Clinical trial NCT04696653: A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations
Official title: Using an Innovative Quality Improvement Process to Increase Delivery of Evidence-based Cardiovascular Risk Factor Care in Community Mental Health Organizations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Dyslipidemias
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-01-06
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: In this pilot study, the investigators will work with health home programs and pilot test an adapted Comprehensive Unit Safety Program (CUSP) implementation strategy to improve mental health providers' delivery of evidence-based cardiovascular risk factor care for hypertension, dyslipidemia and diabetes for individuals with serious mental illness. The project will also characterize implementation processes, organizational and provider-level factors, and cardiovascular disease risk factor care and control.

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

Primary outcomes:
measure: Change in quality improvement culture as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in self-efficacy as assessed by an adapted version of Compeau & Higgins' task-focused self-efficacy scale
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in acceptability as assessed by the Acceptability of Intervention Measure
timeFrame: Baseline, 12 months
measure: Change in appropriateness as assessed by the Intervention Appropriateness Measure
timeFrame: Baseline, 12 months
measure: Change in feasibility as assessed by the Feasibility of Intervention Measure
timeFrame: Baseline, 12 months
measure: Change in Hypertension control
timeFrame: Baseline, 6 and 12 months
measure: Change in dyslipidemia control
timeFrame: Baseline, 6 and 12 months
measure: Change in diabetes control
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received HBA1c measurement
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received a lipid panel
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received statin therapy
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received a dilated eye exam
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received a foot exam
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with dyslipidemia who received a lipid panel
timeFrame: Baseline, 6 and 12 months
measure: Change in teamwork within units as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in supervisor promotion of quality improvement as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in organizational learning as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in management support for quality improvement as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in overall perceptions of quality improvement culture as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in feedback and communication as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in communication openness as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in mistake reporting as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in teamwork across units as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in staffing capacity as assessed by the modified version of the validated Survey on Patient Safety
timeFrame: Baseline, 12 months
measure: Change in the percent of individuals with systolic blood pressure with poorly controlled hypertension who had a blood pressure measurement
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received a urine-protein-creatinine test
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with dyslipidemia who are on a statin medication
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with hypertension who received lifestyle counseling
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with diabetes mellitus who received lifestyle counseling
timeFrame: Baseline, 6 and 12 months
measure: Change in the percent of individuals diagnosed with dyslipidemia who received lifestyle counseling
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Adult Psychiatric Rehabilitation Program
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gail L Daumit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGinty EE, Thompson D, Murphy KA, Stuart EA, Wang NY, Dalcin A, Mace E, Gennusa JV 3rd, Daumit GL. Adapting the Comprehensive Unit Safety Program (CUSP) implementation strategy to increase delivery of evidence-based cardiovascular risk factor care in community mental health organizations: protocol for a pilot study. Implement Sci Commun. 2021 Mar 4;2(1):26. doi: 10.1186/s43058-021-00129-6.