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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
This is the primary outcomes article for CTN-0075.
Physician and pharmacist collaboration may help address the shortage of buprenorphine-waivered physicians and improve care for patients with opioid use disorder (OUD). This study, CTN-0075, investigated the feasibility and acceptability of a new collaborative care model involving buprenorphine-waivered physicians and community pharmacists.
The study was a nonrandomized, single-arm, open-label feasibility trial held in three office-based buprenorphine treatment (OBBT) clinics and three community pharmacies in the United States. Participants were six physicians, six pharmacists, and 71 patients aged 18 or older with DMS-5 OUD on buprenorphine maintenance. After screening, eligible patients’ buprenorphine care was transferred from their OBBT physician to a community pharmacist for 6 months. Primary outcomes included recruitment, treatment retention and adherence, and opioid use. Secondary outcomes were intervention fidelity, pharmacists’ use of prescription drug monitoring program (PDMP), participant safety, and satisfaction with treatment delivery.
A high proportion (93.4%) of eligible participants enrolled into the study. There were high rates of treatment retention (88.7%) and adherence (95.3%) at the end of the study. The proportion of opioid-positive urine drug screenings (UDSs) among complete cases (i.e., those with all six UDSs collected during 6 months) at month 6 was 4.9%. Intervention fidelity was excellent. Pharmacists used PDMP at 96.8% of visits, and there were no opioid-related safety events. Over 90% of patients endorsed that they were “very satisfied with their experience and the quality of treatment offered,” that “treatment transfer from physician’s office to the pharmacy was not difficult at all,” and that “holding buprenorphine visits at the same place the medication is dispensed was very or extremely useful/convenient.” Similarly, positive ratings of satisfaction were found among physicians/pharmacists.
Conclusions: Overall success of this pilot trial offers strong support for a physician-pharmacist collaborative care model to help improve buprenorphine treatment access for OUD. Future randomized trials are needed to test the efficacy, effectiveness, and implementation of physician-pharmacist collaborative care models for management and treatment of patients with OUD as part of real-world practice.
Related protocols: CTN-0075
Pharmacists are on the frontline caring for patients at risk of an opioid overdose and for patients with an opioid use disorder (OUD). Dispensing naloxone and medications for OUD and counseling patients about these medications are way pharmacists can provide care. Key to pharmacists’ involvement is their willingness to take on these practice responsibilities.
As part of NIDA Clinical Trials Network protocol CTN-0075, Physician-Pharmacist Collaboration in the Management of Patients with Opioid Use Disorder, this scoping review aimed to identify, evaluate, and summarize published literature describing pharmacists’ attitudes toward naloxone and medications for OUD, i.e., methadone, buprenorphine, and naltrexone. All searches were performed on December 7, 2015, in 5 databases: Embase.com, PubMed.gov, Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCOhost, Cochrane Central Register of Controlled Trials via Wiley, and Clarivate Web of Science. Articles included original research conducted in the United States, described attitude-related language toward naloxone and medications for OUD, and pharmacists.
A total of 1323 articles were retrieved, 7 were included. Five studies reported on pharmacists’ attitudes toward naloxone dispensing; 1 study reported on attitudes toward naloxone, buprenorphine, and buprenorphine/naloxone; and 1 reported on attitudes toward buprenorphine/naloxone. Respondents were diverse, including pharmacists from different practice specialties.
Studies found that pharmacists agreed with a naloxone standing order, believed that naloxone should be dispensed to individuals at risk of an opioid overdose, and were supportive of dispensing buprenorphine. A minority of pharmacists expressed negative attitudes. Barriers cited to implementation included education and training, workflow, and management support.
Conclusions: Pharmacists were positive in their attitudes toward increased practice responsibilities for patients at risk of an opioid overdose or with an OUD. Pharmacists must receive education and training to be current in their understanding of OUD medications, and they must be supported in order to provide effective care to this patient population.
Related protocols: CTN-0075