Diabetes MellitusNCT04696653
A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations
A study testing Comprehensive Unit Based Safety Program (CUSP) in people with Diabetes Mellitus and Hypertension, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Dyslipidemias
- What is being tested?
- Comprehensive Unit Based Safety Program (CUSP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Adult Psychiatric Rehabilitation Program
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension, Dyslipidemias
- Being tested
- Comprehensive Unit Based Safety Program (CUSP)
- Medical subject headings
- Diabetes Mellitus, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Unit Based Safety Program (CUSP)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive unit based safety (CUSP) intervention arm | Other | 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. Receives: Other: Comprehensive Unit Based Safety Program (CUSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety
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.
Measured: Baseline, 12 Months
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale
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.
Measured: Baseline, 12 Months
Secondary outcomes (28)
Acceptability as Assessed by the Acceptability of Intervention Measure
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.
Measured: Baseline, 12 Months
Appropriateness as Assessed by the Intervention Appropriateness Measure
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.
Measured: Baseline, 12 Months
Feasibility as Assessed by the Feasibility of Intervention Measure
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.
Measured: Baseline, 12 Months
Clients With Hypertension Control
Measured with blood pressure (BP) readings reported by staff . Clients with control defined as a BP <130/80 mmHg.
Measured: Baseline and 12 Months
Clients With Dyslipidemia Control
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.
Measured: Baseline and 12 Months
Clients With Diabetes Control
Measured using HbA1c tests reported by staff . Clients with controlled diabetes defined as HbA1c<7.0.
Measured: Baseline and 12 Months
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement
The number of clients who have a HBA1c measurement reported by the participating staff.
Measured: Baseline and 12 Months
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Lipid Panel
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Statin Therapy
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Dilated Eye Exam
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Foot Exam
Measured: Baseline, 6 and 12 months
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel
The number of clients who have a lipid panel reported by the participating staff.
Measured: Baseline and 12 Months
Teamwork Within Teams as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Organizational Learning Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Management Support for Patient Safety as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Feedback and Communication About Error as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Communication Openness as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Frequency of Events Reported as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Teamwork Across Teams as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Staffing as Assessed by the Implementation Climate Scale
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.
Measured: Baseline, 12 Months
Clients With Hypertension Who Had a Blood Pressure Measurement
The number of clients who have a blood pressure measurement reported by the participating staff.
Measured: Baseline and 12 Months
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Urine-protein-creatinine Test
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Are on a Statin Medication
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Hypertension Who Received Lifestyle Counseling
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Lifestyle Counseling
Measured: Baseline, 6 and 12 months
Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Received Lifestyle Counseling
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start24 Feb 2021
- Primary completion21 Nov 2022
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gail L Daumit, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696653
- Sponsor's protocol ID
- IRB00269855
- Other IDs
- P50MH115842
- Status last verified
- Sep 2025
- First submitted
- 4 Jan 2021
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy KA, Gennusa J, Dalcin AT, Cook C, Goldsholl S, Fink T, Daumit GL, Wang NY, Thompson D, McGinty EE. Pilot of a team-based quality improvement strategy to improve cardiovascular risk factors care in community mental health centers. Front Psychiatry. 2025 Jan 31;16:1446985. doi: 10.3389/fpsyt.2025.1446985. eCollection 2025.
PubMed 39958153McGinty 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.
PubMed 33663620
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Innovative Quality Improvement Process to Increase Delivery of Evidence-based Cardiovascular Risk Factor Care in Community Mental Health Organizations
- ClinicalTrials.gov ID
- NCT04696653
- Acronym / sponsor ID
- IRB00269855
- Conditions
- Diabetes Mellitus, Hypertension, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive unit based safety (CUSP) intervention arm | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- People with serious mental illness participating in psychiatric rehabilitation health home programs.
- English-speaking
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Comprehensive unit based safety (CUSP) intervention arm |
Primary outcome
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.
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.
28 secondary outcomes
Acceptability as Assessed by the Acceptability of Intervention Measure
Time frame: Baseline, 12 Months
Appropriateness as Assessed by the Intervention Appropriateness Measure
Time frame: Baseline, 12 Months
Feasibility as Assessed by the Feasibility of Intervention Measure
Time frame: Baseline, 12 Months
Clients With Hypertension Control
Time frame: Baseline and 12 Months
Clients With Dyslipidemia Control
Time frame: Baseline and 12 Months
Clients With Diabetes Control
Time frame: Baseline and 12 Months
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement
Time frame: 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
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Statin Therapy
Time frame: 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
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Foot Exam
Time frame: Baseline, 6 and 12 months
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel
Time frame: Baseline and 12 Months
Teamwork Within Teams as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Organizational Learning Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Management Support for Patient Safety as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Feedback and Communication About Error as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Communication Openness as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Frequency of Events Reported as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Teamwork Across Teams as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Staffing as Assessed by the Implementation Climate Scale
Time frame: Baseline, 12 Months
Clients With Hypertension Who Had a Blood Pressure Measurement
Time frame: 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
Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Are on a Statin Medication
Time frame: 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
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Lifestyle Counseling
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39958153Murphy KA, Gennusa J, Dalcin AT, Cook C, Goldsholl S, Fink T, Daumit GL, Wang NY, Thompson D, McGinty EE. Pilot of a team-based quality improvement strategy to improve cardiovascular risk factors care in community mental health centers. Front Psychiatry. 2025 Jan 31;16:1446985. doi: 10.3389/fpsyt.2025.1446985. eCollection 2025.
- Derived from this study: PubMed 33663620McGinty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail L Daumit, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Unit Based Safety Program (CUSP) in people with Diabetes Mellitus and Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety (time frame: Baseline, 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696653, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.