Titrated Disease Management for Patients With Hypertension (TDM)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01390272
First received: July 6, 2011
Last updated: August 4, 2014
Last verified: August 2014

July 6, 2011
August 4, 2014
July 2012
December 2014   (final data collection date for primary outcome measure)
Change in systolic blood pressure [ Time Frame: Over 18 months of study intervention ] [ Designated as safety issue: No ]
Will the titrated disease management protocol result in reduced systolic blood pressure over 18-months, compared to LPN-delivered behavioral support phone calls occurring every two months [control arm]?
Same as current
Complete list of historical versions of study NCT01390272 on ClinicalTrials.gov Archive Site
  • Hypertension Control [ Time Frame: At 18 months after start of study intervention ] [ Designated as safety issue: No ]
    Will the titrated disease management protocol result in improved SBP control at 18-months, compared to LPN-delivered behavioral support phone calls occurring every two months [control arm]?
  • Cost Effectiveness [ Time Frame: Over 18 months of study intervention ] [ Designated as safety issue: No ]
    If the intervention results in greater reduction in SBP than the control group, is it cost effective?
  • Medication Adherence [ Time Frame: Over 18 months of study intervention ] [ Designated as safety issue: No ]
    Will a titrated disease management result in better medication adherence compared to the control arm?
Same as current
Not Provided
Not Provided
 
Titrated Disease Management for Patients With Hypertension
Randomized Trial of Titrated Disease Management for Patients With Hypertension

This randomized clinical trial will examine 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.

Project Objectives: The study seeks to determine whether a titrated disease management program based on clinically reasonable titration criteria leads to better outcomes than a low-intensity strategy involving non-tailored behavioral telephone calls. We will assess the intervention by comparing change in systolic blood pressure for patients in the intervention and control arms. We will also examine medication adherence and potential cost-effectiveness.

Project Methods: We will conduct a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic blood pressure is not controlled ( >=140 mmHg for non-diabetic or >=130mmHg 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: a registered nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring; 2) High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and 3) Booster (low) resource intensity: a licensed practical 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 component of the titrated intervention).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Hypertension
  • Behavioral: Booster/ low resource
    A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
    Other Name: Control Arm - Low resource
  • Behavioral: Booster/ low resource
    A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
    Other Name: Intervention Arm - Booster
  • Behavioral: Medium/Level 1 resource intensity
    Monthly tailored RN delivered calls + home BP monitoring.
    Other Name: Intervention Arm - Level 1
  • Behavioral: High/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).
    Other Name: Intervention Arm - Level 2
  • Experimental: Arm 1

    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.

    Interventions:
    • Behavioral: Booster/ low resource
    • Behavioral: Medium/Level 1 resource intensity
    • Behavioral: High/Level 2 resource intensity
  • Active Comparator: Arm 2
    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.
    Intervention: Behavioral: Booster/ low resource
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
August 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01390272
IIR 10-383
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: George Lee Jackson, PhD MHA Durham VA Medical Center
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP