Implementation Trials

Section

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Section lead: Kelly Aschbrenner, PhD

This section provides a brief overview of approaches to addressing, measuring, and evaluating health equity in implementation trials. There is no standard in the field for measuring health equity. This presents both challenges and opportunities for implementation researchers. Importantly, investigators must identify the health disparity or inequity they are targeting to advance health equity and then design a measurement and evaluation approach that will show whether the planned research reduced the disparities or inequities. In this section, we provide an overview of three approaches investigators have used to address, measure, and evaluate health equity outcomes. We then provide two examples of how investigators have applied each of these approaches in implementation research.

Below are three approaches to addressing, measuring, and evaluating the impact on health equity:

  1. Focusing on a subpopulation that experiences health disparities or inequities in health or health care. Measuring health service access, use and/or health outcomes within the subpopulation; and evaluating the impact of intervention efforts on health service access, use and/or health outcomes in the subpopulation (e.g., increasing colorectal cancer screening in rural primary care patients; improving mental health of persons with substance use disorders).
  2. Monitoring equitable outcomes of a trial. Measuring health services access, use and/or health outcomes; and comparing the impact of the intervention on health services access, use and/or health outcomes across different subpopulations in the sample based on factors such as race/ethnicity, sexual orientation, and gender identity and disability status.
  3. Focusing on social determinants of health known to contribute to health disparities in persons who experience or are at-risk for health disparities; measuring the social determinants of health (SDOH) that are the target of the intervention (e.g., reducing food insecurity); and evaluating the impact of the intervention on SDOH factors.

Approach 1. Focusing on a subpopulation that experiences health disparities or inequities in health or health care

Healthy People 2030 defines a health disparity as “a particular type of health difference that is closely linked with social, economic, and/or environmental disadvantage. Health disparities adversely affect groups of people who have systematically experienced greater obstacles to health based on their racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion.”1 Health disparities are known differences in outcomes or disease burden between groups. With a health disparity, there is a higher burden of illness, injury, disability, or mortality in one group relative to another.

With respect to the relationship between health disparities and health equity, Dr. Paula Braveman2 asserted that “Health disparities are the metric we use to measure progress toward achieving health equity. A reduction in health disparities (in absolute and relative terms) is evidence that we are moving toward greater health equity.”

Example 1. An example of implementation research targeting a several health disparity groups at once is a (type II) hybrid effectiveness–implementation trial testing the Family Check-Up 4 Health (FCU4Health) program.3 FCU4Health was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The investigators planned to enroll 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) and will be enrolled at three primary care clinics (two Federally Qualified Healthcare Centers [FQHCs] and a children’s hospital). All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. This type II trial is designed to address the lack of penetration of evidence-based programs into the primary health care system, particularly those that reach health disparity groups.

Approach 2. Monitoring equitable outcomes of a trial

Another approach to research addressing health disparities to advance health equity involves targeting a diverse sample of participants; measuring health services access, use and/or health outcomes; and comparing the impact of the intervention on health services access, use and/or health outcomes across different subpopulations in the sample based on factors such as race/ethnicity, sexual orientation and gender identity, and disability status. Braveman and colleagues 4 developed a systematic approach to studying and monitoring disparities and other indicators of health and health care that involves comparing groups based on social disadvantage and advantage. Specifically, this approach involves: 1) categorizing participants into groups with different levels of underlying social advantage (e.g., groups defined by family income, education, neighborhood poverty, and race/ethnicity); 2) describing and graphically displaying rates of the indicator and relative size for each social group; 3) identifying and measuring disparities, calculating relative risks and rate differences to compare each group with its a priori most-advantaged counterpart; 4) examining changes in rates and disparities over time; and 5) conducting multivariate analyses for the overall sample and “at-risk” groups to identify particular factors that contribute to the disparity. Examples of this approach include examining colorectal cancer screening rates by disability status; attendance at counseling sessions by socio-economic status; and weight loss outcomes by race and ethnicity.

Example 2. Hoskins and colleagues5 evaluated signals of inequities in the context of a pilot study of equitable implementation of a firearm safety promotion, S.A.F.E., Suicide and Accident Prevention Through Family Education, in pediatric primary care prior to an effectiveness-implementation trial in two large health systems. Clinician-documented program delivery, or reach, was the primary implementation outcome. The independent variables were patients’ medical complexity, race and ethnicity, and sex. The investigators hypothesized that clinicians would have higher odds of delivering S.A.F.E. Firearm to parents of youth classified as medically non-complex compared to parents of youth classified as medically complex. They also hypothesized that clinicians would have higher odds of delivering S.A.F.E. to parents of youth in non-Hispanic/Latino (NH) white groups compared to parents of youth from NH-Black/African American and Hispanic/Latino groups. The final sample comprised 694 patients and 47 clinicians across five clinics in two health systems. The investigators found greater odds of documented reach, discussions, and lock offers for NH-White than the NH-Other group. They also discovered that clinicians were more likely to deliver the program to parents of male than female patients. The investigators concluded that the pilot identified differences in critical for equity-informed implementation trials.

Approach 3. Focusing on social determinants of health

A third approach involves focusing on social determinants of health known to contribute to health disparities in persons who experience or are at-risk for health disparities; measuring the social determinants of health (SDOH); and evaluating the impact of the intervention on SDOH factors. Social determinants of health are the conditions in which people are born, grow, live, work, and age that shape health.6

Examples of SDOH include:

  • housing, transportation, and neighborhoods
  • racism, discrimination, and violence
  • education, job opportunities, and income
  • access to nutritious foods and physical activity opportunities
  • polluted air and water
  • language and literacy skills

Example 3. Gold and colleagues7 are conducting a 5-year, mixed-methods, stepped-wedge trial designed to test the impact of providing 30 community health centers with step-by-step guidance on implementing electronic health record-based social determinants of health documentation. Results will inform how to tailor implementation strategies to help community health centers adopt social determinants of health documentation and action. Secondary analyses will assess impacts of social determinants of health documentation and referral-making on diabetes outcomes. This study addresses the pressing need for implementation strategies that support adoption of social determinants of health documentation and action using electronic health and interventions.

References

Approach 1

  1. Gómez CA, Kleinman DV, Pronk N, et al. Addressing health equity and social determinants of health through Healthy People 2030. J Public Health Manag Pract. 2021;27(Suppl 6):S249-S257. doi:10.1097/PHH.0000000000001297
  2. Braveman P. What are health disparities and health equity? We need to be clear. Public Health Rep. 2014;129(Suppl 2):5-8. doi:10.1177/00333549141291S203
  3. Smith JD, Berkel C, Jordan N, et al. An individually tailored family-centered intervention for pediatric obesity in primary care: Study protocol of a randomized type II hybrid effectiveness–implementation trial (Raising Healthy Children study). Implement Sci. 2018;13(1):11. doi:10.1186/s13012-017-0697-2

Approach 2

  1. Braveman PA, Egerter SA, Cubbin C, Marchi KS. An approach to studying social disparities in health and health care. Am J Public Health. 2004;94(12):2139-2148. doi:10.2105/ajph.94.12.2139
  2. Hoskins K, Linn KA, Ahmedani BK, et al. Equitable implementation of S.A.F.E. Firearm: A multi-method pilot study. Prev Med. 2022;165(A):107281. doi:10.1016/j.ypmed.2022.107281

Approach 3

  1. Whitehead M, Dahlgren G, World Health Organization. Levelling Up (Part 1): A Discussion Paper on Concepts and Principles for Tackling Social Inequities in Health. WHO Regional Office for Europe; 2006.
  2. Gold R, Bunce A, Cottrell E, et al. Study protocol: A pragmatic, stepped-wedge trial of tailored support for implementing social determinants of health documentation/action in community health centers, with realist evaluation. Implement Sci. 2019;14(1):9. doi:10.1186/s13012-019-0855-9