Abstract
Objective
To assess consent rates and reasons for refusing consent after the introduction of peer navigators into the Outcomes of Babies with Opioid Exposure (OBOE) study.
Design
Secondary analysis of data from the OBOE Study, a multi-site observational study.
Setting
Medical centers in Alabama, Ohio, and Pennsylvania (N = 4).
Participants
Data about the use of peer navigators were obtained from the primary study, including 1,255 mothers or caregivers who were approached regarding participation in the study.
Methods
We used Chi-square tests to compare study consent rates and reasons for refusing consent before and after the use of peer navigators.
Results
Following the addition of peer navigators, study consent rates significantly improved (29% of 852 before vs. 38% of 403 after; p = .001) and the percentage of potential participants who indicated that they were not interested in sharing information for research significantly decreased (41% of 247 vs. 26% of 115; p = .005).
Conclusion
Our results demonstrate the potential effect of peer navigators on consent and interest in sharing information for research in a longitudinal research study. We recommend the inclusion of peer navigators in studies with high-risk populations.
Keywords: Informed consent, recruitment, patient enrollment, neonatal opioid withdrawal syndrome, pregnancy, opioids, prenatal drug exposure
Precis
This study demonstrated the positive effects of incorporating peer navigators into a longitudinal research study with a high-risk population.
The opioid epidemic has become a public health crisis both within the United States and abroad over the past two decades. Evidence of its pervasive presence is exemplified by the increase in rates of opioid use disorders (OUD) in pregnant women, documented at over 125% between 2010 and 2017 alone (Hirai et al., 2021). Investigators have attempted to understand the transgenerational effect of this experience by evaluating development and behavior in children with antenatal opioid exposure. As these longitudinal studies continue, more is being learned about clinical research practices and about how standard practices of enrollment, engagement, and retention can be modified for optimal success in this population (e.g., Beasley et al., 2020).
The Advancing Clinical Trials for Neonatal Opioid Withdrawal Syndrome (ACT NOW) Outcomes for Babies with Opioid Exposure (OBOE) study is a prospective, longitudinal cohort study examining the effect of antenatal opioid exposure on infant outcomes from birth to 2 years of age. The study team recruited infants with antenatal opioid exposure and nonexposed controls, through discussions with mothers and families prenatally at obstetric clinics and substance use treatment programs or postnatally in the birth hospital. A team of well-trained clinical experts—including research nurse coordinators, nurse practitioners, neonatologists, and social workers—disseminated information and actively engaged with potential participants. During the study, we determined that additional nuanced and focused approaches would be helpful in recruiting and retaining participants in the study.
Mothers with OUD may experience many challenges and risks in addition to opioid use (Preis et al., 2020) that could affect their engagement in health care and research studies. In a review article, Arnaudo and colleagues (2017) found that 25% to 33% of pregnant individuals with OUD had psychiatric comorbidities with depression and anxiety being most commonly reported. Trauma was prevalent among women with OUD who, on average, had experienced three or more adverse childhood events (Evans et al., 2020; Gannon et al., 2021). Mothers with OUD may also encounter stigma within health care settings (Schiff et al., 2021) that could potentially affect their willingness to participate in research when health care workers approach them.
As with other high-risk populations, mothers with OUD have a complicated and complex background of needs that may be best understood by those with similar lived experience. Peer navigators have emerged as a promising solution to breaking down barriers to health care and improving outcomes among traditionally marginalized or high-risk populations, such as those with mental health disorders, HIV, homelessness, or substance use disorders, like populations of individuals with OUD with complex and intersecting identities and lived experiences (Corrigan et al., 2017, 2018; Kennedy et al., 2024). Peer navigators are individuals with lived experience who combine peer support with patient navigation. Within the substance use context, Tillson and colleagues (2022, p. 1) indicated that “Peer navigators’ serve…support and advocacy functions, but additionally act as linkage facilitators to connect individuals to services and support treatment engagement and retention. Peer navigators can be seen as an extension of a clinical care team, much like community health workers, and can play key roles in engaging individuals in research and linkage to care.”
Ramdin and colleagues (2022) found that the incorporation of a peer navigator program was associated with an increase in distribution of naloxone kits and administration of buprenorphine to individuals with OUD within emergency departments. Beyond immediate access to treatment in hospital, the integration of peer support in long-term treatment has also shown potential to increase engagement in therapeutic support, to decrease relapse, and to encourage ongoing sobriety (Stanojlović & Davidson, 2021; Zuccarini & Stiller, 2024). Less is known about the potential effect of peer navigators on informed consent, enrollment, and retention in research studies, particularly for samples of individuals with a history of OUD in the postpartum period. Considering the stigma these individuals have experienced in medical settings at the intersection of competing and compounding needs, the potential for a peer navigator who has similar life experience and may be living in a similar community seemed promising for the longitudinal OBOE study to increase engagement of caregivers of infants with neonatal opioid withdrawal syndrome.
Peer navigators were incorporated into the OBOE Study to assist with participant recruitment and retention and to provide support for enrolled families. The recruitment time for the peer navigator position ranged from 3 to 15 months across sites and required the use of non-traditional recruitment approaches with the greatest success achieved by reaching out to community agencies that work with individuals with substance use to ask whether they had any contacts who might be interested in the position.
Specific tasks performed by peer navigators are outlined in Figure 1. A central feature of the peer navigator role involved building rapport with potential and current participants. From the initial contact during the consent process to follow-up visits, peer navigators served as a source of support for families of exposed and unexposed infants. A unique contribution of the peer navigators was sharing their personal experiences. For example, one OBOE Study nurse coordinator explained, “The PN [peer navigator] has been able to be at the bedside during the consenting process … She shares her own personal experience and how follow-up would have been something her child would have benefited from.” The coordinator further described how this peer navigator’s influence extended beyond study recruitment to being supportive of recovery among mothers of potential study infants: “The PN has been able to go with [the] coordinator when the study is presented in clinic and share her lived experiences and offer hope as a person of long-time recovery with similar lived experiences.” In this article, we assess the effects of peer navigators on consent rates and reasons for refusing consent after their introduction into the OBOE Study.
Figure 1.
Peer Navigator Study Contributions
Methods
Design
We conducted a secondary data analysis of data from the ACT NOW OBOE Study, a multisite prospective longitudinal cohort study of the effect of antenatal opioid exposure on infant development over the first 2 years of life with targeted enrollment of 300 term-born infants (200 opioid-exposed and 100 unexposed). Study enrollment took place from August 2020 to December 2023 with follow-up visits ongoing as of November 2024.
Participants
The analytic sample for this study included mothers or caregivers of opioid-exposed and unexposed infants who were eligible for and approached about participation as a part of the OBOE primary study. Participants for the primary study were recruited at prenatal clinics and during hospital stays following birth. Mothers with heavy alcohol use during pregnancy, defined as 8 or more drinks per week, were excluded from the primary study.
Measures
We collected data on whether the mother or caregiver consented to have their infant participate in the primary study. For those who did not consent to study participation, coordinators recorded the reasons consent was not obtained.
Analysis
We classified participants based on whether they were screened for eligibility before or after the site had incorporated peer navigators into the study. Peer navigators joined the study from June to November 2022 with varying dates across the sites due to differences in the length of time required for recruitment and hiring. We excluded data from one of the four sites from the analysis because the site was never able to confirm and place a peer navigator. That is, although this site hired a peer navigator, the individual could not onboard to the study because they could not meet employee training requirements within the institution’s required time frame.
We conducted chi-square tests to compare study consent rates before versus after the addition of the peer navigators. We conducted these analyses for the overall sample and separately by opioid exposure status. We conducted similar chi-square tests to assess changes in the reasons for not consenting to enroll in the study. We did not analyze reasons for not consenting separately by exposure status due to small cell sizes for some reasons.
Results
Overall, study consent rates significantly improved after the addition of peer navigators (29% of 852 before vs. 38% of 403 after; p = .001; Table 1). Consent rates were higher following the inclusion of peer navigators for exposed infants; however, the difference was not statistically significant (41% of 389 vs. 49% of 177; p = .074). There was a significant improvement in consent rates among unexposed infants (18% of 463 vs. 29% of 226, p = .002).
Table 1.
Eligible Potential Participants Who Consented to Participate in the Study Before and After Inclusion of Peer Navigators
| Group | Before Peer Navigators n/N (%) | After Peer Navigators n/N (%) | p a |
|---|---|---|---|
| Consent Rates | |||
| All | |||
| Consented to participate | 244/852 (29) | 152/403 (38) | .001 |
| Refused consent/Did not respond | 608/852 (71) | 251/403 (62) | |
| Exposed | |||
| Consented to participate | 160/389 (41) | 87/177 (49) | .07 |
| Refused consent/Did not respond | 229/389 (59) | 90/177 (51) | |
| Unexposed | |||
| Consented to participate | 84/463 (18) | 65/226 (29) | .002 |
| Refused consent/Did not respond | 379/463 (82) | 161/226 (71) |
Among potential participants who did not consent to participate in the study, the percentage who indicated they were not interested in sharing information for research significantly decreased after the addition of peer navigators (41% of 247 vs. 26% of 115; p = .005). Meanwhile, the percentage reporting that they did not consent due to the time commitment significantly increased over time (35% of 247 vs. 46% of 115; p = .040). No significant differences were observed for the other reasons (Table 2).
Table 2.
Reasons for Refusing Consent Among All Participants Before and After Inclusion of Peer Navigators
| Reason | Before Peer Navigators n/N (%) | After Peer Navigators n/N (%) | p b |
|---|---|---|---|
| Time commitment of follow-up visits/questionnaires | 86/247 (35) | 53/115 (46) | .04 |
| Not interested in sharing information for research | 102/247 (41) | 30/115 (26) | .01 |
| Lives too far from follow-up clinic | 12/247 (5) | 7/115 (6) | .63 |
| Undergoing study procedures (e.g. MRI) | 17/247 (7) | 13/115 (11) | .16 |
| Other reason | 30/247 (12) | 12/115 (10) | .64 |
Reasons for refusing consent were not analyzed separately by exposure group due to small cell sizes for some reasons.
Discussion
Our study demonstrated the positive effect of incorporating peer navigators into a longitudinal research study. The inclusion of the peer navigators had a tangible effect on recruitment in the primary study, with overall consent rates increasing following the incorporation of peer navigators into the study. An unanticipated finding when we examined results by exposure group was that peer navigators had a greater effect on consent rates among parents of unexposed than exposed infants. Throughout the study, enrollment has been most challenging with families of unexposed infants, who have expressed fewer concerns regarding their child’s development and less interest in having the assessments provided by the study. The peer navigators were effective in increasing consent rates among this hard-to-reach group.
Among those who chose not to participate in the study, we saw a decrease in the number who indicated that they were not interested in sharing information for research as their reason for refusing consent. This finding may reflect peer navigators having helped to increase trust and reduce stigma among potential participants. Interestingly, we noted an increase in the percentage of potential participants who chose not to participate due to the time commitment for the study, which could suggest that peer navigators may have been more effective at explaining the amount of time required for the study, thereby helping participants to make a more informed decision. Further research is needed to understand the role of peer navigators in promoting informed consent, such as for longitudinal studies employing a dynamic consent process.
Limitations
Study limitations could affect the generalizability of the results. The OBOE study is focused on infant outcomes and, therefore, mothers provided consent for their child undergoing the study procedures (e.g., MRI scans). Results could differ if the mothers themselves were the target population. Potential participants were also being approached during a potentially stressful time following the birth of a child when mothers with OUD may face legal and child custody issues due to the baby’s prenatal drug exposure. It is possible that the effect of the peer navigators could vary if mothers were approached at a different point during the perinatal period.
Conclusion
Our results suggest that peer navigators are a viable approach to improve the consent and enrollment process in longitudinal research studies. Peer navigators proved to be valuable team members for this study. Their contributions were beneficial to the research staff and study participants. They also strengthened connections with organizations serving the target population, allowing them to expand study recruitment efforts and connect participants to needed resources. Researchers should further explore the role of peer navigators in research settings and consider developing a recruitment protocol for filling this role in longitudinal studies.
CALLOUTS.
Women with opioid use disorder may experience a variety of challenges and risks that can affect their engagement in health care and research studies.
Including peer navigators in a multisite longitudinal research study had a positive effect on consent rates.
Peer navigators can improve study operations and support participants in studies involving high-risk populations.
Acknowledgement
The authors acknowledge medical and nursing colleagues at our clinical sites, Dr. Michele Walsh, and NIH colleagues Dr. Nahida Chakhtoura, Dr. Andrew Bremer, and Ms. Stephanie Archer for their collaboration and support.
Funding
Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the National Institutes of Health Helping to End Addiction Long-term (HEAL) Initiative via the following grant numbers: 1PL1HD101059-01; 1RL1HD104251-01; 1RL1HD104252-01; 1RL1HD104253-01; 1RL1HD104254-01; 3PL1HD101059-01(S1-4). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or its NIH HEAL Initiative.
Footnotes
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Disclosure The authors report no conflict of interest or relevant financial relationships.
Contributor Information
Carla M. Bann, Analytics Division, RTI International, Research Triangle Park, NC..
Jamie Newman, Analytics Division, RTI International, Research Triangle Park, NC..
Leslie Clarke, Department of Pediatrics, Case Western Reserve University, Cleveland, OH..
Sandra Russell, University of Alabama at Birmingham, Birmingham, AL..
Megan Dhawan, Division of Neonatology, Children’s Hospital of Philadelphia, Philadelphia, PA..
Traci Beiersdorfer, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH..
Sara DeMauro, Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, PA..
Deanne Wilson-Costello, Case Western Reserve University, Cleveland, OH..
Myriam Peralta-Carcelen, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL..
Stephanie Merhar, Division of Neonatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH..
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