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Sponsor study identifier
NIH
interventional
1,211
1 country
1
Study Start
February 21, 2013
Actual (reported)Primary Completion
November 19, 2018
Actual (reported)Study Completion
April 25, 2019
Actual (reported)General medical hospitals provide care for a disproportionate share of patients who misuse substances. Motivational interviewing (MI) is a well-recognized, evidenced-based substance use treatment. However, it is unclear which implementation strategies lead to the efficient and proficient uptake of MI in general medical settings, such as medical inpatient units. Because medical providers have multiple practice demands and time constraints, new practices have the greatest chance of being implemented if they are simple and compatible with existing workflows and systems. Two widely used strategies to bring specialized practices into use within general hospital settings are the apprenticeship model of training and use of consultation-liaison (CL) services. The apprenticeship model requires that appropriate patients and trainers are available with high flexibility for teaching and supervision; when applied to behavioral counseling approaches, this model may be incompatible with the providers' medical role and time constraints. In contrast, ordering MI through CL is relatively simple, minimally burdensome, and highly compatible with the way clinicians secure other specialist services for their patients in the hospital. This cluster randomized controlled trial examines the effectiveness of three different strategies for integrating MI into the practice of medical providers working within an academically affiliated internal medicine hospitalist service. Specifically, the trial randomizes 38 healthcare providers to one of three conditions: (1) a continuing medical education workshop that provides background and "shows" healthcare providers how to conduct MI (the control condition, called SEE ONE); (2) a "see one, do one" apprenticeship model involving workshop training plus live supervision of bedside practice (DO ONE); and (3) ordering MI from CL after learning about it in a workshop (ORDER ONE). Following the respective MI trainings, each healthcare provider will be assessed for the provision of MI to 40 study-eligible inpatients, recruited by the research team after admission to our general medical units. Trial hypotheses are 1) the percentage of MI sessions delivered by providers to study-eligible inpatients will be higher in both Do One and Order One than See One, and 2) providers in both Do One and Order One will conduct MI sessions with greater integrity than those in See One. This study is an implementation trial examining provider, not patient, outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 25, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 21, 2013
Actual (reported)March 28, 2013
Actual (reported)April 5, 2013
Actual (reported)November 19, 2018
Actual (reported)April 25, 2019
Actual (reported)March 25, 2021
Actual (reported)Percentage of Motivation Interviewing Sessions Audio Recorded
The percentage of audio recorded Motivational Interviewing sessions conducted by providers for their 40 consecutively enrolled study-eligible patients
Provider participants will be followed for the duration of the trial period, an expected average of 24 weeks to see 40 study-enrolled patients per provider.
The Independent Tape Rater Scale - Fundamental Adherence Score
All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
The Independent Tape Rater Scale- Fundamental Competence Score
All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
The Independent Tape Rater Scale- Advanced Adherence Score
All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
The Independent Tape Rater Scale- Advanced Competence Score
All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Adequately Performing MI
All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Providers in See One only receive MI workshop training, giving them an opportunity to "see" the MI intervention and learn how to conduct it. The trainer encourages them to screen their patients for substance misuse and apply MI as indicated.
Following workshop training, MI-trained CL clinicians directly supervise providers' live bedside provision of MI to patients twice before beginning the trial and once midstream. In addition, providers have the option to request additional live supervision from CL clinicians during the trial, consistent with the apprenticeship model.
A 1-day workshop conducted by a member of the Motivational Interviewing Network of Trainers (MINT), according to MINT recommendations, to build providers' skills needed to use MI with patients who misuse substances.
A 1-day workshop conducted by a member of the Motivational Interviewing Network of Trainers (MINT), according to MINT recommendations, to build providers' skills needed to use MI with patients who misuse substances. Following the workshop training, providers conduct two motivational interviews bedside with patients under the supervision of one of the MI-trained CL clinicians, who subsequently give them performance feedback and coaching. Providers receive one more supervised practice case mid-trial. In addition, they can request additional supervision at any point during the trial.
Yale School of Medicine
New Haven, Connecticut, 06511, United States
Martino S, Zimbrean P, Forray A, Kaufman J, Desan P, Olmstead TA, Gueorguieva R, Howell H, McCaherty A, Yonkers KA. See One, Do One, Order One: a study protocol for cluster randomized controlled trial testing three strategies for implementing motivational interviewing on medical inpatient units. Implement Sci. 2015 Sep 29;10:138. doi: 10.1186/s13012-015-0327-9.
Martino S, Zimbrean P, Forray A, Kaufman JS, Desan PH, Olmstead TA, Gilstad-Hayden K, Gueorguieva R, Yonkers KA. Implementing Motivational Interviewing for Substance Misuse on Medical Inpatient Units: a Randomized Controlled Trial. J Gen Intern Med. 2019 Nov;34(11):2520-2529. doi: 10.1007/s11606-019-05257-3. Epub 2019 Aug 29.
This study was conducted across medical units within one urban hospital, reducing generalizability. We did not follow patients' substance use following hospital discharge; the effectiveness of MI delivered in this study is unknown.
Steve Martino, Ph.D.
Yale University
Kimberly A Yonkers, MD
Yale University
1,211 participants (actual enrollment reported by the registry).
Following the workshop, providers either administer MI themselves or "order" a MI for delivery by one of the MI-trained CL clinicians. Only providers in Order One can specifically request MI through a separate CL order in the electronic health record. The physicians or PAs directly place MI orders. Nurses contact physicians or PAs to place the MI order. The CL clinicians are trained in MI via a clinical trials training approach: 1) a 2-day skill-building workshop; 2) three post-workshop supervised practice cases based on review of audio recorded sessions; and 3) follow-up monthly group supervision to maintain and monitor the CL clinicians' MI practice. CL clinicians also learned supervisory practices to provide live supervision to providers in Do One.
A 1-day workshop conducted by a member of the Motivational Interviewing Network of Trainers (MINT), according to MINT recommendations, to build providers' skills needed to use MI with patients who misuse substances. Following the workshop, providers have the option to conduct MI with patients themselves or to "order" a MI for delivery by one of the MI-trained CL clinicians.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Serowik KL, Yonkers KA, Gilstad-Hayden K, Forray A, Zimbrean P, Martino S. Substance Use Disorder Detection Rates Among Providers of General Medical Inpatients. J Gen Intern Med. 2021 Mar;36(3):668-675. doi: 10.1007/s11606-020-06319-7. Epub 2020 Oct 27.
First Submitted
March 28, 2013
First Posted
April 5, 2013
Study Start
February 21, 2013
Actual (reported)Primary Completion
November 19, 2018
Actual (reported)Study Completion
April 25, 2019
Actual (reported)Last Updated
March 25, 2021
Results First Posted
March 25, 2021
Record last verified: 2021-03
Data will be made available to other researchers upon request. PIs will screen requests.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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