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CRAMER et al .
3 | RESULTS
between satisfaction and patient outcomes (Attkisson & Zwick, 1982; Nguyen, Attkisson, & Stegner, 1983). Participants were also asked to provide comments on their satisfaction or dissatisfaction with the intervention upon completion of the study. Enrollment was examined for efficiency (time of recruitment and problems encountered) and attrition. Problems and solutions rele‐ vant to the intervention were identified from monthly community board meetings and research team meetings. Data on intervention fidelity came from our weekly research team meetings to discuss is‐ sues regarding delivery, receipt, and enactment of the intervention. Information on data collection was examined in terms of ease, time required, and missing data, and this information came from inter‐ views with those who collected the study data (i.e., clinic nurses, CHW, project coordinators, health economist). Aim 2 primary birth outcome measures were preterm (<37 weeks gestation) and low birth weight (<2,500 g), which were collected from hospital delivery notes. Secondary outcome measures were adherence to medical appointments (ratio of kept‐to‐scheduled ap‐ pointments) collected from clinic medical records, and the Patient Activation Measures (PAM). The PAM is a 13‐item questionnaire having strong psychometric properties measuring patient activa‐ tion. Patient activation refers to an individual’s knowledge, skills, and confidence in self‐care management which has been associated with better health outcomes and the ability to make a positive change in one’s health status (Hibbard, Mahoney, Stockard, & Tusler, 2005). Based on scores from 0 to 100, the PAM assigns patients to levels from 1 (least activated) to 4 (most activated). PAM scores are closely associated with health care costs (Hibbard, Greene, Sacks, Overton, & Parrotta, 2016). The CHW administered the PAM as a retrospec‐ tive pre‐post survey at the 36‐week home visit. Aim 3 measures for health care cost‐effectiveness were col‐ lected from hospital billing and financial departments for each par‐ ticipants’ (i.e., mother and baby) total charges. Data also included primary payer, primary payment, secondary payer, secondary pay‐ ment, patient payments, total charges, primary diagnosis, and diag‐ nosis description. 2.4 | Analytic strategy Chi‐square ( χ 2 ) and likelihood ratio tests (LRT) were used to examine differences between the intervention and control groups for demo‐ graphics, risk factors, insurance, and emergency room use. We used t tests to analyze differences in prepregnancy BMI, weight gain dur‐ ing pregnancy, age, and weeks pregnant. The Mann–Whitney U test (in place of t tests due to nonnormal distributions) compared birth weight and weeks’ gestation between the control and intervention groups. The LRT tested differences between the two groups for (1) low birth weight versus normal birth weight, and (2) preterm versus full term gestation. Results were analyzed with SPSS 23. Due to the small sample size and the pilot nature of this study, results were not significant at the 5% level; therefore, analysis results are reported as descriptive statistics and trends.
3.1 | Demographic information Of 98 enrolled participants, 21 did not complete the program. The reasons for noncompletion included four miscarriages, 1 “opt‐out,” and 16 who moved or switched health care out of the area with‐ out notification and for whom no final birth data were available. Thus, the final sample for analysis was n = 77 ( n = 41/52 interven‐ tion [79%]; n = 36/46 control [78%]). The sample was mostly white race, married with spouse present, educated with some college, em‐ ployed, and had insurance. Nearly half were Hispanic/Latino ethnic‐ ity, and about one‐third spoke a primary language other than English another language (mostly Spanish and some Somali). Only four par‐ ticipants smoked, and one reported using alcohol (all in the inter‐ vention group). About two‐thirds were overweight, and one‐quarter were obese. Prepregnancy BMIs for the intervention and control ( M = 27.46 and M = 27.49, respectively) were nearly identical.
3.2 | Feasibility
3.2.1 | Recruitment Efficiency
Recruitment was slower than anticipated due to 2–4‐day lag times between clinic referral and the CHW enrollment home visit. Three months into the study less than half of the total sample was en‐ rolled. The community board proposed adding a $50 diaper incen‐ tive (half at enrollment and half at close) to increase enrollment. The IRB approval for change of protocol took 6–7 weeks for ap‐ proval which further reduced efficiency. The diaper incentive change increased total referrals, but not enrollment. We had dif‐ ficulty recruiting the high‐risk population of teens and undocu‐ mented Hispanic women, a priority population as identified by the community board. To increase enrollment of this population, the community board proposed (1) translating intervention materials into Spanish and (2) seeking a waiver of parental consent for mi‐ nors. The IRB approved translation but only agreed to parental waivers for 17–18‐year olds living alone. These changes led to a slight increase in recruitment ( n = 10) of Spanish‐speaking only participants but did not increase the number of minors in the study. All referred patients under 17 years of age refused to obtain their parents’ approvals, and several undocumented minors could not obtain parental consent because they were living in the U.S. without parents. Undocumented women especially those who were 17–19 years expressed discomfort or hesitancy signing what they perceived to be “government forms” (e.g., consents). Many of the undocumented pregnant women recruited from Africa or Central America chose not to participate due to language or read‐ ing barriers. The final problem with recruitment was maintaining provider interest in the study. The researchers and community board worked to maintain provider interest, but as recruitment slowed so did provider interest and support.
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