Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03591107
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2018-07-06
Brief Title:
Trauma-informed Collaborative Care for Low-income African Americans With PTSD
Sponsor:
RAND
Organization:
RAND
Study Overview
Official Title:
Trauma-informed Collaborative Care for Low-income African Americans With Posttraumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
2022-11
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:
None
Brief Summary:
The purpose of this study is to optimize culturally adapt implement and pilot test a trauma-informed collaborative care intervention for low-income African Americans who receive care in Federally Qualified Health Centers FQHCs in New Orleans Louisiana We will randomize 40 patients to either a Posttraumatic Stress Disorder PTSD collaborative care intervention or to an enhanced usual care control and will evaluate the effectiveness of the intervention including whether outcome expectancy coping efficacy and trust mediate the impact of the intervention as well as its feasibility tolerability and acceptability
Detailed Description:
Posttraumatic stress disorder PTSD is prevalent in the general population especially among low-income African Americans Within primary care settings PTSD may affect as many as one in four patients PTSD is among the most difficult and costly psychiatric disorders to treat because it is necessary to go beyond traditional medical care to also address the trauma in patients lives that interferes with treatment and potentially attenuates treatment benefits African Americans are also less likely to receive care for mental health problems Several social psychological barriers eg mistrust in healthcare providers skepticism about treatment efficacy negative beliefs in ones ability to cope with PTSD and logistical barriers eg limited access to care lack of transportation and childcare lack of financial resources impede engagement into care Thus a trauma-informed approach to care that emphasizes the promotion of trust safety self-efficacy peer support cultural competency collaboration and coordinates with social services in the community to address logistical barriers is required to treat PTSD in low-income African Americans
Growing evidence suggests that collaborative care for PTSD in primary care is effective In two studies Telemedicine-Based Collaborative Care for PTSD TOP and Stepped Enhancement of PTSD Services Using Primary CARE STEPS-UP collaborative care significantly improved outcomes relative to usual care and attributed success in large part to the high levels of patient engagement 100 associated with strategies to connect patients to care including behavioral activation problem solving and motivational interviewing Three trials showed overall improvements but no relative advantage for collaborative care over usual care The Coordinated Anxiety Learning and Management CALM study of anxiety disorders among civilians showed a trend favoring collaborative care the effect in the PTSD subgroup was not statistically significant due to the insufficient sample size but engagement was high 95 Another trial for veterans Re-Engineering Systems for the Primary Care Treatment of PTSD RESPECT-PTSD found no difference between arms Our recently completed Violence and Stress Assessment ViStA trial for low-income patients in Federally Qualified Health Centers FQHCs also found no differential effect In both ViStA and RESPECT-PTSD patient engagement was low - only 73 and 62 of patients initiated treatment respectively However in both studies use of mental health services was significantly higher among the patients who engaged in collaborative care suggesting that adding strategies to boost engagement would increase its effectiveness Also in ViStA prior to the intervention there were significant disparities in care for the African Americans in our sample with rates of minimally adequate care of only 21 compared to Whites 33 This suggests that a trauma-informed approach that addresses social psychological and logistical barriers may better engage patients enhance collaborative care and ultimately improve outcomes
The Institute of Medicine has prioritized effective delivery approaches that engage individuals with PTSD We propose to optimize culturally adapt and pilot test a collaborative care intervention that uses a trauma-informed approach to identify specific target mechanisms to improve treatment engagement and reduce PTSD diagnosis and symptoms in primary care settings that serve low-income African Americans Specifically we will test the effectiveness of collaborative care optimized based on lessons from previous studies adapted to be culturally relevant for this population and will directly address target mechanisms outcome expectancy coping efficacy and trust All components of collaborative care will be delivered by African American care managers CMs with the guidance of a local African American community workgroup We will compare this PTSD collaborative care with a CM PCM approach to minimally enhanced usual care MEU We submit this R34 application in response to RFA-MH-16-410 which elicits pilot effectiveness trials for treatment preventive and services intervention This proposal is an excellent fit for this funding opportunity because our intervention has potential to substantially impact practice and public health by improving mental health outcomes among African Americans with PTSD in New Orleans FQHCs using an empirically grounded approach Our three Specific Aims are to
Aim 1 Optimize culturally adapt and implement an evidence-based trauma-informed model of PTSD collaborative care PCM compared with MEU for underserved African Americans We will recruit patients at two FQHCs in New Orleans LA to assess the feasibility tolerability and acceptability of PCM
Aim 2 Conduct a pilot randomized trial of the optimizedadapted PCM intervention compared with MEU in two FQHCs with 40 African American patients to evaluate its impact on social psychological target mechanisms - outcome expectancy coping efficacy and trust in facilitating treatment engagement
Aim 3 Evaluate the effectiveness of the PCM intervention compared with MEU on outcomes - PTSD diagnosis and symptoms primary outcomes and use of mental health care and non-medical community services and resources secondary outcomes either directly or indirectly as mediated by the target mechanisms before and one year after the start of the intervention
Preliminary data from this pilot effectiveness trial will pave the way for a larger-scale intervention
Growing evidence suggests that collaborative care for PTSD in primary care is effective In two studies Telemedicine-Based Collaborative Care for PTSD TOP and Stepped Enhancement of PTSD Services Using Primary CARE STEPS-UP collaborative care significantly improved outcomes relative to usual care and attributed success in large part to the high levels of patient engagement 100 associated with strategies to connect patients to care including behavioral activation problem solving and motivational interviewing Three trials showed overall improvements but no relative advantage for collaborative care over usual care The Coordinated Anxiety Learning and Management CALM study of anxiety disorders among civilians showed a trend favoring collaborative care the effect in the PTSD subgroup was not statistically significant due to the insufficient sample size but engagement was high 95 Another trial for veterans Re-Engineering Systems for the Primary Care Treatment of PTSD RESPECT-PTSD found no difference between arms Our recently completed Violence and Stress Assessment ViStA trial for low-income patients in Federally Qualified Health Centers FQHCs also found no differential effect In both ViStA and RESPECT-PTSD patient engagement was low - only 73 and 62 of patients initiated treatment respectively However in both studies use of mental health services was significantly higher among the patients who engaged in collaborative care suggesting that adding strategies to boost engagement would increase its effectiveness Also in ViStA prior to the intervention there were significant disparities in care for the African Americans in our sample with rates of minimally adequate care of only 21 compared to Whites 33 This suggests that a trauma-informed approach that addresses social psychological and logistical barriers may better engage patients enhance collaborative care and ultimately improve outcomes
The Institute of Medicine has prioritized effective delivery approaches that engage individuals with PTSD We propose to optimize culturally adapt and pilot test a collaborative care intervention that uses a trauma-informed approach to identify specific target mechanisms to improve treatment engagement and reduce PTSD diagnosis and symptoms in primary care settings that serve low-income African Americans Specifically we will test the effectiveness of collaborative care optimized based on lessons from previous studies adapted to be culturally relevant for this population and will directly address target mechanisms outcome expectancy coping efficacy and trust All components of collaborative care will be delivered by African American care managers CMs with the guidance of a local African American community workgroup We will compare this PTSD collaborative care with a CM PCM approach to minimally enhanced usual care MEU We submit this R34 application in response to RFA-MH-16-410 which elicits pilot effectiveness trials for treatment preventive and services intervention This proposal is an excellent fit for this funding opportunity because our intervention has potential to substantially impact practice and public health by improving mental health outcomes among African Americans with PTSD in New Orleans FQHCs using an empirically grounded approach Our three Specific Aims are to
Aim 1 Optimize culturally adapt and implement an evidence-based trauma-informed model of PTSD collaborative care PCM compared with MEU for underserved African Americans We will recruit patients at two FQHCs in New Orleans LA to assess the feasibility tolerability and acceptability of PCM
Aim 2 Conduct a pilot randomized trial of the optimizedadapted PCM intervention compared with MEU in two FQHCs with 40 African American patients to evaluate its impact on social psychological target mechanisms - outcome expectancy coping efficacy and trust in facilitating treatment engagement
Aim 3 Evaluate the effectiveness of the PCM intervention compared with MEU on outcomes - PTSD diagnosis and symptoms primary outcomes and use of mental health care and non-medical community services and resources secondary outcomes either directly or indirectly as mediated by the target mechanisms before and one year after the start of the intervention
Preliminary data from this pilot effectiveness trial will pave the way for a larger-scale intervention
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