Substance use disorder telehealth treatment in the emergency department/inpatient unit with peer support workers
| ISRCTN | ISRCTN33100750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33100750 |
| Secondary identifying numbers | 1H79FG000817-01 |
- Submission date
- 10/10/2023
- Registration date
- 16/10/2023
- Last edited
- 25/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In 2020, New Mexico had the highest alcohol-related death and the 11th-highest drug overdose rate in the USA. Toward the long-term goal of addressing this public health problem, the study team are implementing and evaluating an integrated multi-level intervention designed to identify adults at risk of substance use disorder (SUD) and encourage linkage to and retention in treatment. The study plans to expand on previous research related to the implementation of treatment strategies for patients presenting at EDs and admitted to medical inpatient units wherein there is a significant window of opportunity to link patients with follow-up behavioral and clinical service for alcohol and/or drug misuse.
Who can participate?
Patients aged 18 years old and over accessing the ED or medical inpatient services at Sandoval Regional Medical Center (SRMC)
What does the study involve?
The study will use a Type 1 hybrid implementation design with a non-randomized approach to enrol patients who screen positive for unhealthy use of alcohol, prescription medications (used nonmedically), and illicit drugs.
Four approaches will be implemented:
1. Equipping the emergency department (ED) and medical inpatient units of a safety-net hospital with a method to screen individuals at risk of a SUD
2. Motivational interviewing (MI)
3. Seeking Safety (SS), a trauma-specific treatment for PTSD and SUD
4. Pharmacotherapy for SUD
Peer support workers (PSWs) are responsible for screening, MI to increase engagement in screening and treatment, and delivery of SS.
Pharmacotherapy is provided by addiction clinical specialists. All treatment is provided post-discharge via telehealth to increase access to care.
Participants are identified through (1) a review of electronic health records for individuals with a chief or secondary complaint or mental health condition relating to alcohol and/or other drug use, (2) referrals from clinical staff, and (3) screening in the ED and medical inpatient units. Feasibility will be measured through various process data. The primary outcomes that will inform our assessment of effectiveness will be changes in: (i) post-traumatic stress disorder symptom severity; and (ii) substance use.
What are the possible benefits and risks of participating?
It is not known if patients will get any benefit from participating in this study. However, by participating in this study, the information learned may help others with SUD. Potential risks include being asked to share information about the services they receive that may be unpleasant or mildly stressful. Despite our best efforts to protect patient information, there is inevitably a small risk of loss of privacy and/or confidentiality.
Where is the study run from?
The University of New Mexico (UNM) (USA)
When is the study starting and how long is it expected to run for?
May 2022 to September 2024
Who is funding the study?
The Substance Abuse and Mental Health Services Administration (SAMHSA - 1H79FG000817-01) (USA)
Who is the main contact?
Justine Saavedra (Program Manager), jlsaavedra@salud.unm.edu
Contact information
Public
MSC 09 5030
1 University of New Mexico
Albuquerque
87131
United States of America
| Phone | +1 5052890637 |
|---|---|
| jlsaavedra@salud.unm.edu |
Scientific, Principal Investigator
MSC 09 5030
1 University of New Mexico
Albuquerque
87131
United States of America
 ORCID ID |
0000-0001-5272-8472 |
|---|---|
| Phone | +1 (505) 272-6238 |
| acrisanti@salud.unm.edu |
Study information
| Study design | Single-center non-randomized Type 1 hybrid implementation design study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Internet/virtual, Telephone |
| Study type | Quality of life, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Peer support model to address substance use disorders treatment engagement in rural communities |
| Study objectives | By the end of the project period, participants enrolled in the SRMC TH-SUD treatment will demonstrate a decreasing trend in PTSD symptom severity and substance use. |
| Ethics approval(s) |
Approved 14/10/2022, The University of New Mexico Health Sciences Office of Research Human Research Protections Program (1 University of New Mexico, MSC08 4560, Albuquerque, 87131, United States of America; +1 (505) 272-1129; hsc-hrpo@salud.unm.edu), ref: 22-305 |
| Health condition(s) or problem(s) studied | Substance use disorder |
| Intervention | The purpose of this single-centre project is to evaluate the effectiveness of the Sandoval Regional Medical Center (SRMC) Telehealth Substance Use Disorder Treatment (hereafter referred to as SRMC TH-SUD treatment), among individuals who are admitted to the emergency department (ED) or medical inpatient units at the University of New Mexico’s (UNM) SRMC using a Type 1 hybrid implementation design with a non-randomized approach. Participants are recruited through the ED after screening positive for at-risk substance use disorder. The intervention includes Seeking Safety (SS), Medication for Addiction Treatment (MAT), Motivational Interviewing (MI) and psychosocial support. Peer support workers (PSWs) provide SS and MI and Addiction Specialists provide MAT. The intervention is provided via telehealth and is time-unlimited. The study's primary outcome includes: Post-traumatic Symptom Checklist – Civilian Version (PCL-C): The PCL-C is a valid, reliable and sensitive tool to monitor PTSD symptom change as a result of services. The checklist consists of 17 self-report items that can be used with any population and can be completed within approximately 5-10 minutes. To be completed at baseline and every 60 days thereafter. Secondary outcomes include: Barriers Questionnaire (one for Alcohol and one for Drugs): The Barriers Questionnaire was developed to ask people about the reasons why they had not previously sought treatment for either their alcohol use or their drug use. Both instruments contain 50 items rated on a 4-point Likert-type scale with response options ranging from no, not at all to very important. Craving Scale: The Craving Scale is a 3-item measure of craving related to the participant's drug of choice (e.g., cocaine, alcohol, opioids, etc.). The items are measured on a 10-point Likert-type scale ranging from 0 – 10 Motivation for Change (one for Alcohol and one for Drugs): The Motivation to Change Questionnaire was developed as a brief screening measure of motivation for change. The questionnaire includes 12 items measured on a 10-point Likert-type scale ranging from definitely not to definitely. Questionnaire about the Process of Recovery (QPR): The QPR is a 15-question self-report survey that measures aspects of recovery related to mental health and well-being. The survey takes approximately 5-10 minutes to complete. The QPR tool has been found to be a reliable and valid measure of recovery in serious mental illness. RAND 36-Item Short Form Health Survey (SF-36): The SF-36 is a set of 36 generic, coherent and easily administered questions to measure quality of life. Addiction Severity Index (ASI): One section of the ASI will be used to measure drug and alcohol use. Items assess the frequency of drug and alcohol use within the past 60 days. Substance Abuse Self-Stigma Scale (SASSS): One section of the SASSS will be used to measure self-devaluation as a result of substance use. It includes 8 items measured on a Likert-type scale with response options ranging from “Never or almost never”, “Rarely”, “Sometimes”, “Often” and “Very Often”. Criminal Justice Involvement: We developed a survey to measure criminal justice involvement in the past 60 days. If the respondent says yes to the various illegal activities asked about then they will be prompted to report the number of times. One of the outcomes of the evaluation is to determine the impact of the intervention on reducing the cost of crime to society. To be able to do this we need details on whether certain crimes were committed because the cost to society varies by crime type. Service Use: We developed a survey to measure service use in the past 6 months. This survey includes 7 questions that ask about the number of visits to the emergency department and the number of days spent overnight in a hospital or other treatment facility for either mental health, physical health and/or substance use. The survey includes branch logic, to that if a respondent says that he/she hasn’t spent any time in a hospital, then they are not asked the five additional questions about the type of hospital stay. Client Satisfaction: Client satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8) at follow-up interviews only. The CSQ-8 is an 8-item generic and unidimensional instrument that broadly measures current satisfaction with the quality of services, the amount of help, recommendation of the program to friends, and overall general satisfaction. For each of the eight items, participants reported how satisfied they were using a Likert-type scale ranging from 1 (low) to 4 (high). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. |
| Intervention type | Behavioural |
| Primary outcome measure | PTSD symptom change as a result of services measured using the Post-traumatic Symptom Checklist – Civilian Version (PCL-C) at baseline and every 60 days thereafter |
| Secondary outcome measures | The following secondary outcome measures are completed at baseline and every 60 days thereafter: 1. Reasons why they had not previously sought treatment for either their alcohol use or their drug use measured using the Barriers Questionnaire (one for Alcohol and one for Drugs) 2. Craving related to the participant's drug of choice (e.g., cocaine, alcohol, opioids, etc.) measured using the Craving Scale 3. Motivation for change measured using the Motivation to Change Questionnaire (one for Alcohol and one for Drugs) 4. Aspects of recovery related to mental health and well-being measured using the Questionnaire about the Process of Recovery (QPR) 5. Quality of life measured using the RAND 36-Item Short Form Health Survey (SF-36) 6. The frequency of drug and alcohol use within the past 60 days measured using the Addiction Severity Index (ASI) 7. Self-devaluation as a result of substance use measured using the Substance Abuse Self-Stigma Scale (SASSS) 8. Criminal justice involvement in the past 60 days measured using a bespoke Criminal Justice Involvement Survey 9. Service use in the past 6 months measured using a bespoke Service Use Survey 10. Client satisfaction will be measured using the Client Satisfaction Questionnaire (CSQ-8) at follow-up interviews only |
| Overall study start date | 01/05/2022 |
| Completion date | 29/09/2024 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 110 |
| Total final enrolment | 61 |
| Key inclusion criteria | 1. Age 18 years old and over 2. English speaking 3. Have an SUD 4. Accessing the ED or medical inpatient services at SRMC |
| Key exclusion criteria | 1. Adults unable to consent 2. Non-English speaking 3. Individuals who are not yet adults (infants, children, teenagers) 4. Prisoners |
| Date of first enrolment | 15/11/2022 |
| Date of final enrolment | 19/07/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Rio Rancho
87144
United States of America
Sponsor information
University/education
1 University of New Mexico
Albuquerque
87131
United States of America
| Phone | +1 505-272-2321 |
|---|---|
| unmsominfo@salud.unm.edu | |
| Website | http://www.unm.edu/ |
"ROR" |
https://ror.org/05fs6jp91 |
Funders
Funder type
Industry
Government organisation / National government
- Alternative name(s)
- U.S. Substance Abuse and Mental Health Services Administration, The Substance Abuse and Mental Health Services Administration, United States Substance Abuse and Mental Health Services Administration, HHS Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, SAMHSA
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to not obtaining consent from participants during the consent process to share raw data beyond the purposes of the main study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 16/05/2024 | 11/06/2024 | Yes | No |
Editorial Notes
25/07/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2024 to 29/09/2024.
2. The total final enrolment was added.
11/06/2024: Publication reference added. The recruitment end date was changed from 30/06/2024 to 19/07/2024.
13/10/2023: Study's existence confirmed by The University of New Mexico Health Sciences Office of Research Human Research Protections Program.
