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Background: The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) has supported clinical trials of substance use disorder (SUD) interventions for 25 years. This review describes the use of implementation outcomes across CTN trials, characterizes outcomes included, and identifies gaps and potential opportunities to strengthen implementation research within the CTN and the field of SUD treatment.
Methods: This systematic review included active or completed studies listed on the CTN Dissemination Library webpage as of August 18, 2021, and approved by the CTN for development by January 1, 2022. Study summaries and protocols were reviewed if they: 1) measured at least one implementation outcome and 2) examined a practice change, intervention, or process. Extracted data elements included trial design characteristics, implementation frameworks, and outcome assessment domains informed by the RE-AIM and Proctor Implementation Outcomes Frameworks.
Results: 114 protocols were considered, 42 full-text protocols were screened, and 25 were included for data extraction. Start dates of trials spanned a 20-year period (2004–2024) with latter studies including more implementation outcomes. Fidelity (n = 29) and reach/penetration (n = 26) were the most included implementation outcomes. Equity was not identified in any protocols. Methods of defining, capturing, and evaluating outcomes data varied across trials and outcomes.
Conclusions: The inclusion of implementation outcomes increased over time, perhaps reflecting a growing emphasis on implementation research. Incorporating measures of equity could advance knowledge about differential receipt or effectiveness of SUD interventions. Future research should seek to improve the consistency and comprehensiveness in descriptions of implementation science elements.
Related protocols: CTN-0016, CTN-0056, CTN-0062-Ot, CTN-0064, CTN-0065, CTN-0069, CTN-0074, CTN-0074-A-1, CTN-0075, CTN-0076-Ot, CTN-0079, CTN-0079-A-1, CTN-0088, CTN-0090, CTN-0091, CTN-0095, CTN-0096, CTN-0097, CTN-0098, CTN-0099, CTN-0102, CTN-0103, CTN-0107, CTN-0116, CTN-0121
Screening for substance use in rural primary care clinics faces unique challenges due to limited resources, high patient volumes, and multiple demands on providers. To explore the potential for electronic health record (EHR)-integrated screening in this context, researchers conducted an implementation feasibility study with a rural federally-qualified health center (FQHC) in Maine. This was an ancillary study to a NIDA Clinical Trials Network study of screening in urban primary care clinics (CTN-0062).
Researchers worked with stakeholders from three FQHC clinics to define and implement their optimal screening approach. Clinics used the Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool, completed on tablet computers in the waiting room, and results were immediately recorded in the EHR. Adult patients presenting for annual preventive care visits, but not those with other visit types, were eligible for screening. Data were analyzed for the first 12 months following implementation at each clinic to assess screening rates and prevalence of reported unhealthy substance use, and documentation of counseling using an EHR-integrated clinical decision support tool, for patients screening positive for moderate-high risk alcohol or drug use.
Screening was completed by 3749 patients, representing 93.4% of those with screening-eligible annual preventive care visits, and 18.5% of adult patients presenting for any type of primary care visit. Screening was self-administered in 92.9% of cases. The prevalence of moderate-high risk substance use detected on screening was 14.6% for tobacco, 30.4% for alcohol, 10.8% for cannabis, 0.3% for illicit drugs, and 0.6% for non-medical use of prescription drugs. Brief substance use counseling was documented for 17.4% of patients with any moderate-high risk alcohol or drug use.
Conclusions: Self-administered EHR-integrated screening was feasible to implement, and detected substantial alcohol, cannabis, and tobacco use in rural FQHC clinics. Counseling was documented for a minority of patients with moderate-high risk use, possibly indicating a need for better support of primary care providers in addressing substance use. There is potential to broaden the reach of screening by offering it at routine medical visits rather than restricting to annual preventive care visits, within these and other rural primary care clinics.
Related protocols: CTN-0062-Ot
This is the outcomes article for CTN-0062-Ot.
Guidelines recommend that adult patients receive screening for alcohol and drug use during primary care visits, but the adoption of screening in routine practice remains low. Clinics frequently struggle to choose a screening approach that is best suited to their resources, workflows, and patient populations.
The purpose of this study was to evaluate how to best implement electronic health record (EHR)-integrated screening for substance use by comparing commonly used screening methods and examining their association with implementation outcomes. This article presents the outcomes of phases 3 and 4 of a 4-phase quality improvement, implementation feasibility study (CTN-0062-Ot) in which researchers worked with stakeholders at 6 primary care clinics in 2 large urban academic health care systems to define and implement their optimal screening approach. Site A was located in New York City and comprised 2 clinics, and Site B was located in Boston, MA, and comprised 4 clinics.
Clinics integrated validated screening questions and a brief counseling script into the EHR, with implementation supported by the use of clinical champions (i.e., clinicians who advocate for change, motivate others, and use their expertise to facilitate the adoption of an intervention) and the training of clinic staff. Clinics varied in their screening approaches, including the type of visit targeted for screening (any visit vs. annual examinations only), the mode of administration (staff-administered vs. self-administered by the patient), and the extent to which they used practice facilitation and EHR usability testing.
Data from the EHRs were extracted quarterly for 12 months to
measure implementation outcomes. The primary outcome was screening rate for alcohol and drug use. Secondary outcomes were the prevalence of unhealthy alcohol and drug use detected via screening, and clinician adoption of a brief counseling script.
Patients of the 6 clinics had a mean (SD) age ranging from 28.9 (17.3) years at clinic B2 to 59.1 (16.7) years at clinic B3, were predominantly female (52.4% at A1 to 64.6% at A2), and were English-speaking. Racial diversity varied by location. Of the 93,114 patients with primary care visits, 71.8% received screening for alcohol use and 70.5% received screening for drug use. Screening at any visit (implemented at site A) in comparison with screening at annual examination only (implemented at site B) was associated with higher screening rates for alcohol use (90.3%-94.7% vs. 24.2%-72%, respectively) and drug use (89.6%-93.9% vs. 24.6%-69.8%). The 5 clinics that used a self-administered screening approach had a higher detection rate for moderate- to high-risk alcohol use (14.7%-36.6%) compared with the 1 clinic that used a staff-administered screening approach (1.6%). The detection of moderate- to high-risk drug use was low across all clinics (0.5%-1%). Clinics with more robust practice facilitation and EHR usability testing had somewhat greater adoption of the counseling script for patients with moderate-high risk alcohol or drug use (1.4%-12.5% vs. 0.1%-1.1%).
Conclusions: In this quality improvement study, EHR-integrated screening was feasible to implement in all clinics and unhealthy alcohol use was detected more frequently when self-administered screening was used at any primary care clinic visit. The detection of drug use was low at all clinics, as was clinician adoption of counseling. These findings can be used to inform the decision-making of health care systems that are seeking to implement screening for substance use.
Related protocols: CTN-0062-Ot
Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S. and screening for alcohol and drug use in primary care is recommended. However, such screening has not become part of routine health care, and substance use information is not systematically collected in electronic health records. This presentation describes the objectives, methods, and outcomes of CTN-0062-Ot, a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment common data elements into a widely used EHR.
Related protocols: CTN-0062-Ot
Alcohol and drug use are leading causes of morbidity and mortality that frequently go unidentified in medical settings. As part of a multi-phase study to implement electronic health record-integrated substance use screening in primary care clinics (the CTN-EHR-PC study, CTN-0062-Ot), researchers interviewed key clinical stakeholders to identify current substance use screening practices, barriers to screening, and recommendations for its implementation. Focus groups and individual interviews were conducted with 67 stakeholders, including patients, primary care providers (faculty and resident physicians), nurses, and medical assistants, in two urban academic health systems affiliated with the NIDA Clinical Trials Network. Themes were identified using an inductive approach, revised through an iterative process, and mapped to the Knowledge to Action (KTA) framework, which guides the implementation of new clinical practices.
Factors affecting implementation based on KTA elements were identified from participant narratives:
- Identifying the problem: Participants consistently agreed that having knowledge of a patient’s substance use is important because of its impacts on health and medical care, that substance use is not properly identified in medical settings currently, and that universal screening is the best approach.
- Assessing barriers: Patients expressed concerns about consequences of disclosing substance use, confidentiality, and the individual’s own reluctance to acknowledge a substance use problem. Barriers identified by providers included individual-level factors such as lack of clinical knowledge and training, as well as systems-level factors including time pressure, resources, lack of space, and difficulty accessing addiction treatment.
- Adapting to the local context: Most patients and providers stated that the primary care provider should play a key role in substance use screening and interventions. Opinions diverged regarding the optimal approach to delivering screening, although most preferred a patient self-administered approach. Many providers reported that taking effective action once unhealthy substance use is identified is crucial.
Conclusions: Participants expressed support for substance use screening as a valuable part of medical care, and identified individual-level as well as systems-level barriers to its implementation. These findings suggest that screening programs should clearly communicate the goals of screening to patients and proactively counteract stigma, address staff concerns regarding time and workflow, and provide education as well as treatment resources to primary care providers.
Related protocols: CTN-0062-Ot
Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S., but screening for alcohol and drug use is not part of routine health care and substance use information is not systematically collected in electronic health records.
This presentation described two protocols in the CTN that aimed to address this issue: CTN-0059, in which the TAPS Tool for screening and brief assessment was developed and validated, and CTN-0062, a feasibility and proof-of-concept study to assess incorporating the NIDA CTN Common Data Elements into electronic health records in large primary care settings.
Related protocols: CTN-0059, CTN-0062-Ot
Alcohol and drug use are significant drivers of preventable morbidity and mortality that are not routinely identified or treated in medical settings. Screening, brief intervention, and referral to treatment (SBIRT) to address substance use in primary care is widely promoted, but has proven challenging to implement. Validated screening tools that can quickly and accurately identify substance use have been designated common data elements (CDEs), but are not widely integrated into electronic health records (EHRs). As part of a study of the NIDA Clinical Trials Network (CTN-0062-Ot), a clinical decision support system (CDSS) was developed to support the delivery of substance use screening and interventions in primary care.
This presentation reports on usability testing performed to address the challenges of developing the CDSS. Usability testing identified important issues related to workflow and content, as well as human-computer interactions problems. An iterative process of usability testing and content adaptation allowed researchers to successfully modify a commercial EHR for delivery of a complex behavioral intervention, though some limitations to its functionality remain. Future phases of this study will examine adoption of this CDSS in multiple primary care clinics.
Related protocols: CTN-0062-Ot
This webinar provided an update on CTN-0062-Ot, a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment of common data elements (CDEs) into a widely used electronic health record (EHR), explore the logistics and time required to do this, and assess impacts on the frequency of identification, diagnosis, and referral to treatment in large healthcare organizations.
The webinar included these components (click each title for the individual slides):
- A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements into the Electronic Health Record in Large Primary Care Settings (CDE-EHR-PC Study, CTN-0062-Ot). Jennifer McNeely, MD, MS, New York University School of Medicine
- Usability: An Introduction. Joseph Kannry, MD, Mount Sinai Health System
- Usability in Healthcare IT: Data Collection and Analysis Approaches. Andrew Kushniruk, PhD, School of Health Information Science, University of Victoria
- Lessons Learned and Conclusion.
Related protocols: CTN-0062-Ot