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

September 8, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Adult Psychiatric Rehabilitation Program

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety
Time Frame: 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.
Baseline, 12 Months
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale
Time Frame: 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.
Baseline, 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability as Assessed by the Acceptability of Intervention Measure
Time Frame: 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.
Baseline, 12 Months
Appropriateness as Assessed by the Intervention Appropriateness Measure
Time Frame: 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.
Baseline, 12 Months
Feasibility as Assessed by the Feasibility of Intervention Measure
Time Frame: 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.
Baseline, 12 Months
Clients With Hypertension Control
Time Frame: Baseline and 12 Months
Measured with blood pressure (BP) readings reported by staff . Clients with control defined as a BP <130/80 mmHg.
Baseline and 12 Months
Clients With Dyslipidemia Control
Time Frame: 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.
Baseline and 12 Months
Clients With Diabetes Control
Time Frame: Baseline and 12 Months
Measured using HbA1c tests reported by staff . Clients with controlled diabetes defined as HbA1c<7.0.
Baseline and 12 Months
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement
Time Frame: Baseline and 12 Months
The number of clients who have a HBA1c measurement reported by the participating staff.
Baseline 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
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
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel
Time Frame: Baseline and 12 Months
The number of clients who have a lipid panel reported by the participating staff.
Baseline and 12 Months
Teamwork Within Teams as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Organizational Learning Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Management Support for Patient Safety as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Feedback and Communication About Error as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Communication Openness as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Frequency of Events Reported as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Teamwork Across Teams as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Staffing as Assessed by the Implementation Climate Scale
Time Frame: 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.
Baseline, 12 Months
Clients With Hypertension Who Had a Blood Pressure Measurement
Time Frame: Baseline and 12 Months
The number of clients who have a blood pressure measurement reported by the participating staff.
Baseline 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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