See OneNCT01825057
Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units
A study testing See One, Do One and Order One in people with See One and Do One, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- See One, Do One and Order One
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,211 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2013to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assignment to one of the general medical inpatient units during day-time shifts; intensive care units will be excluded given the morbidity of patients in this setting.
- Volunteer to serve as study clinicians, attend a workshop about MI, and possibly receive live supervision.
- Agree to all procedures of this trial (randomization to training condition and of assigned patients, audio recording MI sessions, and completing assessments).
- Are 18 years of age or older.
- Acknowledge use of a substance within past 28 days and meets screening criteria consistent with substance (illicit drugs, licit drugs that are used in a non-medically indicated fashion, alcohol, or nicotine) use disorder.
- Are willing to consent to audio recording of interview with the provider or CL clinician.
Who cannot join
- Have been formally supervised to use MI with patients on the units.
- Intend to give notice that they plan to leave the hospital or are scheduled for medical or family leave such that they will not be able to interview 40 patients during the study period.
- For patient participants:
- Have an altered mental status such as delirium, encephalopathy, dementia or mental retardation or a score on the Confusion Assessment Method > 0 since this would impair provision of consent and ability to participate
- Inability to speak English. Most of providers are mono-lingual English speakers, and all MI integrity raters only speak English. We therefore do not have the capacity to include Spanish-only speaking patients in the study.
- Stroke (that precludes participation)
Show all 12Show fewer
- Resides in a nursing home, skilled nursing facility or Hospice Care
- Receiving palliative care
- Deaf
- Unable to speak lucidly
- Previous participation in the protocol
- An information sheet was requested and approved for a subset of patient subjects. This is due to the study being conducted within an acute medical inpatient unit, where conditions that might limit a person's ability to sign the consent form may occasionally occur. This subset of patients includes: patients that are physically unable to write (i.e. hand tremors, spinal cord injury, stroke that precludes signing, broken hand, broken shoulder, muscular dystrophy and other physical ailments preventing a patient from physically signing), unable to see (i.e. legally blind, uncontrolled type 2 diabetes mellitus which led to blurred vision), unable to read (i.e. patient does not have their glasses on them).
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units: See One, Do One, Order One
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.
Read the detailed description
General medical hospitals provide care for a disproportionate share of patients who abuse or are dependent upon substances. This group is among the most costly to treat and has the poorest medical and substance use outcomes. Motivational interviewing(MI) is a well-recognized, evidenced-based substance use treatment that has been adapted for use as a brief intervention in health care settings. MI is applicable to many health-related behavioral problems, and can be taught to a broad range of health care clinicians. However, it is unclear which implementation strategies will lead to the efficient and proficient uptake of MI in general medical settings, such as medical inpatient units.
Primary care clinicians 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 "see one, do one" apprenticeship model of training and use of consultation-liaison (CL) services. "See one, do one" has been a modus operandi in medical education for centuries and relies upon a competency-based supervision training approach. While it has been empirically validated in the specialty addiction field, less controlled testing of this implementation strategy is available in general medical settings. The apprenticeship approach requires that appropriate patients and trainers are available with high flexibility for teaching and supervision; when applied to behavioral counseling approaches, this may be seen as incompatible with the medical role and time constraints of clinicians. In contrast, ordering MI through CL is a relatively simple, minimally burdensome process and highly compatible with the way clinicians secure other specialist services for their patients in the hospital.
We propose to conduct a randomized controlled implementation trial using mixed quantitative and qualitative methods to examine the effectiveness of three different strategies for integrating MI into the practice of healthcare providers working within Yale New Haven Hospital's internal medicine hospitalist service and other general medical inpatient units. Specifically, we will randomize 40 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.We hypothesize that the percentage of MI sessions delivered by providers to study-eligible inpatients would be higher in both Do One and Order One than See One. We also hypothesize that providers in both Do One and Order One would conduct MI sessions with greater integrity (i.e., adherence to core components of MI and delivery of them with competence) than those in See One.
Please note, as an implementation trial, the primary outcomes for this study focus on provider behaviors, namely, uptake of MI sessions with patients and the adherence and competence in which they conduct MI sessions. No outcome data will be collected and reported at the patient level.
- Being tested
- See One, Do One, Order One
- Keywords
- implementation study, motivational interviewing, substance use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
See OneBehavioural
Also called Workshop
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.
Do OneBehavioural
Also called Workshop plus live supervision
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.
Order OneBehavioural
Also called Workshop plus consultation-liaison service
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.
| Study group | Role | What they receive |
|---|---|---|
| See One | Active comparator | 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. Receives: Behavioral: See One |
| Do One | Experimental | 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. Receives: Behavioral: Do One |
| Order One | Experimental | 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. Receives: Behavioral: Order One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Secondary outcomes (5)
The Independent Tape Rater Scale - Fundamental Adherence Score
The Independent Tape Rater Scale assessed the integrity of MI interviews. The Independent Tape Rater Scale includes 5 fundamental MI items important for building rapport and understanding patients' experiences (e.g. reflections), rated for adherence (i.e. the extent/frequency of intervention delivery) on a scale from 1 (not at all) to 7 (extensively). The fundamental adherence score is the average of these 5 items, with scores ranging from 1-7 and higher scores indicating greater adherence. Only MI sessions conducted within each study arm by the providers with patient participants were included in this analysis. Since 3 MI sessions were conducted by providers in See One, 11 sessions were conducted by providers in Do One, and 100 sessions were conducted by providers in Order One, this analysis includes 114 MI sessions as the unit of analysis.
Measured: 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
The Independent Tape Rater Scale assessed the integrity of MI interviews. The Independent Tape Rater Scale includes 5 fundamental MI items important for building rapport and understanding patients' experiences (e.g. reflections), rated for competency (i.e., the skill/quality of intervention delivery) on a scale of 1 (not at all) to 7 (excellent). The fundamental competence score is the average of these 5 items, for which there was adherence, with higher scores indicating greater competence. Only MI sessions conducted within each study arm by the providers with patient participants were included in this analysis. Since 3 MI sessions were conducted by providers in See One, 11 sessions were conducted by providers in Do One, and 100 sessions were conducted by providers in Order One, this analysis includes 114 MI sessions as the unit of analysis.
Measured: 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
The advanced adherence score is the average of these 5 items. The Independent Tape Rater Scale assessed the integrity of MI interviews. The Independent Tape Rater Scale includes 5 advanced MI items critical for eliciting patients' motivations for change (e.g., asking for reasons for change), rated for adherence (i.e., the extent/frequency of intervention delivery) on a scale of 1 (not at all) to 7 (extensively). The advanced adherence score is the average of these 5 items, with scores ranging from 1-7 and higher scores indicating greater adherence. Only MI sessions conducted within each study arm by the providers with patient participants were included in this analysis. Since 3 MI sessions were conducted by providers in See One, 11 sessions were conducted by providers in Do One, and 100 sessions were conducted by providers in Order One, this analysis includes 114 MI sessions as the unit of analysis.
Measured: 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
The Independent Tape Rater Scale assessed the integrity of MI interviews. The Independent Tape Rater Scale includes 5 advanced MI items critical for eliciting patients' motivations for change (e.g., asking for reasons for change), rated for competency (i.e., the skill/quality of intervention delivery) on a scale of 1 (not at all) to 7 (excellent). The advanced competence score is the average of these 5 items, for which there was adherence, with higher scores indicating greater competence. Only MI sessions conducted within each study arm by the providers with patient participants were included in this analysis. Since 3 MI sessions were conducted by providers in See One, 11 sessions were conducted by providers in Do One, and 100 sessions were conducted by providers in Order One, this analysis includes 114 MI sessions as the unit of analysis.
Measured: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Adequately Performing MI
The Independent Tape Rater Scale includes 5 fundamental MI items and 5 advanced MI items. Items are rated for adherence on a scale of 1 (not at all) to 7 (extensively) and competency on a scale of 1 (not at all) to 7 (excellent). Higher scores are better adherence or competence. An adequately performed MI session occurs when at least half the MI consistent items are rated average or above (i.e., score of 4, 5, 6, or 7) for both adherence and competence. Percentage of MI sessions reaching this adequate performance threshold, per arm, served as the secondary outcome measure. Only MI sessions conducted within each study arm by the providers with patient participants were included in this analysis. Since 3 MI sessions were conducted by providers in See One, 11 sessions were conducted by providers in Do One, and 100 sessions were conducted by providers in Order One, this analysis includes 114 MI sessions as the unit of analysis.
Measured: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study start21 Feb 2013
- Primary completion19 Nov 2018
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for See OneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this three-arm parallel assignment, study-eligible and consented provider participants are randomized to one of three conditions (See One, Do One, or Order One) in which they receive their respective motivational interviewing training in parallel with provider participants assigned to the other conditions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,211 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Steve Martino, National Institute on Drug Abuse (NIDA)
- Investigators
- Steve Martino, Ph.D., Principal investigator, Yale UniversityKimberly A Yonkers, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825057
- Sponsor's protocol ID
- R01DA034243
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2013
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be made available to other researchers upon request. PIs will screen requests.
Publications
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.
PubMed 26420671Martino 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.
PubMed 31468342Serowik 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.
PubMed 33111239
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units: See One, Do One, Order One
- ClinicalTrials.gov ID
- NCT01825057
- Acronym / sponsor ID
- R01DA034243
- Keywords
- implementation study, motivational interviewing, substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,211 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 21 Feb 2013 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 25 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
General medical hospitals provide care for a disproportionate share of patients who abuse or are dependent upon substances. This group is among the most costly to treat and has the poorest medical and substance use outcomes. Motivational interviewing(MI) is a well-recognized, evidenced-based substance use treatment that has been adapted for use as a brief intervention in health care settings. MI is applicable to many health-related behavioral problems, and can be taught to a broad range of health care clinicians. However, it is unclear which implementation strategies will lead to the efficient and proficient uptake of MI in general medical settings, such as medical inpatient units.
Primary care clinicians 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 "see one, do one" apprenticeship model of training and use of consultation-liaison (CL) services. "See one, do one" has been a modus operandi in medical education for centuries and relies upon a competency-based supervision training approach. While it has been empirically validated in the specialty addiction field, less controlled testing of this implementation strategy is available in general medical settings. The apprenticeship approach requires that appropriate patients and trainers are available with high flexibility for teaching and supervision; when applied to behavioral counseling approaches, this may be seen as incompatible with the medical role and time constraints of clinicians. In contrast, ordering MI through CL is a relatively simple, minimally burdensome process and highly compatible with the way clinicians secure other specialist services for their patients in the hospital.
We propose to conduct a randomized controlled implementation trial using mixed quantitative and qualitative methods to examine the effectiveness of three different strategies for integrating MI into the practice of healthcare providers working within Yale New Haven Hospital's internal medicine hospitalist service and other general medical inpatient units. Specifically, we will randomize 40 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.We hypothesize that the percentage of MI sessions delivered by providers to study-eligible inpatients would be higher in both Do One and Order One than See One. We also hypothesize that providers in both Do One and Order One would conduct MI sessions with greater integrity (i.e., adherence to core components of MI and delivery of them with competence) than those in See One.
Please note, as an implementation trial, the primary outcomes for this study focus on provider behaviors, namely, uptake of MI sessions with patients and the adherence and competence in which they conduct MI sessions. No outcome data will be collected and reported at the patient level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In this three-arm parallel assignment, study-eligible and consented provider participants are randomized to one of three conditions (See One, Do One, or Order One) in which they receive their respective motivational interviewing training in parallel with provider participants assigned to the other conditions.
| Arm | Type | Receives |
|---|---|---|
| See One | Active comparator | Behavioral: See OneProviders 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. |
| Do One | Experimental | Behavioral: Do OneFollowing 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. |
| Order One | Experimental | Behavioral: Order OneFollowing 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Assignment to one of the general medical inpatient units during day-time shifts; intensive care units will be excluded given the morbidity of patients in this setting.
- Volunteer to serve as study clinicians, attend a workshop about MI, and possibly receive live supervision.
- Agree to all procedures of this trial (randomization to training condition and of assigned patients, audio recording MI sessions, and completing assessments).
- Are 18 years of age or older.
- Acknowledge use of a substance within past 28 days and meets screening criteria consistent with substance (illicit drugs, licit drugs that are used in a non-medically indicated fashion, alcohol, or nicotine) use disorder.
Key exclusion criteria (12 listed)
- Have been formally supervised to use MI with patients on the units.
- Intend to give notice that they plan to leave the hospital or are scheduled for medical or family leave such that they will not be able to interview 40 patients during the study period.
- Have an altered mental status such as delirium, encephalopathy, dementia or mental retardation or a score on the Confusion Assessment Method > 0 since this would impair provision of consent and ability to participate
- Inability to speak English. Most of providers are mono-lingual English speakers, and all MI integrity raters only speak English. We therefore do not have the capacity to include Spanish-only speaking patients in the study.
- Stroke (that precludes participation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| See OneAlso: WorkshopA 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. | Behavioural | See One |
| Do OneAlso: Workshop plus live supervisionA 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. | Behavioural | Do One |
| Order OneAlso: Workshop plus consultation-liaison serviceA 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. | Behavioural | Order One |
Primary outcome
Percentage of Motivation Interviewing Sessions Audio Recorded
Time frame: 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 percentage of audio recorded Motivational Interviewing sessions conducted by providers for their 40 consecutively enrolled study-eligible patients
5 secondary outcomes
The Independent Tape Rater Scale - Fundamental Adherence Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Adequately Performing MI
Time frame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26420671Martino 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.
- Results publication: PubMed 31468342Martino 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.
- Derived from this study: PubMed 33111239Serowik 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.
- Individual participant dataSharing planned: Yes. Data will be made available to other researchers upon request. PIs will screen requests.
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Vision, Healthy
Enrolling by invitation
Evaluating App-Based Vision Testing (WHOeyes) Combined With the Questionnaire as a Substitute for One-Week Postoperative In-Clinic Follow-Up in Age-Related Cataract Patients: A Multi-center Randomized Controlled Trial
Cataract Senile
RecruitingObservational study
Evaluation of One-Shot Vision Differential Diagnosis (OSVDE) and Multi-Step Conversational Non-Inferiority (MSCNE) in AI Medical Interviewing
Differential Diagnosis, Diagnostic Accuracy
Not yet recruiting
Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Low Vision, One Eye, Unspecified Eye, Low Vision Blindness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Martino, Ph.D. principal investigator
Yale University
Kimberly A Yonkers, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing See One, Do One and Order One in people with See One and Do One, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Motivation Interviewing Sessions Audio Recorded (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.