Clinical trial NCT01825057: Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units
Official title: Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units: See One, Do One, Order One
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: See One
Do One
Order One
Keywords: implementation study
motivational interviewing
substance use
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2013-04-05
Enrollment: 1211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: For Healthcare provider participants:

Inclusion criteria :

* 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).

Exclusion criteria:

* 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:

Inclusion criteria:

* 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.

Exclusion criteria:

* 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)
* 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).

Primary outcomes:
measure: Percentage of Motivation Interviewing Sessions Audio Recorded
timeFrame: 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:
measure: The Independent Tape Rater Scale - Fundamental Adherence Score
timeFrame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
measure: The Independent Tape Rater Scale- Fundamental Competence Score
timeFrame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
measure: The Independent Tape Rater Scale- Advanced Adherence Score
timeFrame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
measure: The Independent Tape Rater Scale- Advanced Competence Score
timeFrame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
measure: Adequately Performing MI
timeFrame: All sessions conducted and recorded by providers with study-enrolled patients during the trial period, an expected 24 weeks per provider.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Steve Martino, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Kimberly A Yonkers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.