Reducing Readmissions: BNI Trial in Substance Use Disorder

NCT ID: NCT06223191

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-09-15

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

Conditions

Substance Use Disorders; Substance Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Brief Negotiated Interview

The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. Instead of telling the patient what changes he/she should make, the BNI is intentionally designed to elicit reasons for change and action steps from the patient. It gives the patient voice and choice, making any potential behavior changes all the more empowering to the patient.

Group Type: EXPERIMENTAL

Brief Negotiated Interview

Intervention Type: OTHER

The BNI is a specialized "brief intervention" for the medical setting, has foundations in motivational interviewing techniques. The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. The BNI is in the form of an algorithm, or "script", that guides providers through the health intervention with carefully phrased key questions and responses, all at the providers' fingertips

Narrative Interview

The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions.

Group Type: PLACEBO_COMPARATOR

Narrative Interview

Intervention Type: OTHER

The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions.

Standards of Care

This arm includes the use of benzodiazepines (Diazepam or Lorazepam) when CIWA-Ar scale is ≥9. Other medications may include Thiamine, Potassium Chloride, oral rehydration salts, parenteral fluids, antiemetics, and gastric protectants if medically necessary. Patients undergo a psychological evaluation on the third day of admission. All patients receive at least one psychoeducational session on alcohol and substance use during their hospitalization. Psychiatric evaluation is available for those with dual diagnoses such as mood disorders, anxiety disorders, psychotic disorders, or multiple substance use. The total hospitalization time in the ward is 8 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief Negotiated Interview

The BNI is a specialized "brief intervention" for the medical setting, has foundations in motivational interviewing techniques. The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. The BNI is in the form of an algorithm, or "script", that guides providers through the health intervention with carefully phrased key questions and responses, all at the providers' fingertips

Intervention Type: OTHER

Narrative Interview

The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Nacional Autonoma de Honduras

OTHER

Sponsor Role: lead

Responsible Party

Carlos Manuel Rosales Gomez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos M. Rosales, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional Autonoma de Honduras

Locations

Facultad de Ciencias Medicas

Tegucigalpa, Francisco Morazán Department, Honduras

Countries

Honduras

Other Identifiers

BNIReadmissions

Identifier Type: -

Identifier Source: org_study_id