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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696653
• Other study ID #: IRB00269855
• Secondary ID: P50MH115842
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: April 5, 2023

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: April 5, 2023
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemias
• Hypertension

Intervention

Other:
• Comprehensive Unit Based Safety Program (CUSP)
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Adult Psychiatric Rehabilitation Program	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in Hypertension control	Measured with blood pressure (BP) readings (Controlled BP defined as <130/80 mmHg).	Baseline, 6 and 12 months
Secondary	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
Secondary	Change in diabetes control	Measured using HbA1c tests (controlled diabetes defined as HbA1c<7.0).	Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received HBA1c measurement		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received a lipid panel		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received statin therapy		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received a dilated eye exam		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received a foot exam		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with dyslipidemia who received a lipid panel		Baseline, 6 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received a urine-protein-creatinine test		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with dyslipidemia who are on a statin medication		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with hypertension who received lifestyle counseling		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with diabetes mellitus who received lifestyle counseling		Baseline, 6 and 12 months
Secondary	Change in the percent of individuals diagnosed with dyslipidemia who received lifestyle counseling		Baseline, 6 and 12 months