Why Wait? Initiating Contingency Management in Traumatically Injured Patients During Hospitalization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen's Medical Center
About this trial
This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients.
The goals are:
* Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury * To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program. * To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants. * To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital.
For total of 12 weeks, participants will:
* Be visited on Mondays/Thursdays or Tuesdays/Fridays by the research team to complete urine analysis during the hospitalization * Visit a follow up clinic up to 2 times per week on Mondays/Thursdays or Tuesdays/Fridays to complete urinalysis following discharge from the hospital * Complete Treatment Effectiveness Assessments at 6 and 12 weeks * Engage in qualitative interview at the end of the CM program
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted trauma patients
Age greater than 18 years old
Urine drug screen positive for methamphetamines during the current hospitalization
Report at least weekly methamphetamine use
Disqualifiers
Active psychosis (reporting auditory or visual hallucinations)
Under ongoing cardiorespiratory monitoring
Evidence of moderate or severe traumatic brain injury
Patients who are known to be pregnant
Trial design
Design model
Single group
Treatments tested in this trial
Contingency management
BehavioralIf the urine sample is methamphetamine negative, participant will be positively reinforced and offered incentives. Participants immediately draw the reinforcement slip of paper to receive a prize from a selection kept on-site. Approximately 50% of the slips offer written praises (i.e. "great job!"). The other 50% of slips are the divided between low value (i.e. food gift cards, bus passes), medium value (i.e. prepaid cellphone, clothing gift cards), and a few large value rewards (i.e. electronic tablet, jewelry). Should the sample be positive for methamphetamine, no reinforcement and/or incentive to be provided. Participant will be encouraged to continue to participate in CM program and follow-up on the next CM date.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Contingency management interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Effectiveness Assessments (TEA) at 6- and 12-weeks post-enrollment
TEA (Treatment Effectiveness Assessment) at 6- and 12-weeks post-enrollment to assess both patient-reported medium-term program effectiveness. TEA asks individuals to respond to changes in four domains following a drug treatment program: Substance use, health, lifestyle, and community. The score for each domain can range from 1 (no change or not much) to 10 (much better), for total score of 4-40. This score allows for the prioritization of each participants values, and therefore does not require strict abstinence to demonstrate benefit from drug treatment.
Time frame
From enrollment to 6 and 12 weeksSecondary outcomes
1
Conduct qualitative interviews with participants post-program
Interviews will be conducted as semi-structured qualitative interviews with participants post-program and will be transcribed and analyzed using a Template Analysis approach. Coders will conduct coding of the interview data to ultimately identify themes that will be used as the basis for interpretation. The final analysis of the qualitative data will include contrasts and comparisons made across interviews to examine overlaps and divergences across any relevant sub-samples (i.e. sex, age). Results will present thematic patterns, how frequently each code occurs, and any contradictory evidence. This will allow for the identification of common themes and perspectives, which will provide necessary cultural insights and possible adaptations for further implementation efforts.
Time frame
At the end of the treatment at 12 weeksOther outcomes
1
Assessment of rate of AMA and treatment completion in acute hospital setting in participants
To assess the rate of AMA and treatment completion in acute hospital setting in participants To assess the optimal timing of CM initiation for trauma injury hospitalized patients by comparing patient outcomes to the Schumann's pilot project 2024 (7/2024-6/2025) (NCT06532370 - Implementing a Contingency Management Program Addressing Methamphetamine Use For and With the People of Hawaii). We will compare the duration of CM participation and the rates of CM program completion and providing negative urine samples.
Time frame
From enrollment to the end of treatment at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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