Making prescriptions "talk" to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study).

BACKGROUND: We developed and tested the effectiveness of a tailored health information technology driven intervention: "Talking Prescriptions" (Talking Rx) to improve medication adherence in a resource challenged environment. METHODS: We conducted a parallel, randomized, controlled, assessor-blinded trial at the Aga Khan University (AKU), Karachi, Pakistan. Adults with diagnosis of cerebrovascular accident (CVA) or coronary artery disease (CAD) diagnosed least one month before enrollment, on anti-platelets and statins, with access to a mobile phone were enrolled. The intervention group received a) Daily Interactive Voice Response (IVR) call services regarding specific statin and antiplatelet b) Daily tailored medication reminders for statin and antiplatelet and c) Weekly lifestyle modification messages for a period of 3 months. We assessed Medication adherence to statin and antiplatelets by a validated version of the 8-item Morisky Medication Adherence scale 8 (MMAS-8) at 3 months by a blinded assessment officer. Analysis was conducted by intention-to-treat principle (ITT). RESULTS: Between April 2015 and December 2015, 197 participants (99 in intervention and 98 in the usual care group) enrolled in the Talking Rx Study. The dropout rate was 9.6%. Baseline group characteristics were similar. At baseline, the mean MMAS-8 was 6.68 (SD = 1.28) in the intervention group and 6.77 (SD = 1.36) in usual care group. At end of follow-up, the mean MMAS-8 increased to 7.41(0.78) in the intervention group compared with 7.38 (0.99) in usual care group with mean difference of 0.03 (S.D 0.13) (95% C.I [-0.23, 0.29]), which was not statistically significant. (P-Value = 0.40) CVA patients showed a relatively greater magnitude of adherence via the MMAS-8 at the end of follow up where the mean MMAS-8 increased to 7.29 (S.D 0.82) in the intervention group as compared to 7.07(S.D 1.24) in usual care group with mean difference of 0.22 (SD = 0.22) 95% C.I (-0.20, 0.65) with (P-value = 0.15). Around 84% of those on intervention arm used the service, calling at least 3 times and listening to their prescriptions for an average of 8 minutes. No user was excluded due to technologic reasons. CONCLUSION: The use of a phone based medication adherence program was feasible in LMIC settings with high volume clinics and low patient literacy. In this early study, with limited follow up, the program did not achieve any statistically significant differences in adherence behavior as self-reported by the MMAS-8 Scale. TRIAL REGISTRATION: Clinical Trials.gov NCT02354040.

Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial.

BACKGROUND: Vascular disease, manifesting as myocardial infarction and stroke, is a major cause of morbidity and mortality, especially in low- and middle-income countries. Current estimates are that only one in six patients have good adherence to medications and very few have sufficient health literacy. Our aim is to explore the effectiveness and acceptability of Prescription Interactive Voice Response (IVR) Talking Prescriptions (Talking Rx) and SMS reminders in increasing medication adherence and health literacy in Pakistani patients with vascular disease. METHODS: This is a randomized, controlled, single center trial. Adult participants, with access to a cell phone and a history of vascular disease, taking multiple risk-modifying medications (inclusive of anti-platelets and statins) will be selected from cerebrovascular and cardiovascular clinics. They will be randomized in a 1:1 ratio via a block design to the intervention or the control arm with both groups having access to a helpline number to address their queries in addition to standard of care as per institutional guidelines. Participants in the intervention group will also have access to Interactive Voice Response (IVR) technology tailored to their respective prescriptions in the native language (Urdu) and will have the ability to hear information about their medication dosage, correct use, side effects, mechanism of action and how and why they should use their medication, as many times as they like. Participants in the intervention arm will also receive scheduled SMS messages reminding them to take their medications. The primary outcome measure will be the comparison of the difference in adherence to anti-platelet and statin medication between baseline and at 3-month follow-up in each group measured by the Morisky Medication Adherence Scale. To ascertain the impact of our intervention on health literacy, we will also compare a local content-validated and modified version of Test of Health Literacy in Adults (TOFHLA) between the intervention and the control arm. We estimate that a sample size of 86 participants in each arm will be able to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 %. Accounting for an attrition rate of 15 %, we plan to enroll 100 participants in each arm (total study population = 200). We hypothesize that a linguistically tailored health IT intervention based on IVR and SMS will be associated with an improvement in adherence (to anti-platelet and lipid-lowering medications) and an improvement in health literacy in Pakistani patients with vascular disease. DISCUSSION: This innovative study will provide early data for the feasibility of the use of IT based prescriptions in an lower middle incorme country setting with limited numeracy and literacy skills. TRIAL REGISTRATION: Clinical Trials.gov: NCT02354040 - 2 February 2015.