Table 2.
Measurement, timing and statistical power considerations for primary and secondary outcomes
| Outcome | Measurement | Timing | Minimum detectable effects* |
|---|---|---|---|
| Primary outcomes | |||
| Severe maternal morbidity | Modified Centers for Disease Control and Prevention algorithm | Delivery through 42 days and through 365 days postpartum | Assuming a baseline rate of 5%, the largest detectable difference is 1.21% point |
| Person-reported health and wellbeing | Mothers Autonomy in Decision-Making scale [41] and Mothers On Respect index [42] | Pregnancy through 365 days postpartum | Assuming a baseline score of 35, the minimum detectable difference in score of BIPOC beneficiaries versus not is 3.4 points in the score |
| Evidence-based postpartum care for chronic conditions: treatment for hypertension | Follow-up visit within 10 days for blood pressure evaluation and screening (source ACOG [43]) or outpatient visit with first position diagnosis code related to hypertension or outpatient visit with cardiologist | 7–365 days postpartum | Among NHB women with hypertension, assuming a prevalence rate of 21.4%, bringing sample size down to 50 883. Assuming a baseline treatment rate of 18% [44], the largest detectable difference is 4.93% point |
| Evidence-based postpartum care for chronic conditions: treatment for mental health conditions (excluding substance use disorders) | Screening for depression during the postpartum period (source: ACOG [45, 46]) in either maternal or infant claims [47] or outpatient visit with first position diagnosis code for a mental health disorder or outpatient visit with mental health specialist | 7–365 days postpartum | Among NHB women with MH disorder, assuming a prevalence rate of 21%, bringing the sample size to 49 932. Assuming a baseline treatment rate of 80%, the largest detectable difference is 4.88% point |
| Evidence-based postpartum care for chronic conditions: treatment for substance use disorders | Use of medication for opioid use disorder (Source: ACOG [48]) or outpatient visit with first position diagnosis code for substance use disorder or outpatient visit with substance use disorder specialist | 7–365 days postpartum | Among NHB women with SUD disorder, assuming a prevalence rate of 10%, bringing the sample size to 23 777. Assuming a baseline treatment rate of 60%, the largest detectable difference is 8.79% point |
| Secondary outcomes | |||
| All-cause mortality | Number of postpartum persons who die of any cause per 100 000 births | Delivery through 365 days postpartum | No statistical models will be applied |
| Participant experiences of discrimination or medical racism: racial or socioeconomic discrimination | Everyday Discrimination Scale | Delivery through 365 days postpartum | Assuming a baseline score of 3, the minimum detectable difference in score of BIPOC participants versus not is 0.14 point in the score |
*Detectable effect sizes were calculated at a significance level of 0.05 and a power of 0.8, assuming at least 1% of the population of interest (i.e. non-Hispanic Black) engages with doula care over a period of 4 years, with a total sample size of 237 700. The total sample size was inferred from the number of non-Hispanic Black persons with deliveries paid for by Medicaid in 2020 among the six states, multiplied by four. If a greater proportion of the population uses doula services, we will be powered to detect even smaller effect sizes.