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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
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Booster/ low resource
Behavioral: Medium/Level 1 resource intensity
Behavioral: High/Level 2 resource intensity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Trial of Titrated Disease Management for Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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]?


Secondary Outcome Measures:
  • 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?


Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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.
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390272

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: George Lee Jackson, PhD MHA Durham VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01390272     History of Changes
Other Study ID Numbers: IIR 10-383
Study First Received: July 6, 2011
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hypertension
Telephone
Disease Management
Veterans
Pharmacists
Nurses

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014