N/A
N=85
A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations
Diabetes Mellitus · Hypertension · Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT04696653 ↗Enrolled (actual)
85
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety — 3.8; 3.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Comprehensive Unit Based Safety Program (CUSP) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety |
3.8; 3.8 | — |
| PRIMARY Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale |
6.0; 7.1; 5.9; 7.0; 6.2; 7.3 | — |
| SECONDARY Acceptability as Assessed by the Acceptability of Intervention Measure |
4.4; 4.2; 4.4; 4.2 | — |
| SECONDARY Appropriateness as Assessed by the Intervention Appropriateness Measure |
4.3; 4.2; 4.4; 4.2 | — |
| SECONDARY Feasibility as Assessed by the Feasibility of Intervention Measure |
4.3; 4.2; 4.3; 4.2 | — |
| SECONDARY Clients With Hypertension Control |
41; 59 | — |
| SECONDARY Clients With Dyslipidemia Control |
70; 75 | — |
| SECONDARY Clients With Diabetes Control |
53; 55 | — |
| SECONDARY Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement |
92; 99 | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Lipid Panel |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Statin Therapy |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Dilated Eye Exam |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Foot Exam |
— | — |
| SECONDARY Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel |
131; 133 | — |
| SECONDARY Teamwork Within Teams as Assessed by the Implementation Climate Scale |
4.1; 4.0 | — |
| SECONDARY Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale |
4.0; 4.1 | — |
| SECONDARY Organizational Learning Assessed by the Implementation Climate Scale |
3.9; 3.9 | — |
| SECONDARY Management Support for Patient Safety as Assessed by the Implementation Climate Scale |
3.7; 3.7 | — |
| SECONDARY Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale |
3.7; 3.6 | — |
| SECONDARY Feedback and Communication About Error as Assessed by the Implementation Climate Scale |
3.8; 3.7 | — |
| SECONDARY Communication Openness as Assessed by the Implementation Climate Scale |
3.5; 3.5 | — |
| SECONDARY Frequency of Events Reported as Assessed by the Implementation Climate Scale |
4.0; 4.1 | — |
| SECONDARY Teamwork Across Teams as Assessed by the Implementation Climate Scale |
3.9; 3.9 | — |
| SECONDARY Staffing as Assessed by the Implementation Climate Scale |
2.9; 2.8 | — |
| SECONDARY Clients With Hypertension Who Had a Blood Pressure Measurement |
166; 186 | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Urine-protein-creatinine Test |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Are on a Statin Medication |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Hypertension Who Received Lifestyle Counseling |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Lifestyle Counseling |
— | — |
| SECONDARY Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Received Lifestyle Counseling |
— | — |
Summary
This pilot study will examine whether an implementation strategy will improve delivery of evidence-based care for cardiovascular risk factors for people with serious mental illness.
Eligibility Criteria
Inclusion Criteria
Study population 1:
- Psychiatric rehabilitation program and health home team staff, including providers and leadership are those employed by the psychiatric rehabilitation program or health home program.
- English-speaking.
Study population 2:
- People with serious mental illness participating in psychiatric rehabilitation health home programs.
- English-speaking
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04696653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.