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Table 1 ACE screening trial outcomes

From: Using a participatory method to test a strategy supporting the implementation of a state policy on screening children for adverse childhood experiences (ACEs) in a Federally Qualified Health Center system: a stepped-wedge cluster randomized trial

Outcome

Measurement

Data source

Frequencya

Clinic level outcomes (primary)

Reach of ACE screenings

Proportion of eligible children participating in ACE screenings. We expect between 80 and 92% of eligible children will be screened; based on pediatric screening studies in primary care [49, 50]

FQHC EMR system

Week 10 of each time period

Mental health referral rates

Number of mental health referrals (behavioral analysis, behavioral health, care coordinator, care management, child development center or social work) divided by the total # of eligible children. For children deemed at high risk for toxic stress and/or mental health needs. Expect 11.4% increased referral rate based on a similar study [29] and using current referral rate of 3.8% to inform this threshold and per FQHC i2itracks report

FQHC EMR system

Week 10 of each time period

Clinic level outcomes (secondary)

Implementation feasibility [6]

Self-reported 4-item survey evaluating feasibility of implementation efforts. 4-pt Likert scale; average score of 4+ shows ACE policy and implementation strategy perceived as feasible. Good internal consistency (α=0.89). Test-retest reliability r = 0.88

FQHC personnel

Week 10 of the intervention time period

Implementation acceptability [6]

Self-reported 4-item survey evaluating acceptability of ACE policy and implementation efforts. 4-pt Likert scale; average score of 4+ shows acceptability. Good internal consistency (α = 0.83). Test-retest reliability r = 0.83

 

Week 10 of the intervention time period

Fidelity

Checklist assessing adherence to ACE screening protocols and competence of performance. Deviations/concerns will be documented and immediately reported back to clinic personnel. We expect at least 67% fidelity (number of endorsed deviations/all items in the checklist) based on a previous study [49]. Adaptations and emerging challenges will be documented and reported to the research team. Observation checklists/audits are effective strategies to improve fidelity of performance [51]

Implementation coach

Weeks 5 and 10 of each time period

Child/parent level outcomes

Changes in PSC scores

Mean score differences from eligible screened children who were deemed at high or at intermediate risk.

Randomly selected group of caregivers

10 weeks after child’s ACE screening

Mediators

Implementation leadership [48]

12-item survey comprised of four subscales measuring proactive leadership, knowledgeable leadership, supportive leadership, and perseverant leadership. Strong reliability for the total scale (α = 0.98). An average score of 4+ will be used as threshold; 5-point Likert scale (not at all-very great extent). Subscale score is based on the mean score for the items; total score is the mean of the subscale scores [48]

Clinic personnel

Week 7—intervention period—and week 9—every other time period

Implementation climate [52]

6-item survey measuring the strategic climate for the implementation of interventions. Items are rated on a 5-item Likert scale (completely disagree-completely agree)

 

Week 7—intervention period—and week 9—every other time period

Other measures

Child socio-demographic characteristics

Variables include sex, self-identified race and ethnicity, age, language of preference for health care receipt, born in the USA. Note: EMR system does not report data on caregivers of child patients

EMR system

Week 10 of each time period

  1. aWithin a 10-week time period. The SW-RCT is comprised of six 10-week time periods: baseline, intervention, and four follow-up periods, depending on clinic schedule