Randomized Trial of Titrated Disease Management for Patients with Hypertension
George Lee Jackson PhD MHA
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: October 2011 - September 2015

BACKGROUND/RATIONALE:
Patients with chronic disease benefit from having dose and type of medication titrated based upon clinical parameters, for example, higher and lower blood pressure (BP). Similarly, patients may also require differing intensity of disease management based upon clinical outcomes. We are conducting a pragmatic clinical trial to evaluate the effectiveness of titrated disease management for patients with hypertension. The goal is to best match disease management resources to the clinical needs of Veteran patients. Moreover, this approach, as opposed to a single disease management program that is delivered the same way to all Veterans, is likely to be well-accepted and understood by clinicians.

OBJECTIVE(S):
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 BP for patients in the intervention and control arms. We will also examine medication adherence and potential cost-effectiveness. The study is in response to two HSR&D priority areas: access and health informatics.

METHODS:
We 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 is 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 (RN) 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).

FINDINGS/RESULTS:
Findings are forthcoming.

IMPACT:
The research is examining whether a disease management program that is titrated by matching the intensity of resources to patients' disease control leads to superior outcomes compared to a low-intensity management strategy. Using a pragmatic clinical trial, this study will provide important evidence of a clinically-sensible disease management program that has the potential for widespread implementation, especially as the VA continues to adopt patient-aligned care teams (PACTs).

PUBLICATIONS:
None at this time.

DRA: Cardiovascular Disease, Health Systems
DRE: Treatment - Comparative Effectiveness
Keywords: Adherence, Cardiovascular Disease, Comparative Effectiveness, Symptom Management
MeSH Terms: none