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

NCT04696653 | Completed Results

• 2 other identifiers: IRB00269855P50MH115842
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 12 Months

Secondary Outcomes (28)

• Acceptability as Assessed by the Acceptability of Intervention Measure

  Baseline, 12 Months

• Appropriateness as Assessed by the Intervention Appropriateness Measure

  Baseline, 12 Months

• Feasibility as Assessed by the Feasibility of Intervention Measure

  Baseline, 12 Months

• Clients With Hypertension Control

  Baseline and 12 Months

• Clients With Dyslipidemia Control

  Baseline and 12 Months

Study Arms (1)

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.

Other: Comprehensive Unit Based Safety Program (CUSP)

Interventions

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.

Comprehensive unit based safety (CUSP) intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins Adult Psychiatric Rehabilitation Program

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

• 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.

  PMID: 39958153 DERIVED

• 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.

  PMID: 33663620 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Results Point of Contact

• Title: Gail Daumit, MD, MHS
• Organization: Johns Hopkins University School of Medicine

gdaumit@jhmi.edu

410-614-6460

Study Officials

• Gail L Daumit, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: February 24, 2021
• Primary Completion: November 21, 2022
• Study Completion: April 5, 2023
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)