Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Phase: NA
Conditions: Drug Use, Alcohol Use, Congestive Heart Failure, Pneumonia, Acute Myocardial Infarction, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, End-Stage Renal Disease
Sponsor: Treatment Research Institute

Study Title: Specialized Community Disease Management to Reduce Substance Use and 
Hospital Readmissions 
NCT Number: NCT02059005 
Document Date: March 4, 2016 

 
 
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Treatment Research Institute—Institutional Review Board 
 
SUMMARY OF HUMAN SUBJECTS RESEARCH PROTOCOL 
 
Please address all applicable points to create a complete and succinct synopsis of the protocol. Use 
language, insofar as is possible, that can be understood by an external, non-scientist layperson, and provide 
meanings for all acronyms used. Form must be typewritten. 
 
 
(Maintain subheadings in body of text.) 
 
Title of project: Specialized Community Disease Management to Reduce Substance Use and Hospital 
Readmissions 
 
Funding Source and Funding Dates (Start and End Dates): Patient Centered Outcomes Research 
Institute (PCORI), 3/1/2014 – 2/28/2017 
 
Name, address, agency, and phone number of principal investigator: 
Adam C. Brooks, Ph.D., Senior Scientist 
Treatment Research Institute 
600 Public Ledger Building 
150 S Independence Mall West 
Philadelphia, PA, 19106 
215-399-0980 x 128 
 
1. Introduction and rationale for study 
 
Hospitalized patients with substance use disorders (SUDs) face significant complications in their 
medical care. They are more likely to be discharged against medical advice, rehospitalized after 
discharge, and experience personal chaos and reduced family support. Rapid rehospitalization (RRH) is 
receiving increasing focus as a healthcare quality issue, and the Centers for Medicare and Medicaid 
Services (CMS) have instituted penalties on hospitals where there is a significant rate of RRH within 30 
days. Currently, hospital penalties are adjudicated based on the RRH rates of three conditions: congestive 
heart failure, acute myocardial infarction, and pneumonia.  Due in large part to these Medicaid penalties, 
hospital systems are moving quickly to implement hospital-based and community disease management 
strategies to help patients transition post-discharge.  However, few hospitals provide specialized follow-
up for discharged patients with SUDs. Inpatients with substance use disorders may not be served well by 
existing disease management programs intended to reduce rehospitalizations because the programs do not 
attend to their SUD and related psychosocial problems (isolation, unstable housing, mental illness, HIV 
infection, etc.). 
The Institute for Population Health at Temple University Hospital (our partner in this project) has 
partially reduced the 30 day RRH rates for discharged patients who are diagnosed with a variety of 
conditions, including congestive heart failure (CHF), pneumonia (PN), acute myocardial infarction 
(AMI), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), end-stage renal disease 
(ESRD), and other conditions through the Advantage Program, in which a team of nurse navigators and 
community health workers follow eligible patients (primarily by telephone) for 90 days post-discharge. 
However, this program does not address the specific needs of SUDs.  Developing specialized, well-timed, 
targeted interventions of adequate duration and intensity built around evidenced-based approaches might 
be significantly more effective for patients with SUDs than embarking on a redesign of hospital system 
strategies.  This study, conducted in collaboration with the Institute for Population Health at Temple 

 
 
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University Hospital, is highly significant because it will test whether an extended, Specialized 
Community Disease Management (SCDM) program can improve outcomes over an existing nurse 
navigator disease management strategy for patients with co-morbid medical conditions and SUDs. 
 
 
2. Specific aim(s)  
 
Aim 1: Our core SCDM intervention will be adapted and refined with patient, provider, and stakeholder 
input through an active community advisory board. It will use evidence-based strategies to engage 
comorbid patients while in the hospital, and follow them into the community using an empirically 
validated telephone based treatment approach as well as contact with a trained community health worker 
peer specialist.   
 
Aim 2: We will test whether SCDM can impact substance use, treatment engagement, and reduction of 
HIV risk, while also reducing rates of RRH.  Importantly, this proposal will aim to impact 
rehospitalization rates for six-months, which is longer than the arbitrary CMS-designated 30 days.  We 
will conduct a three-year, randomized controlled trial of 222 patients enrolled prior to discharge who are 
1) diagnosed with CHF, AMI, PN, COPD, DM, or ESRD (hereafter referred to as the targeted medical 
conditions), or have a previous hospitalization within the past six months regardless of medical condition, 
and 2) have a SUD. We will test the following four hypotheses:  
Primary Hypothesis:  Patients randomized to SCDM will demonstrate larger reductions in substance use 
measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients 
randomized to TAU. 
Secondary Hypothesis (a): Patients randomized to SCDM will attend more specialty substance abuse 
intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU.  
Secondary Hypothesis (b): Patients randomized to SCDM will demonstrate a) reduced HIV transmission 
risk behaviors, and b) greater rates of HIV testing over the 6 month follow-up than patients randomized to 
TAU. 
Exploratory Hypothesis:  Patients randomized to SCDM will experience fewer days of rehospitalization 
and use of acute emergency services than patients randomized to TAU. 
 
Aim 3: We will disseminate SCDM clinical techniques and the results of the clinical trial to the scientific 
community, the medical community, our stakeholders, and the public. 
 
 
3. Endpoint(s) to be measured  
 
Patient variables that will be measured include drug and alcohol use and problems, intervention and 
treatment engagement, health and medical functioning, hospital utilization (i.e. rehospitalization), 
psychosocial functioning, and HIV risk.  In addition, client satisfaction, implementation barriers, and 
treatment integrity will be measured.     
 
 
4. Number of subjects to be enrolled per year and in total. These numbers should incorporate 
numbers screened and consented to reach enrollment. 
 
We anticipate screening approximately 1000 patients who are referred or flagged with a potential 
substance use issue, and have either a diagnosis of one of the targeted medical conditions or a previous 
hospitalization within the past six months. We expect approximately 25% of screened patients will 

 
 
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meet eligibility criteria and consent to take part in the study (about 250 patients).  Of those patients 
consented, we expect approximately 222 participants will be enrolled to participate in the study (n=111 
per condition). 
 
Year 1: We anticipate we will screen and enroll 80 participants 
Year 2: We anticipate we will screen and enroll 120 participants 
Year 3: We anticipate we will screen and enroll 22 participants 
 
Additionally, approximately 12 participants from the study will be enrolled into an additional sub-study 
in Year 1 and complete a semi-structured interview. 
 
 
5. Considerations of statistical power in relation to enrollment 
 
The power analysis for the primary hypothesis was conducted following the recommendations of 
Diggle et al. for mixed effects models. Using a two-sided alpha of .05, an estimated intraclass correlation 
of .7 between the repeated measurements, and a 15% attrition rate by month 6, we will have 85% power 
to detect a moderate effect of the intervention (d = .4) with a sample size of 111 patients in each group. 
 
 
6. Explain procedures that will involve the subject 
 
As part of their treatment experience, all patients who provide informed consent will continue to 
receive all other standard TUH medical treatment.  Enrolled participants will be randomly assigned to 
either Treatment as Usual (TAU) via Temple’s standard Advantage program or to Specialized 
Community Disease Management (SCDM).  Random assignment will be stratified by 1) severity of 
DSM-V SUD (Low or High) as measured by the Mini-International Neuropsychiatric Interview Plus 5.0. 
(MINI, Sheehan et al., 1998), 2) index medical condition (CHF or Other), and 3) frequency of previous 
hospital utilization (high utilizer vs. non-frequent utilizer). Hospital utilization will be considered frequent 
if the patient has had 5 or more hospitalizations in the past year, or 2 or more hospitalizations in the past 6 
months for patients with CHF.  Randomized participants will receive brief intervention and referral to 
SUD treatment as part of their discharge planning.  
 
Intervention Procedures 
 
Treatment as Usual (TAU):  TUH currently has a bridge to discharge program (Advantage) 
which consists of a nurse navigator / community health worker team which is managed through the 
Institute for Population Health.  Participants randomized to the TAU condition will be enrolled into this 
program, which lasts for 90 days post-discharge.  Prior to discharge from TUH, participants will be 
approached by the nurse navigator (RN) or a community health worker (CHW) and will complete a brief 
clinical assessment concerning barriers in adhering to self-care instructions (e.g., diet, weight monitoring, 
medication adherence) and in complying with follow-up medical visits. If a participant is discharged from 
the hospital before the RN or CHW is able to meet with them, the RN or CHW will contact the participant 
in the community.  Following discharge, the RN and/or CHW will call participants 1 to 2 times each 
week for 90 days to complete a brief assessment and help them problem-solve any adherence / 
compliance issues they have.  Participants may also be visited at their home or in the community by a 
CHW.  The CHW will assist patients to get to appointments and to survey the home environment in order 
to identify other outstanding issues as needed.  The CHW services will be employed based on the 
recommendation of the RN (e.g. if the RN detects that the patient is struggling with adherence / 
compliance issues).  The CHW will prioritize and increase the number of visits for participants that report 

 
 
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poor medication compliance or missed appointments.  Substance misuse, addiction, and mental illness are 
not specifically addressed in the TUH Advantage program. 
In addition to the standard TUH Advantage program described here, participants who are 
randomly assigned to TAU will receive one session of Brief Intervention and Referral to SUD Treatment 
by the study Behavioral Health Consultant (BHC) while in the hospital. If a participant is discharged from 
the hospital before the BHC is able to conduct an initial brief intervention session, the BHC will contact 
the participant in the community and complete the initial session within one week after the participant’s 
discharge from the hospital. The intervention will be similar to the strategy described immediately below, 
and will include providing patients with normative feedback and encouragement to engage in SUD 
treatment; the BHC will work with the discharge team to find suitable referrals and work to secure an 
appropriate discharge plan for willing participants. 
For those patients that express a need for ongoing support past 90 days, the RN or CHW may 
continue to provide some additional support up to 180 days to help the patient stabilize in the community. 
This ongoing support will include at a maximum: initiating weekly contacts in months 4 and 5 until the 
patient is able to transition, and possibly initiating bi-weekly contacts in month 6 if still needed. These 
contacts will focus on helping the patient transition to other forms of support – treatment, case 
management in the community, etc. 
 
Specialized Community Disease Management (SCDM):  The SCDM intervention will last for 
90 days and will be administered by a Licensed Clinical Social Worker (LCSW) functioning as a 
Behavioral Health Consultant (BHC) trained in evidence-based brief intervention and brief treatment 
approaches.  After enrollment in the study, the BHC will conduct 1-2 brief intervention sessions at 
bedside. If a participant is discharged from the hospital before the BHC is able to conduct an initial brief 
intervention session, the BHC will contact the participant in the community and complete the initial 
session within one week after the participant’s discharge from the hospital. These sessions will last 20-40 
minutes each, and the BHC will employ motivational enhancement treatment (MET) with targeted 
behavioral strategies to create a problem-centered, flexible intervention strategy for patients at various 
levels of readiness to change.  Patients are provided with direct normative feedback based on their use 
level and encouraged to quit or cut down.  In most cases, this will include a discussion of the patient’s 
past efforts to quit and previous treatment attempts.  The BHC will negotiate an open, modifiable goal 
regarding how patients would like to handle their substance use.  This approach is flexible as patients who 
would not consider treatment or working towards abstinence can often still connect with the BHC around 
less stringent goals (cutting down / harm reduction). The BHC’s feedback will emphasize the importance 
of considering and engaging in treatment.   
If a patient is willing to enter treatment, the BHC will work with the hospital discharge planning 
team to find suitable referrals and work to secure a place in an appropriate facility.  Additionally, the 
BHCs will explore the participant’s risk for contracting HIV and determine whether the patient has been 
tested; participants at risk who have not been tested recently will be encouraged to be tested while an 
inpatient.  The BHC will provide the participant with various health communication materials from our 
Brief Intervention Toolkit.  Finally, while still inpatient, the BHC will orient the participant to the 
procedures of the telephone-based follow-up calls and introduce the peer CHW, who can follow-up on 
treatment and recovery matters with participants (see below for the full description of the CHW’s role). 
Following hospital discharge, the BHC will conduct follow-up phone calls with participants as a 
part of continuing care.  The BHC will call the participant twice a week for the first four weeks following 
discharge, and then once a week for the next 8 weeks of the intervention.  The phone calls will be about 
15-20 minutes long.  During the call, the BHC will conduct a brief assessment using RecoveryTrack™ 
(14 questions; 5-7 minutes).  The BHCs will respond to elevated risk reported by the patient (e.g., 
frequent drug use, intravenous drug use, high cravings).  On each call, the BHC will deploy one simple 
intervention from the Brief Intervention Toolkit with the goal of helping the patient 1) reduce risk, 2) 
accept the need for drug treatment and engage with it, and 3) set small goals related to risk reduction and 
problem solve to achieve those goals.  The questions also focus on medication adherence and follow-up at 

 
 
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outpatient visits for medical issues.  The BHC will directly handle most of the situations raised by 
patients regarding their medical adherence (keeping primary care visits, monitoring diet, etc.); however, 
should the patient’s self-report indicate medical deterioration, the BHCs will involve the Temple 
Advantage RN in the call.  In these cases, the RN will follow TUH’s standard Advantage practices, as 
described above in TAU.  If a participant enters community treatment during the 90-day SCDM 
intervention, the BHC will continue the follow-up phone calls on schedule to support treatment 
engagement and facilitate the transition.  
In the SCDM condition, participants will also receive CHW support, but their CHW will be a 
peer in stable recovery from addiction.  Based on the patient’s level of risk, the BHC will dispatch the 
peer CHW to visit with the patient in the community.  The Peer CHW will work closely with the study 
BHC to support patient decisions and goals around treatment engagement and harm reduction.  The Peer 
CHW will make home and community visits (no fewer than 1 per month) and will perform such tasks as 
accompanying patients to treatment visits and 12-Step meetings, and surveying patients’ living situations. 
The Peer CHW can provide encouragement and support to patients engaged in treatment, and also provide 
a model of a recovery lifestyle. In the event that patients discontinue calls, the SCDM team will try to 
reach the patient by telephone or through contacts and check in on them. To encourage patients to stay in 
contact with the study social worker and peer specialist, participants in the SCDM condition will receive 
small incentives for completing at least weekly phone calls with the SCDM clinical team. Participants 
must complete at least one full phone call, including a RecoveryTrack™ assessment, per week to receive 
the incentive. SCDM participants who maintain this level of contact will receive a $10 gift card to a 
retailer in the community (e.g., Rite Aid, CVS) for each of the first two weeks of the intervention, and 
they will receive a $5 gift card for each of the subsequent 10 weeks. These incentives will help ensure that 
the study social worker and peer specialist can maintain adequate contact with participants and thus 
effectively deliver the intervention. 
For those patients that express a need for ongoing support past 90 days, the BHC and Peer CHW 
may continue to provide some minimal support up to 180 days to help the patient get connected to 
treatment and stabilize in the community. This ongoing support will include at a maximum: initiating 
weekly contacts in months 4 and 5 until the patient is able to transition, and possibly initiating bi-weekly 
contacts in month 6 if still needed. These contacts will focus on helping the patient transition to other 
forms of support – treatment, case management in the community, etc. 
 
 
Participant Screening Procedures 
 
Patients will be screened for the study following the procedures outlined in Item 9 below. Screened 
patients who meet eligibility criteria will be invited to participate in the study. 
 
Participant Baseline Procedures 
Patients will be recruited following the procedures outlined in Item 9 below.  Following informed 
consent (described below in item 9), a Research Assistant will complete an assessment battery with 
participants at the bedside.  As a part of this assessment, participants will provide a self-report of drug 
use, and complete other measures (see Participant Measures section below).  We will also record the 
results from any urine toxicology screens conducted by Temple University Hospital at the time of 
participant’s hospital intake.  If we are not able to obtain these results (e.g. a toxicology screen was not 
conducted or results are incomplete), then we will ask the participant to provide a urine sample as a part 
of the Baseline Interview.  As a part of informed consent, research staff will also collect a comprehensive 
Locator Form that elicits extensive contact information for the participant.  Participants will be paid a $50 
gift card for completing the Baseline Interview.  Participants may choose to complete some of the 
Baseline Interview on one day, and return to complete it within one week (ideally within 48 hours).  In 
these cases, participants will be paid $25 for completing the first half of the Baseline Interview, and the 
remaining $25 when they return and complete the full interview. Additionally, participants will receive a 
$5 gift card to a retailer in the community for each verified collateral contact they provide on the Locator 

 
 
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Form (up to 3 contacts, or $15 total). Research staff will attempt to contact each collateral provided on the 
Locator Form, and a collateral contact will be considered verified if research staff are able to establish 
contact with the person. 
Temple University Hospital staff responsible for the patient’s care (e.g., nurses, doctors, social 
workers) will be made aware that the patient is participating in the study so that hospital staff members do 
not duplicate treatment referral and case management efforts. After consent, the study social worker will 
insert a temporary chart flag into the patient’s medical record indicating that the patient is enrolled in the 
study and which condition the patient is assigned to. This chart flag will be removed by hospital staff 
(which is standard procedure) after the patient is discharged from the hospital. During the consent 
process, patients will be informed that Temple staff responsible for their care will be notified that they are 
participating in the study and will also be notified which condition they are assigned to. 
 
Participant Follow-up Procedures 
We will complete follow-up assessment interviews with participants at 3 and 6 months after 
intake, as well as brief check-in calls at 1 and 2 months after intake. We will use patient-provided 
information on the Locator form to contact participants. If we are unable to contact the participant using 
Locator information, we will use contact information from the participant’s TUH medical chart. 
Participant tracking software will be employed by the research staff to ensure that research staff are 
alerted when call windows open at each assessment point. Research staff will call participants at the times 
and numbers indicated on their Locator Form as the best time to reach them.  For participants who are 
more difficult to reach, call times and call numbers will be alternated.  Participants will also be mailed 
reminder notices informing them of an upcoming interview.  Research staff will also attempt to contact 
participants via any other mechanisms that the participant consented to on the Locator (e.g. email, 
Facebook).  For participants who are unreachable, messages will be left at all contacts that the participant 
consented to on the Locator Form. A postcard will also be mailed to the Locator contacts for whom the 
participant provided addresses to remind the participant of their upcoming appointment. Should contact 
persons indicate that they have lost track of the participant, research staff will search for the patient using 
available public search mechanisms (www.whitepages.com, etc.). If the participant still remains 
unreachable through all of the aforementioned methods, research staff will conduct an outreach visit to 
the home address that the participant provided on the Locator form. Research staff will travel in pairs 
when conducting home outreach and will not conduct outreach visits alone.  When participants are 
reached, research staff will schedule the date and time of the interview, and will update the Locator Form 
in case the patient’s contact information has changed. 
Additionally, research coordinators may call a random selection of participants (up to 10%) who 
have completed follow-ups to 1) confirm that they completed a follow-up assessment with a research 
assistant, 2) confirm that they were compensated with the correct amount for the assessment, and 3) ask if 
they have any questions or concerns related to the study. To select participants for these check-in calls, 
we will randomly pre-assign each study ID number to be selected or not for the calls in an Excel 
spreadsheet separate from participant tracking. We will use a random number generator, and select the 
highest 10% of random numbers. These random checks will improve our data integrity and quality 
assurance procedures. 
 
Confidentiality.  We have devised IRB-approved procedures to safeguard patient confidentiality 
while attempting to locate participants.  Research assistants will call participants from either a study 
provided cell phone or from TRI’s office phone.  TRI’s calling system blocks the name “Treatment 
Research Institute” off of its listing, preventing the incoming phone from accessing TRI’s name.  If a 
participant registers more significant confidentiality concerns, research staff will call from blocked cell 
phone numbers that do not display the return number.  When messages are left for the participant on 
recording devices or with collaterals, research staff members report that they are trying to reach the 
participant to complete a “health care survey” that the participant volunteered for. The postcard that will 
be sent to collateral contacts includes very basic language indicating that we are trying to reach the 
participant, and it does not include any language about substance use or participating in a research study. 

 
 
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The postcard will be sent to the participant at the collateral’s address; it will be addressed to the 
participant, care of the collateral. Additional protections for patient follow-up can be found in the Human 
Subjects Protections section (item 11). 
  The 3-month and 6-month follow-up assessments will take place in-person, generally at Temple 
University Hospital.  If the participant is not able to travel to the hospital, then we will meet them in a 
safe, neutral location such as a restaurant or public library, or at their home if the participant prefers. 
Research staff will travel in pairs when conducting an assessment at a participant’s home and will not 
conduct these visits alone.   The assessment battery will be similar to that collected at Baseline (see 
Participant Measures section below), and we will collect a urine sample.  Participants will be provided 
with a payment of a $50 gift card for each of the 1-hour assessments. The 1-month and 2-month check-in 
assessments will be conducted over the phone. On these brief calls, research staff will ask the participants 
for updated locator information and will administer a 5-10 minute modified NSMOS assessment to gather 
basic information about hospitalizations, ER visits, and substance use in past 30 days.  Participants be 
paid $10 via check or money order for completing each of the 1-month and 2-month calls.  If a participant 
is incarcerated at any follow-up point, research staff will not attempt to contact the participant while 
incarcerated. 
 
Participant Semi-Structured Interview Procedures 
Twelve participants who complete the SCDM or TAU protocol will be invited to participate in a 
supplemental in-depth interview: 6 at 1 month after study enrollment (3 from each condition), and 6 at 
their Month 3 follow-up (3 from each condition).  These participants will be asked about the acceptability 
of the intervention they received, and asked for recommendations on how to improve the intervention.  
This interview will be audio-recorded.  The audiotapes will be transcribed, and all personal identifiers 
will be stripped from transcripts. 
For the 1-month interviews, we will ask the first 3 TAU participants and first 3 SCDM 
participants who enroll in the study to participate in this interview.  Should any participant decline, we 
will ask the next participant from that condition who enrolls in the study.  For the 3-month interviews, we 
will ask the first 3 TAU participants and first 3 SCDM who complete the 3-month assessment but did not 
complete a 1-month interview to participate.  As with the 1-month interviews, should any participant 
decline, we will ask the next participant from that condition who completes the 3-month assessment.  
Participants who agree to be interviewed will complete a separate informed consent for this portion of the 
study, as outlined in Item 9 below.  Participants will be paid $50 for their time and travel to the 
interviews.   
 
 
7. Identify the sources of research material obtained from individually identifiable living human 
subjects in the form of specimens, records, or data. 
 
Variable 
Purpose 
Instrument 
Time 
Points 
S   B   3   6 
     Completed by:   
 
Patient  BHC      RA 
Drug and Alcohol Problems Screen/Urn Randomize 
AUDIT, DAST-10, 
MINI 
X 
 
 
 
 
X 
X 
Substance Use 
Primary Hypothesis 
Timeline Followback , 
Uritox Quick Test, 
Medical Records 
 X X X 
X 
 
X 
Intervention & Treatment 
Engagement 
Secondary Hypothesis A NSMOS 
 X X X 
X 
 
X 
HIV Risk Reduction 
Secondary Hypothesis B HIV-RA 
 X X X 
X 
 
X 
Rehospitalization 
Exploratory Hypothesis 
Temple Hospital 
Utilization Review 
 
 
 X 
 
 
X 

 
 
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Screening Instruments 
Alcohol Use Disorders Identification Test (AUDIT). The AUDIT (Babor et al., 2007) was developed by 
the World Health Organization to serve as a brief screening instrument and includes questions on 
frequency and alcohol problems and dependence (Allen et al., 1997, Reinert & Allen, 2002, Saunders et 
al., 1993).  
Drug Abuse Screening Test (DAST-10). The DAST-10 (Skinner, 1982) is a 10-item face valid self-report 
measure of problematic substance use that is utilized for clinical screening and treatment/evaluation 
research and which surveys potential involvement with drugs during the past 12 months (Allen et al., 
1997; Maisto et al., 2000; Saunders et al., 1993; Yudko, Lozhkina & Fouts, 2007). 
DSM-V SUD Diagnosis: MINI Plus 5.0. The MINI is a short structured diagnostic interview developed in 
the United States and Europe for DSM-IV and ICD-10 psychiatric disorders (Sheehan et al., 1998). The 
MINI has become the structured psychiatric interview of choice for psychiatric evaluation and outcome 
tracking in clinical psychopharmacology trials and epidemiological studies. We will modify the MINI to 
meet DSM-V criteria for SUD.  In DSM-V, the 7 DSM-IV items for dependence and 4 items for abuse 
have been merged into a single entity of 11 items called a “Substance Use Disorder” but with the 
following two changes - the abuse item of recurrent legal problems will be removed and an item for 
craving or strong desire to use will be added (American Psychiatric Association, 2013).  A diagnosis of 
SUD requires 2 or more of the 11 items, and SUDs have three levels of severity: 2-3 items = mild, 4-5 = 
moderate, and 6+ = severe; any diagnosis of SUD results in study eligibility. 
Patient Outcomes  
90-Day Timeline Followback (TLFB): The TLFB (Sobell & Sobell, 1992) is a structured interview which 
helps patients recall their substance use to reflect a 90-day period.  Patients are presented with a calendar 
representing the past 90 days, and the interviewer helps the patient anchor the calendar with memorable 
events to reconstruct their use (dates, amounts) over the designated period.  Administered at 0,3,6 months. 
Urine Toxicology Results:  We will record the results of participants’ urine toxicology screens from 
medical charts.  We will record results for the following illicit substances: cocaine, opiates, 
amphetamines, methamphetamines, benzodiazepines, cannabis, barbiturates, PCP, and Blood Alcohol 
Content (BAC). Administered at Baseline only. 
Urine testing:  Urine drug testing will be done using kits that test for cocaine, opiates, amphetamines, 
methamphetamines, benzodiazepines, cannabis, barbiturates, and PCP. These will be purchased from 
ACON International. These kits provide a rapid (5-minute) on-site urine test.  Administered at 0,3,6 
months. 
Non-Study Medical and Other Services (NSMOS):  This questionnaire was adapted from the Treatment 
Services Review (McLellan et al., 1992) for patients in medical settings.  The NSMOS counts substance 
abuse treatment, medical services, visits to medical offices, hospitalizations, and emergency room visits 
received that were not a part of the assigned treatment.  Administered at 0,3,6 months. Brief version 
administered at 1 and 2 months. 
Patient Demographics and 
Medical Functioning 
Covariates 
ASI, Healthy Days  
 X X X 
X 
 
X 
Patient Mental Health 
Functioning 
Covariates 
PHQ-9, ACES 
(Baseline only) 
 X X X 
X 
 
X 
Satisfaction 
Covariate 
Client Satisfaction 
 
 
 X 
X 
 
X 
Social Support 
Covariate 
MOS-SSS-6 
 X X X 
X 
 
X 
Quality of Life 
Covariate 
Q-LES-Q-SF 
 X X X 
X 
 
X 
Distress Tolerance 
Covariate 
DTS 
 X  
 
X 
 
X 
Sensation Seeking 
Covariate 
BSSS 
 X  
 
X 
 
X 

 
 
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Temple Hospital Utilization Review: TUH conducts utilization reviews on all patients discharged for the 
targeted medical conditions to determine whether patients experience rehospitalization and use the 
emergency room. This data is pulled through a pre-written algorithm which can be adjusted to pull all 
inpatient and ER encounters over a six-month period. The TUH Institute for Population Health will 
supply this data for study participants. 
HIV Risk Assessment (HIV-RA): The HIV Risk Assessment provides a brief self-report measure of HIV 
testing history and sexual risk and uses the preceding three months as the time interval of interest.  The 
HIV-RA was developed Lisa Bond, PhD, and David Metzger, PhD, experts in the field of HIV risk 
behaviors. Administered at 0,3,6 months. 
Addiction Severity Index-6th Edition Modified Version (ASI6-Modified) . The ASI is a multi-
dimensional interview used to measure the substance use, health, and social problems of those with 
alcohol and other drug problems, both at admission to treatment and subsequently at follow-up contacts 
(McLellan et al., 1992; McLellan et al., 1980).  We are using an abbreviated version of the ASI-6 that 
eliminates many of the items that do not contribute to our primary hypotheses and takes approximately 20 
minutes to complete.  We will use only the ASI domains for medical, drug use, alcohol use, and 
psychological status for covariate analysis.  The ASI-6 produces Recent Status Scores in each of these 
four areas, which have demonstrated high levels of inter-rater, test-retest, and concurrent reliability 
(Cacciola et al., 2011). Administered at 0,3,6 months. 
Healthy Days Symptoms:  The Healthy Days Symptoms Module (Newschaffer, 1998) was taken from the 
CDC’s Health-Related Quality of Life Survey, which is part of the State-based Behavioral Risk Factor 
Surveillance System (BRFSS). This module measures the number of days over the past month that a 
patient was affected by symptoms such as pain and anxiety, as well as the number of healthy days. 
Administered at 0,3,6 months. 
Patient Health Questionnaire-9 (PHQ-9).  The PHQ-9 is a self-administered diagnostic screener for 
depression (Kroenke, Spitzer & Williams, 2001).  It scores each of the 9 DSM-IV criteria for despression 
based on the mood module from the Primary Care Evaluation of Mental Disorders (PRIME-MD). 
Administered at 0,3,6 months. 
Adverse Childhood Experiences Scale (ACES).  The ACES is a self-administered scored scale that assess 
10 types of childhood trauma.  It was developed as a part of the Adverse Childhood Experiences Study, 
and has been shown to be related to adult health and mental health outcomes (Felitti et al., 1998). We 
have also included items from the Philadelphia Urban ACE (Public Health Management Corporation, 
2013). The Philadelphia ACE expands the assessment of adverse childhood experiences to examine 
additional stressors that are specifically related to the urban Philadelphia community setting. 
Administered at baseline only. 
Medical Outcomes Study Social Support Survey – 6 item. The MOS Social Support Survey 6-item 
(MOS-SSS-6) (Holden et al., 2014; Sherbourne & Stewart, 1991) is a 6-item self-administered social 
support survey that was developed for patients with chronic conditions. A higher score indicates more 
global functional social support. Administered at 0, 3, 6 months. 
Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form. The Q-LES-Q-SF (Endicott, 
Harrison, & Blumenthal, 1993) is a 16-item self-report measure designed to measure participant 
enjoyment and satisfaction experienced in various areas of daily functioning. Administered at 0, 3, 6 
months. 
Distress Tolerance Scale (DTS).  The DTS (Simons & Gaher, 2005) is a 15-item self-report questionnaire 
in which respondents indicate the degree to which they believe they can experience and endure distressing 
emotional states. Lower on the DTS scores indicate a tendency to experience psychological distress as 
intolerable or unacceptable. Low distress tolerance has been posited to be related to substance use, 
suggesting that an intolerance of distress is an underlying mechanism for maintaining use (Leyro, 
Zvolensky, & Bernstein, 2010).  DTS total score has been used as a global index of perceived distress 
tolerance.  Administered at baseline only. 

 
 
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Brief Sensation Seeking Scale (BSSS).  The BSSS is a self-report measure adapted from the 1979 
Sensation Seeking Scale originally designed by Zuckerman (Hoyle et al, 2002) which attempts to capture 
behaviors and attitudes towards activities that are often associated with risk and/or danger, as well as the 
willingness to engage in dangerous activities for the sake of such thrilling (Zuckerman et al, 1993).  High 
sensation seeking has been shown to be associated with substance use (Zuckerman et al, 1993). The BSSS 
has been validated for use with adult populations as well as adolescent populations (Stephenson et al, 
2009). Administered at baseline only. 
Client Satisfaction Questionnaire: The Client Satisfaction Questionnaire was developed for this study and 
assesses the extent to which participants perceived the intervention to be helpful and useful. It contains 
both closed- and open-ended questions in order to obtain information that will help us further refine the 
intervention for dissemination. Administered at 6 months only. 
 
 
8. Describe characteristics of the subject population, such as their anticipated number, age ranges, 
sex, ethnic background, and health status. The study should employ a study design with gender 
and race representation appropriate to the purpose of the research. Strong justification must be 
provided for exclusion of broad population groups. Identify the criteria for inclusion or exclusion. 
Explain the rationale for the use of vulnerable populations as research subjects (i.e., prisoners, 
pregnant women, disabled persons, drug users, children). 
 
Research participants will be inpatients at Temple University Hospital (TUH) in Philadelphia, PA 
who 1) are diagnosed with congestive heart failure (CHF), pneumonia (PN), acute myocardial infarction 
(AMI), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), or end-stage renal 
disease (ESRD), or have a previous hospitalization within the past six months regardless of medical 
condition, and 2) meet criteria for a SUD by DSM-V criteria.  We expect that 222 participants will enroll 
in the study.  We will not exclude any potential participant based on race or gender, and members of 
gender and minority groups, the elderly, and disabled will be included in the research in the same 
proportion as they are represented in the populations of patients served at TUH. These patients are, on 
average, 35% female, 82% Black, 15% White, 3% other minorities, and 20% Hispanic. Elderly subjects 
and those with medical problems will be included in the research as long as they are able to give 
competent, informed consent and understand the content of the research instruments.  Participants with 
disabilities will be accommodated. We will monitor gender and minority representation to ensure that it is 
representative of the target population, and will over-sample any gender and racial groups that are 
significantly under-represented.  
 
 
9. Describe plans for recruitment of subjects, including advertisement and posters and the consent 
procedures to be followed, including the circumstances under which consent will be sought and 
obtained, who will seek it, the nature of the information to be provided to prospective subjects 
and the methods of documenting consent. 
 
Prior to beginning study recruitment, we will conduct a utilization review to identify potential 
study participants. This review will identify patients who: 1) have been hospitalized within the past three 
years for one of the targeted medical conditions; and 2) have diagnostic history of a SUD in their medical 
record.  A previous diagnosis of these conditions does not necessarily mean that the patient either 
currently or ever truly met criteria for these conditions.  These patients will be flagged and if they are 
readmitted into TUH they will be assessed and if found to meet inclusion criteria, invited to participate.  
In addition to flagging the patients identified during the utilization review, admitted patients with a 
diagnosis of one of the targeted medical conditions and who have a diagnosis of SUD in their medical 
record will be identified through the electronic flagging system at TUH. Patients admitted to TUH who 

 
 
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have a previous hospitalization within the past six months and a diagnosis of SUD in their medical record 
will also be flagged. Additionally, the LCSW and/or RAs will identify potential patient participants on 
key hospital units via referral from the medical team.  Flagged or referred patients will then be 
approached for screening by an RA. We will maintain a recruitment log that will include basic 
demographic information (gender, age, race, and ethnicity) for any patient approached to be in the study 
and will indicate whether the patient consented, refused, or was found ineligible. 
Inclusion and Exclusion Criteria 
Inclusion Criteria: 1) patient is 18 years or older, 2) admitted to the hospital for one of the target medical 
conditions or has a previous hospitalization within the past six months, 3) a screening score of at least 8 on 
the AUDIT, or a screening score of at least 3 on the DAST, 4) patient meets criteria for a substance use 
disorder as defined by DSM-V and assessed via the MINI Plus 5.0, and 5) patient reports that s/he used 
alcohol or drugs in the 60 days prior to his/her current hospitalization. 
Exclusion Criteria: (a) the medical practitioner or BHC overrule these criteria because medical and 
psychiatric complications exist that would contraindicate research participation or because after questioning 
the patient it appears that the substance use is mild enough that further intervention is not warranted; (b) 
the patient was admitted to the hospital directly from a drug and alcohol inpatient rehabilitation facility; (c) 
the patient reports plans to leave the Philadelphia greater metropolitan area within the next 6 months; (d) 
the patient reports that s/he is currently homeless (i.e., s/he is living in a place not meant for human 
habitation, such as the street, a car, or a park);  (e) the patient is not English-speaking; (f) patient has had 
an organ transplant; (g) patient is being discharged on a ventilator; (h) patient has a ventricular assist device 
or an artificial heart or (i) if the patient is unable to provide valid informed consent by correctly describing 
the key components of consent to the RA.  
 
 
Patients who are identified as potential study participants through the processes described above 
will be asked to complete a screening consent with an RA. We are requesting a waiver of written 
documentation of consent for the screening process. According to 45 CFR 46.117(c), written documentation 
may be waived if “the only record linking the subject and the research would be the consent document and 
the principal risk would be potential harm resulting from breach of confidentiality.” The screening consent 
form would be the only written document linking the patient to the research, thus a requirement for written 
consent would paradoxically be the only real danger to loss of privacy and confidentiality for participants 
who agree to be screened. We will provide an information sheet to patients prior to screening that contains 
informed consent information, and we will obtain verbal consent that the patient is willing to participate in 
the screening. For patients who consent to screening, the RA will administer the AUDIT, DAST, and MINI 
to determine if they meet inclusion criteria. Patients who meet the inclusion criteria and are interested in 
participating will be asked to provide written informed consent with an RA. Patients will be selected for 
the semi-structured interview via a convenience sampling procedure.  For the 1-month interviews, we will 
ask the first 3 TAU participants and first 3 SCDM participants who enroll in the study to participate in this 
interview.  Should any participant decline, we will ask the next participant from that condition who enrolls 
in the study.  For the 3-month interviews, we will ask the first 3 TAU participants and first 3 SCDM who 
complete the 3-month assessment but did not complete a 1-month interview to participate. Participants who 
agree to be interviewed will complete a separate informed consent for this portion of the study. 
During the informed consent process, patients will be fully informed of the procedures, the nature 
of the study conditions, the randomization procedure, inclusion and exclusion criteria for the study, and 
the compensation associated with participating in the study. They will be informed that all research data 
collected in the study will be kept strictly confidential, and that we have applied for or obtained an NIH 
Confidentiality Certificate that will shield the research data from a subpoena or court order. The only 
exceptions to confidentiality (clearly specified in the consent form) will pertain to information related to 
medical emergencies, disclosure of current child/elder/dependent abuse or neglect, or imminent risk of 
death or serious injury to the participant or others. Finally, these individuals will be informed of all 
known potential risks and benefits of participation, their right to refuse or revoke consent at any time, and 

 
 
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the names and phone numbers of responsible individuals they may contact for additional information or to 
register complaints about study procedures. They will also be asked to complete a brief consent quiz to 
ensure their understanding of the study requirements, the risk and benefits, and their human subject 
protections. All items answered incorrectly will be reviewed with the participant to ensure adequate 
understanding. This process will continue until participants demonstrate at least a 95% understanding of 
the essential elements of the informed consent document. Potential participants will then be asked if they 
have any questions and will be asked to sign the informed consent form to document their agreement to 
participate. They will receive a duplicate copy of the consent form for their records. The original signed 
consent form will be kept in a locked filing cabinet only accessible to staff working on this study. 
 
 
10. Discuss whether risks to the subject are ‘minimal’ or ‘greater than minimal.’ List the major risks 
of subject participation. Describe any possible benefits of subject participation. Are the risks to 
subjects reasonable in relation to the anticipated benefits to subjects and in relation to the 
importance of the knowledge that may reasonably be expected to result? 
 
The risks to subjects enrolled in this study are minimal.  There are four anticipated potential risks 
associated for participants enrolled in this study.  
1. Perception of coercion:  It is possible that some participants may feel coerced to participate in the 
research study because a healthcare professional at the hospital told them about it. 
2. Discomfort answering research questions, providing biological data, and/or being audio-recorded: 
Participants may experience mild and transitory psychological discomfort from completing research 
measures that deal with emotionally laden material or from providing urine samples. Participants in 
the Semi-Structured Interviews may also experience discomfort from having their interviews audio-
recorded. The probability of these risks and the magnitude of the anticipated harm are likely to be 
small. 
3. Discomfort associated with the treatment intervention: Participants may experience emotional distress 
given that the interventions are designed to encourage them to become more aware of their own 
substance use behaviors and how those behaviors may be impacting their physical and psychological 
wellbeing. We expect this level of distress to be similar to that which patients would experience 
during any psychological or psychoeducational intervention, and thus is not a function of the research 
participation per se. 
4. Harm from Breach of Confidentiality:  Participants are at risk for harm as a result of being identified 
as a study participant or as someone with an alcohol or drug problem. The likelihood of this occurring 
is small. 
 
Benefits to participants: Participants in this study may benefit from receiving an intervention (either TAU 
or SCDM) which is designed to reduce the risk of rapid rehospitalization (RRH). Participants in the 
SCDM intervention may additionally benefit from receiving the expanded intervention which could lead 
them to reduce their substance use and / or seek treatment. This project will also yield considerable 
information on behavioral changes associated with the SCDM intervention. 
 
Importance of Knowledge to be Gained:  The aim of this project is to test the impact of an intensive 
Specialized Community based Disease Management (SCDM) approach to assist substance-dependent 
patients with medical comorbidity in reducing substance use and avoiding rehospitalization. If this SCDM 
approach proves to be effective, patients will demonstrate detectable reductions in substance use, higher 
engagement rates with specialty care, and reduced use of acute care (hospitalizations and Emergency 
Department visits) during the six-month follow-up period, resulting in reduced health care costs. 
 
The risks associated with participating in this study are reasonable given the benefits and importance of 
knowledge to be gained.  

 
 
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11. Describe the procedures for protecting against or minimizing any potential risks, including 
physical, psychological, legal and confidentiality risks, and assess their likely effectiveness. Where 
appropriate, discuss provisions for insuring necessary medical or professional intervention in the 
event of adverse events to the subjects and for monitoring the data collected to insure the safety 
of subjects. Also, where appropriate, describe alternative treatment and procedures that might 
be advantageous to the subjects. 
 
1. Perception of coercion:  The RAs and LCSW will be trained to describe the study to eligible patients, 
including the risks and benefits, prior to offering an invitation to participate in the study. The 
RA/LCSW will clearly state that the patient’s decision to participate is voluntary and that it will not 
impact the services they receive at the hospital. Patients will be informed that Temple staff responsible 
for their care will be notified that they are participating in the study and which condition they are 
assigned to. However, patients will be told that these individuals have no vested interest in their 
participation and will receive no benefit if they choose to participate. All potential participants will be 
told that if they feel any pressure to participate from hospital staff they can voice this concern to the PI 
or other TRI research staff, and the PI will discuss this matter with the TUH PI and/or other 
appropriate individuals. 
2. Discomfort answering research questions, providing biological data, and/or being audio-recorded:  
Individuals enrolled in any study may experience mild and transitory emotional discomfort when 
answering the questions posed in interviews and on questionnaires, or providing a urine sample. All 
participants will be informed about these possible risks before signing the consent form. In order to 
minimize discomfort with providing a urine sample, the sample will not be collected under 
observation. The research staff will complete a training regarding monitoring and addressing 
emotional distress among research participants, as well as an additional training on the urine collection 
process which will include suggestions for decreasing participant discomfort. Participants will be told 
that they can choose not to respond to a question that they find upsetting and can withdraw from 
participation at any time without negative consequence. Participants completing an audio-recorded 
Semi-Structured Interview will be told that they can decline to have their interview recorded at any 
time. 
3. Discomfort associated with the treatment interventions:  Participants may experience mild and 
transitory psychological discomfort while participating in the treatment interventions. Drs. Brooks and 
Morrison will jointly train the Nurse Navigators and LCSW to monitor patient participants for distress 
by observing their behavior during their brief intervention sessions, as well as during check-in 
telephone calls. This training will focus specifically on helping patients to manage difficult feelings, 
screening them for potential harm to self and others, and implementing methods to help ensure their 
physical safety and emotional well-being. If necessary, the LCSW and Nurse Navigators can obtain 
timely clinical consultation about the participant’s distress by contacting their clinical supervisor. 
4. Harm from Breach of Confidentiality:  Data collected in the study will be kept strictly confidential and 
will not be shared with anyone outside of the research team. The only exceptions to confidentiality, 
which will be clearly specified in the consent form, will be for information related to medical 
emergencies, current child abuse or neglect, elder abuse, or imminent risk of death or serious injury to 
the participant or others. If a participant tells us that s/he has been abusing a minor or elder, then we 
will report this to the appropriate authorities. All research materials will be coded with a research 
number and will contain no other identifying information. Information collected on paper (e.g., 
consent forms, HIPAA forms, Locator Forms) will be stored in locked filing cabinets at TUH or TRI, 
and computer spreadsheets will be saved in password-protected files. Participants will be assigned a 
study identification number which will be affixed to all collected data. Linkage between participant 
identity and identification numbers will be stored in a password protected electronic file available only 
to the PI and designated research staff. All research instruments will be computerized for this study, 

 
 
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and the data will be entered via the Web into a secure server located at the University of 
Pennsylvania’s Data Management Unit. All computers have security codes and password protections 
to prevent unauthorized access. The Web-based RecoveryTrack™ information collected by the 
LCSWs as a part of the SCDM intervention will be stored in a separate secure data entry system at TRI 
given that it will contain identifying information (e.g., patient name). This application is “role” based 
(e.g., counselor, RA), allowing for assignment of specific access privileges for different users. Efforts 
to contact participants for telephone check-ins or follow-up appointments will make no mention of the 
study until it is established that the participant has been reached. Access to participants’ telephone 
numbers, addresses, and other contact information will be limited only to research staff members who 
need to contact a participant for study purposes. Should any breaches of participant confidentiality 
occur, they will be reported to the relevant IRB (i.e. TRI and Temple), DSMB, and PCORI officials. 
 
 
12. Describe procedures for reporting Serious Adverse Events (SAEs) and Adverse Events (AEs), 
and Unanticipated Problems.  Include the definition of SAEs and AEs.   
 
Serious Adverse Events (SAEs) will be defined as death; a life threatening event due to post-
discharge health problems related to the index condition or the targeted disease (e.g. CHF, AMI, PN, 
COPD, DM, ESRD, or the health condition that the patient was initially hospitalized for if not one of the 
six previously listed conditions), suicidal behavior (i.e. serious ideation/attempt), psychiatric distress, or 
drug/alcohol complications/overdose. Participants in this study are substance dependent and at risk for 
RRH, and are thus at risk for clinical worsening. Although we do not believe the study procedures or 
intervention places participants at increased risk for clinical worsening (significant increase in 
alcohol/drug use compared to baseline), we will review and report events of clinical worsening that leads 
to hospitalization. A component of the study interventions involves referral to specialty treatment, 
including inpatient hospital-based treatment as appropriate. Admission to hospital-based inpatient 
substance use treatment will not be defined as an SAE unless, as noted above, it occurs as a result of or in 
conjunction with clinical worsening, overdose, or complications due to alcohol/drug use. Childbirth, pre-
planned elective procedures, and unrelated medical events that require hospitalization will not be 
considered SAEs. 
Adverse Events (AEs) will be defined as report of coercion to participate in the study; significant 
discomfort from answering research questions or providing urine samples such that the participant 
decides to stop their participation; significant discomfort or distress from participating in the intervention; 
negative side effects due to breach of confidentiality; significant increase in drug/alcohol use compared to 
baseline; significant increase in psychiatric symptoms compared to baseline; or significant increase in 
symptoms of the index medical disease. We will monitor attrition rates, but drop out from the study will 
not be reported as an AE. Clinically insignificant events are not considered AE’s. Examples of clinically 
insignificant events include mild viral illness (e.g., colds, flu, and runny nose), common headaches, minor 
scratches, and mild symptoms or problems associated with medical conditions not related to the index 
condition. Participants may have medical and psychiatric problems which may continue during the course 
of the study. As per the definition of AEs, only significant worsening of baseline medical and psychiatric 
status or new problems will be reported as AEs.  
All adverse and serious adverse events occurring during the study are documented on a form, 
reviewed and signed by the PI or Co-I and reported to TRI and other applicable IRBs. All non-fatal 
adverse events that meet the above definition of “Severe” are reported to the IRBs and relevant PCORI 
Office within 48 hours of our awareness of the event (24 hours for fatal events). A summary of all SAEs 
and AEs that occurred during the previous year will be including the annual progress report to the 
relevant IRBs. 
As described below, we are collecting medical chart data, including emergency room visits and 
hospitalizations, from study participants for a period beginning two years prior to their enrollment in the 
study and ending three years after their enrollment in the study. However, since participants are actively 

 
 
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engaged in the study for only a 6-month period, we will not report any AEs that are discovered via chart 
data collection that occurred outside of the participant’s period of active participation in the study. 
However, we will report any AEs discovered through chart data collection if they occurred during the 
participant’s period of active engagement in the study and were not previously reported. The period of 
active engagement in the study will be defined as beginning with the date of consent and ending six 
months after the date of consent. 
 
 
 
13. If this study is a chart review, indicate the time frame of data to be collected (from when to when). 
Also, will the data be collected anonymously (meaning that only aggregate data will be collected, 
and there will be no names or codes maintained to match the data with the original files)? 
We will collect data from participants’ medical charts at TUH as part of this study. This information will 
include the patient’s name, health insurance status, hospitalizations, emergency room visits, diagnoses, 
medications, and results of urine drug tests at TUH. We will collect this information beginning on the 
date two years prior to the participant’s study enrollment date and ending on the date three years after 
their study enrollment date. The data will not be collected anonymously, as we will need to link the chart 
data to specific participants in order to determine study outcomes. However, we will de-identify all 
research data collected from the charts; this data will be linked and stored under the participants’ research 
identification numbers. All chart data will be provided to TRI by TUH. 
 
 
14. Children, defined as individuals under the age of 21, must be considered for potential enrollment 
in every study as subjects unless there are scientific or ethical reasons for excluding them. See 
below for the permissible exclusionary circumstances listed in the NIH Policy. If no exclusion 
applies: 1) discuss your plan for the inclusion of children; 2) justify the age range of children to 
be enrolled; 3) indicate the expertise of the research team with regard to children; 4) describe the 
facilities for the children; 5) indicate the number of children to be enrolled to give sufficient power 
for meaningful analysis; 6) describe how the assent process for children 7 to 17 years of age will 
be carried out. 
 
Justify your exclusion based on one of the exclusionary circumstances listed: 
 
The research topic is irrelevant for children 
 
Children are barred by law from participation because of the risk 
 
Study is redundant; knowledge is being obtained in another study or is already available 
 
Separate age-specific children study is preferable 
 
Rarity of disorder makes inclusion of children extremely difficult 
 
The limited number of available children are already enrolled in a nation-wide pediatric 
disease network 
 
Study design precludes direct applicability to children 
 
Insufficient adult data to judge potential risk for children 
 
Study design is a follow-up of an adult study 
 
As the NIH definition of children includes all persons less than 21 years old, we will include 
children between the ages of 18 and 21 in this investigation. Based on census data provided by the TUH 
Outreach program, we expect that less than 1% of our participants will be between the ages of 18-21. We 
will exclude potential participants who report that they are younger than the age of 18, as this research 
topic is not relevant for this population.  The targeted medical conditions are rare in children, and the 
intervention may not be appropriate for children under the age of 18 with SUDs. 
 
15. This study involves research to be performed at: 

 
 
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[please list site(s)]  Temple University Hospital 
 
 
 
3401 N Broad St. 
 
 
 
Philadelphia, PA 19140 
 
Data collection and intervention procedures will be conducted at TUH.  Intervention procedures involving 
the Community Health Worker or Peer Specialist will also be conducted throughout the surrounding 
community (e.g. participants’ homes, 12-Step meetings, treatment programs). The Principal Investigator 
at TUH, Dr. Mary Morrison, will assist Dr. Brooks by providing supervision of research procedures at 
TUH and the surrounding community.  
 
Reminder:  It is Principal Investigator’s responsibility to obtain copies of FWAs for each 
performance site. 
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