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Clinical Trials/NCT04696653
NCT04696653
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country85 target enrollmentFebruary 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Johns Hopkins University
Enrollment
85
Locations
1
Primary Endpoint
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety
Status
Completed
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 24, 2021
End Date
April 5, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Clients With Diabetes Control(Baseline and 12 Months)
  • Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement(Baseline and 12 Months)
  • Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Lipid Panel(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Statin Therapy(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Dilated Eye Exam(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Foot Exam(Baseline, 6 and 12 months)
  • Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel(Baseline and 12 Months)
  • Teamwork Within Teams as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Organizational Learning Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Management Support for Patient Safety as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Feedback and Communication About Error as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Communication Openness as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Frequency of Events Reported as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Teamwork Across Teams as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Staffing as Assessed by the Implementation Climate Scale(Baseline, 12 Months)
  • Clients With Hypertension Who Had a Blood Pressure Measurement(Baseline and 12 Months)
  • Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Urine-protein-creatinine Test(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Are on a Statin Medication(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Hypertension Who Received Lifestyle Counseling(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Lifestyle Counseling(Baseline, 6 and 12 months)
  • Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Received Lifestyle Counseling(Baseline, 6 and 12 months)

Study Sites (1)

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