Cardiovascular Intervention Improvement Telemedicine Study

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01142908
• Collaborator: (none)
• Enrollment: 428
• Location: 1
• Arms: 2
• Actual Duration (Months): 42.6
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death in the United States; more than 80% of veterans have > 2 risk factors for CVD. Our study is one of the first to examine the implementation of a tailored behavioral/educational self-management intervention in primary care clinics designed to improve CVD risk. The proposed study could result in a leap forward in CVD risk management among veterans for several reasons: 1) ) This is a novel extension of our previous interventions that have demonstrated improved BP, now designed to address multiple chronic conditions contributing to CVD risk, particularly hyperlipidemia and diabetes. The study focuses on both multiple CVD-related risk factor management and medication management 2) The intervention is multi-behavioral; it addresses patients' various health behavior (e.g., smoking, diet, and medication adherence). 3) Components of the intervention will include specific recommendations and transportability of intervention application software and tracking packages that will allow clinic managers to implement the intervention if it is effective.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease; Hypertension; Diabetes; Hyperlipidemia	Behavioral: Pharmacist CVD	N/A

Detailed Description

Anticipated Impacts on Veteran's Healthcare: Cardiovascular disease (CVD) is the leading cause of death in the U.S.; more than 80% of veterans have > 2 risk factors for CVD. An intervention that addresses multiple CVD risk factors among high-risk veterans has the greatest potential to improve morbidity and mortality.

Project Background/Rationale: The proposed study will take place in two VA primary care clinics (1-Community-Based Outpatient Clinics and 1-primary care clinic affiliated with a hospital). We will improve CVD risk among veterans by addressing the modifiable risk factors of systolic blood pressure (SBP), smoking, and low-density lipoprotein cholesterol (LDL-C). The intervention will be tailored to the needs of vulnerable high risk patients (e.g. African Americans, low literate) and integrated into clinics, thereby enhancing the potential for benefit and generalizability to other settings.

The proposed study could significantly improve CVD risk management among veterans for several reasons: 1) This intervention is a novel extension of our previous efficacious interventions, but provides a novel extension to address multiple chronic conditions contributing to CVD risk. 2) The intervention focuses on both multiple CVD-related behaviors and medication management. 3) The intervention was developed to ensure implementation across a large and representative sample of veterans; and; 4) The intervention, if found efficacious and financially self-sustaining, could be widely implemented within the VA healthcare system.

Project Objectives: The proposed study will examine two research questions:

1. Can patients randomized to a clinical pharmacist-administered telephone behavioral/ medication management intervention tailored to their needs improve CVD outcomes relative to a control group over 12 months? Primary Hypothesis: (H1) Veterans who receive the behavioral/medication intervention will have greater improvement of their CVD Risk Profile over the 12 months of follow-up as compared to the control group.

Secondary Hypotheses: (H2) Veterans who receive the intervention will have improved medication adherence, physical activity, improved diet, lower body mass index as compared to the control group over 12 months of follow-up. (H3) Veterans who receive the intervention will have greater improvements in LDL over the 12 months of follow-up as compared to the control group. (H4) Veterans with diabetes who receive the intervention will have greater improved HbA1c as compared to the control group over 12 months of follow-up.

1. If the intervention is found to be effective, is it cost effective? Project Methods: To address these hypotheses, we propose a two-arm randomized clinical trial design in which 500 patients with cardiovascular disease will be randomized to either the education control group or the intervention group. Patients randomized to the intervention group will receive a clinical pharmacist-administered intervention, which focuses on behavioral and a medication management. The intervention will occur over 12 months. Patients randomized to the control group will receive educational material about CVD reduction. Given the national prevalence of CVD and the dismal rates of risk factor control, intensive, but easily disseminated interventions such as the one proposed could significantly improve treatment of this epidemic in the VA.

Study Design

• Study Type: Interventional
• Actual Enrollment: 428 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiovascular Intervention Improvement Telemedicine Study
• Actual Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Apr 30, 2015
• Actual Study Completion Date: May 22, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	Behavioral: Pharmacist CVD; clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
No Intervention: Arm 2 The education control group - these participants will receive educational material about CVD reduction.

Outcome Measures

Primary Outcome Measures

1. Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) [Baseline]

   Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

2. Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) [6 months]

   Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

3. Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) [12 months]

   Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.

Secondary Outcome Measures

1. Mean Systolic Blood Pressure [Baseline]

   Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

2. Mean Systolic Blood Pressure [6 months]

   Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

3. Mean Systolic Blood Pressure [12 months]

   Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

4. Mean Diastolic Blood Pressure [Baseline]

   Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

5. Mean Diastolic Blood Pressure [6 months]

   Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

6. Mean Diastolic Blood Pressure [12 months]

   Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews

7. Medication Non-adherence [Baseline]

   First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

8. Medication Non-adherence [6 months]

   First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

9. Medication Non-adherence [12 months]

   First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.

10. Cholesterol LDL [Baseline]

    Collected during interview visit by lab personnel

11. Cholesterol LDL [6 months]

    Collected during interview visit by lab personnel

12. Cholesterol LDL [12 months]

    Collected during interview visit by lab personnel

13. Body Mass Index [Baseline]

    Calculated from vitals (height & weight) obtained during interview

14. Body Mass Index [6 months]

    Calculated from vitals (height & weight) obtained during interview

15. Body Mass Index [12 months]

    Calculated from vitals (height & weight) obtained during interview

16. HBA1C in Diabetic Patients [Baseline]

    Lab values collected at interview visit by lab personnel

17. HBA1C in Diabetic Patients [6 months]

    Lab values collected at interview visit by lab personnel

18. HBA1C in Diabetic Patients [12 months]

    Lab values collected at interview visit by lab personnel

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Enrolled in one of three Durham Veterans Affairs Medical Center (DVAMC) Primary Care Clinics affiliated with the hospital or the Raleigh Community-Based Outpatient Clinic (CBOC) for at least one year;

• At least one visit to a primary care physician (PCP) at the Raleigh CBOC or Durham Veterans Affairs Medical Center (VAMC) associated primary care clinics in the previous 12 months;

• Outpatient diagnostic code for hypertension and/or hypercholesterolemia and lab values indicating either poorly controlled BP levels (>150/90 Hg) AND/OR LDL (>130mg/dl) in the previous year.

Exclusion Criteria:

• diagnosed with metastatic cancer,

• diagnosed with dementia,

• active diagnosis of psychosis,

• treated with dialysis,

• most recent creatinine lab level >2.5 or no creatinine lab value within past year

• hospitalized for a stroke, heart attack, or had surgery for blocked arteries in the past 3 months,

• participating in another interventional trial,

• not currently receiving care at the Durham VAMC or the Raleigh CBOC

• resident of a nursing home,

• hard time seeing type/printing on books, magazines articles, etc.

• hard time hearing on the telephone

• limited/no access to telephone

• plans to move medical care from DVAMC or Raleigh CBOC in next 12 months

• CVD care is currently being managed by a clinical pharmacist

• HbA1C value in the last 90day > 10% and patient is currently not on an insulin regimen.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Hayden B Bosworth, PhD, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01142908
• Other Study ID Numbers: IIR 08-297; 08-297
• First Posted: Jun 11, 2010
• Last Update Posted: Oct 19, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Cardiovascular Disease; Hypertension; Diabetes; Hyperlipidemia; Adherence
• Additional relevant MeSH terms: Hypertension; Cardiovascular Diseases; Hyperlipidemias; Hyperlipoproteinemias

Study Results

Participant Flow

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Period Title: Overall Study
STARTED	215	213
6 Month f/u	188	196
COMPLETED	183	191
NOT COMPLETED	32	22

Baseline Characteristics

Arm/Group Title	Pharmacist CVD	Education Control	Total
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.	Total of all reporting groups
Overall Participants	215	213	428
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (8.4)	61.5 (8.9)	61.2 (8.7)
Sex: Female, Male (Count of Participants)
Female	33 15.3%	32 15%	65 15.2%
Male	182 84.7%	181 85%	363 84.8%
Race/Ethnicity, Customized (participants) [Number]
White	93 43.3%	106 49.8%	199 46.5%
Black	111 51.6%	102 47.9%	213 49.8%
Other	10 4.7%	4 1.9%	14 3.3%
Refused/Missing	1 0.5%	1 0.5%	2 0.5%
Region of Enrollment (participants) [Number]
United States	215 100%	213 100%	428 100%

Outcome Measures

1. Primary Outcome

Title	Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
Description	Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	213	213
Mean (Standard Deviation) [% 10 yr Risk]	32.4 (18.8)	31.6 (18.6)

2. Secondary Outcome

Title	Mean Systolic Blood Pressure
Description	Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	214	213
Mean (Standard Deviation) [mmHg]	130.6 (18.5)	129.7 (18.8)

3. Secondary Outcome

Title	Mean Systolic Blood Pressure
Description	Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	187	190
Mean (Standard Deviation) [mmHg]	128.3 (16.5)	127.7 (16.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -2.8 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

4. Secondary Outcome

Title	Mean Systolic Blood Pressure
Description	Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	179	183
Mean (Standard Deviation) [mmHg]	128.5 (15.4)	126.4 (16.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -1.5 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

5. Secondary Outcome

Title	Mean Diastolic Blood Pressure
Description	Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	214	213
Mean (Standard Deviation) [mmHg]	75.8 (11.5)	75.8 (12.4)

6. Secondary Outcome

Title	Mean Diastolic Blood Pressure
Description	Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	187	190
Mean (Standard Deviation) [mmHg]	74.0 (11.0)	74.1 (11.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -2.0 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

7. Secondary Outcome

Title	Mean Diastolic Blood Pressure
Description	Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	179	183
Mean (Standard Deviation) [mmHg]	73.4 (10.3)	73.1 (10.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; -1.5 to 2.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

8. Primary Outcome

Title	Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
Description	Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	186	189
Mean (Standard Deviation) [% 10 yr Risk]	30.0 (17.2)	30.2 (18.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -3.9 to 0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

9. Primary Outcome

Title	Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
Description	Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). "New cases" of diabetes are allowed to be updated at 6 and 12 months f/u.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	172	180
Mean (Standard Deviation) [% 10 yr Risk]	28.9 (15.5)	28.4 (18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.74
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -2.4 to 1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

10. Secondary Outcome

Title	Medication Non-adherence
Description	First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	210	211
Number [participants]	137 63.7%	110 51.6%

11. Secondary Outcome

Title	Medication Non-adherence
Description	First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	187	195
Number [participants]	92 42.8%	85 39.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	Gen. Est. Equation with a Logit Link
	Comments	Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	logit-difference (Net)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

12. Secondary Outcome

Title	Medication Non-adherence
Description	First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	180	189
Number [participants]	96 44.7%	82 38.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.36
	Comments
	Method	Gen. Est. Equation with a Logit Link
	Comments	Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	logit-difference (Net)
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

13. Secondary Outcome

Title	Cholesterol LDL
Description	Collected during interview visit by lab personnel
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	211	211
Mean (Standard Deviation) [mg/dL]	125.5 (37.3)	123.9 (36.2)

14. Secondary Outcome

Title	Cholesterol LDL
Description	Collected during interview visit by lab personnel
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	186	191
Mean (Standard Deviation) [mg/dL]	114.9 (34.9)	118.9 (34.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.9
	Confidence Interval	(2-Sided) 95%; -10.3 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

15. Secondary Outcome

Title	Cholesterol LDL
Description	Collected during interview visit by lab personnel
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	181	186
Mean (Standard Deviation) [mg/dL]	114.4 (36.8)	115.3 (34.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -6.6 to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

16. Secondary Outcome

Title	Body Mass Index
Description	Calculated from vitals (height & weight) obtained during interview
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	210	212
Mean (Standard Deviation) [kg/m^2]	31.9 (5.8)	31.6 (5.7)

17. Secondary Outcome

Title	Body Mass Index
Description	Calculated from vitals (height & weight) obtained during interview
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	185	190
Mean (Standard Deviation) [kg/m^2]	32.1 (6.3)	31.5 (5.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.83
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.2 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

18. Secondary Outcome

Title	Body Mass Index
Description	Calculated from vitals (height & weight) obtained during interview
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	176	182
Mean (Standard Deviation) [kg/m^2]	31.9 (6.0)	31.6 (5.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.54
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender, diabetes, and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

19. Secondary Outcome

Title	HBA1C in Diabetic Patients
Description	Lab values collected at interview visit by lab personnel
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	81	84
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	8.0 (2.3)	7.6 (1.7)

20. Secondary Outcome

Title	HBA1C in Diabetic Patients
Description	Lab values collected at interview visit by lab personnel
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	73	75
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	7.5 (1.8)	7.7 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 6 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -0.6 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

21. Secondary Outcome

Title	HBA1C in Diabetic Patients
Description	Lab values collected at interview visit by lab personnel
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.

Arm/Group Title	Pharmacist CVD	Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.	The education control group - these participants will receive educational material about CVD reduction.
Measure Participants	71	71
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	7.5 (1.8)	7.7 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pharmacist CVD, Education Control
	Comments	Comparison at 12 months
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	Mixed Models Analysis
	Comments	Adjusted for gender and smoking status stratification variables
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Direction of the test of comparison is Pharmacist Intervention minus Control

Adverse Events

Time Frame	Adverse events were collected through out the study from baseline thru completion.
Adverse Event Reporting Description	Adverse events information was collected by questionnaire from patients at 6 month and 12 month outcome assessments. Adverse event information was also collected from patients through contact with the Pharmacist interventionist or if during updating of clinical records it was discovered that an adverse event had occurred with a patient.
Arm/Group Title	Pharmacist CVD		Education Control
Arm/Group Description	The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.		The education control group - these participants will receive educational material about CVD reduction.
All Cause Mortality
	Pharmacist CVD		Education Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pharmacist CVD		Education Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	126/215 (58.6%)		123/213 (57.7%)
Blood and lymphatic system disorders
Non_Cardiac Pain	1/215 (0.5%)	2	0/213 (0%)	2
Emergecy Room Visit	2/215 (0.9%)	2	0/213 (0%)	2
Cardiac disorders
Coronary Issues	3/215 (1.4%)	4	7/213 (3.3%)	8
Emergency room visit	21/215 (9.8%)	34	15/213 (7%)	15
Non_Cardiac Pain	2/215 (0.9%)	2	0/213 (0%)	2
Orthopedic	1/215 (0.5%)	1	0/213 (0%)	1
Planned Surgery	0/215 (0%)		2/213 (0.9%)	2
Study Safety Protocol	10/215 (4.7%)	10	13/213 (6.1%)	16
Ear and labyrinth disorders
Emergency room visit	3/215 (1.4%)	3	4/213 (1.9%)	6
Infection	0/215 (0%)		1/213 (0.5%)	1
Non_Cardiac Pain	1/215 (0.5%)	1	0/213 (0%)	1
Endocrine disorders
Death	0/215 (0%)		1/213 (0.5%)	1
Emergency room visit	4/215 (1.9%)	7	9/213 (4.2%)	13
Endocrine	2/215 (0.9%)	2	1/213 (0.5%)	1
Non_Cardiac Pain	1/215 (0.5%)	1	0/213 (0%)	1
Eye disorders
Emergency room visit	1/215 (0.5%)	1	5/213 (2.3%)	6
Optometry	0/215 (0%)		2/213 (0.9%)	3
Planned Surgery	0/215 (0%)		1/213 (0.5%)	1
Gastrointestinal disorders
Emergency room visit	18/215 (8.4%)	21	13/213 (6.1%)	16
Gastro_Intestinal	0/215 (0%)		1/213 (0.5%)	1
Planned Surgery	0/215 (0%)		1/213 (0.5%)	1
General disorders
Allergic Reaction (non_med SE)	1/215 (0.5%)	1	0/213 (0%)	1
Death	0/215 (0%)		2/213 (0.9%)	2
Emergency room visit	14/215 (6.5%)	23	21/213 (9.9%)	22
Medication Refill	1/215 (0.5%)	1	1/213 (0.5%)	1
Neurologic	1/215 (0.5%)	2	0/213 (0%)	2
Non_Cardiac Pain	2/215 (0.9%)	2	2/213 (0.9%)	4
Planned Surgery	2/215 (0.9%)	2	0/213 (0%)	2
Psychological	1/215 (0.5%)	1	0/213 (0%)	1
Infections and infestations
Emergency room visit	22/215 (10.2%)	22	5/213 (2.3%)	6
Gastro_Intestinal	0/215 (0%)		1/213 (0.5%)	1
Infection	6/215 (2.8%)	8	2/213 (0.9%)	2
Medication Refill	0/215 (0%)		1/213 (0.5%)	1
Injury, poisoning and procedural complications
Emergency room visit	3/215 (1.4%)	4	1/213 (0.5%)	3
Non_Cardiac Pain	1/215 (0.5%)	1	0/213 (0%)	1
Investigations
Protocol Deviation	2/215 (0.9%)	2	0/213 (0%)	2
Study Safety Protocol	2/215 (0.9%)	2	0/213 (0%)	2
Metabolism and nutrition disorders
Emergency room visit	1/215 (0.5%)	1	0/213 (0%)	1
Musculoskeletal and connective tissue disorders
Circulatory	1/215 (0.5%)	1	0/213 (0%)	1
Emergency room visit	27/215 (12.6%)	37	30/213 (14.1%)	44
Endocrine	1/215 (0.5%)	1	0/213 (0%)	1
Neurologic	1/215 (0.5%)	1	0/213 (0%)	1
Non_Cardiac Pain	5/215 (2.3%)	8	3/213 (1.4%)	3
Orthopedic	3/215 (1.4%)	3	4/213 (1.9%)	4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death	0/215 (0%)		1/213 (0.5%)	1
Dermatologic	2/215 (0.9%)	2	1/213 (0.5%)	1
Emergency room visit	0/215 (0%)		1/213 (0.5%)	1
Protocol Deviation	1/215 (0.5%)	1	0/213 (0%)	1
Nervous system disorders
Coronary issues	0/215 (0%)		1/213 (0.5%)	1
Emergency room visit	2/215 (0.9%)	2	2/213 (0.9%)	2
Neurologic	1/215 (0.5%)	1	3/213 (1.4%)	3
Non_Cardiac Pain	1/215 (0.5%)	1	0/213 (0%)	1
Psychiatric disorders
Emergency room visit	5/215 (2.3%)	7	5/213 (2.3%)	5
Medication Refill	1/215 (0.5%)	1	0/213 (0%)	1
Non_Cardiac Pain	1/215 (0.5%)	2	0/213 (0%)	2
Psychological	4/215 (1.9%)	4	4/213 (1.9%)	4
Renal and urinary disorders
Emergency room visit	4/215 (1.9%)	5	5/213 (2.3%)	5
Endocrine	1/215 (0.5%)	1	0/213 (0%)	1
Non_Cardiac Pain	1/215 (0.5%)	1	0/213 (0%)	1
Planned Surgery	1/215 (0.5%)	1	0/213 (0%)	1
Reproductive system and breast disorders
Non_Cardiac Pain	0/215 (0%)		1/213 (0.5%)	1
Emergency room visit	3/215 (1.4%)	4	0/213 (0%)	4
Respiratory, thoracic and mediastinal disorders
Death	1/215 (0.5%)	1	0/213 (0%)	1
Emergency room visit	16/215 (7.4%)	21	12/213 (5.6%)	14
Infection	1/215 (0.5%)	3	1/213 (0.5%)	1
Pulmonary	2/215 (0.9%)	3	3/213 (1.4%)	3
Skin and subcutaneous tissue disorders
Dermatologic	1/215 (0.5%)	1	2/213 (0.9%)	3
Emergency room visit	5/215 (2.3%)	7	6/213 (2.8%)	8
Infection	0/215 (0%)		3/213 (1.4%)	3
Social circumstances
Emergency room visit	0/215 (0%)		1/213 (0.5%)	1
Surgical and medical procedures
Coronary issues	1/215 (0.5%)	1	1/213 (0.5%)	1
Emergency room visit	2/215 (0.9%)	2	1/213 (0.5%)	2
Gastro_Intestinal	0/215 (0%)		1/213 (0.5%)	1
Infection	0/215 (0%)		1/213 (0.5%)	1
Orthopedic	3/215 (1.4%)	3	1/213 (0.5%)	1
Planned Surgery	18/215 (8.4%)	19	9/213 (4.2%)	10
Pulmonary	1/215 (0.5%)	1	0/213 (0%)	1
Vascular disorders
Circulatory	1/215 (0.5%)	1	0/213 (0%)	1
Coronary issues	1/215 (0.5%)	1	1/213 (0.5%)	1
Emergency room visit	1/215 (0.5%)	2	3/213 (1.4%)	3
Neurologic	1/215 (0.5%)	1	1/213 (0.5%)	1
Planned Surgery	1/215 (0.5%)	1	1/213 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Pharmacist CVD		Education Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/215 (0%)		0/213 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.