Trial Outcomes & Findings for Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes (NCT NCT01135420)

NCT ID: NCT01135420

Last Updated: 2016-12-29

Results Overview

Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 406 participants
• Primary outcome timeframe: 3 months post-intervention
• Results posted on: 2016-12-29

Participant Flow

Patients were recruited from inpatient psychiatry settings.

Participant milestones

Measure	Usual Care Psychiatry inpatient usual care Usual care: All patients in the trial received usual care (i.e., the care they would have received in the absence of a study).	Telephone Monitoring Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention incorporated motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation. Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition received an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention had a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition was to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.
Overall Study STARTED	199	207
Overall Study COMPLETED	155	175
Overall Study NOT COMPLETED	44	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes

Baseline characteristics by cohort

Measure	Usual Care n=199 Participants Psychiatry inpatient usual care Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).	Telephone Monitoring n=207 Participants Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation. Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety	Total n=406 Participants Total of all reporting groups
Age, Continuous	45 Years STANDARD_DEVIATION 13 • n=5 Participants	45 Years STANDARD_DEVIATION 13 • n=7 Participants	45 Years STANDARD_DEVIATION 13 • n=5 Participants
Gender Female	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Gender Male	183 Participants n=5 Participants	189 Participants n=7 Participants	372 Participants n=5 Participants
Region of Enrollment United States	199 participants n=5 Participants	207 participants n=7 Participants	406 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-intervention

Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.

Outcome measures

Measure	Usual Care n=155 Participants Psychiatry inpatient usual care Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).	Telephone Monitoring n=175 Participants Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation. Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.
Readiness to Attend Substance Use Disorder Continuing Care	1.8 units on a scale Standard Deviation 1.1	2.2 units on a scale Standard Deviation 1.3

Adverse Events

Usual Care

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Telephone Monitoring

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=199 participants at risk Psychiatry inpatient usual care Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).	Telephone Monitoring n=207 participants at risk Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation. Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.
Cardiac disorders death	1.5% 3/199	1.9% 4/207

Other adverse events

Measure	Usual Care n=199 participants at risk Psychiatry inpatient usual care Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).	Telephone Monitoring n=207 participants at risk Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation. Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.
Psychiatric disorders hospitalization	1.5% 3/199 • Number of events 3	1.9% 4/207 • Number of events 4

Additional Information

Christine Timko

Department of Veterans Afairs

Phone: 650-493-5000

Email: Christine.Timko@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place