Study design and setting
We conducted an observational study of ED patients with non-medical opioid use. Participants were enrolled from the ED at Yale New Haven Hospital (YNHH), a 1,450-bed teaching hospital located in New Haven, Connecticut with a catchment area of 350,000 that includes a diverse ethnic and cultural mix; non-Latino white (48%), non-Latino Black (30%), Latino (18%), Other (2.5%) and Asian (< 1%) and is the most nationally representative community in terms of socioeconomics and education . The YNHH ED has 58 treatment spaces and an estimated 106,600 annual patient encounters. The study received Institutional Review Board approval at Yale University and was registered at Clinicaltrials.gov (NCT03985163).
Characteristics of participants
The study enrolled patients presenting to the YNHH ED for opioid overdose or those screening positive for OUD or non-medical opioid use, based on the NIDA Quick Screen, a brief 30-day substance use screener . Eligible participants were identified by electronic health record (EHR), emergency clinician referral and bed-to-bed screening and were enrolled at the bedside between 6am and 11 pm daily. Exclusion criteria included age < 18 years, non-English speaking, active psychiatric evaluation, and inability to provide consent or follow-up contact information. Over the course of study recruitment, RAs developed a more effective process for enrolling patients who were cleared by the psychiatric team after evaluation prior to ED discharge.
After providing informed consent, participants enrolled in an mHealth platform, Hugo, and were asked to (1) access and share EHR data with the study and (2) complete electronic questionnaires at enrollment, 3-day and 30-days post discharge from the hospital accessible by an electronically delivered link by text or email. A detailed study flow is illustrated in Fig. 1.
Hugo is a sync-for-science platform that allows patients to access personal data from multiple health systems, share data with researchers, and complete surveys for researchers using personal email and/or mobile devices . To enroll in Hugo, participants were asked to access the app via a tablet or smartphone, create an account using a personal email, link available EHR data through their healthcare system’s secure online patient portal (“MyChart” at YNHH), and join the study to receive surveys. Participants agreed to share EHR data with researchers for one year following enrollment. As needed, a tablet and/or laptop were provided to participants during the registration process, and a research assistant (RA) assisted in addressing any challenges encountered such as password recovery, setting up and accessing a personal email, and creation of a MyChart account. If participants were admitted to the hospital during enrollment, the RA continued the registration process in the new patient location, as permitted, and follow-up surveys were scheduled following discharge from the hospital.
Based on patient preference, surveys were delivered by email and/or text using a secure link and could be completed on any computer or smart device. No questions were mandatory, and participants were permitted to skip questions they preferred not to answer. Surveys were considered “complete” if they had ≥ 1 answer, and participants clicked through the entire survey and received a gift card. Participants received a minimum of four email, text or phone reminders as needed and were given up to 30 days to complete each survey, after which they were considered lost to follow-up (LTFU). The baseline, 3-day and 30-day surveys included 12, 33–42 and 44–56 questions total, based on skip logic. Participants received a $10 electronic gift card for each survey completion, which was delivered automatically through a third-party vendor (Tremendous). Participants were given the option to receive an electronic gift card by text or email instantly or provide an address to have the gift card mailed. Electronic gift cards could be redeemed online only, while mailed gift cards were redeemable at brick and mortar stores.
Patient reported outcomes
PRO selection was guided by our interdisciplinary steering committee that included technical experts and representatives from National Institute on Drug Abuse, National Library of Medicine, Centers for Disease Control and Prevention, U.S. Food and Drug Administration, U.S. Department of Health and Human Services, academic researchers, and a community member with personal experience with OUD. Survey questions represent a mix of investigator generated questions designed to collect outcomes that could inform ED quality improvement for which validated surveys were not available (i.e. difficulty scheduling a follow-up appointment or filling a medication) and validated structured instruments designed to collect PROs (PROMIS surveys). The baseline survey consisted of demographics, DSM-5 criteria for OUD, and history of overdose and treatment for OUD, while the 3-day and 30-day surveys included recent treatment and prescription history, an overdose risk behavior survey as well as standardized patient reported outcomes including PROMIS Global-10, PROMIS Severity of Substance Use (Past 30 days) and Treatment Effectiveness Assessment (TEA) . The PROMIS Global-10 includes questions on the general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life . The PROMIS Severity of Substance Use includes questions about drug use other than alcohol or prescribed medications in past 30 days [22, 23].
As EDs often have staff responsible for making follow-up patient calls regarding late resulting tests (blood and urine cultures, results finalized after patient discharge) referrals, or patient satisfaction, this step was designed to test the feasibility of a pragmatic strategy to integrate PRO feedback to enhance patient outcomes using an existing resource at many EDs. Following the 3-day questionnaire only, a phone call was triggered if the patient reported challenges picking up a prescription or scheduling a follow-up appointment for OUD treatment. During the phone call, a trained RA provided information and resources about OUD treatment, as appropriate. Challenges were captured qualitatively based on interviews and feedback from study RAs.
Feasibility and acceptability outcomes
Our feasibility outcomes included the proportion of eligible patients who were willing to enroll in the study overall and the ability to link patient’s EHR to the mHealth platform. Acceptability outcomes include response rates to the baseline, 3-day and 30-day surveys and the ability to reach patients by telephone when a PRO triggered a follow-up telephone call.
Data collection and analysis
Screening, enrollment, and follow-up data were recorded by study RAs in case report forms using the Qualtrics XM Platform. Survey data were collected and stored by Hugo and were extracted and transferred via the Hugo platform by researchers. At the end of the study, Hugo staff shared a comprehensive analytic dataset including EHR data for all participants via secure transfer. Using a unique identifier to link participants, all data were merged in Microsoft Excel and analysis was performed using SAS version 9.4. For analysis purposes, “completers” included participants completing two or more surveys and “non-completers” completed no surveys or baseline only, as nearly all baseline surveys (97%) were completed during enrollment in the ED and do not accurately capture engagement post-discharge from the hospital. As a pilot feasibility study, no power analyses were used.