Objective
CenteringPregnancy group prenatal care has been demonstrated to improve pregnancy outcomes. However, there is likely variation in how the model is implemented in clinical practice, which may be associated with efficacy, and therefore variation, in outcomes. We examined the association of fidelity to process and content of the CenteringPregnancy group prenatal care model with outcomes previously shown to be affected in a clinical trial: preterm birth, adequacy of prenatal care, and breast-feeding initiation.
Study Design
Participants were 519 women who received CenteringPregnancy group prenatal care. Process fidelity reflected how facilitative leaders were and how involved participants were in each session. Content fidelity reflected whether recommended content was discussed in each session. Fidelity was rated at each session by a trained researcher. Preterm birth and adequacy of care were abstracted from medical records. Participants self-reported breast-feeding initiation at 6 months postpartum.
Results
Controlling for important clinical predictors, greater process fidelity was associated with significantly lower odds of both preterm birth (B = –0.43, Wald χ 2 = 8.65, P = .001) and intensive utilization of care (B = –0.29, Wald χ 2 = 3.91, P = .05). Greater content fidelity was associated with lower odds of intensive utilization of care (B = –0.03, Wald χ 2 = 9.31, P = .001).
Conclusion
Maintaining fidelity to facilitative group processes in CenteringPregnancy was associated with significant reductions in preterm birth and intensive utilization of care. Content fidelity also was associated with reductions in intensive utilization of care. Clinicians learning to facilitate group care should receive training in facilitative leadership, emphasizing the critical role that creating a participatory atmosphere can play in improving outcomes.
For Editors’ Commentary, see Contents
CenteringPregnancy, an innovative model of group prenatal care that integrates physical assessment with extensive health education and group support, has been demonstrated to improve several important pregnancy outcomes. In a large multisite randomized controlled trial, CenteringPregnancy group prenatal care reduced the likelihood of preterm birth by 33%, with an even greater reduction among African American women, compared with individual prenatal care. CenteringPregnancy also reduced the likelihood of inadequate care and increased initiation of breast-feeding.
Despite the success of CenteringPregnancy, obstetrical providers and clinical sites likely differ in how they implement the model. Although data are limited, elements considered essential for model fidelity are sometimes dropped, and such variation in implementation may be associated with variation in intervention efficacy. A small body of existing literature suggests that greater fidelity to a structured intervention is associated with improvements in health and educational outcomes. We consider 2 types of fidelity: process fidelity refers to the strategies and skill with which the intervention is delivered by individuals providing the intervention, whereas content fidelity is the provision of the model’s treatment, programmatic material, or knowledge with the frequency and duration prescribed by the model’s designers. Understanding whether and how implementation factors influence intervention efficacy is crucial for widespread translation of an efficacious intervention into clinical practice. This study examined the association of fidelity to CenteringPregnancy’s recommended processes and content with outcomes affected by CenteringPregnancy in the prior randomized controlled trial: preterm birth, adequacy of care, and breast-feeding initiation.
CenteringPregnancy group prenatal care
CenteringPregnancy group prenatal care provides prenatal care to groups of women of similar gestational age and their significant others. This model has been discussed in detail elsewhere, and will be described briefly here. Group sessions begin in the second trimester and follow the standard prenatal visit schedule for a total of 10 sessions. CenteringPregnancy is provided by a prenatal care provider such as a nurse-midwife, nurse practitioner, or physician, along with another clinician or staff member. CenteringPregnancy groups consist of 8-12 pregnant women, and may include the father of the baby and/or other persons (eg, sister, mother).
During CenteringPregnancy sessions, women first check and record their own weight and blood pressure, followed by a prenatal examination conducted by a clinician within the group space. While waiting, women chat informally and fill out self-assessment sheets, which are used later in the discussion. The remainder of the session consists of group discussion facilitated by the clinician and a cofacilitator, which lasts approximately 60-90 minutes. The group format provides pregnant women with 15-20 hours of contact time with the same provider, which contrasts with approximately 2.5 hours of total contact time during 10 traditional, individual prenatal visits. This allows for discussion of a wide range of pregnancy-related health content, including early pregnancy concerns, childbirth preparation, and psychological and social issues ( Table 1 ). Participation in group discussions is voluntary, and women decide what personal information they would like to share with the group. To maintain privacy, confidentiality guidelines are discussed in the group and all participants sign a confidentiality agreement.
| Variable | Session no. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Topic | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Centering overview | X | |||||||||
| Nutrition | X | X | ||||||||
| Common discomforts of pregnancy | X | |||||||||
| Body mechanics and exercise | X | |||||||||
| Substance use/toxic exposures | X | |||||||||
| Relaxation | X | X | X | X | X | X | X | X | ||
| Labor | X | X | X | X | X | |||||
| Family and parenting issues | X | X | ||||||||
| Baby feeding | X | X | X | |||||||
| Contraception/birth control/condom use | X | X | X | |||||||
| Relationship issues/sexuality | X | X | ||||||||
| HIV/STI a | X | X | ||||||||
| Sexual communication and negotiation a | X | X | ||||||||
| Signs of labor | X | X | X | |||||||
| Premature labor | X | |||||||||
| Birth experience | X | X | X | |||||||
| Tour of birthing unit | X | |||||||||
| Early postpartum care b | X | X | ||||||||
| Emotional adjustment postpartum | X | |||||||||
| Baby care | X | X | X | |||||||
| Discussion of siblings | X | |||||||||
| Sharing birth stories | X | X | ||||||||
| Future plans | X | |||||||||
a Only recommended in CenteringPregnancy Plus arm
Although there is a schedule of recommended topics for discussion during each session, an important feature of CenteringPregnancy is the use of a facilitative, or nondidactic, leadership approach. Group leaders guide rather than control the group discussions, so participants’ interests significantly influence the direction discussions take and the topics covered. Group leaders also promote engagement by employing participatory group activities, by referring questions raised during discussions back to the group, and by encouraging women to share information with one another. Therefore, the model can be considered more process driven, rather than content driven. To create a social atmosphere and to stimulate interaction, everyone sits in an open circle, time is allotted for socializing, and healthy snacks are provided. The CenteringPregnancy model thus incorporates several elements that are quite distinct from individual prenatal visits: self-care, prenatal examinations in the group space, extended contact time with clinicians, expanded educational content, facilitated group discussion, and peer support. To date, however, no studies have explored how fidelity to the implementation of CenteringPregnancy may be associated with intervention outcomes. The goal of these analyses was to examine the associations of process and content fidelity with pregnancy outcomes. We hypothesized that participants in groups with higher fidelity to facilitative group process and to content recommendations would have lower likelihood of preterm birth and higher likelihood of receiving adequate care and initiating breast-feeding.
Materials and Methods
We conducted a secondary analysis of data from the randomized controlled trial of group prenatal care that demonstrated a reduced likelihood of preterm birth and inadequate care and increased likelihood of breast-feeding initiation. Inclusion in the parent study required that participants were <24 weeks’ gestation, were between 14-25 years old, did not have high-risk pregnancies at enrollment (eg, diabetes, human immunodeficiency virus [HIV]), spoke English or Spanish, and were receiving prenatal care at 2 public health centers in Atlanta, GA, and New Haven, CT. Women were randomized to 1 of 3 arms: (1) standard individual care; (2) standard CenteringPregnancy group prenatal care (CP); or (3) CenteringPregnancy Plus, which included the same content as CP with added HIV prevention components (CP+). Because fidelity measures were not collected for the standard individual care visits, we analyzed only women randomized to 1 of the 2 group conditions (CP or CP+). Women were assigned to prenatal groups based only on gestational age. Groups therefore included women of different ages and ethnicities.
Group prenatal care providers were nurse-midwives, obstetrical residents, and attending obstetricians who worked in the 2 hospital-based clinics. All providers received 2 full days of formal training in CenteringPregnancy group prenatal care and facilitative leadership. Providers also received extensive training in the research protocol. Procedures were approved by human investigation committees at both sites (no. 11972, Yale University, New Haven, CT; and no. 197–2001, Emory University, Atlanta, GA).
Prior to entry into group prenatal care, women provided self-report data during their first trimester of pregnancy. Follow-up data collection and sexually transmitted infection (STI) testing occurred during the third trimester and again at 6 months postpartum. There was no evidence of differential attrition across arms of the intervention. Inclusion in analyses examining preterm birth and adequacy of prenatal care required that a woman’s medical records had been reviewed and that she had a singleton pregnancy, provided complete data on all first-trimester control variables, and participated in STI testing during her third trimester (n = 519). Inclusion in breast-feeding initiation analyses required participation in the 6-month postpartum interview when breast-feeding was assessed (n = 435).
Measures
Outcomes
Gestational age at delivery was obtained by review of inpatient medical records. Reviews were conducted by trained medical abstractors who were independent of care and blinded to study assignment. Gestational age at delivery was dichotomized as full term vs preterm (<37 weeks). Adequacy of prenatal care was assessed by review of outpatient medical records and was categorized into inadequate, adequate, and intensive utilization of care using standard scoring on the Kotelchuck Index. These terms are defined as follows: inadequate care reflects women who began prenatal care after the fourth month of gestation or attended ≤79% expected visits; adequate care and intensive utilization of care reflect women who began care by the fourth month and attended 80-109% or ≥110% of expected visits, respectively. In analyses, adequate care was always the reference group, compared against inadequate or intensive utilization of care. Whether or not a woman had initiated breast-feeding (yes or no) was assessed 6 months postpartum in a structured interview.
Fidelity
Process fidelity was measured using 2 items: “To what extent was the group session didactic vs facilitative?” and “How much were group members involved and connected?” Response options ranged from 1-10 (didactic to facilitative, and not at all to very much, respectively). Leader facilitation and group involvement scores were created by averaging ratings for each item across all 10 intervention sessions. Leader facilitation and group involvement scores were highly correlated (r = 0.76) and analyses examining each as a separate predictor were consistent across outcomes; therefore the 2 items were averaged to reflect a measure of process fidelity. Content fidelity was assessed using a checklist to indicate which of the recommended topics had been discussed during the session. For each session, we calculated the proportion of topics recommended for that session that were actually discussed. Content fidelity scores reflect average adherence to recommended topics across all 10 sessions.
Process and content fidelity were assessed independently by both a trained researcher assigned to each group and the group care provider at the end of each session. Researcher fidelity ratings were not made available to intervention providers. Researcher and intervention providers’ ratings of fidelity to process and content converged (r = 0.55, P = .001 for process fidelity; mean kappa = .59, mean agreement = 86% for content fidelity). Because the trained researchers provided more complete data, their ratings were used as the primary indicators of fidelity. When the researchers’ ratings were missing, they were supplemented with ratings provided by the prenatal care providers.
Data analysis
Analyses were collapsed across study arms because mean levels of process fidelity, content fidelity, and the examined outcomes did not differ between CP and CP+ (all P values > .09). Associations of process and content fidelity with preterm birth, adequacy of care, and breast-feeding initiation were examined using generalized estimating equations to account for nonindependence among women assigned to the same prenatal care group. As interpreting generalized estimating equations with multinomial data can be complicated, adequacy of care was examined as 2 separate dichotomous outcomes (inadequate vs adequate care; intensive vs adequate care). We first examined unadjusted associations of process and content fidelity with outcomes. When significant unadjusted relationships were observed ( P ≤ .05), the associations of process and content fidelity were then examined in adjusted analyses.
Study arm, study site, and clinical factors related to preterm birth, adequacy of care, and breast-feeding were included as covariates in adjusted analyses. These included study arm (CP vs CP+), study site (Atlanta, GA, vs New Haven, CT), race (African-American vs all others), age, education, employment, relationship status, parity (0 vs ≥1), body mass index, any history of adverse pregnancy outcomes (eg, stillbirth), any current pregnancy complications (eg, gestational diabetes), acquiring STI during pregnancy, any cigarette use, any drug use, depressive symptomatology, stress, self-esteem, and social support. Because inadequate care relates to preterm birth, dummy codes capturing inadequate and intensive utilization of care vs adequate care were included as covariates in the adjusted preterm birth analysis.
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