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

Not Applicable

Completed

Conditions: Hypertension
Diabetes Mellitus
Dyslipidemias

Registration Number: NCT04696653

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 85

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety	Baseline, 12 Months	Each of the items in the modified survey is scored individually on 1-5 Likert scales. An average score is calculated by summing responses across all 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.
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale	Baseline, 12 Months	Each of the items (Hypertension, Dyslipidemia, Diabetes) are 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 items and dividing by the total number of items. The average score ranges from 1-10. A higher score signifies greater self-efficacy.

Secondary Outcome Measures

Name	Time	Method
Acceptability as Assessed by the Acceptability of Intervention Measure	Baseline, 12 Months	Validated 4-item instrument measuring intervention acceptability of the Evidence based practice and CUSP strategy using the Acceptability of Intervention Measure. Each of the 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 items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater acceptability.
Appropriateness as Assessed by the Intervention Appropriateness Measure	Baseline, 12 Months	Four item instrument measuring intervention appropriateness of Evidence based practice and CUSP strategy using the Intervention Appropriateness Measure. Each of the 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 items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater appropriateness.
Feasibility as Assessed by the Feasibility of Intervention Measure	Baseline, 12 Months	Four item instrument measuring intervention feasibility of Evidence based practice and CUSP strategy using the Feasibility of Intervention Measure. Each of the 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 items and dividing by the total number of items. The average score ranges from 1-5. A higher score signifies greater feasibility.
Clients With Hypertension Control	Baseline and 12 Months	Measured with blood pressure (BP) readings reported by staff . Clients with control defined as a BP \<130/80 mmHg.
Clients With Dyslipidemia Control	Baseline and 12 Months	Measured with cholesterol readings reported by staff. Clients with controlled dyslipidemia defined as total cholesterol \<200 mg/dL and low-density lipoprotein (LDL) \<130 mg/dL.
Clients With Diabetes Control	Baseline and 12 Months	Measured using HbA1c tests reported by staff . Clients with controlled diabetes defined as HbA1c\<7.0.
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement	Baseline and 12 Months	The number of clients who have a HBA1c measurement reported by the participating staff.
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
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel	Baseline and 12 Months	The number of clients who have a lipid panel reported by the participating staff.
Teamwork Within Teams as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Four items measuring teamwork. Each of the 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.
Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Four items measuring the degree to which a provider's supervisor promotes quality improvement. Each of the 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.
Organizational Learning Assessed by the Implementation Climate Scale	Baseline, 12 Months	Three items measuring organizational learning environment. Each of the 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.
Management Support for Patient Safety as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Three items measuring the degree to which organization management supports quality improvement. Each of the 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.
Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Three items measuring the perception's of the organization's quality improvement culture. Each of the 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.
Feedback and Communication About Error as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Three items measuring feedback and communication about quality improvement. Each of the 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.
Communication Openness as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Three items measuring perceptions of communication openness in the organization. Each of the 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.
Frequency of Events Reported as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Three items assessing the degree to which mistakes are reported at the organization. Each of the 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.
Teamwork Across Teams as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Four items assessing teamwork across units. Each of the 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.
Staffing as Assessed by the Implementation Climate Scale	Baseline, 12 Months	Two items assessing staffing capacity. Each of the 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.
Clients With Hypertension Who Had a Blood Pressure Measurement	Baseline and 12 Months	The number of clients who have a blood pressure measurement reported by the participating staff.
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

Trial Locations

Locations (1): Johns Hopkins Adult Psychiatric Rehabilitation Program
🇺🇸
Baltimore, Maryland, United States
Johns Hopkins Adult Psychiatric Rehabilitation Program
🇺🇸Baltimore, Maryland, United States