BACKGROUND Opioid overdose is a leading cause of pregnancy-associated deaths largely occurring after delivery. Birthing people with opioid use disorder (OUD) face unique stressors during the transition from pregnancy to postpartum that are challenging to recovery and increase overdose risk. Prenatal education is insufficient to prepare birthing people with OUD for the pregnancy-to-postpartum transition. Use of evidence-based, technology-delivered interventions as a supplement to standard prenatal care may provide more robust preparation for those facing this transition. To date, no technology-based interventions specific to the pregnancy-to-postpartum transition for people receiving MOUD have been developed and evaluated. OBJECTIVE The primary aim of this manuscript is to describe the iterative development process of a novel technology-delivered intervention tailored for pregnant people receiving medication for OUD (MOUD) as it underwent refinement in preparation for its subsequent evaluation in a prospective randomized clinical trial. METHODS Three evidence-based technology-delivered intervention modules were developed and are described. Formative data from patients and providers identified module content: 1) recovery-oriented strategies for the pregnancy-to-postpartum transition, 2) guidance around caring for an infant with withdrawal symptoms, and 3) preparation for child welfare interactions. Module content matching these content areas was reviewed in successive rounds by an expert panel and modified by the study team. Then, novel modules were programmed into the web-based, easily accessible platform where information is delivered via professionally produced videos and an interactive narrator using behavioral techniques. Pregnant and postpartum people receiving MOUD pre-tested the modules and provided feedback in semi-structured interviews. Feedback from the expert panel and patient pre-testing is summarized. RESULTS Expert panel members (n=15) including patients, multidisciplinary providers, and technology-based intervention researchers identified module strengths and areas for improvement. Panel members liked the intervention format and the informative content. Primary areas for improvement included adding content, providing more structure to help participants navigate the intervention more easily, and revising language. Pre-testing participant (n=9) qualitative data highlighted four themes: reactions to intervention content, navigability of the intervention, feasibility of the intervention, and recommendation of the intervention. Participants also provided some areas for improvement. All iterative feedback was incorporated into final modules for the prospective randomized clinical trial. CONCLUSIONS When developing technology-delivered interventions tailored for pregnant people receiving MOUD, it is feasible (and recommended) for the intervention to be informed by patient-reported needs and multidisciplinary perspectives. Assessment of intervention feasibility, acceptability, and effectiveness with a large sample in a clinical research setting is warranted.
IntroductionWe aimed to streamline the NIDA Phenotyping Assessment Battery (PhAB), a package of self‐report scales and neurobehavioral tasks used in substance use disorder (SUD) clinical trials, for clinical administration ease. Tailoring the PhAB to shorten administration time for a treatment setting is critical to expanding its acceptability in SUD clinical trials. This study's primary objectives were to develop a brief version of PhAB (PhAB‐B) and assess its operational feasibility and acceptability in a female clinical treatment sample.MethodsAssessments of the original PhAB were evaluated along several criteria to identify a subset for the PhAB‐B. Non‐pregnant females (N=55) between ages 18–65, stabilized on buprenorphine for opioid use disorder (OUD) at an outpatient addiction clinic, completed this abbreviated battery remotely or after a provider visit in clinic. Participant satisfaction questions were administered. REDCap recorded the time to complete PhAB‐B measures.ResultsThe PhAB‐B included 11 measures that probed reward, cognition, negative emotionality, interoception, metacognition, and sleep. Participants who completed the PhAB‐B (N =55) were 36.1 ± 8.9 years of age, White (54.5%), Black (34.5%), and non‐Latinx (96.0%). Most participants completed the PhAB‐B remotely (n = 42, 76.4%). Some participants completed it in‐person (n = 13, 23.6%). PhAB‐B mean completion time was 23.0 ± 12.0 min. Participant experiences were positive, and 96% of whom reported that they would participate in the study again.ConclusionOur findings support the clinical feasibility and acceptability of the PhAB‐B among a female opioid use disorder outpatient addiction treatment sample. Future studies should assess the PhAB‐B psychometric properties among broader treatment samples.
Background: Postpartum people with opioid use disorder (OUD) report feeling underprepared for the pregnancy to postpartum transition. We developed a novel, technology-delivered educational intervention for pregnant and parenting people with OUD to address this gap. This study provides a theoretically grounded assessment of the feasibility and acceptability of a new technology-delivered educational intervention (Project BETTER) for pregnant and parenting people receiving medication for OUD (MOUD). Materials and Methods: Pregnant and postpartum people receiving MOUD were recruited from a perinatal addiction clinic research registry to pilot test the technology-delivered intervention. Participants completed one of three modules (Postpartum Transition, Neonatal Opioid Withdrawal Syndrome, or Child Welfare Interactions) and a survey assessing acceptability based on the theoretical framework of acceptability (TFA). We measured feasibility using process, resource, management, and scientific assessments. Demographics were self-reported. Clinical characteristics were abstracted from the medical record. Results: Feasibility was promising, with 17 of 28 participants approached (61%) agreeing to participate; 70% of these participants ( N = 12; 58% White and 23% Black, all with public insurance) completed an intervention module and the study assessments, and all reported understanding how the modules worked. Acceptability was strong, with median ratings of 4 or 5 on a 5-point scale for all positively scored TFA domains. Compared to learning from a provider, participants also reported feeling more comfortable and less stigmatized learning from the intervention. Conclusion: Our theoretically grounded assessment suggests high feasibility and acceptability for Project BETTER, and provides justification for further evaluation in a clinical trial setting. Technology-delivered educational interventions may help reduce stigma and enhance prenatal education.
Birthing people with opioid use disorder (OUD) face unique stressors during the transition from pregnancy to postpartum that can negatively impact the maternal–infant dyad. This study aimed to describe the development of a family-centered, technology-delivered intervention tailored to help pregnant people receiving medication for OUD (MOUD) prepare for this transition. Formative data from patients and providers identified intervention content: (1) recovery-oriented strategies for the pregnancy-to-postpartum transition; (2) guidance around caring for an infant with opioid withdrawal symptoms; and (3) preparation for child welfare interactions. The content was reviewed in successive rounds by an expert panel and modified. Pregnant and postpartum people receiving MOUD pre-tested the intervention modules and provided feedback in semi-structured interviews. The multidisciplinary expert panel members (n = 15) identified strengths and areas for improvement. Primary areas for improvement included adding content, providing more structure to help participants navigate the intervention more easily, and revising language. Pre-testing participants (n = 9) highlighted four themes: reactions to intervention content, navigability of the intervention, feasibility of the intervention, and recommendation of the intervention. All iterative feedback was incorporated into the final intervention modules for the prospective randomized clinical trial. Family-centered interventions tailored for pregnant people receiving MOUD should be informed by patient-reported needs and multidisciplinary perspectives.
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