A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations
Primary Purpose
Diabetes Mellitus, Hypertension, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Unit Based Safety Program (CUSP)
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus
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
Sites / Locations
- Johns Hopkins Adult Psychiatric Rehabilitation Program
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Comprehensive unit based safety (CUSP) intervention arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Change in Hypertension control
Measured with blood pressure (BP) readings (Controlled BP defined as <130/80 mmHg).
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).
Change in diabetes control
Measured using HbA1c tests (controlled diabetes defined as HbA1c<7.0).
Change in the percent of individuals diagnosed with diabetes mellitus who received HBA1c measurement
Change in the percent of individuals diagnosed with diabetes mellitus who received a lipid panel
Change in the percent of individuals diagnosed with diabetes mellitus who received statin therapy
Change in the percent of individuals diagnosed with diabetes mellitus who received a dilated eye exam
Change in the percent of individuals diagnosed with diabetes mellitus who received a foot exam
Change in the percent of individuals diagnosed with dyslipidemia who received a lipid panel
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
Change in the percent of individuals diagnosed with diabetes mellitus who received a urine-protein-creatinine test
Change in the percent of individuals diagnosed with dyslipidemia who are on a statin medication
Change in the percent of individuals diagnosed with hypertension who received lifestyle counseling
Change in the percent of individuals diagnosed with diabetes mellitus who received lifestyle counseling
Change in the percent of individuals diagnosed with dyslipidemia who received lifestyle counseling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04696653
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension, Dyslipidemias
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
628 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive unit based safety (CUSP) intervention arm
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Unit Based Safety Program (CUSP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality improvement culture as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in self-efficacy as assessed by an adapted version of Compeau & Higgins' task-focused self-efficacy scale
Description
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.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in acceptability as assessed by the Acceptability of Intervention Measure
Description
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.
Time Frame
Baseline, 12 months
Title
Change in appropriateness as assessed by the Intervention Appropriateness Measure
Description
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.
Time Frame
Baseline, 12 months
Title
Change in feasibility as assessed by the Feasibility of Intervention Measure
Description
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.
Time Frame
Baseline, 12 months
Title
Change in Hypertension control
Description
Measured with blood pressure (BP) readings (Controlled BP defined as <130/80 mmHg).
Time Frame
Baseline, 6 and 12 months
Title
Change in dyslipidemia control
Description
Measured with cholesterol readings (controlled dyslipidemia defined as total cholesterol <200 mg/dL and low-density lipoprotein (LDL) <130 mg/dL).
Time Frame
Baseline, 6 and 12 months
Title
Change in diabetes control
Description
Measured using HbA1c tests (controlled diabetes defined as HbA1c<7.0).
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received HBA1c measurement
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received a lipid panel
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received statin therapy
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received a dilated eye exam
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received a foot exam
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with dyslipidemia who received a lipid panel
Time Frame
Baseline, 6 and 12 months
Title
Change in teamwork within units as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in supervisor promotion of quality improvement as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in organizational learning as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in management support for quality improvement as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in overall perceptions of quality improvement culture as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in feedback and communication as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in communication openness as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in mistake reporting as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in teamwork across units as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in staffing capacity as assessed by the modified version of the validated Survey on Patient Safety
Description
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.
Time Frame
Baseline, 12 months
Title
Change in the percent of individuals with systolic blood pressure with poorly controlled hypertension who had a blood pressure measurement
Description
Measured with blood pressure (BP) readings (Poorly controlled BP defined as >130/80 mmHg).
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received a urine-protein-creatinine test
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with dyslipidemia who are on a statin medication
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with hypertension who received lifestyle counseling
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with diabetes mellitus who received lifestyle counseling
Time Frame
Baseline, 6 and 12 months
Title
Change in the percent of individuals diagnosed with dyslipidemia who received lifestyle counseling
Time Frame
Baseline, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma E McGinty, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Adult Psychiatric Rehabilitation Program
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33663620
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.
Results Reference
derived
Learn more about this trial
A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations
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