Cardiovascular Disease, Diabetes, Hyperlipidemia, Hypertension
Conditions
Keywords
Cardiovascular Disease, Hypertension, Diabetes, Hyperlipidemia, Adherence
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.
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. 2. 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.
Interventions
clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diastolic Blood Pressure | Baseline | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews |
| 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. |
| Mean Systolic Blood Pressure | Baseline | Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews |
| Body Mass Index | Baseline | Calculated from vitals (height & weight) obtained during interview |
| HBA1C in Diabetic Patients | Baseline | Lab values collected at interview visit by lab personnel |
| Cholesterol LDL | Baseline | Collected during interview visit by lab personnel |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist CVD The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months. | 215 |
| Education Control The education control group - these participants will receive educational material about CVD reduction. | 213 |
| Total | 428 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 4 |
| Overall Study | Excluded - did not meet criteria | 9 | 5 |
| Overall Study | Lost to Follow-up | 19 | 13 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Pharmacist CVD | Education Control | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 8.4 | 61.5 years STANDARD_DEVIATION 8.9 | 61.2 years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Black | 111 participants | 102 participants | 213 participants |
| Race/Ethnicity, Customized Other | 10 participants | 4 participants | 14 participants |
| Race/Ethnicity, Customized Refused/Missing | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 93 participants | 106 participants | 199 participants |
| Region of Enrollment United States | 215 participants | 213 participants | 428 participants |
| Sex: Female, Male Female | 33 Participants | 32 Participants | 65 Participants |
| Sex: Female, Male Male | 182 Participants | 181 Participants | 363 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 215 | 0 / 213 |
| serious Total, serious adverse events | 126 / 215 | 123 / 213 |
Outcome results
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | 28.9 % 10 yr Risk | Standard Deviation 15.5 |
| Education Control | Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | 28.4 % 10 yr Risk | Standard Deviation 18.3 |
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | 32.4 % 10 yr Risk | Standard Deviation 18.8 |
| Education Control | Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | 31.6 % 10 yr Risk | Standard Deviation 18.6 |
Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | 30.0 % 10 yr Risk | Standard Deviation 17.2 |
| Education Control | Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) | 30.2 % 10 yr Risk | Standard Deviation 18.7 |
Body Mass Index
Calculated from vitals (height & weight) obtained during interview
Time frame: 12 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Body Mass Index | 31.9 kg/m^2 | Standard Deviation 6 |
| Education Control | Body Mass Index | 31.6 kg/m^2 | Standard Deviation 5.7 |
Body Mass Index
Calculated from vitals (height & weight) obtained during interview
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Body Mass Index | 32.1 kg/m^2 | Standard Deviation 6.3 |
| Education Control | Body Mass Index | 31.5 kg/m^2 | Standard Deviation 5.4 |
Body Mass Index
Calculated from vitals (height & weight) obtained during interview
Time frame: Baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Body Mass Index | 31.9 kg/m^2 | Standard Deviation 5.8 |
| Education Control | Body Mass Index | 31.6 kg/m^2 | Standard Deviation 5.7 |
Cholesterol LDL
Collected during interview visit by lab personnel
Time frame: 12 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Cholesterol LDL | 114.4 mg/dL | Standard Deviation 36.8 |
| Education Control | Cholesterol LDL | 115.3 mg/dL | Standard Deviation 34 |
Cholesterol LDL
Collected during interview visit by lab personnel
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Cholesterol LDL | 114.9 mg/dL | Standard Deviation 34.9 |
| Education Control | Cholesterol LDL | 118.9 mg/dL | Standard Deviation 34.3 |
Cholesterol LDL
Collected during interview visit by lab personnel
Time frame: Baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Cholesterol LDL | 125.5 mg/dL | Standard Deviation 37.3 |
| Education Control | Cholesterol LDL | 123.9 mg/dL | Standard Deviation 36.2 |
HBA1C in Diabetic Patients
Lab values collected at interview visit by lab personnel
Time frame: 12 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | HBA1C in Diabetic Patients | 7.5 percentage of glycosylated hemoglobin | Standard Deviation 1.8 |
| Education Control | HBA1C in Diabetic Patients | 7.7 percentage of glycosylated hemoglobin | Standard Deviation 1.7 |
HBA1C in Diabetic Patients
Lab values collected at interview visit by lab personnel
Time frame: Baseline
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | HBA1C in Diabetic Patients | 8.0 percentage of glycosylated hemoglobin | Standard Deviation 2.3 |
| Education Control | HBA1C in Diabetic Patients | 7.6 percentage of glycosylated hemoglobin | Standard Deviation 1.7 |
HBA1C in Diabetic Patients
Lab values collected at interview visit by lab personnel
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | HBA1C in Diabetic Patients | 7.5 percentage of glycosylated hemoglobin | Standard Deviation 1.8 |
| Education Control | HBA1C in Diabetic Patients | 7.7 percentage of glycosylated hemoglobin | Standard Deviation 1.8 |
Mean Diastolic Blood Pressure
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time frame: 12 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Mean Diastolic Blood Pressure | 73.4 mmHg | Standard Deviation 10.3 |
| Education Control | Mean Diastolic Blood Pressure | 73.1 mmHg | Standard Deviation 10.9 |
Mean Diastolic Blood Pressure
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Mean Diastolic Blood Pressure | 74.0 mmHg | Standard Deviation 11 |
| Education Control | Mean Diastolic Blood Pressure | 74.1 mmHg | Standard Deviation 11.9 |
Mean Diastolic Blood Pressure
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time frame: Baseline
Population: One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Mean Diastolic Blood Pressure | 75.8 mmHg | Standard Deviation 11.5 |
| Education Control | Mean Diastolic Blood Pressure | 75.8 mmHg | Standard Deviation 12.4 |
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time frame: Baseline
Population: One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Mean Systolic Blood Pressure | 130.6 mmHg | Standard Deviation 18.5 |
| Education Control | Mean Systolic Blood Pressure | 129.7 mmHg | Standard Deviation 18.8 |
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time frame: 12 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Mean Systolic Blood Pressure | 128.5 mmHg | Standard Deviation 15.4 |
| Education Control | Mean Systolic Blood Pressure | 126.4 mmHg | Standard Deviation 16.2 |
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews
Time frame: 6 months
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist CVD | Mean Systolic Blood Pressure | 128.3 mmHg | Standard Deviation 16.5 |
| Education Control | Mean Systolic Blood Pressure | 127.7 mmHg | Standard Deviation 16.8 |
Medication Non-adherence
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacist CVD | Medication Non-adherence | 92 participants |
| Education Control | Medication Non-adherence | 85 participants |
Medication Non-adherence
First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.
Time frame: Baseline
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacist CVD | Medication Non-adherence | 137 participants |
| Education Control | Medication Non-adherence | 110 participants |
Medication Non-adherence
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacist CVD | Medication Non-adherence | 96 participants |
| Education Control | Medication Non-adherence | 82 participants |