Patients who have chronic disease benefit from having the doses and types of medication titrated based upon clinical parameters, for example, higher and lower blood pressure. Similarly, these patients may also require differing intensity of disease management based upon clinical outcomes. We conducted 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 could potentially lead to more efficient use of resources, resulting in 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, was more likely to be well-accepted and understood by clinicians.
This study sought to determine whether a titrated disease management program based on clinically reasonable titration criteria would lead to better outcomes than a low-intensity strategy involving non-tailored behavioral telephone calls. To determine the effectiveness of the titrated disease management intervention, we compared change in systolic blood pressure (SBP) for patients in the intervention and control arms.
We conducted a two-arm, 18-month randomized clinical trial for patients with pharmaceutically treated hypertension for which SBP was not controlled based on clinical practice guidelines in place at the start of the study (>140 mmHg for non-diabetic or >130 mmHg for diabetic patients).
The primary aim was to compare two treatment arms in terms of impact on SBP: Arm 1 - An intervention arm using titrated disease management in which patients' hypertension control, assessed at baseline, 6 and 12 months, were used to decide the resource intensity of strategies:
1) Medium/level 1 resource intensity strategy: a registered nurse provided monthly tailored behavioral support telephone calls + home BP monitoring;
2) High/level 2 resource intensity strategy: a pharmacist provided monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management; and
3) Booster (low) resource intensity strategy: a licensed practice nurse (LPN) provided bi-monthly, non-tailored behavioral support telephone calls to patients whose SBP comes under control.
Arm 2 - A comparison arm, in which an LPN provided bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster (low) resource intensity strategy component of the titrated intervention).
We randomized 385 Veterans. The majority (92.5%) were men, the mean age was 63.5 years, and the majority were Black (61.8% Black; 33.8% White; 4.5% other race). Mean baseline SBP was 143.6 mmHg and 76.6% had a baseline SBP level considered to be out of control. While the SBP (primary outcome) was reduced over 18 months in both the intervention (6.4 mmHg) and comparison (4.8 mmHg) arms, the estimated mean difference between arms was not statistically significant (-1.6 mmHg (95% confidence interval = -5.6 to 2.4; p-value = 0.43).
This research sought to examine whether a disease management program that is titrated by matching the intensity of resources to patients' disease control could lead to superior outcomes compared to a low-intensity management strategy. Using a pragmatic clinical trial design, this study provided important evidence indicating that an algorithm using only blood pressure levels to determine intensity of adjuvant hypertension services does not lead to those services generating better blood pressure outcomes. This suggests potential for the use of lower intensity telephone interventions when addressing the need to reduce blood pressure among primary care patients with hypertension, and that further research is needed to determine if there are better approaches to determining which patients with hypertension should receive advanced services.
- Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Military medicine. 2018 Sep 1; 183(9-10):e583-e588.
- Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemporary clinical trials. 2016 Sep 1; 50:5-15.