Ignite Creation Date:
2024-05-06 @ 10:28 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03261700
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2017-08-17
Brief Title:
Recovering From Intimate Partner Violence Through Strengths and Empowerment RISE
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Recovering From Intimate Partner Violence Through Strengths and Empowerment RISE Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans
Status:
COMPLETED
Status Verified Date:
2023-07
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:
RISE
Brief Summary:
Intimate partner violence IPV is a major health concern for women Veterans IPV is associated with numerous physical and mental health conditions VHA is implementing IPV screening programs to identify female patients who experience past-year IPV Despite strong evidence that screening increases detection of IPV less is established about how to intervene following IPV disclosure in health care settings in order to improve health outcomes Existing healthcare-based interventions result in minimal effects on health and well-being likely because they are too brief and generic
In response the PI has developed Recovering from IPV through Strengths and Empowerment RISE based on the IPV-related health care needs and preferences of women Veterans RISE is designed to be delivered in primary care and is an individualized variable-length modular-based intervention that addresses
safety planning
education on the health effects of IPV and warning signs
increasing coping skills and self-care
enhancing social support
making difficult decisions and
connecting with resources This study is aimed at refining and evaluating RISE for use with female VA patients who have experienced past-year IPV This brief counseling intervention is intended to be administered in conjunction with primary care as this is a frequent point of healthcare contact for women Veterans and where disclosure of IPV is most prevalent
In response the PI has developed Recovering from IPV through Strengths and Empowerment RISE based on the IPV-related health care needs and preferences of women Veterans RISE is designed to be delivered in primary care and is an individualized variable-length modular-based intervention that addresses
safety planning
education on the health effects of IPV and warning signs
increasing coping skills and self-care
enhancing social support
making difficult decisions and
connecting with resources This study is aimed at refining and evaluating RISE for use with female VA patients who have experienced past-year IPV This brief counseling intervention is intended to be administered in conjunction with primary care as this is a frequent point of healthcare contact for women Veterans and where disclosure of IPV is most prevalent
Detailed Description:
Women are the fastest growing group of VHA patients with their population recently increasing by 80 Women Veterans WVs are at higher risk for IPV than their non-Veteran peers with that 1 in 3 WVs report lifetime IPV compared to 1 in 4 women in the general US population Research reports up to 30 of WVs experience past-year IPV As a result WVs are considered an important population for IPV screening and counseling interventions In response VHA Womens Health Services WHS and the IPV Assistance Program of Care Management and Social Work Services CMSWS are implementing IPV screening programs for women and are seeking an effective intervention to implement into care Extant brief counseling interventions for IPV result in minimal effects on patients health and safety A recent review of IPV screening trials highlighted insufficient intensity of post-disclosure counseling interventions concluding that existing interventions are too brief unstructured and generic Such minimal intervention effects of the current standard of care have led leaders in the field to call for the development and testing of new and more comprehensive IPV interventions especially for delivery in conjunction with primary care The Recovering from IPV through Strengths and Empowerment RISE intervention fills this need
The PI a clinical psychologist and health services researcher with expertise in and national recognition for IPV research and care has developed an innovative IPV intervention to respond to this need Recovering from IPV through Strengths and Empowerment RISE is based on the healthcare needs and preferences of WVs who have experienced IPV RISE was developed using rigorous methods building on the evidence base from the applicants HSRD CDA and on input of VHA primary care and behavioral health experts RISE is based on empowerment a highly relevant intervention model for women who experience IPV It is an individualized variable-length modular-based intervention addressing key factors
safety planning
educating about the health effects of IPV and warning signs
improving coping and self-care
enhancing social support
making difficult decisions and
connecting with resources RISE is rooted in empowerment and incorporates aspects of Motivational Interviewing an evidence-based approach designed to facilitate behavior change that is widely used in VHA for numerous health issues
This timely research project addresses the critical gap in current IPV care It will refine and formally evaluate RISE using established methods for rapid and efficient effectiveness testing including a Hybrid 1 randomized clinical trial RCT to evaluate RISE that simultaneously gathers information on barriers to and facilitators of implementation The study is guided by the first two phases of the Replicating Effective Programs REP framework pre-conditions and pre-implementation These phases emphasize tailoring interventions with stakeholder input and iterative cycles of pilot testing within routine practice conditions Use of the REP framework will maximize the likelihood that RISE-should its effectiveness be demonstrated-can easily be integrated into routine care in VHA
The Specific Aims of this study are as follows
1 Tailor and refine RISE to accommodate differences in service structures and personnel in different primary care settings through input from a Stakeholder Advisory Board focus groups with WVs four groups n24-32 and qualitative interviews with providers n24
2 Conduct a formative evaluation of RISE with WVs nup to 20 to inform the development of a user-friendly tailored implementation protocol and intervention manual
3 Examine the effects of RISE on WVs n60 individual psychosocial outcomes eg empowerment self-efficacy health symptoms service use and quality of life in an RCT that compares RISE to an informationreferral condition
3a Evaluate the feasibility and acceptability of RISE in the context of the RCT
This study provides the groundwork to examine the effectiveness of RISE The data will be used to demonstrate whether the effects of RISE appear promising to support a future-large scale effectiveness-implementation RCT including the range of effect sizes that would be reasonable to expect in a future trial
The project was originally conducted at two Womens Health Practice-Based Research Network PBRN sites that have adopted IPV screening - the Womens Health Centers WHC at VA Boston Healthcare System and VA Connecticut Healthcare System RCT study enrollment was discontinued at VA Connecticut in July 2019 due to low enrollment The VA Boston Healthcare System serves as the sole site for data collection from July 2019 on and is the sourced of the RCT data
The COVID-19 pandemic resulted in modifications to IRB protocol to switch from in-person enrollment assessments and sessions There were several women actively involved in the trial during the initial shut-down New recruitment and enrollment were temporarily hauled during early months of COVID-19 with virtual enrollment beginning as of July 2020
Recruitment and enrollment were completed in September 2020 because the enrollment goals were met and the planned sample size was obtained N60
The PI a clinical psychologist and health services researcher with expertise in and national recognition for IPV research and care has developed an innovative IPV intervention to respond to this need Recovering from IPV through Strengths and Empowerment RISE is based on the healthcare needs and preferences of WVs who have experienced IPV RISE was developed using rigorous methods building on the evidence base from the applicants HSRD CDA and on input of VHA primary care and behavioral health experts RISE is based on empowerment a highly relevant intervention model for women who experience IPV It is an individualized variable-length modular-based intervention addressing key factors
safety planning
educating about the health effects of IPV and warning signs
improving coping and self-care
enhancing social support
making difficult decisions and
connecting with resources RISE is rooted in empowerment and incorporates aspects of Motivational Interviewing an evidence-based approach designed to facilitate behavior change that is widely used in VHA for numerous health issues
This timely research project addresses the critical gap in current IPV care It will refine and formally evaluate RISE using established methods for rapid and efficient effectiveness testing including a Hybrid 1 randomized clinical trial RCT to evaluate RISE that simultaneously gathers information on barriers to and facilitators of implementation The study is guided by the first two phases of the Replicating Effective Programs REP framework pre-conditions and pre-implementation These phases emphasize tailoring interventions with stakeholder input and iterative cycles of pilot testing within routine practice conditions Use of the REP framework will maximize the likelihood that RISE-should its effectiveness be demonstrated-can easily be integrated into routine care in VHA
The Specific Aims of this study are as follows
1 Tailor and refine RISE to accommodate differences in service structures and personnel in different primary care settings through input from a Stakeholder Advisory Board focus groups with WVs four groups n24-32 and qualitative interviews with providers n24
2 Conduct a formative evaluation of RISE with WVs nup to 20 to inform the development of a user-friendly tailored implementation protocol and intervention manual
3 Examine the effects of RISE on WVs n60 individual psychosocial outcomes eg empowerment self-efficacy health symptoms service use and quality of life in an RCT that compares RISE to an informationreferral condition
3a Evaluate the feasibility and acceptability of RISE in the context of the RCT
This study provides the groundwork to examine the effectiveness of RISE The data will be used to demonstrate whether the effects of RISE appear promising to support a future-large scale effectiveness-implementation RCT including the range of effect sizes that would be reasonable to expect in a future trial
The project was originally conducted at two Womens Health Practice-Based Research Network PBRN sites that have adopted IPV screening - the Womens Health Centers WHC at VA Boston Healthcare System and VA Connecticut Healthcare System RCT study enrollment was discontinued at VA Connecticut in July 2019 due to low enrollment The VA Boston Healthcare System serves as the sole site for data collection from July 2019 on and is the sourced of the RCT data
The COVID-19 pandemic resulted in modifications to IRB protocol to switch from in-person enrollment assessments and sessions There were several women actively involved in the trial during the initial shut-down New recruitment and enrollment were temporarily hauled during early months of COVID-19 with virtual enrollment beginning as of July 2020
Recruitment and enrollment were completed in September 2020 because the enrollment goals were met and the planned sample size was obtained N60
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I01HX002178-01A1 | NIH | None | httpsreporternihgovquickSearch1I01HX002178-01A1 |