Skip to main content
OpenTrials
Completed

NCT Number: NCT04696653

A Quality Improvement Process to Support Delivery of Cardiovascular 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Adult Psychiatric Rehabilitation Program

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Lipid Panel

    Time frame: Baseline, 6 and 12 months

  9. Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Statin Therapy

    Time frame: Baseline, 6 and 12 months

  10. Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Dilated Eye Exam

    Time frame: Baseline, 6 and 12 months

  11. Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Foot Exam

    Time frame: Baseline, 6 and 12 months

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Urine-protein-creatinine Test

    Time frame: Baseline, 6 and 12 months

  25. Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Are on a Statin Medication

    Time frame: Baseline, 6 and 12 months

  26. Change in the Percent of Individuals Diagnosed With Hypertension Who Received Lifestyle Counseling

    Time frame: Baseline, 6 and 12 months

  27. Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Lifestyle Counseling

    Time frame: Baseline, 6 and 12 months

  28. Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Received Lifestyle Counseling

    Time frame: Baseline, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 6, 2021
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.