Diabetes Mellitus, Dyslipidemias, Hypertension
Conditions
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.
Interventions
OTHERComprehensive 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.
Sponsors
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality Improvement Culture as Assessed by the Modified Version of the Validated Survey on Patient Safety | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability as Assessed by the Acceptability of Intervention Measure | 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. |
| Appropriateness as Assessed by the Intervention Appropriateness Measure | 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. |
| Feasibility as Assessed by the Feasibility of Intervention Measure | 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. |
| Clients With Hypertension Control | Baseline and 12 Months | Measured with blood pressure (BP) readings reported by staff . Clients with control defined as a BP \<130/80 mmHg. |
| Clients With Dyslipidemia Control | 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. |
| Clients With Diabetes Control | Baseline and 12 Months | Measured using HbA1c tests reported by staff . Clients with controlled diabetes defined as HbA1c\<7.0. |
| Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement | Baseline and 12 Months | The number of clients who have a HBA1c measurement reported by the participating staff. |
| 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 | The number of clients who have a lipid panel reported by the participating staff. |
| Teamwork Within Teams as Assessed by the Implementation Climate Scale | 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. |
| Supervisor/Manager Expectations and Actions Promoting Quality as Assessed by the Implementation Climate Scale | 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. |
| Organizational Learning Assessed by the Implementation Climate Scale | 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. |
| Management Support for Patient Safety as Assessed by the Implementation Climate Scale | 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. |
| Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale | 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. |
| Feedback and Communication About Error as Assessed by the Implementation Climate Scale | 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. |
| Communication Openness as Assessed by the Implementation Climate Scale | 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. |
| Frequency of Events Reported as Assessed by the Implementation Climate Scale | 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. |
| Teamwork Across Teams as Assessed by the Implementation Climate Scale | 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. |
| Staffing as Assessed by the Implementation Climate Scale | 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. |
| Clients With Hypertension Who Had a Blood Pressure Measurement | Baseline and 12 Months | The number of clients who have a blood pressure measurement reported by the participating staff. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | left organization | 18 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Comprehensive Unit Based Safety (CUSP) Intervention Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants |
| Age, Continuous | 35.2 years STANDARD_DEVIATION 11.9 |
| Comprehensive Unit Safety Program (CUSP) team membership | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Region of Enrollment United States | 85 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
95% CI: [-0.2, 0.1]
Primary
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.
Time frame: Baseline, 12 Months
Population: CUSP team members with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
Comparison: hypertension95% CI: [0.2, 1.8]
Comparison: dyslipidemia95% CI: [0, 2.1]
Comparison: diabetes95% CI: [0.1, 2]
Secondary
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.
Time frame: Baseline, 12 Months
Population: CUSP team members with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Acceptability as Assessed by the Acceptability of Intervention Measure | Evidenced Based Practice - Baseline | 4.4 score on a scale | Standard Deviation 0.5 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Acceptability as Assessed by the Acceptability of Intervention Measure | Evidenced Based Practice - 12 Months | 4.2 score on a scale | Standard Deviation 0.5 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Acceptability as Assessed by the Acceptability of Intervention Measure | CUSP Strategy - Baseline | 4.4 score on a scale | Standard Deviation 0.5 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Acceptability as Assessed by the Acceptability of Intervention Measure | CUSP Strategy - 12 Months | 4.2 score on a scale | Standard Deviation 0.6 |
Comparison: Evidenced based practice95% CI: [-0.6, 0.1]
Comparison: CUSP strategy95% CI: [-0.6, 0.1]
Secondary
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.
Time frame: Baseline, 12 Months
Population: CUSP team members with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Appropriateness as Assessed by the Intervention Appropriateness Measure | Evidenced Based Practice - Baseline | 4.3 score on a scale | Standard Deviation 0.5 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Appropriateness as Assessed by the Intervention Appropriateness Measure | Evidenced Based Practice - 12 Months | 4.2 score on a scale | Standard Deviation 0.7 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Appropriateness as Assessed by the Intervention Appropriateness Measure | CUSP Strategy - Baseline | 4.4 score on a scale | Standard Deviation 0.5 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Appropriateness as Assessed by the Intervention Appropriateness Measure | CUSP Strategy - 12 Months | 4.2 score on a scale | Standard Deviation 0.7 |
Comparison: CUSP strategy95% CI: [-0.6, 0.2]
Comparison: Evidenced based practice95% CI: [-0.5, 0.1]
Secondary
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Dilated Eye Exam
Time frame: 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
Secondary
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Foot Exam
Time frame: 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
Secondary
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Lipid Panel
Time frame: 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
Secondary
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received a Urine-protein-creatinine Test
Time frame: 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.
Secondary
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Lifestyle Counseling
Time frame: 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.
Secondary
Change in the Percent of Individuals Diagnosed With Diabetes Mellitus Who Received Statin Therapy
Time frame: 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
Secondary
Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Are on a Statin Medication
Time frame: 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.
Secondary
Change in the Percent of Individuals Diagnosed With Dyslipidemia Who Received Lifestyle Counseling
Time frame: 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.
Secondary
Change in the Percent of Individuals Diagnosed With Hypertension Who Received Lifestyle Counseling
Time frame: 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.
Secondary
Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement
The number of clients who have a HBA1c measurement reported by the participating staff.
Time frame: Baseline and 12 Months
Population: Clients identified as having diabetes at either baseline or 12 months were analyzed under modeling approach.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement | Baseline | 92 Participants |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients Diagnosed With Diabetes Mellitus Who Received HBA1c Measurement | 12 Months | 99 Participants |
95% CI: [1.2, 2.6]
Secondary
Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel
The number of clients who have a lipid panel reported by the participating staff.
Time frame: Baseline and 12 Months
Population: Clients identified as having dyslipidemia at either baseline or 12 months were analyzed under modeling approach.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel | Baseline | 131 Participants |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients Diagnosed With Dyslipidemia Who Received a Lipid Panel | 12 Months | 133 Participants |
95% CI: [1, 1.6]
Secondary
Clients With Diabetes Control
Measured using HbA1c tests reported by staff . Clients with controlled diabetes defined as HbA1c\<7.0.
Time frame: Baseline and 12 Months
Population: Clients identified as having diabetes with collected HBA1c at either baseline or 12 months were analyzed under modeling approach.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Diabetes Control | Baseline | 53 Participants |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Diabetes Control | 12 Months | 55 Participants |
95% CI: [0.7, 1.4]
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Dyslipidemia Control | Baseline | 70 Participants |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Dyslipidemia Control | 12 Months | 75 Participants |
95% CI: [1.1, 1.9]
Secondary
Clients With Hypertension Control
Measured with blood pressure (BP) readings reported by staff . Clients with control defined as a BP \<130/80 mmHg.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Hypertension Control | Baseline | 41 Participants |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Hypertension Control | 12 Months | 59 Participants |
95% CI: [0.9, 2.2]
Secondary
Clients With Hypertension Who Had a Blood Pressure Measurement
The number of clients who have a blood pressure measurement reported by the participating staff.
Time frame: Baseline and 12 Months
Population: Clients identified as having hypertension at either baseline or 12 months were analyzed under modeling approach.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Hypertension Who Had a Blood Pressure Measurement | Baseline | 166 Participants |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Clients With Hypertension Who Had a Blood Pressure Measurement | 12 Months | 186 Participants |
95% CI: [1, 3.3]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Communication Openness as Assessed by the Implementation Climate Scale | Baseline | 3.5 score on a scale | Standard Deviation 0.8 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Communication Openness as Assessed by the Implementation Climate Scale | 12 Months | 3.5 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.1, 0.3]
Secondary
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.
Time frame: Baseline, 12 Months
Population: CUSP team members with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Feasibility as Assessed by the Feasibility of Intervention Measure | Evidenced Based Practice - Baseline | 4.3 score on a scale | Standard Deviation 0.4 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Feasibility as Assessed by the Feasibility of Intervention Measure | Evidenced Based Practice - 12 Months | 4.2 score on a scale | Standard Deviation 0.6 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Feasibility as Assessed by the Feasibility of Intervention Measure | CUSP Strategy - Baseline | 4.3 score on a scale | Standard Deviation 0.4 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Feasibility as Assessed by the Feasibility of Intervention Measure | CUSP Strategy - 12 Months | 4.2 score on a scale | Standard Deviation 0.6 |
Comparison: evidenced based practice95% CI: [-0.5, 0.1]
Comparison: CUSP strategy95% CI: [-0.5, 0.2]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Feedback and Communication About Error as Assessed by the Implementation Climate Scale | Baseline | 3.8 score on a scale | Standard Deviation 0.9 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Feedback and Communication About Error as Assessed by the Implementation Climate Scale | 12 Months | 3.7 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.3, 0]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Frequency of Events Reported as Assessed by the Implementation Climate Scale | Baseline | 4.0 score on a scale | Standard Deviation 0.9 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Frequency of Events Reported as Assessed by the Implementation Climate Scale | 12 Months | 4.1 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.1, 0.2]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Management Support for Patient Safety as Assessed by the Implementation Climate Scale | Baseline | 3.7 score on a scale | Standard Deviation 1 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Management Support for Patient Safety as Assessed by the Implementation Climate Scale | 12 Months | 3.7 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.2, 0.2]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Organizational Learning Assessed by the Implementation Climate Scale | 12 Months | 3.9 score on a scale | Standard Deviation 0.6 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Organizational Learning Assessed by the Implementation Climate Scale | Baseline | 3.9 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.2, 0.1]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Overall Perceptions of Quality Improvement Culture as Assessed by the Implementation Climate Scale | Baseline | 3.7 score on a scale | Standard Deviation 0.9 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
95% CI: [-0.3, 0]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Staffing as Assessed by the Implementation Climate Scale | Baseline | 2.9 score on a scale | Standard Deviation 0.9 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Staffing as Assessed by the Implementation Climate Scale | 12 Months | 2.8 score on a scale | Standard Deviation 0.9 |
95% CI: [-0.4, 0]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | 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 |
95% CI: [-0.2, 0.2]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Teamwork Across Teams as Assessed by the Implementation Climate Scale | Baseline | 3.9 score on a scale | Standard Deviation 0.9 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Teamwork Across Teams as Assessed by the Implementation Climate Scale | 12 Months | 3.9 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.2, 0.2]
Secondary
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.
Time frame: Baseline, 12 Months
Population: Staff with data collected analyzed under modeling approach.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Teamwork Within Teams as Assessed by the Implementation Climate Scale | Baseline | 4.1 score on a scale | Standard Deviation 0.9 |
| Comprehensive Unit Based Safety (CUSP) Intervention Arm | Teamwork Within Teams as Assessed by the Implementation Climate Scale | 12 Months | 4.0 score on a scale | Standard Deviation 0.8 |
95% CI: [-0.2, 0.1]