Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317987
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-12
Brief Title:
Addressing Barriers to Care for Substance Use Disorder Pilot Study
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Addressing Barriers to Care for Substance Use Disorder Pilot Study Center for Dissemination and Implementation At Stanford Research Component 3
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABCSUD Pilot
Brief Summary:
The Addressing Barriers to Care for Substance Use Disorder Pilot ABC-SUD Pilot is a randomized pilot study that will precede a larger trial The ABC-SUD Pilot is a parallel group cluster-randomized pilot feasibility trial with clinicians care coordinators as the unit of randomization
This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente As part of usual care patients contact the mental health access center and speak to a care coordinator to obtain contact information for potential venues to obtain treatment for substance use disorder
The experimental intervention Care Navigation will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center The investigators note that Care Navigation will be delivered by study care navigators who are distinct from the health systems care coordinators
This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente As part of usual care patients contact the mental health access center and speak to a care coordinator to obtain contact information for potential venues to obtain treatment for substance use disorder
The experimental intervention Care Navigation will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center The investigators note that Care Navigation will be delivered by study care navigators who are distinct from the health systems care coordinators
Detailed Description:
The ABC-SUD Pilot is being conducted to evaluate feasibility of the larger trial Specific goals are to a confirm patient eligibility criteria b confirm selection of the primary and secondary outcomes and the approach to measuring them using electronic health record data c confirm the feasibility and acceptability of randomization procedures d evaluate the feasibility of care navigation protocol delivery by care coordinators e evaluate feasibility of electronic health record templates to assist care coordinators when referring patients to care navigators The pilot will also help refine study implementation needs and statistical analysis plans for the trial
The pilots recruitment goal is to offer care navigation to patients until a total of 10 patients agree to care navigation The investigators will conduct post-intervention quality improvement interviews with enrolled patients to obtain feedback on intervention design to inform changes
To recruit care coordinators for the pilot mental health treatment access center managers will identify 4 care coordinators who volunteer to participate in piloting the care navigator intervention
To maximize the study sample for the larger trial the ABC-SUD study will employ a vanguard randomization approach which is a type of stratified randomization in which pilot or vanguard care coordinators are pre-randomized to begin piloting the intervention but then retain their randomization status for the subsequent trial
The patient eligibility for the pilot period and trial period are distinct Clinicians care coordinators are eligible if they conduct video or phone-based assessment and treatment planning visits in the mental health treatment access center have been employed for at least 1 month have completed trainings related to their clinical role in the health system are scheduled to conduct at least 3 assessments per day and have consented to participate in the study
The sample of patients eligible for the pilot analyses include individuals with a visit to an enrolled care coordinator during the patient eligibility period who are 18 years of age and have a SUD assessment and treatment planning visit with a care coordinator Analyses will follow an intent-to-treat principle whereby care coordinators will be analyzed according to the intervention arm to which they were randomized regardless of the subsequent sequence of events The patient eligibility period is defined as the period in which patients become eligible for the study ie for inclusion in the analytic sample This period is anticipated to start within 2 weeks of the clinicians randomization date to allow for sufficient time for intervention coordinators to be trained The investigators anticipate that approximately 40 patients will comprise the analytic sample
The pilots recruitment goal is to offer care navigation to patients until a total of 10 patients agree to care navigation The investigators will conduct post-intervention quality improvement interviews with enrolled patients to obtain feedback on intervention design to inform changes
To recruit care coordinators for the pilot mental health treatment access center managers will identify 4 care coordinators who volunteer to participate in piloting the care navigator intervention
To maximize the study sample for the larger trial the ABC-SUD study will employ a vanguard randomization approach which is a type of stratified randomization in which pilot or vanguard care coordinators are pre-randomized to begin piloting the intervention but then retain their randomization status for the subsequent trial
The patient eligibility for the pilot period and trial period are distinct Clinicians care coordinators are eligible if they conduct video or phone-based assessment and treatment planning visits in the mental health treatment access center have been employed for at least 1 month have completed trainings related to their clinical role in the health system are scheduled to conduct at least 3 assessments per day and have consented to participate in the study
The sample of patients eligible for the pilot analyses include individuals with a visit to an enrolled care coordinator during the patient eligibility period who are 18 years of age and have a SUD assessment and treatment planning visit with a care coordinator Analyses will follow an intent-to-treat principle whereby care coordinators will be analyzed according to the intervention arm to which they were randomized regardless of the subsequent sequence of events The patient eligibility period is defined as the period in which patients become eligible for the study ie for inclusion in the analytic sample This period is anticipated to start within 2 weeks of the clinicians randomization date to allow for sufficient time for intervention coordinators to be trained The investigators anticipate that approximately 40 patients will comprise the analytic sample
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50DA054072 | NIH | None | httpsreporternihgovquickSearchP50DA054072 |