Trial results for a quality improvement process aimed at improving cardiovascular care in community mental health organizations were posted on ClinicalTrials.gov on 2025-09-26. The study reported a mean difference of 1.0 (95% CI 0.2 to 1.8) for hypertension in key analyses.
Background
Individuals with serious mental illness often face a higher burden of cardiovascular risk factors, including Hypertension, Diabetes Mellitus, and Dyslipidemias. These co-occurring conditions can complicate overall health management and lead to poorer outcomes if not adequately addressed. The delivery of evidence-based care for these cardiovascular risk factors within community mental health organizations is crucial to improve patient health. This study investigated an implementation strategy designed to enhance the quality of care provided to this vulnerable population.
Trial design
This completed study, designated as Phase NA, enrolled 85 participants. The trial focused on conditions including Diabetes Mellitus, Hypertension, and Dyslipidemias. The intervention involved a quality improvement process, specifically a Comprehensive Unit Based Safety (CUSP) strategy, to support the delivery of cardiovascular care. The study's brief summary indicated its purpose was to examine whether an implementation strategy would improve the delivery of evidence-based care for cardiovascular risk factors for people with serious mental illness.
Key results
The trial reported several key measurements and analyses from the Comprehensive Unit Based Safety (CUSP) Intervention Arm:
- Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety (score on a scale):
- Mean score of 3.8 (Standard Deviation 0.7).
- Mean score of 3.8 (Standard Deviation 0.6).
- Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale (score on a scale):
- Mean score of 6.0 (Standard Deviation 2.3).
- Mean score of 7.1 (Standard Deviation 1.2).
- Mean score of 5.9 (Standard Deviation 2.4).
- Mean score of 7.0 (Standard Deviation 1.4).
- Mean score of 6.2 (Standard Deviation 2.6).
- Mean score of 7.3 (Standard Deviation 1.4).
- Acceptability as Assessed by the Acceptability of Intervention Measure (score on a scale):
- Mean score of 4.4 (Standard Deviation 0.5).
- Mean score of 4.2 (Standard Deviation 0.5).
- Mean score of 4.4 (Standard Deviation 0.5).
- Mean score of 4.2 (Standard Deviation 0.6).
Key analyses also provided mean differences:
- Mean Difference (Net) of 0.0 (95% CI -0.2 to 0.1).
- For hypertension, a Mean Difference (Net) of 1.0 (95% CI 0.2 to 1.8).
- For dyslipidemia, a Mean Difference (Net) of 1.1 (95% CI 0.0 to 2.1).
- For diabetes, a Mean Difference (Net) of 1.0 (95% CI 0.1 to 2.0).
- For "Evidenced based practice", a Mean Difference (Net) of -0.2 (95% CI -0.6 to 0.1).
- For "CUSP strategy", a Mean Difference (Net) of -0.2 (95% CI -0.6 to 0.1).
What this means
The results indicate that the quality improvement process, including the Comprehensive Unit Based Safety (CUSP) strategy, showed positive mean differences in key analyses related to cardiovascular risk factors. Specifically, for conditions like hypertension, dyslipidemia, and diabetes, a mean difference of approximately 1.0 was observed, with confidence intervals suggesting a positive effect. The measurements for "Quality Improvement Culture," "Self-efficacy," and "Acceptability" provide insights into the perceived effectiveness and integration of the intervention within community mental health organizations. These findings suggest that such implementation strategies can potentially improve the delivery of evidence-based care for individuals with serious mental illness who also have cardiovascular risk factors.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04696653, titled "A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations", were posted on 2025-09-26 on clinicaltrials.gov.