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American Journal of Public Health logoLink to American Journal of Public Health
. 2014 Feb;104(Suppl 1):S25–S27. doi: 10.2105/AJPH.2013.301276

Moving Toward Evidence-Based Federal Healthy Start Program Evaluations: Accounting for Bias in Birth Outcomes Studies

Cristian I Meghea 1,, Jennifer E Raffo 1, Peggy VanderMeulen 1, Lee Anne Roman 1
PMCID: PMC4011092  PMID: 24354826

Abstract

We used administrative and screening data from 2009 to 2010 to determine if Healthy Start (HS), an enhanced prenatal services program, is reaching the most vulnerable African American women in Kent County, Michigan. Women in HS are at higher risk of key predictors of birth outcomes compared with other women. To advance toward evidence-based HS program evaluations in the absence of randomized controlled trials, future studies using comparison groups need to appropriately establish baseline equivalence on a variety of risk factors related to birth outcomes.


For more than 20 years, the federal Healthy Start (HS) program has worked to reduce disparities in maternal and infant health using a core set of interventions tailored to high-risk communities.1–3 Strong Beginnings, the Grand Rapids, Michigan, HS program, uses a community collaborative model that builds on the state Medicaid-sponsored enhanced prenatal services program, the Michigan Maternal and Infant Health Program (MIHP). MIHP services are available to all Medicaid-insured pregnant women and infants and include case management through office or home visits provided by nurses or social workers employed in multiple community agencies.4 All African American pregnant women in Kent County are eligible for Strong Beginnings HS, and the program relies on outreach, referrals, and other strategies to enroll women at greater risk for adverse birth outcomes. The HS program pairs MIHP professionals with community health workers and mental health coordinators to provide more intensive services.5

HS evaluations, with 1 exception, received low federal evidence-based ratings because they used quasi-experimental designs that did not establish the study groups equivalence at baseline.6–9 One randomized trial HS evaluation compared high intensity to typical HS home visits, and therefore, was not considered evidence of effectiveness.10 Previous HS studies were unable to properly account for potential bias introduced by differences between HS participants, women in other enhanced prenatal programs, and nonparticipants, along with risk factors known to be predictors of adverse birth outcomes.6–9,11,12

To fill this research gap, we aimed to determine if the Strong Beginnings HS program is reaching African American women who are at greater risk than those in traditional MIHP or those in Medicaid. We presented risk factors previously not included in HS effectiveness studies. This would inform future evidence-based HS evaluations on the extent of the differences and the need to establish comparison group equivalence on specific characteristics.

METHODS

The study sample consisted of all African American women in Kent County, Michigan, who were Medicaid eligible and delivered a singleton baby between January 1, 2009, and December 31, 2010. Administrative data on all women included sociodemographics, prenatal care adequacy,13 smoking, drug use, pregnancy history, and birth outcomes, measured on the infant birth records. We used linked pregnancy Medicaid claims to define depression diagnoses and treatment during pregnancy, as well as chronic disease. We used a detailed MIHP psychosocial and health prenatal risk screener to measure a variety of risks for the HS and MIHP participants. The prenatal screener has well-established measures (e.g., Edinburgh Depression Scale14) for specific risk factors, and Medicaid state policy mandates its use at MIHP enrollment. Relevant to HS and birth outcomes, it also includes history of adverse birth outcomes, whether the pregnancy was unwanted, depressive symptoms, perceived stress, and mental health history. Details on the MIHP screener are provided elsewhere.4 We used the χ2 test for the comparisons reported in Tables 1 and 2.

TABLE 1—

Risk Characteristics of African American Medicaid-Insured Pregnant Women (n = 1653) Who Gave Birth in 2009 and 2010: Kent County, MI

Characteristics HS + MIHP No. (%)a MIHP, No HS No. (%)a No HS, No MIHP No. (%)a
Age, y
 < 20 26 (16.35)b 113 (17.97) 98 (11.68)
 20–24 67 (42.14) 233 (37.04) 297 (35.40)
 25–34 54 (33.96) 237 (37.68) 380 (45.29)
 ≥ 35 12 (7.55) 46 (7.31) 64 (7.63)
Married 13 (8.18)bc 100 (15.87) 158 (18.29)
Income < 33% FPL 58 (36.48)b 199 (31.59) 220 (25.46)
Smoke 35 (22.01) 120 (19.05) 147 (17.03)
Drug use 27 (16.98)b 74 (11.75) 67 (7.75)
Chronic diseased 50 (31.45) 182 (28.93) 217 (25.89)
Depression diagnosis during pregnancy 20 (12.58)b 60 (9.52) 42 (4.86)
Previous pregnancies 96 (62.75)b 385 (63.43) 622 (73.96)
Pregnancy rapid repeat (< 18 mo)e 53 (56.99) 199 (54.52) 359 (60.74)
Kotelchuck Index (prenatal care)
 Inadequate 22 (14.19) 112 (18.27) 167 (20.05)
 Intermediate 17 (10.97) 71 (11.58) 94 (11.28)
 Adequate 60 (38.71) 250 (40.78) 321 (38.54)
 Adequate plus 56 (36.13) 180 (29.36) 251 (30.13)

Note. FPL = federal poverty level; HS = Healthy Start; MIHP = Maternal Infant Health Program. Table includes administrative data (birth record, Medicaid claims, program participation).

a

Percentages were reported as the fraction of total valid answers for each question, not of the full sample.

b

Identifies statistically significant differences (P < .05) HS and no HS and no MIHP.

c

Identifies statistically significant differences (P < .05) between HS and MIHP, no HS.

d

History of chronic disease includes asthma, sickle cell, diabetes, hypertension, kidney disease, and heart disease.

e

Percentages for rapid repeat pregnancy exclude women with no previous births.

TABLE 2—

Risk Characteristics of African American Medicaid-Insured Pregnant Women (n = 828) Who Gave Birth in 2009 and 2010: Kent County, MI

Characteristics HS + MIHP, No. (%)a MIHP, No HS No. (%)a
BMI, kg/m2 (before pregnant)
 < 18.5 (underweight) 5 (3.57) 27 (4.57)
 18.5–24.9 (healthy) 54 (38.57) 240 (40.61)
 25.0–29.9 (overweight) 29 (20.71) 149 (25.21)
 ≥ 30.0 (obese) 52 (37.14) 175 (29.61)
History of chronic diseaseb 68 (43.31) 292 (44.38)
Previous adverse pregnancy outcomes 39 (38.61)c 127 (28.29)
Smoking
 Not smoking at conception and during pregnancy 92 (58.60)c 454 (68.89)
 Quit when found out pregnant 24 (15.29) 77 (11.68)
 Currently smoke during pregnancy 41 (26.11) 128 (19.42)
Alcohol use
 Not using alcohol at conception and during pregnancy 110 (70.06) 486 (73.86)
 Quit when found out pregnant 42 (26.75) 164 (24.92)
 Currently drink alcohol during pregnancy 5 (3.18) 8 (1.22)
Someone in household uses drugs 29 (18.47)c 72 (10.94)
Drug use 39 (25.16)c 107 (16.29)
Wanted pregnancy
 Want to be pregnant sooner/now 24 (16.00) 133 (20.59)
 Want to be pregnant later 91 (60.67) 398 (61.61)
 Never want to be pregnant 35 (23.33) 115 (17.80)
Perceived stress, PSS-4 score
 0–3 (low) 39 (24.84) 168 (25.49)
 4–6 (medium) 41 (26.11) 206 (31.26)
 7–16 (high) 77 (49.04) 285 (43.25)
Screened depressive symptoms, EPDS score
 ≥ 13 (moderate–severe) 41 (26.28)c 139 (21.09)
 9–12 (mild) 32 (20.51) 99 (15.02)
 < 9 (not depressed) 83 (53.21) 421 (63.88)
History of depression, bipolar disorder, or schizophrenia 64 (40.76)c 191 (29.12)
History of domestic violence 40 (43.01)c 124 (30.69)
Cut size of meals or skip meals because of lack of money for food 40 (25.48) 122 (18.54)
Moved ≥ 2 times in last 12 mo 50 (32.05)c 139 (21.19)

Note. BMI = body mass index; EPDS = Edinburgh Postnatal Depression Scale; HS = Healthy Start; MIHP = Maternal Infant Health Program; PSS-4 = Cohen Perceived Stress Scale-4. Table includes MIHP prenatal screening data.

a

Percentages were reported as the fraction of total valid answers for each question, not of the full sample.

b

History of chronic diseases include hypertension, anemia or sickle cell, diabetes, asthma, heart, lung, or kidney disease, and otherwise specified.

c

Identifies statistically significant differences (P < .05) between HS and MIHP, no HS.

RESULTS

Based on administrative data (Table 1), HS participants were less likely to be married (8% vs 18%) and to have had previous pregnancies, and more likely to have incomes less than 33% of the federal poverty level, used drugs during pregnancy (17% vs 8%), and had a depression diagnosis during pregnancy (13% vs 5%) compared with women not participating in either HS or in MIHP. There were no statistically significant differences between HS and MIHP participants, except on marital status (8% vs 16% married).

Using the MIHP psychosocial and health risk screener data (Table 2), compared with other MIHP participants, pregnant women in HS were more likely to have a history of adverse pregnancy outcomes (39% vs 28%), smoke during pregnancy, live in a household in which somebody consumed illegal drugs (18% vs 11%), use drugs themselves, and have depressive symptoms, a history of mental health problems (41% vs 29%), and a history of domestic violence (43% vs 31%). All the differences were statistically significant (P < .05).

DISCUSSION

The administrative data suggested that Strong Beginnings HS reached higher risk women than those not enrolled in either Strong Beginnings HS or MIHP, and that Strong Beginnings HS women were at a similar risk compared with those in MIHP. However, the administrative data had limitations, including the fact that mental health and unhealthy behaviors were identified in medical claims only if diagnosed or treated. Among the women enrolled in either HS or MIHP, risk screener data showed that HS participants were at significantly higher risk on key predictors of adverse birth outcomes compared with other women in MIHP. This suggested that the community was successfully getting the women at the highest risk for adverse birth outcomes into the more intensive HS program. Although these findings might be relevant to other HS programs, they only represented the situation at 1 HS site. Future studies need to account for an extensive set of risk factors, which are often unavailable in administrative data. Most HS programs screen for risk factors. However, systematic multidimensional prenatal risk screening is needed as a practice for identifying the highest risk pregnancies and as a source of program evaluation baseline data.4,15

Healthy Start evaluations will need to minimize the bias induced by differences between participants and nonparticipants on a variety of risk factors that have not been considered before. In general, randomized controlled trials were not available to evaluate programs like HS. This study underscored the importance of establishing baseline equivalence when evaluating programs using matched comparison groups, which is an accepted alternative to randomized controlled trials. Rigorous evaluations will provide a better answer to whether HS improves birth outcomes and other health indicators.

Acknowledgments

This work was supported by the Health Resources and Services Administration’s Healthy Start Initiative (grant H49MC03591) and the W. K. Kellogg Foundation (grant P3018058).

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