Trial Outcomes & Findings for Treatment Engagement With Technology-assisted Treatment (NCT NCT02674477)

Last Updated: 2019-08-22

Results Overview

The acceptability assessment asks about hospital satisfaction for both groups. The questionnaire is a series of questions on Qualtrics on a scale of 0-10. Higher scores signified a more positive response and a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

95 participants

Primary outcome timeframe

prior to discharge from the hospital up to 30 days

Results posted on

2019-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Therapeutic Education System (TES) Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.	Treatment as Usual (TAU) Standard treatment comprises a psychiatrist-led interdisciplinary team as well as face-to-face group counseling for substance use and skills for improving general mental health. There will be no change to the routine care (treatment at usual \[TAU\]) provided to patients on the service. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization.
Overall Study STARTED	48	47
Overall Study COMPLETED	40	45
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapeutic Education System (TES) Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.	Treatment as Usual (TAU) Standard treatment comprises a psychiatrist-led interdisciplinary team as well as face-to-face group counseling for substance use and skills for improving general mental health. There will be no change to the routine care (treatment at usual \[TAU\]) provided to patients on the service. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization.
Overall Study Protocol Violation	8	2

Baseline Characteristics

Treatment Engagement With Technology-assisted Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapeutic Education System (TES) n=48 Participants Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.	Treatment as Usual (TAU) n=47 Participants Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization.	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.5 years STANDARD_DEVIATION 10.4 • n=5 Participants	39.8 years STANDARD_DEVIATION 8.1 • n=7 Participants	39.01 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	27 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants

PRIMARY outcome

Timeframe: prior to discharge from the hospital up to 30 days

Outcome measures

Outcome measures
Measure	Therapeutic Education System (TES) n=40 Participants Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.	Treatment as Usual (TAU) n=45 Participants Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization.
Acceptability of Treatment Based on Survey Questionnaire Completed by Participants	8.78 score on a scale Standard Error 0.2	8.23 score on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: 30 days after discharge from the hospital

Population: We only analyzed those who were referred to substance abuse treatment, and for whom we were able to receive the information from their treatment program

Outcome measures

Outcome measures
Measure	Therapeutic Education System (TES) n=41 Participants Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.	Treatment as Usual (TAU) n=35 Participants Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization.
Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge	23 Participants	19 Participants

SECONDARY outcome

Timeframe: 30 days after discharge from the hospital

Population: We only analyzed those who were referred to other mental health treatment, and for whom we were able to receive the information from their treatment program

Outcome measures

Outcome measures
Measure	Therapeutic Education System (TES) n=36 Participants Participants will have the opportunity to use the TES program while hospitalized, at specific, monitored times, and can also use it when discharged by using their specific login information. They can use it as much or as little as they like. They will continue with treatment as usual during and after hospitalization, as well. Therapeutic Education System (TES): The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.	Treatment as Usual (TAU) n=39 Participants Participants will have the typical treatment during and after their hospitalizations, without additional intervention. Treatment as Usual (TAU): Participants will received standard treatment during and after hospitalization.
Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge	18 Participants	22 Participants

Adverse Events

Therapeutic Education System (TES)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual (TAU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexis Hammond

Johns Hopkins University

Phone: 410-550-0045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place