Improving Control of Thyroid Hormone in Congenital Hypothyroidism: A Quality Improvement Approach

Background The prevalence of congenital hypothyroidism (CH) in the United States is approximately 1 in 2,000 to 1 in 3,000 newborns. Thyroid hormone replacement should be initiated within two weeks of life for optimal growth and neurocognitive development. Thyroid stimulating hormone (TSH) levels should be maintained within reference range, particularly during the early childhood years, when clinical and laboratory evaluation every three months is the standard of care. Objective Increase the percentage of young children (below 3.5 years of age) with CH in biochemical control by 15% within a 12-month period. Methods Patients younger than 3.5 years diagnosed with CH and on levothyroxine before 6 months of age were reviewed for inclusion of cohort. Transient CH was excluded. Each month, charts were reviewed for thyroid function tests, appointments, and the status of biochemical control. A key driver diagram was developed implementing Plan-Do-Study-Act (PDSA) cycles. Interventions included notifying providers of missed appointments, reviewing CH standards of care as a department, scheduling appointments for three and six months to ensure continuity, designing and distributing a “Thyroid 3 for 3” handout to families, reviewing missed appointments after clinic sessions, and using telehealth for patients needing an urgent appointment. Results The cohort included 105 patients with CH. Prior to intervention, an average of 59.6% of children with CH had biochemical control. There was an average gap of +24.4% between white and Black patients each month, with higher biochemical control rates in white patients. In the most recent six months of data, an average of 73.0% of children with CH were in biochemical control each month. In addition, there was no longer a large disparity in biochemical control by racial background (-2.6%). Conclusion For children with CH, TSH levels can be maintained within range on levothyroxine with frequent clinic visits and lab draws every three months. Plain Language Summary Congenital hypothyroidism (CH) is a common disorder that causes low levels of thyroid hormone, which is necessary in early childhood for normal physical growth and brain development. It is diagnosed by screening newborns for high levels of thyroid stimulating hormone (TSH) and can be treated with the medication levothyroxine, a thyroid hormone replacement that must be taken orally daily. Although best practices recommend TSH monitoring and management of CH patients with frequent clinic visits and lab draws every three months until age 3, the reality is that many families miss appointments and follow up inconsistently. This initiative aimed to increase the percentage of young children with CH in biochemical control by 15% within a year. Through multiple quality improvement cycles which included changes in scheduling and follow-up processes, as well as family-focused education, the percentage of children age 3 and younger with CH in biochemical control increased 14 percentage points from July 2022 to June 2024, from a pre-intervention average of 59.6% to 73.0%. Their findings support that increased availability and management of clinical appointments improves care and treatment adherence, leading to better outcomes for children with CH during the critical years of development.