Reducing Readmissions: BNI Trial in Substance Use Disorder

NCT06223191 | Active Not Recruiting DMC

• 1 other identifier: BNIReadmissions
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Substance Withdrawal

Outcome Measures

Primary Outcomes (2)

• Hospital Readmission Rate

  Measurement of the readmissions rate at 3 months from the study's initiation. This could be a key indicator to assess the impact of interventions on relapse prevention.

  3 months

• Risk Rate of Readmission

  Measurement of the risk rate through the ratio of the readmission rate treatment group and the control group rate

  3 months

Secondary Outcomes (1)

• HADS Score

  3 months

Study Arms (3)

Brief Negotiated Interview

EXPERIMENTAL

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.

Other: Brief Negotiated Interview

Narrative Interview

PLACEBO COMPARATOR

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.

Other: Narrative Interview

Standards of Care

NO INTERVENTION

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.

Interventions

Brief Negotiated Interview 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

Brief Negotiated Interview

Narrative Interview 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.

Narrative Interview

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Honduras: lead

Study Sites (1)

Facultad de Ciencias Medicas

Tegucigalpa, Francisco Morazán Department, Honduras

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Carlos M. Rosales, MD

  Universidad Nacional Autonoma de Honduras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 25, 2024
• Study Start: January 29, 2024
• Primary Completion: May 22, 2024
• Study Completion: September 15, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)