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Electronic decision support system fails to improve outcomes in hypertension, diabetes
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CHICAGO — A mobile health-based electronic decision support system did not lead to better control of BP or HbA1c, according to the mWellcare study results presented at the American Heart Association Scientific Sessions.
The researchers conducted the trial to evaluate a system offering electronic clinical decision support and task sharing to assist management of patients with hypertension or diabetes.
The mWellcare study was a cluster-randomized trial of 40 centers in India managing 3,698 patients aged at least 30 years with hypertension, defined as systolic BP of at least 140 mm Hg and/or diastolic BP of at least 90 mm Hg, or type 2 diabetes, defined as fasting blood glucose of at least 140 mg/dL and/or postprandial blood glucose of at least 200 mg/dL.
The mWellcare system is an Android app viewed on a tablet that can generate a tailored management plan for hypertension, diabetes and concomitant depression, alcohol and tobacco use, Dorairaj Prabhakaran, MD, DM, MSc, FRCP, FNASc, professor of chronic disease epidemiology and vice president at the Public Health Foundation of India and executive director of the Centre for Chronic Disease Control, said during a presentation.
“It also has the capability to store health records electronically, enabling long-term monitoring and follow-up,” he said.
Both groups used clinical management guidelines, and the intervention group also used the mWellcare system, he said. In the intervention group (mean age, 56 years; 57% men), the doctor either agreed with the decision-support recommendation or modified the treatment plan, the nurse provided lifestyle guidance based on prompts from the system and pamphlets and the system recorded all visit details and sent reminders to patients about follow-up and medication adherence. In the control group (mean age, 55 years; 53% men), doctors managed patients based on clinical judgment, nurses provided lifestyle advice using pamphlets and recorded clinical parameters in registers and there were no reminders sent to patients.
The primary outcomes were between-group differences in changes in systolic BP and HbA1c at 1 year.
There were no significant differences in either primary outcome. For the hypertension outcome, the intervention arm had a reduction in systolic BP that was 1 mm Hg greater than that observed in the control arm (95% CI, –4.6 to 2.7), which remained nonsignificant after adjustment. For the diabetes outcome, the intervention arm had a reduction in HbA1c that was 0.11% greater than in the control arm (95% CI, –0.24 to 0.45), which also remained nonsignificant after adjustment, Prabhakaran said.
The results did not vary by subgroup.
At 1 year, there were also no significant differences between the groups in changes to other parameters, including fasting blood glucose, total cholesterol, CVD risk score, BMI, change in tobacco use and change in alcohol use, according to the researchers.
At the study’s end, the alcohol use score and the depression score were similar in both groups.
“We did not find an incremental benefit of mWellcare over enhanced usual care in the management of the chronic conditions studied,” Prabhakaran said during the presentation. “Major factors that may have influenced the results include the presence of noncommunicable disease nurses in both arms, the training given to the nurses and physicians, the charts on treatment algorithms, the research team advocating improved drug availability and the Hawthorne effect due to the open-label nature of the trial.” – by Erik Swain
References:
Prabhakaran D, et al. LBS.03 – Late Breaking Clinical Trial: Harnessing Technology and Improving Systems for Global Health. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.
Prabhakaran D, et al. Circulation. 2018;doi:10.1161/CIRCULATIONAHA.118.038192.
Disclosure: Prabhakaran reports he holds a copyright for the mPower Heart mHealth System.
Perspective
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Khaldoun Tarakji, MD, MPH
This study is interesting because it is no longer just communicable diseases affecting lower- and middle-income countries. They are facing the same problems with noncommunicable diseases that we face in the Western world. But some locations have not made similar leaps in terms of quality of care. We always talk about access, but this study takes it a step further as far as providing quality care in low- to middle-income countries.
In the past, this was probably unimaginable, but with the availability of digital health technology, the process of improving quality of care is potentially feasible. The researchers attempted to show this in a cluster-designed study at 40 centers in India. They tried to use digital technology to provide care for chronic conditions. In the intervention arm, the protocol included text message reminders. The control arm was somewhat enhanced in terms of providing education and making guidelines available.
The study did not show any difference in clinical outcomes. While that may be disappointing, it provided a great example of the feasibility of how to conduct these studies. It’s a reminder that these tools were unimaginable many years ago. The simple fact that you can text message patients in third-world countries to remind them about their appointments is incredible. These devices are widely available. This is an opportunity for us to enhance care, providing quality as well as access through different initiatives. The use of digital health is not limited to rich countries.
Staff Physician, Section of Electrophysiology and Pacing
Robert and Suzanne Tomsich Department of Cardiovascular Medicine
Sydell and Arnold Miller Family Heart & Vascular Institute
Cleveland Clinic
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