Newswires
Improving the Integration of Mental Health and Substance Use Treatment Into Ryan White-Funded Care Sites in Atlanta Using an Implementation Science Approach: Mental Health Diseases and Conditions – Bipolar Disorders
Insurance Daily News
2022 JUN 27 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT05415891 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training [ Time Frame: Immediately post-training ] -- 4-item self-report measure to assess clinic staff’s satisfaction with the stigma reduction training |
| •Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform [ Time Frame: 3 months follow-up ] -- 4-item measure to assess provider satisfaction with the YouRx Decision platform | |
| •Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform [ Time Frame: 3 months follow-up ] -- 4-item measure to assess provider perception that the YouRx Decision platform can be integrated into usual care | |
| •Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform [ Time Frame: Weekly (12 weeks) ] -- Provider use of the YouRx Decision prescribing platform | |
| •Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform [ Time Frame: 3 months follow-up ] -- 21-item survey to assess the ease of use of the YouRx Decision prescribing platform | |
| •Clinic Staff-Level Outcome: Observed Stigma Reduction [ Time Frame: 3 months follow-up ] -- Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders | |
| •Health Consumer-Level Outcome: Observed Stigma Reduction [ Time Frame: 3 months follow-up ] -- Experienced or observed stigma and discrimination from clinic staff based on serious mental health or substance use disorder | |
| •Provider-Level Outcome: Provider Self-Efficacy [ Time Frame: 3 months follow-up ] -- 11-item survey to assess providers confidence to treat serious mental health disorders and AUD | |
| •Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone [ Time Frame: 3 months follow-up ] -- Percentage of eligible patients who receive a prescription for psychiatric medication or naltrexone or an in-house referral for psychiatric treatment from their HIV care provider. | |
| •Clinic-Level Outcome: |
|
| Current Secondary Outcome Measures | Not Provided |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT05415891 |
Descriptive Information
| Brief Title | |
| Official Title | Improving the Integration of Mental Health and Substance Use Treatment Into Ryan White-Funded Care Sites in Atlanta Using an Implementation Science Approach |
| Brief Summary | This project consists of a pilot trial to assess the preliminary impact of a stigma-reduction training to reduce clinic-level stigma and the YouRx Decision prescribing platform to increase HIV care providers’ self-efficacy related to prescribing psychiatric medication for depression, post-traumatic stress disorder (PTSD), and bipolar disorder as well as naltrexone for alcohol use disorder (AUD). |
| Detailed Description | The study will pilot test a two-level strategy to improve integration of pharmacotherapy for serious mental health and alcohol use disorders among people living with HIV (PLHIV) in |
| Study Type | Interventional |
| Study Phase | Not Applicable |
| Study Design | Allocation: Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: |
|
| Masking: None (Open Label) | |
| Intervention Model Description: This study will include two levels of randomization: clinic level and provider level. We will randomize the two clinic study sites into one of two study conditions. One clinic will be randomized to the stigma-reduction training arm, and one clinic will be randomized to the no stigma-reduction training arm (but will receive the training at the end of the study). At the provider level, we will use a multiple baseline design that is fundamental to idiographic approaches. All providers will receive the YouRx Decision prescribing platform. Providers will be randomized to one of four intervention schedules: (a) 1-week baseline + 11-week intervention, (b) 2-week baseline + 10-week intervention, © 3-week baseline + 9-week intervention, and (d) 4-week baseline + 8-week intervention. Randomization will be stratified by clinic. Two providers (one from each site) will be randomized to each intervention schedule (for a total of 8 providers). | |
| Condition | Mental Health Disorder |
| Substance Use Disorder | |
| Stigmatization | |
| Implementation Science | |
| Intervention | •Behavioral: |
| •Device: YouRx Decision prescribing platform | |
| The YouRx Decision prescribing platform is a mobile application that serves as a reference to quickly inform providers about the medications recommended for serious mental health disorders and naltrexone to treat AUD; the appropriate dosing regimen; and potential contraindications or interactions related to antiretroviral therapy medications or other psychiatric medication. Information for the platform is adapted from the Department of Veteran Affairs’ Manual for HIV Care in Primary Care settings. | |
| Study Arms | •Experimental: Stigma-Reduction Training Arm + YouRx Prescribing Platform |
| Staff working in the clinic in this arm will be offered a whole-site stigma reduction training. Participating HIV care providers will have access to the YouRx Prescribing Platform. | |
| Interventions: | |
| ⚬Behavioral: |
|
| ⚬Device: YouRx Decision prescribing platform | |
| •Experimental: YouRx Prescribing Platform Only | |
| Staff working in the clinic in this arm will not be offered a whole-site stigma reduction training. However, staff will be offered this training at the conclusion of the study. Participating HIV care providers will have access t | |
| Interventions: | |
| ⚬Device: YouRx Decision prescribing platform |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 333 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | Inclusion Criteria: Stigma Reduction Training be 18 years of age or older be a staff member at the clinic study site randomized for the stigma-reduction training |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 18 years and older |
| Yes | |
| Contacts | Primary contact: Courtney Peasant Bonner, PhD, 7709865052, [email protected] |
| Backup contact: Wendee M Wechsberg, PhD, , [email protected] | |
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT05415891 |
| Other Study ID Numbers | Pro00063322 |
| R34MH124628 | |
| Has Data Monitoring Committee | Yes |
| Not Provided | |
| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | Not Provided |
| Collaborators | ⚬SisterLove, Inc. |
| ⚬Positive Impact Health Centers | |
| ⚬National Institute of Mental Health (NIMH) | |
| Investigators | Principal Investigator: Courtney Peasant Bonner, PhD, |
| Information Provided By | |
| Verification Date |
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