- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696653
A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations
December 18, 2023 updated by: Johns Hopkins University
Using an Innovative Quality Improvement Process to Increase Delivery of Evidence-based Cardiovascular Risk Factor Care in Community Mental Health Organizations
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
628
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Adult Psychiatric Rehabilitation Program
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Comprehensive unit based safety (CUSP) intervention arm
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.
|
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.
|
What is the study measuring?
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 6 and 12 months
|
Measured with blood pressure (BP) readings (Controlled BP defined as <130/80 mmHg).
|
Baseline, 6 and 12 months
|
Change in dyslipidemia control
Time Frame: Baseline, 6 and 12 months
|
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
Time Frame: Baseline, 6 and 12 months
|
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
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with diabetes mellitus who received a lipid panel
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with diabetes mellitus who received statin therapy
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with diabetes mellitus who received a dilated eye exam
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
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Change in the percent of individuals diagnosed with diabetes mellitus who received a foot exam
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with dyslipidemia who received a lipid panel
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in teamwork within units as assessed by the modified version of the validated Survey on Patient Safety
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 12 months
|
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
Time Frame: Baseline, 6 and 12 months
|
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
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with dyslipidemia who are on a statin medication
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with hypertension who received lifestyle counseling
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with diabetes mellitus who received lifestyle counseling
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
|
Change in the percent of individuals diagnosed with dyslipidemia who received lifestyle counseling
Time Frame: Baseline, 6 and 12 months
|
Baseline, 6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gail L Daumit, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2021
Primary Completion (Actual)
November 21, 2022
Study Completion (Actual)
April 5, 2023
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00269855
- P50MH115842 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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