Clinical trial NCT01390272: Titrated Disease Management for Patients With Hypertension
Official title: Randomized Trial of Titrated Disease Management for Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Telephone
Disease Management
Veterans
Pharmacists
Nurses
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-07-11
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Systolic Blood Pressure
timeFrame: 6 months
measure: Systolic Blood Pressure
timeFrame: 12 months
measure: Systolic Blood Pressure
timeFrame: 18 months
Secondary outcomes:
measure: Number of Participants With Hypertension Control
timeFrame: Baseline
measure: Number of Participants With Hypertension Control
timeFrame: 6 months
measure: Number of Participants With Hypertension Control
timeFrame: 12 months
measure: Number of Participants With Hypertension Control
timeFrame: 18 months
measure: Cost Effectiveness
timeFrame: Over 18 months of study intervention
measure: Number of Participants Who Did Not Achieve Medication Adherence
timeFrame: Baseline
measure: Number of Participants Who Did Not Achieve Medication Adherence
timeFrame: 6 months
measure: Number of Participants Who Did Not Achieve Medication Adherence
timeFrame: 12 months
measure: Number of Participants Who Did Not Achieve Medication Adherence
timeFrame: 18 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: George L Jackson, PhD MHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.
citation: Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Mil Med. 2018 Sep 1;183(9-10):e583-e588. doi: 10.1093/milmed/usx111.