iHeal: Final Report
Introduction
Intimate partner violence (IPV) has substantial and often prolonged impacts on women’s physical and mental health and quality of life that are intertwined with women’s histories and life contexts. However, comprehensive, trauma-and-violence informed interventions that concurrently address women’s safety, the health consequences of IPV, the social and economic challenges which create barriers to change, and which fit women’s lives, have not been developed and systematically tested. We developed the Intervention for Health Enhancement and Living (iHEAL) to address this gap, drawing on our qualitative grounded theory research of women’s health promotion after separation from an abusive partner, an Indigenous lens, and current theory and evidence about IPV, women’s health, trauma- and violence-informed care, cultural safety, and effective health promotion interventions. The overall goal of this project was to test the effectiveness of a complex, evidence-based, health promotion intervention, iHEAL, in enhancing quality of life, mental and physical health, capacities, and resources of women who have separated from an abusive partner.
This 5-year project had 6 objectives:
1) to refine the iHEAL and associated tools and resources, drawing on lessons from feasibility studies conducted in 3 provinces,
2) to develop guidelines for standardizing delivery of the intervention, including clinical supervision guidelines, delivery protocols, documentation systems, and a training program for nurse interventionists;
3) to prepare for a trial of iHEAL in 3 provinces by finalizing elements of the study design, securing sites, hiring and training staff, seeking ethics approval and registering the trial;
4) to conduct a Randomized Controlled Trial (RCT) of iHEAL across 3 provinces to assess the effectiveness of iHEAL versus usual care in 3 provinces;
5) to adapt the iHEAL for Francophone women living in New Brunswick and then test the feasibility, acceptability, and initial impact of this version of the intervention; and,
6) to develop a knowledge exchange and mobilization plan to ensure ongoing communication with key stakeholders.
The Public Health Agency of Canada provided $3,048,413 from October 1 2016 to March 31 2022, through the Supporting the Health of Survivors of Family Violence investment.
Researchers from the Universities of Western Ontario, British Columbia and New Brunswick provided in-kind financial contributions through support of iHEAL the research team.
Background
Separation from an abusive partner is a critical transition point for women. There is good evidence that violence does not end for many women after separation and that the health, social and economic consequences of IPV can be longstanding. Post-separation, women are challenged to deal with these issues at a time when they are trying to heal from abuse and create a new life. iHEAL supports women to develop their capacity to address intrusive problems such as ongoing violence, social isolation, distressing health problems, and the ‘costs’ of accessing help from services which may not respond to their needs. iHEAL helps women focus on their priorities related to safety, health, healing and renewal, family relationships, community connections, and basic resources.
iHEAL draws on insights gained in developing, testing, and refining the intervention over the past 15 years, with attention to ensuring it is inclusive and appropriate for all women regardless of their diverse histories and life circumstances. Feasibility studies conducted in Ontario (ON), New Brunswick (NB) and British Columbia (BC) demonstrated that iHEAL is acceptable to women from varied backgrounds. In BC, we partnered with Indigenous Elders and leaders in policy, practice and research to adapt iHEAL through an Indigenous lens and then test it with Indigenous women from diverse Nations and communities.
The current version of iHEAL is delivered by Registered Nurses (RNs) working in partnership with women in 10-18 sessions over a 6-month period. Nurses complete approximately 60 hours of education specific to iHEAL and work in a team, supported by a Clinical Supervisor. During iHEAL sessions with women, RNs address both short-term and longer-term goals of safety, health and well-being. Following the key principle of being “woman-led”, nurses support women to address a broad range of issues, tailoring the intervention to the woman and her context and drawing on local supports and services. iHEAL is designed to complement and extend, rather than duplicate, existing resources.
Key Activities and Outputs
A research team, comprised of people with expertise in violence against women, RCT methods, nursing education and education related to IPV, knowledge mobilization, and reflective practice and supervision provided guidance related to all research and intervention activities.
In preparation for the RCT, initial project activities centred on integrating findings and lessons learned from previous feasibility studies to refine the intervention based and develop guidelines for clinical supervision, safety, and other practice-based protocols. A Practice Guide for Nurses was refined to include activities, tools and resources to support the nurses’ work in each component of iHEAL, and provide general guidelines for documentation, communication, and administrative issues. As a ‘companion’ to the nurses’ practice guide, a Woman’s Workbook was created for use by women enrolled in the iHEAL intervention. Finally, Guidelines for Clinical Supervisors provided information and resources to support supervisor’s responsibilities, including administrative oversight and leadership of iHEAL implementation, ongoing support and education of nurses, and guidelines for reflective supervision of nurses. Throughout, we sought and integrated user feedback, and improved the materials with support of a graphic designer and our KMb lead.
We developed a standardized approach to support the nurses learning the foundational iHEAL principles, concepts, components and strategies and the evidence-base underlying them. This education was delivered over ~60 hours using:
• 8 online learning modules, completed asynchronously and accessed on an online platform (Learn Dash).
• Online training in Risk Assessment (Danger Assessment training) and the San’yas Indigenous Cultural Safety Training
• face-to-face education that focused on helping nurses deepen their knowledge and put the intervention into practice. Nurses and supervisors were face-to-face in their respective provinces, with groups linked together by video-conferencing. This promoted a “community of practice” for both nurses and supervisors.
To evaluate the nurse education, we collected the following:
• Answers to reflective questions in each of the online modules
• Surveys at 5 time points measuring nurses’ confidence in carrying out key features of working with women in iHEAL
• Qualitative interviews with nurses at 3 time points about their experiences delivering iHEAL, working with core concepts and principles, and challenges and successes.
These data were analysed, with findings used to refine the education, and are in the process of being prepared for publication.
We developed a custom website for this project that managed important activities in a private, secure environment. For example, women learned about the RCT and assess their eligibility from this website (www.ihealstudy.ca), provided consent and contact information, completed surveys, and receive messages about randomization and other reminders. Research staff were able to monitor women’s progress through the trial using a tracking data base connected to this site, while nurses accessed the Nursing Documentation System (NDS), a custom system that allowed them to keep records about their work with women and communicate with one other securely. The NDS was converted to an online version to support the work of RNs delivering the Francophone iHEAL Study, which was independent of the NDS for the trial.
The iHEAL RCT was conducted between September 2019 and October 2021. Women were eligible to take part if they were: English-speaking women, had experienced IPV in previous 12 months, in transition of separating from an abusive partner; living in one of the study sites (BC, ON, NB); had access to safe email, phone (for contact) and access to an internet device (for online surveys). A total of 891 women completed online eligibility screening; 341 were ineligible for a variety of reasons, including still being with their partner with no plans to separate, living outside of the study area, not having safe access to email or a computer. Of the 550 women who were initially eligible based on the online screen, 359 had their enrollment validated by a staff member and were emailed a link to the baseline survey. The majority of those who could not be enrolled at this step could not be reached for validation. Recruitment was completed in August 2019.
In all, 331 women enrolled in the trial and completed the baseline survey; 175 women were randomized to receive iHEAL nurse visits and 156 to receive information about community services (usual care). Follow up surveys were completed 6, 12, and18 months later to evaluate whether iHEAL had benefits for women over time when compared to usual care. there were benefits for women over time (changes in outcomes over time). Qualitative interviews were conducted with a subset of 31 women, primarily those who were in the intervention group and had varied backgrounds. In a separate phase, we adapted iHEAL for Francophone women and tested for acceptability with a small group of Francophone women in New Brunswick.
Of the 175 women who were randomized to the intervention, 40 did not engage in the intervention (i.e., they had no nurse visits). This is not unexpected for women in the process of separating from an abusive partner who are often dealing with uncertainty and change in their lives. To account this and achieve our required sample size, we altered our randomization protocol. We ran our analysis two different ways: 1) an Intention-to-Treat (ITT) analysis was completed including all women in the study (331, including those with no visits) and 2) a Per- Protocol (PP) analysis included 135 women who had been randomized to iHEAL and received at least 1 visit, along with all 156 women in the control group (i.e. 40 women who did not have visits were removed from the analysis).
Project Outcomes
The collective evidence confirms that iHEAL is acceptable to women in varied contexts and that women showed strong improvements in the quality of life and mental health health that were maintained 12 months after the intervention ended.
Fidelity, Acceptability, and Safety: Fidelity of the intervention was measured post-intervention by asking women to indicate their level of agreement with 12 statements that reflect the principles and activities of iHEAL. The questions were measured on a 5-point scale; higher scores reflected more positive responses with a total possible scale range of 12-60. Some examples of the questions asked were:
1) The nurse helped me see what I was doing well;
2) It was up to me to decide what I worked on and who was involved; and
3) The nurse offered help that fit with my needs and concerns.
The women who were engaged in our intervention had a mean of 54.34 on this fidelity scale (4.5/5), meaning that overall, the women perceived that the intervention was delivered in a way that is consistent with the guiding principles and structure.
We also sought women’s feedback about the acceptability, safety and harms associated with iHEAL and found that:
• Although almost half of women felt that taking part in the iHEAL was sometimes upsetting, 94.5% agreed or strongly agreed that they felt comfortable and safe in the iHEAL visits
• 92.9% would recommend iHEAL to other women, based on their experiences. Less than 2% disagreed with this statement.
Short-term Changes in Outcomes by Group (iHEAL versus control):
Immediately post-intervention, women who were engaged in iHEAL consistently improved more than women randomized usual care, on a range of outcomes.
For the primary outcomes, women who engaged in iHEAL had significantly more improvement than those who received usual care in their:
• quality of life (in both ITT and PP analyses)
• symptoms of PTSD (in the PP)
For the secondary outcomes, iHEAL was also more effective than usual care in improving symptoms of depression, increasing women’s confidence (self-efficacy) and increasing control (personal agency) across both ITT and PP analyses. Although not statistically significant, there was also a trend toward iHEAL being more effective than usual care in reducing the experience of coercive control (PP analysis).
There was no effect on chronic pain disability; in fact, for women in both groups, chronic pain increased from baseline to 6 months. This is not necessarily an unexpected finding given that chronic pain is difficult to treat and the lack of specialized chronic pain services. Further, survey questions related to chronic pain and disability, repeated 4 times, may have increased awareness of pain for women in both groups.
Longer-Term Effectiveness of iHEAL: Where the benefits of iHEAL maintained?
In comparison to usual care, women who engaged in iHEAL showed significantly greater sustained improvements (up 12 months post-intervention) in their quality of life, mental health (PTSD and depression, PP analysis) and confidence (self-efficacy).
Although we did not initially expect that iHEAL would reduce the violence women experienced, those who engaged in iHEAL had a significantly greater and sustained reduction in IPV compared to those who received usual care. The effects of iHEAL on severity of IPV were the largest of any outcome we assessed (.41, .45 for ITT and PP).
Different Benefits for Different Groups of Women
Interventions typically have different levels of benefit for different groups. The goal of iHEAL is for all women to benefit but we are particularly concerned with benefits for women who face the most challenges and who may not be well- served by existing services. Compared to other women in the intervention group, three groups benefitted more from iHEAL including women with: 1) problematic alcohol use, 2) problematic drug use; and 3) less financial stress/strain. These findings are important because substance use/alcohol use is often a criterion for excluding women from services as they may be considered ‘not ready to engage’. Additionally, women who reported less financial strain at baseline benefitted more than those with more financial strain, suggesting that stress from finances is a barrier to improvement in women’s health and quality of life.
Women’s Experiences of iHEAL
Qualitative analysis of women’s interviews underscores the importance of the women-led approach of iHEAL. Specifically, how nurses ‘became’ what the woman needed supporting each woman to take control of what was happening in her life, and providing the type of guidance and support she wanted. Women’s stories illustrated the power of the iHEAL approach and the importance of nurses using a flexible, respectful, safe, personalized approach that offered practical support. Women did not experience iHEAL in exactly the same ways – and what they identified as most personally important to them varied. We are confident in the value and benefit of the iHEAL program for women. iHEAL is flexible to fit the needs of all women and fits with local contexts.
Building Nurses’ Capacity to Support Women Experiencing IPV
Analysis of data collected from nurses shows that their knowledge, skills and confidence increased as a result of the initial education and continued to increase over time as they worked directly with women, supported by their team and clinical supervisor.
Next Steps
Project outcomes affirmed the importance of adopting a flexible, tailored approach in working with women who have experienced IPV and – in particular – being woman-led. Given the complexity and the interconnectedness of women’s health, economic situation, social support, safety and access to resources/services, this is an important way of working to ensure that the support offered really ‘fits’ with what is most important to each women, increasing the chance of positive impacts.
The iHEAL approach is useful beyond the formal intervention delivered by specially trained nurses. For this reason, a version of the online education that is not specific to iHEAL that would be appropriate for health and social services providers working with women in many different contexts is planned. The intention is to support service providers in adopting the principles of being ‘woman-led’ and trauma- and violence-informed in any service setting.
The adaptation of iHEAL continues to have strong support from community stakeholders who are engaging in implementation studies.
