A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using an Innovative Quality Improvement Process to Increase Delivery of Evidence-based Cardiovascular Risk Factor Care in Community Mental Health Organizations

Conditions
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Diabetes Mellitus, Hypertension, Dyslipidemias

Intervention / Treatment
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* Other: Comprehensive Unit Based Safety Program (CUSP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Comprehensive unit based safety (CUSP) intervention arm<br>CUSP is a quality improvement strategy developed by the Johns Hopkins University Armstrong Institute for Patient Safety and Quality that is used to improve care delivery. | Other: Comprehensive Unit Based Safety Program (CUSP)<br>* CUSP is a quality improvement strategy developed by the Johns Hopkins University Armstrong Institute for Patient Safety and Quality that is used to improve care delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality improvement culture as assessed by the modified version of the validated Survey on Patient Safety | Each of the 34 items in the modified survey is scored individually on 1-5 Likert scales. An average score is calculated by summing responses across all 34 items and dividing by the total number of items. The average score ranges from 1-5. A higher average score signifies an organizational culture that is more supportive of quality improvement. | Baseline, 12 months | 
| Change in self-efficacy as assessed by an adapted version of Compeau & Higgins' task-focused self-efficacy scale | Each of the nine items is scored individually on a 1-10 Likert scale, where 1=not at all confident and 10=totally confident. An average score is calculated by summing responses across all 9 items and dividing by the total number of items. The average score ranges from 1-10. A higher score signifies greater self-efficacy. | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acceptability as assessed by the Acceptability of Intervention Measure | We will use a validated 4-item instrument measuring intervention acceptability, using the Acceptability of Intervention Measure. Each of the 4 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability. | Baseline, 12 months | 
| Change in appropriateness as assessed by the Intervention Appropriateness Measure | We will use a validated 4-item instrument measuring intervention appropriateness, using the Intervention Appropriateness Measure. Each of the 4 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5= completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness. | Baseline, 12 months | 
| Change in feasibility as assessed by the Feasibility of Intervention Measure | We will use a validated 4-item instrument measuring intervention feasibility, using the Feasibility of Intervention Measure. Each of the 4 items will be measured on a 5-point Likert scale, where 1=completely disagree and 5=completely agree. An average score is calculated by summing responses across all four items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility. | Baseline, 12 months | 
| Change in Hypertension control | Measured with blood pressure (BP) readings (Controlled BP defined as <130/80 mmHg). | Baseline, 6 and 12 months | 
| Change in dyslipidemia control | Measured with cholesterol readings (controlled dyslipidemia defined as total cholesterol <200 mg/dL and low-density lipoprotein (LDL) <130 mg/dL). | Baseline, 6 and 12 months | 
| Change in diabetes control | Measured using HbA1c tests (controlled diabetes defined as HbA1c<7.0). | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received HBA1c measurement |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received a lipid panel |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received statin therapy |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received a dilated eye exam |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received a foot exam |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with dyslipidemia who received a lipid panel |  | Baseline, 6 and 12 months | 
| Change in teamwork within units as assessed by the modified version of the validated Survey on Patient Safety | We will use 4 items measuring teamwork. Each of the 4 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies better teamwork within units. | Baseline, 12 months | 
| Change in supervisor promotion of quality improvement as assessed by the modified version of the validated Survey on Patient Safety | We will use 4 items measuring the degree to which a provider's supervisor promotes quality improvement. Each of the 4 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater promotion of quality improvement. | Baseline, 12 months | 
| Change in organizational learning as assessed by the modified version of the validated Survey on Patient Safety | We will use 3 items measuring organizational learning environment. Each of the 3 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater organizational learning. | Baseline, 12 months | 
| Change in management support for quality improvement as assessed by the modified version of the validated Survey on Patient Safety | We will use 3 items measuring the degree to which organization management supports quality improvement. Each of the 3 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater management support for quality improvement. | Baseline, 12 months | 
| Change in overall perceptions of quality improvement culture as assessed by the modified version of the validated Survey on Patient Safety | We will use 3 items measuring the perception's of the organization's quality improvement culture. Each of the 3 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies better quality improvement culture. | Baseline, 12 months | 
| Change in feedback and communication as assessed by the modified version of the validated Survey on Patient Safety | We will use 3 items measuring feedback and communication about quality improvement. Each of the 3 items will be measured on a 5-point Likert scale, where 1=never and 5=always. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies better feedback and communication. | Baseline, 12 months | 
| Change in communication openness as assessed by the modified version of the validated Survey on Patient Safety | We will use 3 items measuring perceptions of communication openness in the organization. Each of the 3 items will be measured on a 5-point Likert scale, where 1=never and 5=always. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies better communication openness. | Baseline, 12 months | 
| Change in mistake reporting as assessed by the modified version of the validated Survey on Patient Safety | We will use 3 items assessing the degree to which mistakes are reported at the organization. Each of the 3 items will be measured on a 5-point Likert scale, where 1=never and 5=always. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies more frequent mistake reporting. | Baseline, 12 months | 
| Change in teamwork across units as assessed by the modified version of the validated Survey on Patient Safety | We will use 4 items assessing teamwork across units. Each of the 4 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies better teamwork across units. | Baseline, 12 months | 
| Change in staffing capacity as assessed by the modified version of the validated Survey on Patient Safety | We will use 2 items assessing staffing capacity. Each of the 2 items will be measured on a 5-point Likert scale, where 1=strongly disagree and 5=strongly agree. An average score is calculated by summing responses across items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies better staffing capacity. | Baseline, 12 months | 
| Change in the percent of individuals with systolic blood pressure with poorly controlled hypertension who had a blood pressure measurement | Measured with blood pressure (BP) readings (Poorly controlled BP defined as >130/80 mmHg). | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received a urine-protein-creatinine test |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with dyslipidemia who are on a statin medication |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with hypertension who received lifestyle counseling |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with diabetes mellitus who received lifestyle counseling |  | Baseline, 6 and 12 months | 
| Change in the percent of individuals diagnosed with dyslipidemia who received lifestyle counseling |  | Baseline, 6 and 12 months |