Clinical Studies

Summary of NIH-sponsored Clinical Trial,
University of Connecticut School of Nursing

The ActualMeds solutions are based on core technology that was developed and validated over the last 5 years at the University of Connecticut in the School of Nursing as part of a project led by Professor  Patricia J. Neafsey.  Dr. Neafsey is a co-founder of ActualMeds and its Prinicipal Scientist. The study of older adult patients with hypertension demonstrated improvement in both primary (clinical) and secondary (reduction in healthcare expenses) outcomes:

As compared with usual care for hypertension, the intervention :

  • Was twice as effective in lowering blood pressure
  • Brought patients to target with fewer drugs and at lower doses
  • Improved adherence and reduced adverse self-medication behavior
  • Reduced health care expenses by as much as 35% in 12 months post trial

Study Design

Following formal software and interface usability studies with older adults and advanced practice registered nurse (APRN) providers (Lin, Neafsey and Strickler 2009; Lin, Neafsey and Anderson 2010), the next generation Personal Education Program (PEP-NG) was tested in a randomized controlled efficacy trial targeting older adults with hypertension (age 60 and over). The PEP-NG provided an e-health, tailored intervention in 11 primary care practices with APRN providers.  Participants (N =160) were randomly assigned by the PEP-NG (accessed via a wireless touchscreen tablet computer) to either control (entailing data collection and 4 routine APRN visits) or tailored intervention (involving PEP-NG intervention and 4 focused APRN visits) group.

The PEP-NG rules engine analyzed patient-entered information about self-medication and immediately delivered educational content tailored to the 3 patient-reported behaviors associated with the highest risk scores (based on an expert developed scale).  The education components included: 1) animations and “medicine facts” that illustrated and described the adverse behaviors identified, 2) “what you can do” tips which offered corrective strategies, and 3) interactive questions that allowed the user to rehearse and apply the information learned. In the case of fewer than 3 reported adverse behaviors, the PEP delivered a set of up to 3 default statements dealing with antihypertensive medication adherence, OTC pain relievers (that can be safely taken with antihypertensives), and dangers of combining different types of pain relievers (prescription and OTC).

A printout generated by the patient-reported data summarized the patient’s self-reported symptoms, medication use (including frequency/time), adverse self-medication behaviors (along with a thumbnail screen shot from a related animation) and corrective strategies. The APRN reinforced the corrective education information (that appeared on the printout) with the patient as part of their primary care BP visit.  At the conclusion of the APRN visit, the patient took a copy of the same printout home for self-study.

Like their counterparts in the intervention group, participants in the control group were asked to complete all questions via the PEP-NG.  They also received a generic education message, an animation and an interactive question at the end of each session, which highlighted how BP medicines work and emphasizes how BP medications must be taken every day.   These participants did not receive a printout at the end of each of their PEP-NG uses or APRN visits.

Summary of Findings for the Intervention as Compared with Usual Care

Improved Self-efficacy and Reduced Adverse Self-medication Behaviors

Compared to patients in the control group, patients receiving the PEP-NG e-health intervention achieved significant increases in both self-medication knowledge and self-efficacy measures, with large effect sizes. Intervention patients also had a significant reduction in adverse self-medication behavior risk scores over time.

Achieved BP Goals Using Fewer Drugs at Lower Doses

There was a 27% reduction in the number of intervention patients not at BP targets by visit 3 compared to only a 4.8% reduction in the number of control participants not at BP targets by visit 3. Among patients not at BP targets upon entry to the study, therapy intensification in controls (increased antihypertensive dose and/or an additional antihypertensive) was significant (p = .001) with an odds ratio of 21.27 in the control compared to the intervention group.  Among patients not at BP targets on visit 1, there was a significant declining linear trend in proportion of the intervention group taking NSAIDs 21-31 days/month (p = 0.008).

Improvements in BP Better Than  Previously Published Reports

Further, the BP reduction of 15 mm Hg for SBP and 6 mm Hg for DBP in the intervention group was more than 2-fold greater than that in the control group not at BP targets at baseline. A report prepared for the Agency for Healthcare Research and Quality (Shojania, McDonald, Wachter and Owens 2005) documented the mean reductions in SBP and DBP of only 4.5 mm Hg and 2.1 mm Hg respectively, across all studies examined and a variety of BP management strategies.  According to unbiased estimates of efficacy from a recent meta-analysis of BP reduction and cardiovascular outcomes, a reduction of 10 mm Hg in systolic BP or 5 mm Hg in diastolic BP reduces coronary heart disease events by 22% and stroke by 41% (Law, Morris and Wald 2009).

High User Satisfaction for Both Providers and Patients

Satisfaction with the PEP-NG and the APRN provider relationship was high in both groups. The results of the trial suggest that the PEP-NG e-health intervention in primary care practices was effective in increasing knowledge and self-efficacy as well as improving behavior regarding adverse self-medication practices among older adults with hypertension. Thus, improving patient self-efficacy, knowledge and self-medication behavior holds promise for improving BP control and cardiovascular outcomes without the added costs and potential ADEs associated with therapy intensification.

As Much as 35% Savings Per Patient  in Healthcare Expenses in Following Year

Cost savings data was evaluated across 10 clinical trial sites – 5 were with  ProHealth physicians, a capitated provider network across a large part of Connecticut (ProHealth serves about 1/5 of the primary care patients in the state) that has integrated Allscripts EHR use at their practices. 5 of the practices were independent small practices and paper records users, which led to some challenges in data collection and analysis at these sites. Net reduction in costs was assessed based on the cost of net numbers of healthcare utilization (1) office visits, (2) ER visits, and (3) hospitalizations for both the control and the trial intervention group.  Averaged cost saving ranged from $194 (for the non-electronic EHR practices), to $845 (35% cost reduction for ProHealth practices with Allscripts) over 12 months following the study period.

References:

Chobanian, A. V.,  Bakris, G. L., Black, H. R., Cushman, W. C., Greeen, L. A., Izzo, J. R. et al. (2003). Seventh report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. Hypertens, 42(6), 1206-1256.

Ho, P. M., Magid, D. J., Shetterly, S. H., Olson, K, L,, Peterson, P. N., Masoudi, F. A. et al. (2008). Importance of therapy intensification and medication nonadherence for blood pressure control in patients with coronary disease. Arch Intern Med, 168(3), 271-276.

Institute of Medicine. (2006). Preventing Medication Errors. Washington, DC: National Academies Press. Retrieved 10/6, 2006, from http://www.nap.edu

Law, M. R., Morris, J. K., Wald, N. J. (2009). Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomized trials in the context of expectations from prospective epidemiological studies. BMJ, 338:b1665 doi:10.1136/bmj.b16

Lin, C. A.,  Neafsey, P. J., Strickler, Z. (2009). Usability testing of a computer-mediated health communication program tailored for older adults with hypertension. J Health Comm, 14(2), 102-118.

Lin, C. A, Neafsey, P. J., Anderson, E. (2010). APRN usability testing of a tailored computer-mediated health communication program. Computers, Informatics, Nurs, 28(1), 32-41. PMCID: NIHMS189964

Neafsey, P.J., M’lan, C.E., Ge, M., Walsh, S.J., Lin, C.A. (2010). Reducing adverse self-medication behaviors in older adults with hypertension: Results of an e-health clinical efficacy trial. Special Technology and Ageing Issue, Ageing International (In Press).

National Heart Lung, & Blood Institute. (2007). Healthy People 2010. Prevent and control America’s high blood pressure: Mission possible. Washington, DC: NHLBI.  Available via: Retrieved November 21 ,2007, from http://hp2010.nhlbihin.net/mission/aboutbp/abouthbp.htm . Cited November 21, 2007.

Shojania, K. G., McDonald, K. M., Wachter, R. M., Owens, D. K. (Eds.) (2005). Closing the quality gap: A critical analysis of quality improvement strategies. Volume 3 – Hypertension Care. Rockville, MD. Agency for Healthcare Research and Quality. AHRQ Pub. No. 04-0051-3  http://hp2010.nhlbihin.net/mission/aboutbp/abouthbp.htm

Schroeder, K., Fahey, T., Ebraham, S. (2004). How can we improve adherence to blood pressure-lowering medication in ambulatory care? A systematic review of randomized controlled trials. Arch Intern Med, 164, 722-732.

Strickler, Z., Neafsey, P. J. (2002). Visual design of interactive software for older adults: Preventing drug interactions in older adults. Visible Lang, 36(1), 4-28.

Strickler, Z., Rauh, C., Lin, C., Neafsey, P. J. (2008). Educating older adults to avoid harmful self-medication. J Comm Healthcare, 1(1), 110-128.

Wong, N. D., Lopez, V. A., L’Italien, G., Chen, R., Kline, S. E., Franklin, S. S. (2007). Inadequate control of hypertension in US adults with cardiovascular disease comorbidities in 2003-2004. Arch Intern Med 167(22), 2431-2436.