OBJECTIVE: Antenatal fetal surveillance is performed in high-risk pregnancies to reduce the risk of stillbirth.¹ Surveillance recommendations require numerous in-clinic appointments for nonstress tests (NSTs).¹ NST attendance is limited by transportation, childcare, and work demands.²

INVU by Nuvo is an United States food and Drug Administration–cleared, remote, self-administered maternal-fetal monitoring approach. In a prospective cohort study, 93.9% of NSTs performed remotely using INVU were clinically acceptable, and >88% were completed without in-clinic evaluation.³

In this study, we explored patient acceptability of remote fetal monitoring using quantitative and qualitative approaches to help clinicians and users understand the experience, while providing actionable insights for optimization.

STUDY DESIGN: This prospective mixed-methods study encompassed survey and qualitative portions. Patients were enrolled in 1 of 2 prospective cohorts that studied the use of INVU to remotely perform clinically indicated NSTs in high-risk pregnancies from October 2020 to March 2023. A device description and the inclusion and exclusion criteria for these cohorts are described in the Supplemental File, and the clinical data have been reported elsewhere.³ These studies were approved by the [University of Pennsylvania] Institutional Review Board.

Survey study: Cohort patients who attempted ≥1 remote NST were eligible for the weekly survey, which included a modified version of the validated Acceptability of Intervention Measure (AIM) (4-item Likert-scale measure) and open-ended questions regarding patient experience.⁴ Descriptive statistics were used, and analyses were performed using Stata, version 15.0 (StataCorp LL, College Station, TX).

Qualitative study: Beginning May 2022, after 2 attempted remote sessions, cohort patients were invited to participate in a semi-structured qualitative interview until thematic saturation was achieved. A Consolidated Framework for Implementation Research influenced interview guide⁵ elicited information on (1) experiences with in-clinic and remote monitoring, (2) barriers to or facilitators of remote monitoring, and (3) suggestions for improvement. For the analysis, an integrated approach was used in NVivo12 with excellent intercoder reliability (the Supplemental File contains detailed information on the qualitative methods).

RESULTS: A total of 56 patients enrolled in the 2 cohort studies (Table 1). Of those, 40 patients (71.4%) completed 105 surveys (median, 2; interquartile range [IQR], 1–4 surveys/person) with a median acceptability of 15 of a possible 20 (IQR, 14–16).

Table 1. Demographic characteristics of participants for each study component, namely the (1) quantitative study and (2) qualitative study

[see link to original article above for table]

When asked to provide feedback about remote monitoring, the most frequently cited issue related to belt connectivity (19/105; 18.1%) or belt fit or comfort (16/105; 15.2%). Patients reported several benefits of remote monitoring, including avoiding in-clinic interactions (53/89; 59.6%), ease and speed of INVU (13/89; 14.6%), avoiding traffic or parking issues (n=6), and decreased costs (n=2). For recommendations for improvement, many reported none (41/89; 46.1%) and others relayed recommendations for improved belt fit or comfort (33/89; 37.1%).

Qualitative: Twelve patients participated in qualitative interviews. Sample interview questions with representative quotes are shown in Table 2.

Table 2. Summary of interview questions in terms of the Consolidated Framework for Implementation Research (CFIR) constructs and representative quotes

[see link to original article above for table]

Previous experiences with in-clinic monitoring: Few participants expressed positive experiences with in-clinic sessions, including a sense of ease or comfort. However, the majority spoke about coordinating childcare and frustrations surrounding travel time, public transportation, work scheduling, and parking with each factor perceived as being financially impactful.

Patient experiences with remote monitoring: The majority reported excitement for at-home monitoring, stating a belief that it would be convenient and less costly. Participants reported feeling relieved of the logistics and expenses of in-clinic monitoring. Concerns with remote monitoring were primarily hypothetical what-ifs. Yet, when probed, the majority reported reassurance about receiving similar monitoring as received in-clinic.

Participants conducted home monitoring in bed or a reclining chair. Generally, at-home sessions lasted for less than 1 hour. Participants also reported that while performing remote monitoring, some worked, whereas others watched TV. Participants reported that household members were either neutral about remote monitoring or provided enthusiastic support. One stated that remote monitoring allowed her spouse to participate, contrasting this with childcare logistics and COVID-19 restrictions.

Barriers and facilitators: Some participants mentioned the need for increased set-up support. One mentioned difficulty with staying still during the experience. For facilitators, in addition to the decreased need for childcare, transportation, and cost, several stated they appreciated clinician communication through the application.

Suggestions for future implementation: A few participants did not have suggestions for improvement, feeling that the experience was straightforward. One brought up fit, expressing body type inclusivity concerns. Other participants felt that remote monitoring may still require additional planning if the home environment includes children.

DISCUSSION: This study demonstrated patient acceptability of remote fetal monitoring using INVU with the use of quantitative and qualitative data to describe concrete barriers and suggestions for improvement. This innovation approach centered the patient, a novel step in academia-industry collaboration, and led to device modifications to improve comfort and signal reliability. These improvements have the potential to maximize the success of our ongoing randomized clinical trial, the Remote Pregnancy Monitoring to Improve Access (REACTIVE) study (https://clinicaltrials.gov/study/NCT05847790), which compares in-clinic and remote monitoring in terms of NST completion and clinical outcomes, focusing on racial and ethnic disparities.

Credit authorship contribution statement

Rebecca F. Hamm: Writing – review & editing, Writing – original draft, Validation, Supervision, Software, Resources, Project administration, Methodology, Investigation, Funding acquisition, Formal analysis, Data curation, Conceptualization. Mary C. Steele: Writing – review & editing, Project administration, Data curation. Caroline O'Brien: Writing – review & editing, Supervision, Software, Resources, Project administration, Methodology, Investigation, Formal analysis, Data curation. Hilena Gebru: Writing – review & editing, Software, Resources, Project administration, Methodology, Investigation, Formal analysis, Data curation. Janelle Purnell: Writing – review & editing, Resources, Project administration, Methodology, Investigation, Data curation. Meaghan McCabe: Writing – review & editing, Supervision, Resources, Project administration, Methodology, Investigation, Funding acquisition, Data curation, Conceptualization. Meghan B. Lane-Fall: Writing – review & editing, Supervision, Methodology, Investigation, Funding acquisition, Conceptualization. Samuel Parry: Writing – review & editing, Supervision, Project administration, Methodology, Investigation, Funding acquisition, Conceptualization. Nadav Schwartz: Writing – review & editing, Supervision, Resources, Project administration, Methodology, Investigation, Funding acquisition, Conceptualization.

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