N/A N=385 Randomized Health Services Research

Titrated Disease Management for Patients With Hypertension

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01390272 ↗

Enrolled (actual)

385

Serious AEs

12.7%

Results posted

Feb 2019

Primary outcome: Primary: Systolic Blood Pressure — 143.5; 143.7 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Booster/ low resource (Behavioral); Medium/Level 1 resource intensity (Behavioral); High/Level 2 resource intensity (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Systolic Blood Pressure	136.1; 138.0	0.43
PRIMARY Systolic Blood Pressure	136.1; 138.0	0.43
PRIMARY Systolic Blood Pressure	136.1; 138.0	0.43
PRIMARY Systolic Blood Pressure	136.1; 138.0	0.43
SECONDARY Number of Participants With Hypertension Control	84; 69	0.09
SECONDARY Number of Participants With Hypertension Control	84; 69	0.09
SECONDARY Number of Participants With Hypertension Control	84; 69	0.09
SECONDARY Number of Participants With Hypertension Control	84; 69	0.09
SECONDARY Cost Effectiveness	—	—
SECONDARY Number of Participants Who Did Not Achieve Medication Adherence	73; 68	0.30
SECONDARY Number of Participants Who Did Not Achieve Medication Adherence	73; 68	0.30
SECONDARY Number of Participants Who Did Not Achieve Medication Adherence	73; 68	0.30
SECONDARY Number of Participants Who Did Not Achieve Medication Adherence	73; 68	0.30

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01390272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.