Hypertension
Conditions
Keywords
Hypertension, Telephone, Disease Management, Veterans, Pharmacists, Nurses
Brief summary
This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.
Detailed description
Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (\>/=140 mmHg for non-diabetic or \>/=130 mmHg for diabetic patients). The primary aim will be to compare two treatment arms/strategies in terms of impact on systolic BP control: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN) will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).
Interventions
BEHAVIORALBooster/ low resource
A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
BEHAVIORALMedium/Level 1 resource intensity
Monthly tailored RN delivered calls + home BP monitoring.
BEHAVIORALHigh/Level 2 resource intensity
Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years. * Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)). * Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year. * Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for \>= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other. * Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements \>= 150 mmHg for non-diabetic or \>= 140 mmHg for diabetic patients over the last year and last systolic BP measurement \>= 140 mmHg for non-diabetic or \>= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of \>= 140 mmHg or diabetic patients with mean outpatient systolic BP of \>= 130 mmHg over the past year may be approached. Patients must indicate that they both: * Have a VA or affiliated clinic provider that they consider to be their main PCP. * Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).
Exclusion criteria
* Active diagnosis of psychosis. * Diagnosis of metastatic cancer. * Type 1 diabetes * Class IV congestive heart failure (CHF). * Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are \<= 15. * Chronic obstructive pulmonary disease (COPD) requiring oxygen. * Resident in nursing home or receiving home healthcare. * Patient is pregnant or reports planning to become pregnant in the next two years * At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial. * Planning to leave the area prior to the anticipated end of participation. * Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits. * Does not have reasonable access to a telephone. * Does not speak English. * Severely impaired hearing or speech (Patients must be able to respond to phone calls.). * Severely impaired vision (Patients must be able to read mailed material). * Refusal or inability to provide informed consent and HIPAA authorization form. * Arm size \> 50 cm * Unable to obtain (including by arm) valid blood pressure readings * Inadequate mental status to complete the protocol, as judged by five or more errors on the Short Portable Mental Status Questionnaire (SPMSQ). * Former, current or pending solid organ or bone marrow transplant patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Baseline | Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hypertension Control | Baseline | The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP \< 130mmHg for hypertensive patients with diabetes and \< 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit. |
| Cost Effectiveness | Over 18 months of study intervention | One of our secondary research questions was: If the intervention results in greater reduction in SBP than the control group, is it cost effective? Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate. While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs. |
| Number of Participants Who Did Not Achieve Medication Adherence | Baseline | The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items: * Do you ever forget to take your blood pressure medicine? * Are you careless at times about taking your blood pressure medicine? * When you feel better do you sometimes stop taking you blood pressure medicine? * Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer. A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent. |
Countries
United States
Participant flow
Recruitment details
The study was conducted among patients receiving primary care at the Durham VAMC, including VA Community Based Outpatient Clinics (CBOC).
Participants by arm
| Arm | Count |
|---|---|
| Titration Intervention The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) \[top number of blood pressure measurement\].
Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring.
High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management.
Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.
Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months. | 192 |
| LPN Control A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.
Booster/ low resource: A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months. | 193 |
| Total | 385 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 2 |
| Overall Study | Patient moved, no longer eligible | 5 | 8 |
| Overall Study | Withdrawal by Subject | 9 | 5 |
Baseline characteristics
| Characteristic | Titration Intervention | LPN Control | Total |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 9 | 62.9 years STANDARD_DEVIATION 8.5 | 63.5 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 176 Participants | 180 Participants | 356 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 192 | 2 / 193 |
| other Total, other adverse events | 117 / 192 | 112 / 193 |
| serious Total, serious adverse events | 40 / 192 | 9 / 193 |
Outcome results
Primary
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.
Time frame: 18 months
Population: 37 out of the 192 participants in the Titration Intervention group and 33 out of the 193 in the LPN control group had missing blood pressure measurement at 18 months due to not completing the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Titration Intervention | Systolic Blood Pressure | 136.1 mmHg | Standard Deviation 17.6 |
| LPN Control | Systolic Blood Pressure | 138.0 mmHg | Standard Deviation 18.5 |
p-value: 0.4395% CI: [-5.6, 2.4]Mixed Models Analysis
Primary
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.
Time frame: 12 months
Population: Analysis Population Description: Analysis Population Description: 53 out of the 192 participants in the Titration Intervention group and 34 out of the 193 in the LPN control group had missing blood pressure measurement at 12 months due to not completing the assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Titration Intervention | Systolic Blood Pressure | 135.9 mmHg | Standard Deviation 15.7 |
| LPN Control | Systolic Blood Pressure | 138.4 mmHg | Standard Deviation 17.5 |
p-value: 0.595% CI: [-4.9, 2.4]Mixed Models Analysis
Primary
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.
Time frame: 6 months
Population: 30 out of the 192 participants in the Titration Intervention group and 22 out of the 193 in the LPN control group had missing blood pressure measurement at 6 months due to not completing the assessment. One additional participant in the LPN control had missing blood pressure measurement at 6 months due to not being able to get a reading.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Titration Intervention | Systolic Blood Pressure | 137.1 mmHg | Standard Deviation 17.7 |
| LPN Control | Systolic Blood Pressure | 140.3 mmHg | Standard Deviation 18 |
p-value: 0.2695% CI: [-5.9, 1.6]Mixed Models Analysis
Primary
Systolic Blood Pressure
Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Titration Intervention | Systolic Blood Pressure | 143.5 mmHg | Standard Deviation 17.7 |
| LPN Control | Systolic Blood Pressure | 143.7 mmHg | Standard Deviation 17.5 |
Secondary
Cost Effectiveness
One of our secondary research questions was: If the intervention results in greater reduction in SBP than the control group, is it cost effective? Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate. While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs.
Time frame: Over 18 months of study intervention
Population: Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis is not appropriate.
Secondary
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items: * Do you ever forget to take your blood pressure medicine? * Are you careless at times about taking your blood pressure medicine? * When you feel better do you sometimes stop taking you blood pressure medicine? * Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer. A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent.
Time frame: 18 months
Population: 37 out of the 192 participants in the Titration Intervention group and 33 out of the 193 in the LPN control group had missing medication adherence at 18 months due to not completing the assessment.~The numbers in the descriptive tables reflect #non-adherent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants Who Did Not Achieve Medication Adherence | 73 Participants |
| LPN Control | Number of Participants Who Did Not Achieve Medication Adherence | 68 Participants |
Comparison: Comparison at 18 monthsp-value: 0.395% CI: [0.8, 1.9]Generalized Estimating Equation
Secondary
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items: * Do you ever forget to take your blood pressure medicine? * Are you careless at times about taking your blood pressure medicine? * When you feel better do you sometimes stop taking you blood pressure medicine? * Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer. A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent.
Time frame: 12 months
Population: 53 out of the 192 participants in the Titration Intervention group and 34 out of the 193 in the LPN control group had missing medication adherence at 12 months due to not completing the assessment.~The numbers in the descriptive tables reflect #non-adherent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants Who Did Not Achieve Medication Adherence | 61 Participants |
| LPN Control | Number of Participants Who Did Not Achieve Medication Adherence | 59 Participants |
Comparison: Comparison at 12 monthsp-value: 0.1295% CI: [0.9, 2.1]Generalized Estimating Equation
Secondary
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items: * Do you ever forget to take your blood pressure medicine? * Are you careless at times about taking your blood pressure medicine? * When you feel better do you sometimes stop taking you blood pressure medicine? * Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer. A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent.
Time frame: 6 months
Population: 30 out of the 192 participants in the Titration Intervention group and 21 out of the 193 in the LPN control group had missing medication adherence at 6 months due to not completing the assessment.~The numbers in the descriptive tables reflect #non-adherent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants Who Did Not Achieve Medication Adherence | 62 Participants |
| LPN Control | Number of Participants Who Did Not Achieve Medication Adherence | 69 Participants |
p-value: 0.9595% CI: [0.7, 1.5]Generalized Estimating Equation
Secondary
Number of Participants Who Did Not Achieve Medication Adherence
The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items: * Do you ever forget to take your blood pressure medicine? * Are you careless at times about taking your blood pressure medicine? * When you feel better do you sometimes stop taking you blood pressure medicine? * Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer. A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence. The numbers in the descriptive tables reflect number non-adherent.
Time frame: Baseline
Population: The numbers in the descriptive tables reflect #non-adherent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants Who Did Not Achieve Medication Adherence | 82 Participants |
| LPN Control | Number of Participants Who Did Not Achieve Medication Adherence | 82 Participants |
Secondary
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP \< 130mmHg for hypertensive patients with diabetes and \< 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6-month study visit.
Time frame: 6 months
Population: 30 out of the 192 participants in the Titration Intervention group and 22 out of the 193 in the LPN control group had missing blood pressure measurement at 6 months due to not completing the assessment. One additional participant in the LPN control had missing blood pressure measurement at 6 months due to not being able to get a reading.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants With Hypertension Control | 66 Participants |
| LPN Control | Number of Participants With Hypertension Control | 63 Participants |
Comparison: Comparison at 6 monthsp-value: 0.8395% CI: [0.7, 1.6]Generalized Estimating Equation
Secondary
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP \< 130mmHg for hypertensive patients with diabetes and \< 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit.
Time frame: Baseline
Population: Mean systolic blood pressure in control (units: participants)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants With Hypertension Control | 47 Participants |
| LPN Control | Number of Participants With Hypertension Control | 43 Participants |
Secondary
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP \< 130mmHg for hypertensive patients with diabetes and \< 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 12-study visit.
Time frame: 12 months
Population: 53 out of the 192 participants in the Titration Intervention group and 34 out of the 193 in the LPN control group had missing blood pressure measurement at 12 months due to not completing the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants With Hypertension Control | 58 Participants |
| LPN Control | Number of Participants With Hypertension Control | 67 Participants |
Comparison: Comparison at 12 monthsp-value: 0.5395% CI: [0.5, 1.4]Generalized Estimating Equation
Secondary
Number of Participants With Hypertension Control
The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP \< 130mmHg for hypertensive patients with diabetes and \< 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visit.
Time frame: 18 months
Population: 37 out of the 192 participants in the Titration Intervention group and 33 out of the 193 in the LPN control group had missing blood pressure measurement at 18 months due to not completing the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Titration Intervention | Number of Participants With Hypertension Control | 84 Participants |
| LPN Control | Number of Participants With Hypertension Control | 69 Participants |
Comparison: Comparison at 18 months.p-value: 0.0995% CI: [0.9, 2.3]Generalized Estimating Equation