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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| See One | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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For Healthcare provider participants:
Inclusion criteria :
Exclusion criteria:
For patient participants:
Inclusion criteria:
Exclusion criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Steve Martino, Ph.D. | Yale University | Principal Investigator |
| Kimberly A Yonkers, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26420671 | Background | 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. | |
| 31468342 | Result | 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. |
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Data will be made available to other researchers upon request. PIs will screen requests.
Data will be made available upon request, with review of request by Drs. Martino or Yonkers, beginning 10/24/19. Data requests will remain available for the subsequent 4 years.
simply use the following emails for all data requests: steve.martino@yale.edu and kimberly.yonkers@yale.edu.
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The study's primary outcome and secondary outcomes are only collected and reported at the provider level - not at the patient level.
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| ID | Title | Description |
|---|---|---|
| FG000 | See One | 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. |
| FG001 | Do One | 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. |
| FG002 | Order One | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient Study Flow |
| |||||||||||||
| Provider Study Flow |
|
Total provider and patient participant characteristics
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| ID | Title | Description |
|---|---|---|
| BG000 | See One | 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. |
| BG001 | Do One |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number analyzed in the rows represented are for two distinct participant groups in this study crossing the three conditions (See One, Do One, Order One), namely 38 providers and 1173 patients, which equals an overall number equal to 1211 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | A percentage of MI sessions audio recorded was calculated for each provider, and a mean percentage was calculated by group. | Posted | Mean | Standard Deviation | percentage of MI sessions audio recorded | 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. |
|
For provider participants, adverse events were monitored/collected over the course of their implementation trial participation from study enrollment until they were assigned their last patient participant; across provider participants, this period was up to one year. For patient participants, adverse events were monitored/collected from study enrollment through the period in which the provider participants were assigned to their care; across patient participants, this period was up to one week.
The Adverse Event Table combines within each arm the number of patient participants and the number of provider participants at risk. Hence, See One includes 336 patient participants and 13 provider participants (subtotal = 349); Do One includes 379 patient participants and 12 provider participants (subtotal = 391); and Order One includes 458 patient participants and 13 provider participants (subtotal = 471). In total, we document adverse events for 1211 participants at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | See One | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Martino | Yale School of Medicine | 203-932-5711 | 7418 | steve.martino@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2015 | Jun 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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Research staff independently screen, assess and obtain consent from eligible substance using patients admitted to the general medical hospitalist service. Patients are included if they are assigned to a participating provider according to the hospital's usual clinical administrative procedures. Thus, patients followed the randomization condition of their assigned provider, but they do not know how their providers have been trained to deliver MI and the providers do not know which patients assigned to them have been enrolled in the study. This approach permits a naturalistic test of the providers' ability to identify and intervene using MI with patients who misuse substances without patients or research staff prompting providers to do so.
|
| Do One | Behavioral | 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 One | Behavioral | 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. |
|
|
| 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. | 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. | 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. | 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. | All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider. |
| 33111239 | Derived | 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. |
| NOT COMPLETED |
|
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. |
| BG002 | Order One | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The number analyzed in the rows represented are for two distinct participant groups in this study crossing the three conditions (See One, Do One, Order One), namely 38 providers and 1173 patients, which equals an overall number equal to 1211 participants. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The number analyzed in the rows represented are for two distinct participant groups in this study crossing the three conditions (See One, Do One, Order One), namely 38 providers and 1173 patients, which equals an overall number equal to 1211 participants. | Count of Participants | Participants |
|
| Type of provider | This baseline data was only collected for provider participants. Patient participants are not included. | Count of Participants | Participants |
|
| OG001 | Do One | 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. |
| OG002 | Order One | 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. |
|
|
|
| Secondary | 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. | Analysis sample includes the N=114 MI sessions completed by providers with study-enrolled patients across all training groups. | Posted | Mean | Standard Deviation | score on a scale | All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider. | MI Sessions completed by providers | MI Sessions completed by providers |
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| Secondary | 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. | Analysis population includes the N=114 MI sessions that were completed by providers across all training groups. | Posted | Mean | Standard Deviation | score on a scale | All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider. | MI Sessions completed by providers | MI Sessions completed by providers |
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|
| Secondary | 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. | Analysis population includes the N=114 MI sessions that were completed by providers across all training groups. | Posted | Mean | Standard Deviation | score on a scale | All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider. | MI Sessions completed by providers | MI Sessions completed by providers |
|
|
|
|
| Secondary | 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. | Analysis population includes the N=114 MI sessions that were completed by providers across all training groups. | Posted | Mean | Standard Deviation | score on a scale | All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider. | MI Sessions completed by providers | MI Sessions completed by providers |
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| Secondary | 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. | Posted | Count of Units | MI Sessions completed by providers | All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider. | MI Sessions completed by providers | MI Sessions completed by providers |
|
|
|
| 0 |
| 349 |
| 0 |
| 349 |
| 0 |
| 349 |
| EG001 | Do One | 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. | 0 | 391 | 0 | 391 | 0 | 391 |
| EG002 | Order One | 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. | 0 | 471 | 0 | 471 | 0 | 471 |
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| Title | Measurements |
|---|---|
|
| Male |
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| non-Hispanic African American |
|
| non-Hispanic Asian |
|
| Hispanic White |
|
| non-Hispanic Other Race |
|
| Title | Measurements |
|---|---|
| non-Hispanic White |
|
| non-Hispanic African American |
|
| non-Hispanic Asian |
|
| Hispanic White |
|
| non-Hispanic Other Race |
|
| Physician's Assistant |
|
| Medical Doctor |
|
| Kruskal-Wallis |
| 0.0126 |
p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method |
| Mean Difference (Final Values) |
| 1.22 |
| 2-Sided |
| Superiority |
mean difference is Order One - See One |
| Kruskal-Wallis | 0.4231 | p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method | Mean Difference (Final Values) | 0.6 | 2-Sided | mean difference is Do One - See One | Superiority |
| Kruskal-Wallis |
| 0.0196 |
p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method |
| Mean Difference (Final Values) |
| 1.04 |
| 2-Sided |
mean difference = Order One - See One |
| Superiority |
| Kruskal-Wallis | 0.2832 | p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method | Mean Difference (Final Values) | 0.60 | 2-Sided | mean difference = Do One - See One | Superiority |
| Kruskal-Wallis |
| 0.0982 |
p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method |
| Mean Difference (Final Values) |
| 0.88 |
| 2-Sided |
mean difference = Order One - See One |
| Superiority |
| Kruskal-Wallis | 0.6631 | p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method | Mean Difference (Final Values) | 0.45 | 2-Sided | mean difference = Do One - See One | Superiority |
| Kruskal-Wallis |
| 0.4097 |
p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method |
| Mean Difference (Final Values) |
| 0.57 |
| 2-Sided |
| Superiority |
mean difference = Order One - See One |
| Kruskal-Wallis | 0.8779 | p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method | Mean Difference (Final Values) | 0.33 | 2-Sided | mean difference = Do One - See One | Superiority |