Clinical trial NCT06223191: Reducing Readmissions: BNI Trial in Substance Use Disorder
Official title: Comparing Brief Negotiated Interview, Narrative Interview, and Standard Care to Reduce Readmission: A 2024 Clinical Trial in Substance Use Disorder Patients at Santa Rosita Psychiatric Specialties Hospital
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Substance Withdrawal
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to assess the effectiveness of Brief Negotiated Interview (BNI) in comparison to Narrative Therapy and Standard Care in reducing readmissions among male patients aged 18 and above with a history of substance use disorder The main questions it aims to answer is: Does the Brief Negotiated Interview reduces rehospitalization rates at least to 50%? Participants will be submitted to a Structured interview with motivational interviewing techniques. Researchers will compare 2 control groups one with standards of care and the other one with a narrative interview to see if they reduce readmission.

Detailed description: The research investigates the effectiveness of the Brief Negotiated Interview (BNI) compared to Narrative Interview and Standards of Care in reducing readmissions among patients with Substance Use Disorder (SUD) in the Alcoholic Detoxification Unit of Santa Rosita Psychiatric Specialties Hospital in 2024. Employing a randomized clinical trial design, the study aims to address a critical gap in understanding the optimal intervention for this vulnerable population.

Study Design: This trial adopts a prospective, randomized, three-arm design, with participants randomly assigned to one of three groups: BNI, Narrative Interview, or Standard Care. The randomization process utilizes a computer-generated list, ensuring an allocation ratio of 1:1:1. The trial encompasses a recruitment period of three months, followed by a three-month follow-up period.

Participants: The target population comprises 150 male patients aged 18 or older admitted to the Alcoholic Detoxification Unit during January 2024.

Interventions:

Brief Negotiated Interview (BNI): Modeled after motivational interviewing techniques, BNI aims to empower patients to explore reasons for change. Administered as a single 30-minute session, BNI encourages patient autonomy in decision-making regarding behavioral changes related to substance use.

Narrative Interview: A 20-minute session applying narrative therapy techniques, encouraging patients to explore and reframe their stories concerning substance use. The session emphasizes externalizing issues and examining social and political factors contributing to the problem.

Standard Care: Following the Alcohol Detoxification Management Protocol, standard care includes pharmacological interventions (benzodiazepines, thiamine, etc.), psychological evaluation on the third day, psychoeducational sessions, and psychiatric assessment for dual diagnoses.

Outcomes: Primary outcomes involve measuring rehospitalization rates at three months, time to relapse, reduction in substance consumption, and changes in depressive and anxious symptoms.

Statistical Analysis:Descriptive statistics will characterize nominal and categorical variables. For continuous variables, means and standard deviations will be calculated. Chi-square tests will assess the relationship between rehospitalization and intervention groups. Risk ratios and incidence rates will be computed to determine the relative risk of readmission.

Ethical Considerations: The study adheres to CONSORT guidelines, receiving approval from the Institutional Review Board. Informed consent is obtained from all participants, ensuring comprehension of the study's purpose, risks, and benefits. Confidentiality is maintained, and participants are informed of their right to withdraw without interference in their clinical care.

Conclusion: This comprehensive research design integrates rigorous methodology, ethical considerations, and a tailored intervention approach to address the multifaceted challenges faced by patients with SUD. The outcomes are expected to contribute valuable insights to the field, guiding evidence-based practices for enhanced patient outcomes and reduced readmission rates

Eligibility criteria: Inclusion Criteria:

* Male patients aged 18 or older who are hospitalized in the Alcohol Detoxification Unit during the period of January to March of 2024
* Patients with a score on the AUDIT scale greater than 15.
* Patients with a score equal to or greater than 4 for any substance on the World Health Organization-ASSIST.
* Patients from the Alcohol Detoxification Unit who provide their consent to participate in the study.

Exclusion Criteria:

* Patients with a score on the AUDIT scale less than 15.
* Patients with a score on the WHO-ASSIST scale for substances less than 4.
* Patients from the Alcohol Detoxification Unit who do not provide their consent to participate in the study.
* Patients from the Alcohol Detoxification Unit diagnosed with Delirium Tremens, Acute Intoxication of any substance, or conditions that alter consciousness.
* Patients from the Alcohol Detoxification Unit diagnosed with intellectual disability documented in the medical records.
* Female patients.

Primary outcomes:
measure: Hospital Readmission Rate
timeFrame: 3 months
measure: Risk Rate of Readmission
timeFrame: 3 months
Secondary outcomes:
measure: HADS Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Facultad de Ciencias Medicas
state: Francisco Morazan
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Carlos M. Rosales, MD
role: PRINCIPAL_INVESTIGATOR
References: