Trial Outcomes & Findings for Titrated Disease Management for Patients With Hypertension (NCT NCT01390272)

Last Updated: 2019-02-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

385 participants

Primary outcome timeframe

6 months

Results posted on

2019-02-11

Participant Flow

The study was conducted among patients receiving primary care at the Durham VAMC, including VA Community Based Outpatient Clinics (CBOC).

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	192	193
Overall Study 6 Month Follow up	162	171
Overall Study 12 Month Follow up	139	159
Overall Study 18 Month Follow up	155	160
Overall Study COMPLETED	175	178
Overall Study NOT COMPLETED	17	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	3	2
Overall Study Withdrawal by Subject	9	5
Overall Study Patient moved, no longer eligible	5	8

Baseline Characteristics

Titrated Disease Management for Patients With Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Titration Intervention n=192 Participants 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.	LPN Control n=193 Participants 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.	Total n=385 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 9.0 • n=93 Participants	62.9 years STANDARD_DEVIATION 8.5 • n=4 Participants	63.5 years STANDARD_DEVIATION 8.8 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	13 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	176 Participants n=93 Participants	180 Participants n=4 Participants	356 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Titration Intervention n=192 Participants 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.	LPN Control n=193 Participants 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.
Systolic Blood Pressure	143.5 mmHg Standard Deviation 17.7	143.7 mmHg Standard Deviation 17.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=162 Participants 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.	LPN Control n=171 Participants 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.
Systolic Blood Pressure	137.1 mmHg Standard Deviation 17.7	140.3 mmHg Standard Deviation 18.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=139 Participants 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.	LPN Control n=159 Participants 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.
Systolic Blood Pressure	135.9 mmHg Standard Deviation 15.7	138.4 mmHg Standard Deviation 17.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=155 Participants 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.	LPN Control n=160 Participants 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.
Systolic Blood Pressure	136.1 mmHg Standard Deviation 17.6	138.0 mmHg Standard Deviation 18.5

SECONDARY outcome

Timeframe: Baseline

Population: Mean systolic blood pressure in control (units: participants)

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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=192 Participants 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.	LPN Control n=193 Participants 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.
Number of Participants With Hypertension Control	47 Participants	43 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Titration Intervention n=162 Participants 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.	LPN Control n=171 Participants 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.
Number of Participants With Hypertension Control	66 Participants	63 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=139 Participants 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.	LPN Control n=159 Participants 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.
Number of Participants With Hypertension Control	58 Participants	67 Participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Titration Intervention n=155 Participants 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.	LPN Control n=160 Participants 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.
Number of Participants With Hypertension Control	84 Participants	69 Participants

SECONDARY outcome

Timeframe: Over 18 months of study intervention

Population: Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis is not appropriate.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: The numbers in the descriptive tables reflect #non-adherent.

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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=192 Participants 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.	LPN Control n=193 Participants 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.
Number of Participants Who Did Not Achieve Medication Adherence	82 Participants	82 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=162 Participants 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.	LPN Control n=172 Participants 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.
Number of Participants Who Did Not Achieve Medication Adherence	62 Participants	69 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=139 Participants 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.	LPN Control n=159 Participants 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.
Number of Participants Who Did Not Achieve Medication Adherence	61 Participants	59 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Titration Intervention n=155 Participants 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.	LPN Control n=160 Participants 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.
Number of Participants Who Did Not Achieve Medication Adherence	73 Participants	68 Participants

Adverse Events

Titration Intervention

Serious events: 40 serious events

Other events: 117 other events

Deaths: 3 deaths

LPN Control

Serious events: 9 serious events

Other events: 112 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Titration Intervention n=192 participants at risk 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.	LPN Control n=193 participants at risk 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.
Cardiac disorders ER Visit	6.8% 13/192 • Number of events 15 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	7.8% 15/193 • Number of events 25 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Gastrointestinal disorders ER Visit	4.7% 9/192 • Number of events 9 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	3.1% 6/193 • Number of events 7 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
General disorders ER Visit	10.4% 20/192 • Number of events 24 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	11.4% 22/193 • Number of events 31 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Infections and infestations ER Visit	8.9% 17/192 • Number of events 20 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	10.9% 21/193 • Number of events 31 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Injury, poisoning and procedural complications ER Visit	6.8% 13/192 • Number of events 14 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	1.0% 2/193 • Number of events 2 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Musculoskeletal and connective tissue disorders ER Visit	10.4% 20/192 • Number of events 31 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	13.5% 26/193 • Number of events 39 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Respiratory, thoracic and mediastinal disorders ER Visit	2.1% 4/192 • Number of events 4 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	4.7% 9/193 • Number of events 12 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Cardiac disorders Hospitalization Other	5.7% 11/192 • Number of events 11 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	5.7% 11/193 • Number of events 19 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Surgical and medical procedures Hospitalization Other	5.7% 11/192 • Number of events 12 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	5.7% 11/193 • Number of events 13 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.

Additional Information

Dr. George Lee Jackson, PhD MHA

Durham VA Medical Center, Durham, NC

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Titration Intervention n=192 participants at risk 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.	LPN Control n=193 participants at risk 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.
Renal and urinary disorders ER Visit	0.00% 0/192 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.52% 1/193 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Infections and infestations ER Visit	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.52% 1/193 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Cardiac disorders ER Visit	1.6% 3/192 • Number of events 4 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Endocrine disorders ER Visit	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Cardiac disorders Heart Attack	1.6% 3/192 • Number of events 4 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Cardiac disorders Hospitalization Other	3.1% 6/192 • Number of events 7 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	1.6% 3/193 • Number of events 3 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Blood and lymphatic system disorders Hospitalization Other	0.00% 0/192 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.52% 1/193 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Gastrointestinal disorders Hospitalization Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.52% 1/193 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
General disorders Hospitalization Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Infections and infestations Hospitalization Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.52% 1/193 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Injury, poisoning and procedural complications Hospitalization Other	1.0% 2/192 • Number of events 2 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Musculoskeletal and connective tissue disorders Hospitalization Other	1.0% 2/192 • Number of events 2 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization Other	1.0% 2/192 • Number of events 2 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Renal and urinary disorders Hospitalization Other	1.0% 2/192 • Number of events 3 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Respiratory, thoracic and mediastinal disorders Hospitalization Other	1.0% 2/192 • Number of events 2 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Surgical and medical procedures Hospitalization Other	3.6% 7/192 • Number of events 10 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Vascular disorders Hospitalization Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Cardiac disorders Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.52% 1/193 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other	1.0% 2/192 • Number of events 2 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Hepatobiliary disorders Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.
Vascular disorders Other	0.52% 1/192 • Number of events 1 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.	0.00% 0/193 • 18 months It is expected that these patients will have a variety of episodes related to cardiovascular and related diseases such as diabetes, age, smoking and drinking. These may include, but are not limited to, heart attack, stroke, and complications of diabetes among those patients with the disease, the diagnosis of cancer and dementia, development of disease of the lung or liver.