This pilot prospective cohort trial will utilize a concurrent mixed-methods design to obtain information about intervention feasibility, acceptability, and sustainability and assess preliminary evidence of improved outcomes.

Intervention

We will implement Centering Patients with Fibroids (CPWF) at Boston Medical Center (BMC) and Grady Memorial Hospital/Emory University Hospital Midtown, two academic-based safety net hospitals that serve racially and socioeconomically diverse patient populations in different regions of the United States. The investigation of patients at these two hospitals will help to detect any existing regional differences in implemention. The study was approved by the Institutional Review Board at both institutions. Eligible participants include patients between the ages of 18 to 45 years old receiving care at one of the study hospitals, with symptomatic UF measuring equal or more than 2 cm, and uterine dimensions of less than 20 cm on pelvic imaging within 12 months of recruitment. Exclusion criteria include inability to speak English, pregnancy at time of recruitment, and no available pelvic imaging. Eligible and interested patients will provide informed consent to participate in an 8-week education and empowerment program, conducted in person and via Zoom in a hybrid modality. Each 1.5 h session will be facilitated by the study site principal investigator (PI), research staff trained in group facilitation by the Centering Healthcare Institute (CHI), and/or members of our advocacy partner, The White Dress Project.

Our investigative team adapted the components of the CenteringPregnancy program, a group model of prenatal care developed through the Centering Healthcare Institute (CHI), to design a complementary education and empowerment program for patients with UF. CHI’s group care framework prioritizes high quality healthcare, interactive learning, and positive health outcomes through building relationships and community among group members. To apply and adapt this model to serve the needs of patients with UF, our research team members were first trained as certified Centering facilitators. CHI facilitator training provides a broad range of strategies for both virtual and in-person engagement, including mindfulness activities, storytelling exchanges, writing exercises, and “ball-toss” interactive conversations. Storytelling exchanges in particular can help to empower and improve patient engagement in their own care by sharing personal experiences [15, 16]. In the broader context, storytelling also has the power to reduce health disparities [17]. Our team used the skills gained from this facilitation training to create CPWF as a group-based care model focused on providing exceptional care to patients with UF through a multidisciplinary, patient-centered, conversational, and evidence-based approach. CPWF curriculum topics mirror CenteringPregnancy and include the role of environment and diet on UF; impact of UF on mental health, fertility and pregnancy, bleeding and anemia, and pain; and UF treatments including non-surgical medical therapies, uterine-sparing procedures, and hysterectomy (Fig. 1). Program participants receive detailed information on all of the surgical and non-surgical options for managing UF and have the chance to discuss their options with peers and clinical staff.

Fig. 1

Adapting the CenteringPregnancy model for uterine fibroids

Healthcare advocates from TWDP co-facilitate each session to aid in maintaining a patient-centered experience.

CPWF cohorts are implemented using a hybrid modality, with the first and last sessions conducted in person, and the remaining sessions conducted via Zoom (Fig. 1). A total of 7 cohorts will receive the program at BMC, and a total of 6 cohorts will receive the program at Emory/Grady. All CPWF participants complete a “Dear Fibroids” letter to their fibroids at the beginning of the session, a personal effort to define and process how fibroids have impacted their daily lives. We utilize Zoom features such as breakout rooms, screen sharing, and polls for greater engagement in the virtual space. For example, one strategy for online engagement includes activities to establish rapport between patients via Zoom breakout rooms, focused on discussing fibroid experiences, unique or fun facts about participants, and hobbies. Other strategies include mindfulness activities, “ball toss” activities to reinforce learning in a playful way, and artistic exercises such as drawing in the “Past, Present and Future” exercise in which participants color a tree with branches symbolizing various stages in their fibroid journey.

Recruitment

Participants will be recruited from the Fibroid Center and Obstetrics and Gynecology (OBGYN) clinics at Boston Medical Center, Emory University Hospital Midtown, and Grady Memorial Hospital. Participants will be identified using the BMC, Emory University Hospital Midtown and Grady Memorial Hospital Electronic Medical Records (EMR), Epic MyChart, clinic schedule, and flyers placed in high-traffic areas in the clinical space (Fig. 2). Potential participants may also be referred from OBGYN providers in the clinic if they meet criteria. A research team member reaches out to patients who meet inclusion criteria by phone or during an in-person clinic encounter to inquire about interest in participating in the study. If a candidate for the study agrees to participate, a trained study researcher/interviewer will contact the subject and explain what the study entails to obtain informed consent.

Fig. 2

Centering Patients with Fibroids (CPWF) recruitment and participation flow

In addition to these screening and recruitment practices, we used EPIC/MyChart to reach patients not seen in the OB/GYN practice who are diagnosed with UF. We obtained a list of non-pregnant patients with fibroid diagnoses as a preliminary eligibility screening, then sent a study recruitment letter with Opt Out language to the patient’s MyChart inbox. We posted digital flyers with QR codes on waiting room television monitors in clinics throughout the hospital to supplement paper recruitment flyers. We reached out to the Family Medicine and General Internal Medicine departments at BMC and Emory/Grady to identify provider research champions to assist us in identifying potentially eligible patients/connecting them with the study opportunity through MyChart. Finally, we will access emergency department and gynecology follow up referral lists to screen patients for CPWF and reach out to potentially eligible subjects. Participants will be remunerated up to $200 via reloadable gift cards called “ClinCards” for survey completion, lab draw, and session attendance. We emphasize that CPWF is a program designed to complement, rather than replace, one-to-one gynecological care with a participant’s provider.

In addition to recruiting patients, we recruited healthcare leaders and providers at Boston Medical Center, Emory University Hospital Midtown, and Grady Memorial Hospital to participate in interviews. We will identify those who are invested in improving access to quality care and health outcomes for patients seeking care at BMC, Emory University Hospital Midtown, and Grady Memorial Hospital. Interviewees will be leaders and providers who have had some level of contact with the Fibroid Center, Emory University Hospital Midtown, and Grady Memorial Hospital or provide care to women seeking care related to symptomatic uterine fibroids. They are contacted via email and asked to participate. If they agree, we will obtain consent and schedule interviews.

Quantitative methods

To assess preliminary program impact on physical and mental health outcomes, participants will complete self-reported surveys during their participation in this study: pretest, posttest, and 3 month follow up. The surveys will include demographic questions and a series of validated measures, including the Uterine Fibroid Symptom and Quality of Life (UFS-QOL), the Everyday Discrimination Scale, Patient Health Questionnaire-9 (PHQ-9), and the Instrument for Evaluation of the Experience of Chronic Patients (IEXPAC).

As the aim of this pilot study is to assess preliminary outcomes as well as feasibility, acceptability, and sustainability, achieving a predetermined sample size for power was not necessary. We anticipate 10-12 participants per cohort for a total of 13 cohorts, 7 at BMC and 6 at Emory/Grady. As such, we will perform comparison of mean scores of the various validated survey instruments using analysis of variance (ANOVA) tests. We will also ask participants to give blood for serum studies including complete blood count (CBC), Anti-Müllerian hormone (AMH), and 25-OH-Vitamin D. Values will be compared at baseline and 3 months after the program completion. We hypothesize decreased anemia and vitamin D deficiency among program participants at 3 month follow up, and variable change in the AMH level related to the age at the time of program participation.

Survey measuresUterine Fibroid Symptom and Quality of Life (UFS-QOL)

The UFS-QOL is designed to assess symptomology and health-related quality of life for patients managing UF. Scores are calculated on a scale of 0-100, with higher scores indicating a higher reported quality of life [18]. The first 11 questions are framed using a Likert scale (Never; Almost Never; Sometimes; Almost Always; Always) and score from 0-10, with higher scores indicating a better patient experience in the past 6 months. The final 3 questions, reported separately, describe continuity of healthcare after hospitalization, emergency department care, home health care, and social services utilization [19].

Everyday discrimination scale

The Everyday Discrimination Scale measures experiences of discrimination in day-to-day life based on racial identity, ancestry and tribal identity, gender and sexuality, income and education, age, religion, ability, and physical appearance including height, weight, and skin tone. Scores range from 0–25, with higher scores indicating more experiences of discrimination [20,21,22].

Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 screens, diagnoses, and assesses symptom severity for depression over the past 2 weeks on a 4-point Likert scale (Not at all; Several days; More than half the days; Nearly every day), with final scores ranging from 0-27. Major depressive disorder is suggested if 5 or more items are marked as “More than half the days,” and if item 1 or 2 is marked as at least “More than half the days.” Other depressive syndrome is suggested if 2-4 items are marked as at least “More than half the days,” and if item 1 or 2 is checked as at least “More than half the days.” Participants are considered to screen positive for depression if their overall score is 5 or higher [23, 24].

Instrument for Evaluation of the Experience of Chronic Patients (IEXPAC)

The IEXPAC survey was developed in the Chronic Care Model theoretical framework [25] and scores participants’ replies to questions about their experience with integrated care for chronic health conditions. IEXPAC focuses on patients’ experiences with entire care teams, and aligns with the Triple Aim framework of improving individual healthcare experience, improving population health, and reducing per capita healthcare expenditures [26]. Overall scores range from 0 (worst experience) to 10 (best experience) [26, 27]. IEXPAC was developed and validated in 2016 to assess patient self-reported experience in the chronic illness context.

Qualitative methodsMethodology and theoretical framework

The qualitative component of this study utilizes methodological triangulation of data: (1) interviews with providers, (2) interviews with patients, and (3) process mapping. Collectively, this formative research will generate comprehensive data needed for improved intervention implementation, scalability, and sustainability.

The Practical, Robust Implementation and Sustainability Model (PRISM) helps facilitate the translation of research into practice by providing a framework for understanding how to promote optimal effectiveness of health services interventions, given the influence of multilevel factors that impact intervention implementation and patient outcomes [22]. PRISM asserts that success of intervention implementation depends on complex interactions between programs, key players, and environments. Specifically, the model details how healthcare interventions influence and are influenced by organizational and patient level factors and how these interactions ultimately impact intervention adoption, implementation, maintenance, reach, and effectiveness (Fig. 1 - Prism Framework) [22]. Based on the PRISM framework, which values and incorporates patient and provider experiences and perspectives, process mapping will be used to comprehensively describe in detail step-by-step patient and provider journeys for CPWF.

Individual interviews

Conducting interviews with both patients and providers will be essential for understanding the experiences of each group, which will likely have different perspectives and unique characteristics that will be important to consider for intervention adaptation, implementation, scalability, and sustainability. As such, interviews will be conducted to clarify (a) how patients enroll in CPWF, receive fibroid diagnoses, and engage in educational content and programming regarding treatment options; (b) organizational, cultural, and behavioral barriers and facilitators of engagement in screening and treatment; and (c) areas of possible implementation failure of the education program.

Recruitment

Convenience and purposive sampling strategies will be used to recruit 15 patients and 15 providers from each hospital for qualitative interviews. Based on previous work and standards in qualitative research, 15 interviews per demographic is sufficient to obtain thematic data saturation. Additional interviews will be conducted if needed to reach saturation. Eligible providers work at partnering hospitals and actively provide care for patients with UF. Providers will be recruited via email, word of mouth, and participant referral.

Participants in CPWF at partnering hospitals ages 18 to 45, with a new diagnosis of UF, will be eligible to participate. We will recruit patients with UF discovered at the time of: routine office pelvic examinations, exams in the setting of intrauterine device placement requiring bimanual exam and/or ultrasound guidance, and audits of pelvic imaging within the last 12 months done at the study institutions with incidental findings of uterine fibroids. Included participants had pelvic imaging showing at least one fibroid measuring equal or more than two cm and with uterine size less than twenty cm within the last six to twelve months. Targeted recruitment will be conducted through flyers emailed to providers and posted in clinical areas. Self-referral mechanisms are also in place in addition to patient recruitment in clinical waiting rooms and through clinic EHR schedule reviews. Providers who newlydiagnose UF will also refer patients to the study (Fig. 3).

Fig. 3

Programmatic flow diagram

Procedure

All interviews will be conducted in English by a health psychologist with 15 years of expertise in qualitative research and trained research assistants. Informed by the PRISM model, the interview guide will be divided into three sections to reflect data collection goals. Interviews will be recorded, transcribed, verified, and entered into NVivo12, a qualitative data analysis software program, for analysis. Information from the interviews will be used to inform the: (1) process mapping, (2) tailoring of intervention content to address patient and organization specific factors that impact engagement in and implementation of the educational program, (3) creation of activities that directly incorporate aspects of culture to promote engagement in program, and (4) inclusion of culture-specific terminology in materials.

Qualitative data analysis

Thematic analysis will be conducted and guided by a five step process outlined by Braun and Clarke to identify key themes that correspond to the theoretical model, PRISM.21 The steps are: (1) Become familiar with the data by reviewing all transcripts, (2) Generate initial codes, (3) Identify themes, (4) Review/revise themes, and (5) Define and name themes. Trained research assistants (RAs) will review each of the transcripts to develop a preliminary coding scheme.

Using NVivo 12, the RAs will code all of the data independently using the preliminary coding scheme as a guide and will create new codes as needed. The RAs will then meet to discuss any coding disagreement until a minimum 90% agreement is achieved. Data analysis will be cyclical and involve continuous development of new codes and constant comparison of themes. To reduce bias, enumeration will be utilized. That is, the frequency of codes applied to transcribed data will be tallied and prevalent codes will be used to form initial thematic categories.

Process mapping

Process mapping is a useful strategy for characterizing and evaluating healthcare processes such as patient navigation. Utilization of process maps facilitate ease of understanding complex processes through visual illustrations. Data to complete the map will be gathered via observation and interviews to clarify processes and timelines. Upon determining steps in the process map and associated timelines, a visual representation of the process will be developed. Next, the research team will identify areas of potential failure to implement the intervention using the process map and the possible causes and consequences of potential implementation failures. The goal is to identify optimal timing for implementation of the CPWF intervention components, areas of potential intervention failure, and strategies to help avoid implementation failure.