Anticipated Impact on Veterans'Healthcare: The proposed research will examine 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 adopts patient-aligned care teams (PACTs). Project Background: Patients with chronic disease benefit from having the doses and types 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 propose to conduct a pragmatic clinical trial to evaluate the effectiveness of titrated disease management for patients with hypertension. By reserving the most intensive and expensive strategies to veterans with greatest need, this titrated strategy may lead to more efficient use of resources, resulting in an overall cost savings to the VA. 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. Project Objectives: The proposed 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 proposal is in response to two HSR&D priority areas: access and health informatics. Project Methods: We propose a two-arm 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which systolic BP is not controlled (e 140 mmHg for non-diabetic or e 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: 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 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 component of the titrated intervention).
The proposed research will examine whether programs aimed at matching resources to patient disease control lead to superior outcomes 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-centered medical homes [systems for providing coordination of the multiple biopsychosocial needs of patients, especially with chronic illness] in the Veterans Affairs and other healthcare systems. Further, the study examines these approaches among Veterans with hypertension, the most widely recognized modifiable risk factor for stroke, myocardial infarction, peripheral vascular disease, heart failure, and end-stage renal disease. In the VA healthcare system, hypertension is the most prevalent chronic condition, affecting 37% of veterans
|Jackson, George L; Weinberger, Morris; Kirshner, Miriam A et al. (2016) Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials 50:5-15|