not affiliated with the study team (e.g., nurse, family member) with 
an unsigned version of the consent form that the study team member will read to the 
patient in the presence of the witness. The study team member will allot enough time for 
questions/answers to ensure full comprehension of the consent information by the 
patient. If the patient decides they do want to participate, the subject will mark the e-

consent form with an “X", the witness and study staff obtaining consent will sign and 
date, and a signed copy will be given to the patient while one is maintained by the study 
team. If a subject is unable to mark the consent form with an “X,” the same procedure 
described above will be used and the witness and study staff obtaining consent will sign 
and date the consent form. If a witness is used, per the UW IRB SOP for informed 
consent documentation, the communication method (e.g., oral) with the subject and the 
means used by the subject to provide consent (e.g., oral consent) will be documented on 
the consent form. 
 
B. Potential Benefits Associated with Study Participation 
Subjects in the intervention group may directly experience the greatest benefits from the 
proposed investigation. Intervention subjects will receive brief intervention and care 
management using the collaborative care framework.  Also, results of the investigation 
may be disseminated beyond the ED settings to other intervention contexts, such as in 
outpatient settings.  Previous research suggests that participation in a brief intervention 
for substance use will benefit the average patient.  needs post-injury.  
 
C. Potential Risks Associated with Study Participation 
1. Emotional discomfort: The survey and subsequent interview asks sensitive 
questions related to health status, and substance use and other emotionally laden 
topics may produce emotional discomfort such as anxiety, shame, or guilt. 
Participants in the intervention group may experience emotional stress during the 
brief intervention.  
 
2. Testing burden: Patients may experience inconvenience and an invasion in privacy 
during an approach. Patients may feel burdened when completing the initial survey 
as well as during follow up interviews.  
 
3. Confidentiality: Patients will contribute personal and protected health information to 
the study both through self-reports during research interviews, as well as through the 
EMR and EDIE. Patients will be initially approached in public clinical locations, 
including the Emergency Department, and asked to answer potentially sensitive 
questions about depression, suicide, and substance use. The follow-up interviews 
which may be conducted in a variety of means including over the phone or in person, 
will also include these and other sensitive questions. There is a risk of breach of 
confidentiality if private information about participants was overheard, taken by, or 
seen by someone who should not have access to it. 
 
4. Coercion: Participants may feel obligated to participate in study protocols especially 
if they present with opioid related complaints. There is a risk that patients perceive 
their clinical care is contingent on participation in the study.  
 
5. Medication side effects: The main risks associated with the study include the 
initiation of medications such as those used for the treatment of opioid overdose 
such as naloxone or buprenorphine. Other medications that may be prescribed for 
those in the patient population target depression, and anxiety. In general, these 
medications are widely used and are well-tolerated in adults. Known side effects of 
these mediations at doses used in this study and for approved indications include, 
headache, upset stomach, nervousness, sleep disturbance, and dizziness. 
 

D. Mitigation of Potential Risks Associated with Study Participation 
1. Emotional discomfort: Patients will be informed during the approach that not all 
questions during the survey or interview need to answer and may be skipped at their 
digression. Patients will be told that the interview can stopped at any point to take breaks 
to be completed at a later time. These options will be discussed with each participant 
during initial recruitment and at every follow-up assessment. Study steam staff will be 
trained in motivational interviewing, empathic listening, and certified in mental health first 
aid.  
 
2. Testing burden: Patients will be informed that they may stop the interview at any time 
to resume at a later point. All efforts will be made to schedule follow-up interviews at a 
time and method that is convenient for the participants. Patients will be told that they can 
withdraw at any point in the study. 
 
3. Confidentiality: All study team members will complete human subjects training (e.g., 
Good Clinical Practice, Collaborative Institutional Training Initiative, HIPAA) prior to 
accessing PHI and engaging with potential participants. The study team will make every 
effort necessary to safe guard data and protect participant privacy.  Exceptions include 
the need to notify relevant authorities in the event that a participant is suicidal or 
homicidal or the research staff becomes aware of child or elder abuse through working 
with the participant (e.g., scheduling, interviews, social media, etc.).  All information 
regarding participant information will be stored in a secure password protected 
databases with the majority of information de-identified. Data will be coded and any 
paper files will be stored in a locked office in a locked filing cabinet. Participants will not 
be personally identified in public conferences or in publications. Study interview 
responses will not be entered into patients’ medical charts or EDIE. Managing risks 
associated with participant confidentiality and security of research data is of the utmost 
importance in the study. A variety of data transmission and storage procedures, as 
described in relevant Data Quality and Data Security sections, will be used to ensure 
that patient data is not inadvertently observed or obtained by persons other than the 
study team members or regulatory bodies who may need to view data to ensure the 
proper conduct of the study. 
 
All participants will be assigned a study ID number, which will be associated with patient 
names and identifiers as well as patient-reported outcomes and intervention process 
data in the REDCap data collection system. To protect patient privacy and limit potential 
intercept by a non-study team member of any identified data, any data collected on hard 
copies will utilize the patient study ID number only until entered into the REDCap 
system. Information regarding the security of REDCap and related systems can be found 
in the Data Security section. To practicably conduct the research, the study data will 
remain in identified format in REDCap until the end of the record retention period (July 1, 
2024), at which point all data will be de-identified and the research data only associated 
with patient study ID. 
 
4. Coercion: As described in the informed consent form procedures, patients will be 
informed that the research is voluntary and non-participation will have no impact on their 
receipt of routine clinical care. Research team members who have clinical roles at 
Harborview Medical Center may come in to contact with patients who may be eligible for 
study participation during the course of their hospital clinical work. However, the 

informed consent procedures will only be conducted by research team members who 
are not actively seeing patients on clinical services in order to avoid potential coercion. 
 
5. Medication side effects: Patients may experience study-related psychotropic 
medication side effects. Although patients may tell a variety of study team members 
about potential medication side effects (e.g., care manager, follow-up interviewers), only 
licensed medical doctors will follow-up with psychotropic medication symptom 
assessments and recommendations.  All administrations of medications associated with 
this study will be provided by licensed medical doctors who evaluate the benefits of the 
medication greater than the potential risks. The clinical team will assess any medical 
side effects and document any side effects that they become aware of.   
 
V. DATA AND SAFETY MONITORING PLAN 
 
This Human Subjects Research meets the definition of a clinical trial 
To address the NIH policy for data and safety monitoring, Dr. Whiteside and her mentorship 
team have developed a system for oversight of the study and its participants.  Dr.’s Whiteside, 
and Zatzick will be responsible for monitoring the data quality and safety.  All research projects 
that involve human subjects at the Harborview Medical Center Emergency Department require 
approval from the University of Washington (UW) Institutional Review Board (IRB).  The UW 
IRB will review and approve the protocol before any data is collected for the project.  Dr. 
Whiteside and her mentorship team will adhere to UW IRB procedures.  Specifically, all 
participants in the trial will: 1) understand, agree to and sign written consent forms prior to 
participation; 2) participant right to withdraw or refuse to answer questions will be maintained; 3) 
consent forms and identifying information will be kept separate from participant data; 4) all 
identifying information will be kept locked at all times and computer files will be saved with 
passwords on secure servers; and 5) participants will be informed in writing how to contact the 
PI and the IRB office at UW with any questions or concerns.  This protocol was presented to the 
University of Washington Emergency Medicine Research Interdisciplinary Research Committee 
(EMIRC) which reviews all study proposals that aim to recruit patients in the Harborview Medical 
Center ED.  In general, this committee provides comments on study design, subject recruitment 
in the ED related to operations and patient flow and will voice human subjects concerns.  This 
protocol (ED-LINC) received review and approval by EMIRC in July, 2018.  Many senior faculty 
members from a variety of disciplines (e.g. surgery, neurology, emergency medicine) with 
extramural funding sit on this committee.  
The Principal Investigator (PI), Dr. Lauren Whiteside, provides day-to-day oversight of the trial 
along with members of the mentorship team.  Dr. Doug Zatzick is a practicing Psychiatrist that 
has clinical duties at Harborview Medical Center.  Dr. Whiteside will train research staff and 
ensure that informed consent is appropriately obtained prior to performing research procedures, 
that all subjects meet eligibility criteria, that all subjects receive information for how to contact 
the study PI and how to contact the UW IRB office for questions or concerns.  Dr. Whiteside will 
ensure the study is conducted according to the IRB-approved research plan.  Quality control 
and reliability of all self-assessments at screening, baseline and follow-up will be monitored by 
Dr. Whiteside via regular meetings and direct observation of the research assistant.  Dr. 
Whiteside will also monitor the quality of the data files by directly supervising research staff 
involved with data management. 
A. Data and Safety Monitoring 

The study team and IRB will provide oversight of patient safety throughout the trial. The 
PI will meet weekly with the study mentorship team including study Psychiatrist, Dr. 
Zatzick and review reports of patient safety data, and make reports of patient safety 
concerns to the IRB as outlined in below. Common research patient safety concerns 
include adverse events, serious adverse events, and unanticipated problems, as defined 
by OHRP below. 
 
1. Reporting of Adverse Events (AE) and Serious Adverse Events (SAE) 
Office of Human Research Protection (OHRP) Definitions: 
 
Adverse Event (AE). An adverse event (AE) is any untoward medical occurrence in a 
subject temporally associated with participation in the clinical study or with use of the 
experimental agent being studied. An adverse finding can include a sign, symptom, 
abnormal assessment (laboratory test value, vital signs, electrocardiogram finding, etc.), 
or any combination of these. 
 
Serious Adverse Event (SAE). A serious adverse event (SAE) is any adverse event 
that results in one or more of the following outcomes: 
• 
Death 
• 
A life-threatening event 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
A persistent or significant disability/incapacity 
• 
A congenital anomaly or birth defect 
• 
An important medical event that may jeopardize the subject’s health and may 
require medical intervention to prevent one of the other events listed above 
(based upon appropriate medical judgment) 
• 
 
Unanticipated Problems. In general, unanticipated problems include any incident, 
experience, or outcome that meets all of the following criteria: 
1) unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the 
IRB-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
2) related or possibly related to participation in the research (in this guidance 
document, possibly related means there is a reasonable possibility that the 
incident, experience, or outcome may have been caused by the procedures 
involved in the research); and 
3) suggest that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
 
AE and SAE Identification 
The study population is known to experience a number of AEs and SAEs, as defined 
by OHRP that are not expected to be study-related. For instance, prior investigation 
by the research group with this population suggests that as many as 50% of subjects 
report “thoughts that they would be better off dead or of harming themselves in some 
way” over the course of the six months after their ED visit (See Appendix C for 
Participant Suicidality Safety Protocol).  Overdose is also common in a population of 

patients with risk for opioid use disorder and in previous work by Dr. Whiteside and 
others approximately 25% of patients in the HMC ED at high risk for opioid overdose 
had an overdose event (e.g. non-fatal or fatal) within 3 years.  The study population 
often suffers from comorbid medical conditions pre-dating and possibly exacerbated 
by the ED visit and thus is likely to experience recurrent hospitalizations. Additionally, 
the study population is known to experience a high rate of incarceration.  
 
Given the high frequency of AE/SAE events in the study population, and having 
identified those SAEs/AEs that we anticipate to be study-related in the patient 
consent form, the study team has opted not to systematically assess for AEs or 
SAEs at each patient contact.  However, the study team may become aware of 
AEs/SAEs through routine interactions with study subjects.  Examples include while 
scheduling interviews or other patient contact, during baseline or follow-up 
interviews, intervention related activities, within the EMR, through a public records 
search (e.g., WA state death records), from public posts or private messages sent 
through the subject’s social media (e.g., Facebook), or relayed by an alternate point 
of contact for the subject. Study team members will ensure that the PI and other 
relevant team members (e.g., research coordinator) are made aware of any relevant 
problems or SAEs via email, phone, or in-person within 24 hours.  
 
SAEs/AEs that the study team becomes aware of through the course of conducting 
study procedures will be reviewed by the PI and study team to assess relatedness 
and expectedness will be classified by attribution, or an assessment of the 
relatedness to participation in the study protocol, with particular regard to the 
intervention. Specifically, they will be classified as one of the following: 
1) Not Related 
2) Probably Related 
3) Related 
 
AE/SAE and Unanticipated Problems Reporting 
Study team members will report unanticipated problems on the Reportable New 
Information (RNI) form to the IRB, consistent with the UW IRB requirements.  The 
UW IRB definition of Unanticipated Problem includes a problem or event that 
meets all of the following criteria: unexpected, probably related to study, and places 
subjects at greater risk of harm. Events meeting these criteria must be reported on a 
Reportable New Information (RNI) form to UW IRB within 10 business days.  
AEs/SAE’s that are not unanticipated problems will not be reported. Additionally, Dr. 
Whiteside will notify the NIDA Project Officer of any unanticipated problems or 
significant human subject protection issues within 24 hours of discovery. 
 
Anticipated AE/SAE  
Anticipated AEs/SAEs will be tracked systematically and will be reviewed within 24 
hours of discovery by the study PI to determine if it is an unanticipated problem.  The 
following AEs/SAEs are anticipated in this study population and will be tracked 
systematically: 
• 
Suicidality including fatal suicide and non-fatal suicide attempt 
• 
Overdose (fatal and non-fatal) 
• 
Hospitalization 
• 
Medication side effects 
   

As mentioned above, the study team may become aware of one of these anticipated 
AEs/SAEs through a variety of means, which may include self-report by the subject 
while completing baseline or follow-up interviews, intervention related activities, 
relayed by an alternate point of contact for the subject, within their EMR or EDIE, 
through a public records search (e.g., WA state death records), or public posts or 
private messages sent through the subject’s social media (e.g., Facebook).  Any 
clinical questions about medications and possible/probably side effects will be 
triaged to the study PI (Dr. Whiteside) and her mentor, Dr. Zatzick (psychiatrist) to 
determine if it is related to the study and to make a determination about medication 
recommendations, reporting, and next steps.  Anticipated AEs/SAEs will be 
systematically tracked using an Excel document to track the event and any 
comments related to this event.  Specific actions around the event will also be 
documented if necessary.  After the study PI is notified a decision will be made to 
determine if it is an unanticipated problem and this will be documented in the 
Anticipated AEs/SAEs log. See the Subject Suicidality Safety Protocol (see Appendix 
C) for details regarding how the study team will address subject suicidality during the 
conduct of the trial. 
 
Other Patient Safety Reporting 
Any other unanticipated problems, compliance issues, or safety concerns identified 
by the study team will be addressed within the study team including Dr. Whiteside 
and/or Dr. Zatzick, and/or other study team members as appropriate, to assess 
severity and what steps, if any, are appropriate to take. 
 
Protocol Deviations 
The study team may determine the need to deviate from the approved study 
protocol. The team will make every effort to anticipate the need for protocol 
deviations and have these approved by the UW IRB prior to engaging in a change to 
procedures; however, the study team may be required to make deviations to 
eliminate hazards to patient safety without prior IRB approval.  
 
The study team will document any known instances of non-compliance and report to 
the IRB per UW Human Subject Division policies per specifications in Table A. 
 
Table A. Protocol Deviation or other Problems Reporting Requirements 
Event Type 
UW IRB Reporting 
Loss or breach of subject 
confidentiality or privacy 
Submit completed RNI form to UW IRB within 24 hours 
Inappropriate use or access of PHI 
Submit completed RNI form to UW IRB within 24 hours 
Other protocol non-compliance 
Submit completed RNI form to UW IRB within 10 business 
days 
 
VI. DATA SECURITY 
The secure collection, transmission, and storage of data to protect patient privacy as well as the 
integrity of the data is detailed below for each data type and source. Any breaches of data 
security that may compromise patient confidentiality will be reported within 24 hours to the 
DSMB and UW IRB 
 
A. Data Management, Collection, Transmission and Storage 
1. REDCap and iPad Data Collection 

The University of Washington (UW) Institute of Translational Health Sciences (ITHS) 
REDCap instance will be utilized for collection and storage of patient enrollment 
data, patient-reported outcomes, intervention and enhanced usual care delivery 
documentation, and the tracking of patients for follow-up assessments. The ITHS 
REDCap installation is configured to be completely HIPAA compliant. REDCap is 
safe-guarded and hosted in a secure data center to maintain physical security. The 
installation is housed in the secure UW data center underneath the 4545 Building in 
Seattle, Washington. The installation currently runs on two virtualized environments, 
one for the webserver and one for the database itself. Both environments are run on 
servers with data encrypted at rest. All web traffic to and from the REDCap 
installation is encrypted with the most current protocols available.  
All connections to the server are automatically encrypted by a 128 bit Secure 
Sockets Layer (SSL) encryption and the Operating System of each server is 
consistently patched and firewalled in accordance with UW Medicine Information 
Security Policy SEC05.04.  
The REDCap support team strives to update the REDCap installation as often as 
possible with minimal interruption to service. Security fixes take priority over normal 
updates with new functionality. The entire REDCap installation is backed up daily to 
a secondary location. REDCap natively tracks any and all user activity and these 
logs are available to project owners and related roles on a project by project basis. IP 
logging happens on a server and network level, but these logs are not made public 
without a compelling reason. The UW Medicine IT security office regularly scans the 
REDCap installation for vulnerabilities and audits the REDCap support team on a 
yearly basis. Additionally, REDCap conducts comprehensive auditing to record and 
track access to the database and any data changes therein.  
Project users must have a valid and current user ID to access the installation. 
Study team members will not share their usernames or passwords with any other 
team member or person outside of the study team, in accordance with UW policy. 
The individual REDCap user passwords will be different than the passwords used to 
log on to study iPads or computers; thus making this data entry system double-
encrypted. Users can only gain access to a project in REDCap after they have been 
authenticated, added, and appropriate user rights have been assigned to them by 
the owner/administrator of the project. Project owners, generally, are responsible for 
who has access as well as the level of access to their project through the user rights 
mechanism.  
 
2. UW Medicine Computers and Servers 
In addition to the use of REDCap to collect data, the study team utilizes UW 
Medicine secure servers for the storage and transmission of electronic or digital files. 
Access to these servers is available only through password-protected UW Medicine 
computers connected to the UW Medicine secure network in accordance with UW 
Administrative Policy Statement (APS) 2.6 Information Security controls and 
Operational Practices, and UW Medicine Compliance Policy COMP.102 
Safeguarding the Privacy and Security of Protected Health Information (PHI). Data 
will be hosted on a MS SQL Server database, exchanged via a webserver, and 
stored on a secure UW server in accordance with UW Information Security Policy 
SP-01 Electronic Data Policy and SP-02 Computing Device and Systems Security 
Policy. Data transmitted through the server utilizes the Transport Layer Security 
(TLS) protocol, a cryptographic protocol that provides transmission security, derived 
from the SSL protocol. TLS and SSL encrypt the segments of network connections 
above the Transport Layer, using asymmetric cryptography for key exchange, 

symmetric encryption for privacy, and message authentication codes for message 
integrity.  
UW security analysts have the ability to drill down into detailed activity logs that 
are tracked, logged, and stored to see what data on the server was accessed by 
whom and when. These activity log files and audits will be able to track any IP traffic 
that reaches the UW server. Backups will be captured and stored in redundant 
copies in separate data centers which all share the same security controls of the 
main database. 
 
3. UW Department of Emergency Medicine Harborview Medical Center Research 
Offices 
The study team has offices in the 3 East Clinic area on the Harborview campus. 
These offices are on a secure part of the 3rd floor, requiring code access to the door 
entering the office space. The study team has access to locked offices and file 
cabinets in this secure space for the storage of hard copies of documents and 
electronic equipment. 
 
B. Data Types 
1. Electronic Medical Record (EMR)  
For daily study activities, a study team member will manually abstract EMR data into 
RedCap to determine eligibility.  Later, to obtain clinical outcome data, the study will 
utilize a UW Medicine EMR data warehouse (Amalga) query to facilitate automated 
abstraction of information.  The study team will work with the Department of 
Emergency Medicine clinical analyst to support this query who has undergone 
extensive GCP training and signed the confidentiality waiver for this study.  The 
clinical analyst will conduct an Amalga query and  data abstraction may occur 
through one of three delivery methods: 
• 
A SQL Server Reporting Services (SSRS) Report hosted on a UW Medicine 
server 
• 
An upload to a custom built REDCap project hosted by the UW ITHS 
• 
A flat file delivered to the study team on a secured shared drive  
Data from the automated Amalga query or manual chart review will be imported or 
entered into the enrollment log housed within REDCap or equivalent data capture 
method (e.g., Excel).   
 
2. Patient Enrollment Log 
The study team will document all patients that screen in or out of the study in an 
electronic log housed within REDCap or equivalent data capture method on a secure 
UW Medicine server (e.g., Excel). The enrollment log will contain a single form with 
variables abstracted from the EHR and PHI will only be obtained for patients that 
screen-in and provide informed consent. At the conclusion of the record retention 
period the form containing identifiers will be deleted from the enrollment log 
database, thus severing the link between participant identifying information and de-
identified study data. 
The enrollment log will also be used to track patient approach date and status 
(e.g., consented, refused, excluded); if the patient was excluded, the reason for 
exclusion (e.g., active psychosis); overall study status (e.g., active, completed, 
withdrawn); and randomization assignment (for those patients that screen in to the 
study and provide informed consent). This data will be obtained from the Harborview 
EMR, from interviewers’ contact with patients, or from patient self-report and entered 
directly entered in to REDCap via secure login and password by a member of the 

study team. The team is aware that at times, due to technical issues or lack of Wi-Fi 
access, the enrollment logging procedures may require the team to take alternative 
measures (e.g., computer/iPad or paper logging) for subsequent entry into REDCap.   
 
3. Patient-Reported Outcomes (PRO) 
The baseline and follow-up study assessments for collecting patient-reported 
outcomes (PRO) may be completed using various methods. PRO data will typically 
be obtained from the patient during in person or telephone interviews with a study 
team member (e.g., research coordinator or research assistant). The study team 
member will log in via user name and password to the REDCap web-based platform 
on a computer on the secure UW Medicine server or log in via user name and 
password to the REDCap application on an encrypted iPad. Participants will also 
have the option of receiving an email link to the survey questions to complete follow-
up interviews on their own directly in to the encrypted REDCap web-based platform. 
If a participant has received the email link from the study team they do not need a 
REDCap user name or login in order to access and complete the survey. 
The study team could also use a hard copy paper version of the assessment to 
be completed by an interviewer in the hospital or convenient location, or the hard 
copy interview could be mailed or faxed directly to participants for them to fill in own 
their own and return in a pre-paid, self-addressed envelope. 
After receiving the hard copy interview back in the a member of the study team 
would then enter the responses from the hard copy or PDF into REDCap. Data 
collected in a hard format (e.g., on paper) will be stored in a locked cabinet in locked 
study office space. Regardless of the data collection method, interview responses 
will not be labeled with directly identifying information; instead, they will be labeled 
with the participant’s study ID number to maintain confidentiality. As mentioned 
above, all data stored in REDCap is encrypted and safe-guarded behind firewalls. 
 
4. ED-LINC Intervention and Usual Care (UC) Delivery Documentation 
Data collected about the process of care, including ED-LINC intervention care 
management notes and UC documentation will be obtained from encounters with the 
patient or their providers, or from the EMR or EDIE, and entered directly into 
REDCap.  Due to the nature of these encounters, the data related to the intervention 
may contain identifying information or may have identifying information piped in or 
linked from the patient contact form (e.g., patient name, birthdate, address) and the 
provider contact form (e.g., provider name, position, phone number) within the 
project. Intervention specific logging will be accessible only to members of the 
intervention team granted permission by the PI in order to maintain the blinding of 
the follow-up interview team. 
If limited by technological constraints, intervention study team members may 
need to take hard copy notes from encounters for subsequent entry into REDCap. As 
these hard copy intervention notes may contain identifiable information, they would 
be stored in a locked office or filing cabinet, separate from participant’s de-identified 
study data. 
 
5. Emergency Department Information Exchange (EDIE) 
Collective Medical Technologies (CMT) owns and manages EDIE, which collects 
health care utilization data including emergency department utilization data for 
patients across WA and OR state. The CMT servers, networks, and databases that 
house and transmit EDIE data are co-located in certified Data Centers with fully 
redundant systems and 24/7/365 security monitoring. CMT Data Centers are certified 

in, or have been audited against the following: SOC I, SOC II Type II and SOC III 
reporting; ISO/IEC 27000 Series; NIST 800-53; ITIL 3.0; HIPAA Privacy and Security 
& HITECH Rules; and Gramm-Leach-Bliley Act (GLBA) Interagency Guidelines.  
 
CMT maintains a HITRUST Common Security Framework (CSF) certification to 
ensure they are compliant with HIPAA and all state and federal patient privacy 
protection laws. HITRUST CSF is a healthcare oriented security framework required 
to safeguard PHI which harmonizes the requirements of existing standards and 
regulations including HIPAA, HITECH, Peripheral Component Interconnect (PCI), 
and Control Objectives for Information and Related Technologies (COBIT). CMT 
undergoes a HITRUST CSF recertification process every two-years to ensure they 
continually meet stringent health care industry standards in protecting PHI and 
managing risk. These safeguards include: intrusion prevention and detection; PHI 
transmission protection, external breach protection, malware protection, restricted 
physical and logical access; strong encryption, password and user account controls; 
and strict change management, software code, network security topologies and 
monitoring system review and approval. 
 
VII. DATA QUALITY AND INTEGRITY MONITORING 
The study team will internally monitor data quality for electronic health record screening 
procedures, enrollment, and process (i.e., intervention and UC documentation) and outcome 
variables.  Data quality is a method of measuring data properties from different perspectives to 
assess a data's fitness to serve its intended purpose. Data quality can be affected by how the 
data is entered, handled, or maintained. Effective data quality assurance procedures involve 
periodic data monitoring and cleaning with regard to the following characteristics: completeness, 
accuracy, credibility, timeliness, consistency, and integrity. With this in mind, data collection, 
documentation, and quality monitoring procedures for the study will be consistent with Good 
Clinical Practice guidelines. 
 
A. Frequency of Review 
Study data will be reviewed internally by the study data team on a weekly-to-monthly 
basis. The study team will prepare reports for weekly study meetings, which will include 
reports on recruitment and refusal rates. Major recruitment, follow-up, or data quality 
concerns will also be reviewed with the study PI and mentorship team on an as-needed 
basis.  
 
B. Data Collection Procedures and Quality Metrics 
 
1. Patient Enrollment and Follow-up Assessment Completion (i.e., CONSORT) 
Data 
The enrollment log will track participant status from the pre-screen; approach status 
(e.g., consented, refused); self-report screen; randomization; and overall study status 
(e.g., active, completed, withdrawn, deceased). Some of this data may be 
automatically imported into REDCap from the Amalga query or entered directly into 
REDCap by a member of the study team. Follow-up assessment completion rates 
will also be tracked by condition in REDCap. This data will be checked against 
signed e-consent forms and patient-reported outcome data received.  
The team is aware that at times, due to computer outage or lack of Wi-Fi access, 
the enrollment logging procedures may require the team to take alternative 
measures (e.g., computer/iPad or paper logging). If a study team member logs 
enrollment information or obtains written informed consent on a hard copy because 

of technological issues, then the data is subsequently entered into the enrollment log 
in REDCap. In these instances, someone on the team other than the person who 
entered the data into REDCap will compare the accuracy of the entry into REDCap 
against the original data source (hard copy). Any hard copy data sources will be kept 
in locked file cabinets and any data with identifying information will be stored 
separately from de-identified study data.   
 
2. Patient-Reported Outcomes 
Patient-reported outcomes are collected using a variety of potential methods, such 
as REDCap, hard copy, emailed PDF and may be completed either by telephone, in 
person, or by the participant independently. Regardless of how they are collected, all 
patient-reported outcomes will ultimately be entered into REDCap, and then 
downloaded into computer software (e.g., SPSS, STATA) at the end of the study for 
data analysis. Data entered into REDCap from a hard copy will be checked by a 
second data enterer to ensure data entry accuracy from the hard copy version.  
 
REDCap data quality will be monitored periodically by the study PI and/or data 
analyst. In the event that any changes need to be made to the data, these changes 
will be made directly in REDCap. There is a data logging tool in REDCap that allows 
administrators to track changes to the project. This tool provides access to an audit 
trail created by REDCap. For each entry that changes data in the database, REDCap 
records the date, time, username of the person logged in at that time, the type of 
event and the changes that were made. This audit trail in the data logging tool stores 
every entry/change throughout the life of the database.  Specific checks for 
completion and accuracy are outlined below for the primary and secondary outcomes 
and for intervention and usual care activity.  Certain patient-reported outcomes 
(PRO) will be used in the ‘Anticipated AE/SAE’ log as well.  Specifically, PRO’s on 
suicide and overdose will be reviewed as described above. 
 
• Feasibility 
Feasibility measures include enrollment rates, retention rates at each outcome and 
followup assessment, intervention completion rates and number and types of 
contacts made by the interventionist.  At team meetings, the CONSORT diagram 
will indicate enrollment and retention rates.  At least monthly, the study RA/RC and 
PI will review the ED-LINC contact log in RedCap for completeness, accuracy and 
content.  Feasibility of implementation will also be assessed using specific 
assessments of ED-LINC participants at the 6-month follow-up visit.  The rates of 
completion of these assessments will be assessed. 
• Substance Use and TLFB 
Past 30-day substance use will be obtained at baseline and every follow-up 
assessment and calendar will be used to track substance use on specific days.  
Prior to performing this assessment, members of the study team will receive 
training on TLFB methods including a webinar published by NIDA, review of the 
methods with current NIDA CTN project coordinators that have performed these 
assessments for a variety of substances in a variety of settings including the ED 
and will practice obtaining this data with practice participant encounters.  This 
training will be completed prior to study start to ensure accuracy of obtaining this 
data.  Episodic shadowing by study PI will be done to ensure there isn’t drift of 
accuracy in data collection.  TLFB data will be captured on a hard copy calendar 
and transferred to RedCap by study staff.  The hard copy will not contain any PHI 
and be labeled with a study ID and will be kept in a locked cabinet in a locked 

office.  At least 25% of these forms will be double-entered into RedCap to ensure 
accuracy of data entry.    
• Health Care Utilization 
Emergency department (ED) utilization will be assessed throughout the duration of 
the trial using either the UW EMR system (e.g., the UW Amalga data repository) or 
the Emergency Department Information Exchange (EDIE) web-based platform on 
an approximately monthly basis. Additionally, EDIE data will be pulled for all 
consented patients to capture all ED visits, inpatient visits and any available 
outpatient visits from five years before enrollment up to five years after enrollment 
in the trial. 
• ED-LINC Intervention and Usual Care 
The study team will document ED-LINC intervention activities in REDCap. These 
notes are not static and are modifiable over the course of the trial. For instance, 
information may be added or modified as a consequence of supervision 
discussion. The study team will review documentation during team meetings and 
case conference supervisions and update notes as needed to provide the most 
complete and accurate picture of what transpired. The data logging tool in REDCap 
allows administrators to track these types of historical changes. REDCap records 
the date, time, username of the person logged in at that time, the type of event and 
the changes that were made. This audit trail in the data logging tool stores every 
entry/change throughout the life of the database which will help the study team 
check completeness of intervention data. 
The study team will document how many and what type of consults each patient in 
the usual care (UC) condition receives. This consultation information will be 
obtained primarily from the EMR and entered in to REDCap. The team will rely on 
information from the EMR to ensure completeness and accuracy of all UC 
documented in REDCap 
 
VIII. 
INTERIM ANALYSIS PLANS 
 
Interim analysis is not relevant as this is a pilot study and effect sizes are not being 
measured. 
 
IX. 
CONTENT AND FREQUENCY OF DSM REPORTS TO NIDA 
Annually, the PI (Dr. Whiteside) will submit a grant report (RPPR) to NIDA.  The grant 
report is due in June every year and will include details on: 
• Study progress which will include details on feasibility measures, 
secondary outcomes including substance use and health care utilization 
and any problems reported to the IRB.  An enrollment table will be 
completed per NIH guidelines 
• Responsible conduct of research training received   
 
 

References 
 
1. 
D'Onofrio G, O'Connor PG, Pantalon MV, et al. Emergency department-initiated 
buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. 
JAMA 2015;313:1636-44. 
2. 
Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and 
implementation of overdose education and nasal naloxone distribution in 
Massachusetts: interrupted time series analysis. Bmj 2013;346:f174. 
3. 
Blow FC, Walton MA, Bohnert AS, et al. A randomized controlled trial of brief 
interventions to reduce drug use among adults in a low-income urban emergency 
department: the HealthiER You study. Addiction 2017. 
4. 
Bohnert AS, Bonar EE, Cunningham R, et al. A pilot randomized clinical trial of 
an intervention to reduce overdose risk behaviors among emergency department 
patients at risk for prescription opioid overdose. Drug Alcohol Depend 2016;163:40-7. 
5. 
Neven D, Paulozzi L, Howell D, et al. A Randomized Controlled Trial of a 
Citywide Emergency Department Care Coordination Program to Reduce Prescription 
Opioid Related Emergency Department Visits. J Emerg Med 2016;51:498-507. 
6. 
Olsen JC, Ogarek JL, Goldenberg EJ, Sulo S. Impact of a Chronic Pain Protocol 
on Emergency Department Utilization. Acad Emerg Med 2016;23:424-32. 
7. 
Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: 
conceptual distinctions, measurement challenges, and research agenda. Administration 
and policy in mental health 2011;38:65-76. 
8. 
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in 
clinical research. Journal of psychiatric research 2011;45:626-9. 
9. 
Whiteside LK, Darnell D, Jackson K, et al. Collaborative care from the 
emergency department for injured patients with prescription drug misuse: An open 
feasibility study. J Subst Abuse Treat 2017;82:12-21. 
10. 
Ali R, Awwad E, Babor TF, et al. The alcohol, smoking and substance 
involvement screening test (ASSIST): development, reliability and feasibility. Addiction 
2002;97:1183-94. 
11. 
Bernstein SL, D'Onofrio G, Rosner J, et al. Successful Tobacco Dependence 
Treatment in Low-Income Emergency Department Patients: A Randomized Trial. 
Annals of Emergency Medicine 2015;66:140-7. 
12. 
Madras BK, Compton WA, Avula D, Stegbauer T, Stein JB, Clark HW. 
Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol 
use at multiple healthcare sites: Comparison at intake and 6 months later. Drug Alcohol 
Depen 2009;99:280-95. 

13. 
Miller WR, Sorensen JL, Selzer JA, Brigham GS. Disseminating evidence-based 
practices in substance abuse treatment: A review with suggestions. J Subst Abus Treat 
2006;31:25-39. 
14. 
Bernstein SL, D'Onofrio G. Screening, treatment initiation, and referral for 
substance use disorders. Addict Sci Clin Pract 2017;12:18. 
15. 
Bogenschutz MP, Donovan DM, Mandler RN, et al. Brief intervention for patients 
with problematic drug use presenting in emergency departments: a randomized clinical 
trial. JAMA internal medicine 2014;174:1736-45. 
16. 
Lo-Ciganic WH, Gellad WF, Gordon AJ, et al. Association between trajectories of 
buprenorphine treatment and emergency department and in-patient utilization. Addiction 
2016;111:892-902. 
17. 
Duber HC, Barata IA, Cioe-Pena E, et al. Identification, Management, and 
Transition of Care for Patients With Opioid Use Disorder in the Emergency Department. 
Ann Emerg Med 2018. 
18. 
Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J 
Psychoactive Drugs 2003;35:253-9. 
 
 
 

Appendix A 
BI Evaluation Sheet 
 
Did the provider 
 
 
What did the provider 
do? 
How did the client 
respond 
Raise 
Subject 
 
 
 
• 
Establish rapport? 
 
• 
Respectfully ask 
permission to 
discuss substance 
use 
 
• 
Ask for description 
of substance use 
patterns? 
Yes 
 
 
Yes 
 
 
 
Yes 
No 
 
 
No 
 
 
 
No 
 
 
Provide 
Feedback 
 
 
 
• 
Ask about 
connection 
between substance 
use & health issues 
(if any)? 
 
• 
Review screening 
results? 
 
• 
Compare results to 
national norms? 
 
• 
Review low risk 
guidelines? 
 
• 
Express 
professional 
concern? 
 
 
 
 
Yes 
 
 
 
Yes 
 
 
Yes 
 
 
Yes 
 
 
 
Yes 
 
 
No 
 
 
 
No 
 
 
No 
 
 
No 
 
 
 
No 
 
 
Enhance 
Motivation 
 
 
 
• 
Review pros and 
cons of use? 
 
• 
Use a scaling 
question (ruler) to 
elicit arguments for 
positive change? 
 
• 
Emphasize 
personal 
responsibility?  
 
Yes 
 
 
 
 
Yes 
 
 
Yes 
No 
 
 
 
 
No 
 
 
No 
 
 

Negotiate 
Plan  
 
 
 
• 
Elicit change plan 
by asking about 
next steps? 
 
• 
Summarize? 
 
• 
Re-state 
professional 
recommendation? 
 
 
Yes 
 
 
Yes 
 
 
Yes 
 
No 
 
 
No 
 
 
No 
 
 
 
To what degree did the clinician use a 
Motivational Interviewing style? 
 
Self-evaluation of the BI session 
focusing on strong points, skills to work 
on, and observations about the entire 
SBIRT process. 
 
 
 
 
 
 
 
 
 

Appendix B. Sample Care Plan 
 
This patient is part of the ED-LINC (Emergency Department Longitudinal 
Integration and Coordination) Pilot Program at Harborview Medical Center.  If you 
have any questions or if we can be of any help, please call or text the 24/7 program cell phone at 
206-636-8372 
 
1. Please provide patient with clinic phone number, provider name and instruct them to 
contact their provider’s office for follow-up visit as needed 
• Provider Name: 
• Clinic Name: 
• Clinic Phone Number: 
 
Updated xx/xx/xxxx (insert date) 
 
 
 
 

Appendix C. ED-LINC PATIENT SAFETY SUICIDALITY PROTOCOL 
This protocol addresses potential subject suicidal risk given that suicidal ideation is common 
among the patient population. Suicidal risk is indicated by subject self-report of suicidality or 
suicidal behavior. The following procedure addresses positive responses to the PHQ-9 or other 
reports of suicidality by study patients.  Importantly, patients with a primary chief complaint of 
suicidal ideation or in the ED for treatment after a suicide attempt are not eligible for 
participation. 
The study team collects patient-reported outcomes at baseline, prior to randomization, and at a 
series of post-randomization follow-up assessments according to a pre-determined schedule (1, 
3, 6 months after the baseline assessment). These assessments include questions about 
patient psychological and emotional distress. Each assessment includes a question about 
having thoughts of self-harm or being better off dead on the Patient Health Questionnaire 9 item 
(PHQ-9) depression measure. The PHQ-9 question #9 asks patients “how often have you been 
bothered by thoughts that you would be better off dead or of hurting yourself in some way?” The 
response choices are: 0 = Not at all, 1 = A little of the time, 2 = More than half the time, 3 = 
Nearly all the time. 
Work by Gregory Simon et al. (2013) in a general medical setting documented a low risk of 
completed and attempted suicide by subjects that endorsed a “1” on the PHQ-9 item #9 
question; of those that responded with a “1”, approximately 1% attempted suicide and 0.08% 
completed suicide. The rates of attempts and completed suicide did increase with higher scores 
on the PHQ-9 item #9; however, the absolute risk remained relatively low; of those that 
endorsed a “3” on the PHQ-9 item #9, 4% attempted suicide over the course of a year The low 
risk of suicide completion associated with a positive PHQ-9 led the study team to include a 
follow-up question to directly assess whether patients are currently having thoughts of suicide.  
Suicidality or suicidal behavior discovered at baseline  
If a patient indicates anything greater than 0, “Not at all,” on PHQ-9 item #9, the interviewer will 
ask a Yes/No follow-up question, labeled #9a “Over the past two weeks, have you had any 
plans to harm yourself or take your own life? (or “in the past month” for follow-up interviews” If 
the patient endorsed a “Yes” to item 9a, following completion of the assessment (or earlier if 
needed), the interviewer will provide the patient with a suicide crisis line and call the study’s 
24/7 cell phone after the assessment to inform the study clinical team about the patient. A 
member of the clinical team will assess the patient either in person at the hospital or via phone 
to assess risk and safety plan. If there is imminent danger of self-harm the interviewer or 
member of the study team will inform the participant of the need to inform hospital staff. Of note, 
if during the baseline interview or during the initial follow-up by the study team to baseline 
interview responses the study team learns that the subject’s initial injury was due to a suicide 
attempt, the subject will be withdrawn by the study team per the exclusion criteria. If the study 
team learns that the initial injury was due to a suicide attempt at any other point during the 
subject’s trial participation, the subject will be eligible to continue study participation. 
 
If the patient reports a “No” to item 9a, but is otherwise positive on PHQ-9 item #9, the 
interviewer will provide the patient with a suicide crisis line (see below). A member of the clinical 
team will visit the patient in the hospital to assess risk and discuss suitable safety planning. 
 
Should the patient inform the interviewer that they have current suicidal ideation and intent 
outside of the interview questions; the interviewer will inform hospital staff. If the patient 

indicates they are having suicidal thoughts at any other time during the baseline assessment, 
even if the response to the PHQ-9 item 9 is 0, the recruiter will inform the clinical team following 
completion of the baseline assessment who will, in turn, follow the aforementioned procedures 
according to randomization assignment. 
 
Suicidality or suicidal behavior discovered at follow-up  
The following protocol is initiated if a subject indicates anything greater than 0, “Not at all,” on 
PHQ-9 item #9. 
 
If the participate indicates a response > 0 on the PHQ-9 item #9, the subject will be asked the 
follow-up question, item #9a: “Do you currently have thoughts of killing yourself or ending your 
life?” 
 
If 9a = Yes 
If the subject responds “yes” to item #9a, (“Over the past two weeks (or “month” at follow ups), 
have you had any plants to harm yourself or take your own life?”) the study team member will 
conduct a warm hand-off with the subject to a member of the study clinical team (e.g., physician 
or MSW). The subject will also be provided with a crisis line number.   
 
*If subject endorses a “Yes” on item #9a and he/she refuses a warm hand-off to the 
clinical team, the follow-up interviewer will let the subject know they will be contacted 
by our clinical team to follow-up. The interviewer will provide the subject with a crisis 
line number and immediately notify the clinical team at the 24/7 study cell.  
• A clinical team member will attempt to call the subject within 24 hours and 
assess the patient’s suicide risk and determine the appropriate action (e.g., 
develop a safety plan; help patient obtain emergency services).  
• If the subject is in the intervention, the subject’s suicidality will be addressed 
ongoing as part of the ED-LINC intervention.  
 
If 9a = No, 9 = 3  
If the subject responds “no” to item #9a and responded as a “3” to item #9, the study team 
member will provide the subject with a crisis line number and inform the subject that the clinical 
team will follow up with the subject over the phone in the coming weeks. The study team will 
add the subject to a list for the clinical team to call and assess risk and discuss suitable safety 
planning. The clinical team will regularly set aside time (e.g., weekly) to call subjects from the 
list. It may take the team more than one week to reach any given subject.  
 
If 9a = No, 9 = 2 or 1 
If the subject responds “no” to item #9a and endorses a “1” or “2” to item #9, the study team 
member will provide the subject a crisis line number.   
 
For all subjects that endorse a positive response to PHQ-9 item #9, the study team will: 
• 
Provide a crisis line number in the payment letter with their check. 
• 
Additionally, crisis line numbers may be texted, emailed, or sent via private social media 
messaging, at subject’s request or approval.  
• 
Inform study clinical team (via electronic log, email, in person, phone, etc.) so they can 
review that procedures have been properly adhered to and address any remaining 
safety concerns.  
 

Should the subject inform the follow-up interviewer that they are having suicidal thoughts at any 
other time during the assessment, even if the response to the PHQ-9 item 9 is 0, the interviewer 
will inform the clinical team to assess the subject’s need for further suicide risk intervention. 
 
There are other ways that the research study team members who conduct follow-up 
assessments with subjects may become aware of suicidal ideation or behavior besides during a 
study assessment. For instance, a study team member may be told by a subject while 
contacting the subject to schedule a study assessment that the subject is suicidal or having 
thoughts of taking his/her own life. In this case, the study team member will follow the protocol 
for a 9a = Yes above (i.e., warm handoff to the clinical team). 
 
A study team member may find out that a subject has attempted suicide or died by suicide 
during attempts to find and contact a subject through a public records search (e.g., WA state 
death records), from public posts or private messages sent through the subject’s social media 
(e.g., Facebook), or even relayed by an alternate point of contact for the subject. In this case, 
research study team members will notify the clinical team, who will address any patient safety 
concerns. 
 
Suicidality or Suicidal Behavior Discovered During Study Intervention Delivery   
Intervention team members interacting with subjects, such as the social worker or peer 
interventionists, may become aware of subject suicidality, such as through care management 
phone calls or other intervention-related activities, assessing symptoms, or when viewing the 
subject’s medical record. If a non-clinical team member becomes aware of subject suicidality 
they will inform the clinical team members  via the 24/7 study cell, so that they can assess 
suicidality severity and make decisions about how to address patient safety concerns for those 
subjects deemed to be at risk for suicide. The intervention team will address suicidality as it 
occurs as a normative part of the ED-LINC intervention.  Actions may include additional 
assessment regarding a subject’s suicidal ideation, plan, means, intent and history of attempts, 
discussion of subject’s suicidality and overall recovery during weekly case reviews, safety 
planning, and referrals to treatment if deemed necessary. 
  
Tracking and Reporting of Subject Suicidality 
Adherence to this protocol and patient suicidality concerns will be tracked; however, this will not 
be reported to the DSMB unless it reaches the level of an SAE (i.e., suicide attempt, 
hospitalization due to suicidal ideation or attempt, or death). 
 
Suicide Prevention Resources  
• 
Crisis Connections 
24 hour, toll-free, telephone hotline provides immediate, confidential assistance to 
people in distress in the King County area. Call 1-866-4-CRISIS (1-866-427-4747) or 
206-461-3222. 
 
• 
National Suicide Prevention Lifeline 
Provides 24 hour, toll-free, telephone support for anyone in suicidal crisis or emotional 
distress and provides information to locate crisis clinics and resources throughout the 
U.S.  1-800-273-TALK (8255) 
 

• 
Veterans Crisis Line 
Veterans and family members can receive confidential help by calling 1-800-273-8255 
(then PRESS 1). Visit online to access confidential online chat help.