Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT01825057
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01825057
Study Brief:
Protocol Section:
NCT01825057