Trial Outcomes & Findings for A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations (NCT NCT04696653)

NCT ID: NCT04696653

Last Updated: 2025-09-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 85 participants
• Primary outcome timeframe: Baseline, 12 Months
• Results posted on: 2025-09-26

Participant Flow

A total of 85 participants (health home staff) were enrolled from 5 behavioral health home programs. The behavioral health home programs had a total of 498 health home clients (not enrolled) with data that was included in the analysis.

Unit of analysis: health home programs

Participant milestones

Measure	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. 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.
Overall Study STARTED	85 5
Overall Study Health Home Clients (Not Enrolled)	498 5
Overall Study COMPLETED	64 5
Overall Study NOT COMPLETED	21 0

Reasons for withdrawal

Measure	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. 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.
Overall Study left organization	18
Overall Study Lost to Follow-up	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=85 Participants 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 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	85 Participants n=5 Participants
Comprehensive Unit Safety Program (CUSP) team membership	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety Baseline	3.8 score on a scale Standard Deviation 0.7
Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety 12 Month	3.8 score on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, 12 Months

Population: CUSP team members with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=22 Participants 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 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.
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale Hypertension - Baseline	6.0 score on a scale Standard Deviation 2.3
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale Hypertension - 12 Months	7.1 score on a scale Standard Deviation 1.2
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale Dyslipidemia - Baseline	5.9 score on a scale Standard Deviation 2.4
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale Dyslipidemia - 12 Months	7.0 score on a scale Standard Deviation 1.4
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale Diabetes - Baseline	6.2 score on a scale Standard Deviation 2.6
Self-efficacy as Assessed by an Adapted Version of Compeau & Higgins' Task-focused Self-efficacy Scale Diabetes - 12 Months	7.3 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: CUSP team members with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=19 Participants 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 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.
Acceptability as Assessed by the Acceptability of Intervention Measure Evidenced Based Practice - Baseline	4.4 score on a scale Standard Deviation 0.5
Acceptability as Assessed by the Acceptability of Intervention Measure Evidenced Based Practice - 12 Months	4.2 score on a scale Standard Deviation 0.5
Acceptability as Assessed by the Acceptability of Intervention Measure CUSP Strategy - Baseline	4.4 score on a scale Standard Deviation 0.5
Acceptability as Assessed by the Acceptability of Intervention Measure CUSP Strategy - 12 Months	4.2 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: CUSP team members with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=19 Participants 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 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.
Appropriateness as Assessed by the Intervention Appropriateness Measure Evidenced Based Practice - Baseline	4.3 score on a scale Standard Deviation 0.5
Appropriateness as Assessed by the Intervention Appropriateness Measure Evidenced Based Practice - 12 Months	4.2 score on a scale Standard Deviation 0.7
Appropriateness as Assessed by the Intervention Appropriateness Measure CUSP Strategy - Baseline	4.4 score on a scale Standard Deviation 0.5
Appropriateness as Assessed by the Intervention Appropriateness Measure CUSP Strategy - 12 Months	4.2 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: CUSP team members with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=19 Participants 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 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.
Feasibility as Assessed by the Feasibility of Intervention Measure Evidenced Based Practice - Baseline	4.3 score on a scale Standard Deviation 0.4
Feasibility as Assessed by the Feasibility of Intervention Measure Evidenced Based Practice - 12 Months	4.2 score on a scale Standard Deviation 0.6
Feasibility as Assessed by the Feasibility of Intervention Measure CUSP Strategy - Baseline	4.3 score on a scale Standard Deviation 0.4
Feasibility as Assessed by the Feasibility of Intervention Measure CUSP Strategy - 12 Months	4.2 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Clients identified as having hypertension with collected blood pressure reading at either baseline or 12 months were analyzed under modeling approach.

Measured with blood pressure (BP) readings reported by staff . Clients with control defined as a BP <130/80 mmHg.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=224 Participants 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 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.
Clients With Hypertension Control Baseline	41 Participants
Clients With Hypertension Control 12 Months	59 Participants

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Clients identified as having dyslipidemia with collected lipid data at either baseline or 12 months were analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=158 Participants 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 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.
Clients With Dyslipidemia Control Baseline	70 Participants
Clients With Dyslipidemia Control 12 Months	75 Participants

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Clients identified as having diabetes with collected HBA1c at either baseline or 12 months were analyzed under modeling approach.

Measured using HbA1c tests reported by staff . Clients with controlled diabetes defined as HbA1c<7.0.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=119 Participants 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 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.
Clients With Diabetes Control Baseline	53 Participants
Clients With Diabetes Control 12 Months	55 Participants

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Clients identified as having diabetes at either baseline or 12 months were analyzed under modeling approach.

The number of clients who have a HBA1c measurement reported by the participating staff.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=145 Participants 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 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.
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement Baseline	92 Participants
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement 12 Months	99 Participants

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Clients identified as having dyslipidemia at either baseline or 12 months were analyzed under modeling approach.

The number of clients who have a lipid panel reported by the participating staff.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=213 Participants 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 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.
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel Baseline	131 Participants
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel 12 Months	133 Participants

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Teamwork Within Teams as Assessed by the Implementation Climate Scale Baseline	4.1 score on a scale Standard Deviation 0.9
Teamwork Within Teams as Assessed by the Implementation Climate Scale 12 Months	4.0 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale Baseline	4.0 score on a scale Standard Deviation 0.9
Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale 12 Months	4.1 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Organizational Learning Assessed by the Implementation Climate Scale Baseline	3.9 score on a scale Standard Deviation 0.8
Organizational Learning Assessed by the Implementation Climate Scale 12 Months	3.9 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Management Support for Patient Safety as Assessed by the Implementation Climate Scale Baseline	3.7 score on a scale Standard Deviation 1.0
Management Support for Patient Safety as Assessed by the Implementation Climate Scale 12 Months	3.7 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale Baseline	3.7 score on a scale Standard Deviation 0.9
Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale 12 Months	3.6 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Feedback and Communication About Error as Assessed by the Implementation Climate Scale Baseline	3.8 score on a scale Standard Deviation 0.9
Feedback and Communication About Error as Assessed by the Implementation Climate Scale 12 Months	3.7 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Communication Openness as Assessed by the Implementation Climate Scale 12 Months	3.5 score on a scale Standard Deviation 0.8
Communication Openness as Assessed by the Implementation Climate Scale Baseline	3.5 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Frequency of Events Reported as Assessed by the Implementation Climate Scale Baseline	4.0 score on a scale Standard Deviation 0.9
Frequency of Events Reported as Assessed by the Implementation Climate Scale 12 Months	4.1 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Teamwork Across Teams as Assessed by the Implementation Climate Scale Baseline	3.9 score on a scale Standard Deviation 0.9
Teamwork Across Teams as Assessed by the Implementation Climate Scale 12 Months	3.9 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: Staff with data collected analyzed under modeling approach.

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.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=84 Participants 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 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.
Staffing as Assessed by the Implementation Climate Scale Baseline	2.9 score on a scale Standard Deviation 0.9
Staffing as Assessed by the Implementation Climate Scale 12 Months	2.8 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Clients identified as having hypertension at either baseline or 12 months were analyzed under modeling approach.

The number of clients who have a blood pressure measurement reported by the participating staff.

Outcome measures

Measure	Comprehensive Unit Based Safety (CUSP) Intervention Arm n=242 Participants 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 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.
Clients With Hypertension Who Had a Blood Pressure Measurement Baseline	166 Participants
Clients With Hypertension Who Had a Blood Pressure Measurement 12 Months	186 Participants

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 and 12 months

Population: This data was supposed to be sourced from the electronic health record of participating sites. Sites did not collect this data, and the study is now completed so there will be no future data collection.

Outcome measures

Outcome data not reported

Adverse Events

Comprehensive Unit Based Safety (CUSP) Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gail Daumit, MD, MHS

Johns Hopkins University School of Medicine

Phone: 410-614-6460

Email: gdaumit@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place