An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial

Abstract

Background In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility. Objective The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients’ health literacy. Methods We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups. Results Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients). Conclusions The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations.

The Effect of Health Literacy Intervention on Patients with Diabetes: A Systematic Review and Meta-Analysis

“…Of the remaining 42 full-text studies retrieved, 21 were excluded because they did not present data of interest or were repeated articles. Ultimately, 21 articles [ 2 , 3 , 6 , 7 , 8 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 ] were included for systematic review. Because the data homogeneity of 12 studies was not high, these were included in a qualitative analysis, and a meta-analysis was conducted for the other nine articles.…”

“…The tools of assessment of HL involved in our study focused on the ability to understand the reading of patients with diabetes, namely functional HL, such as TOFHLA, Newest Vital Sign (NVS) [ 13 , 16 , 25 ], Rapid Estimate of Adult Literacy in Medicine (REALM) [ 16 , 24 ], and Medical Term Recognition Test (METER) [ 13 ]. The assessment tools involving the three types of HL (e.g., functional HL, communicative HL and critical HL) include FCCHL (Functional, Communicative, and Critical Health Literacy Scale) [ 8 ], the Iranian Health Literacy Questionnaire (IHLQ) [ 19 ] and the Health Literacy Questionnaire (HLQ) [ 12 ]. The detailed evaluation contents of the scales are shown in Table S5 .…”

“…In all, 14 studies reported the effect of HL intervention on the HL level of patients with diabetes, of which 11 studies [ 3 , 7 , 13 , 14 , 16 , 17 , 18 , 19 , 22 , 24 , 25 ] showed that the HL level of participants improved after the educational intervention. Three studies [ 8 , 12 , 20 ] found that there were no statistically significant differences in HL scores.…”

“…However, some research results showed that there was no statistical significance in the change in patient health literacy level after intervention. This may be related to the fact that participants had a certain level of HL before being included in the intervention study, suggesting that ceiling effects might have occurred, making the detection of small changes more difficult [ 12 ]. In addition, the short intervention time also affects researchers’ observation of the HL level of participants [ 8 , 12 ].…”

Birinci Basamak Sağlık Kuruluşuna Başvuranlarda Sağlık Okuryazarlığı ile Kanser Bilgi Yükü İlişkisi

“…Sağlık okuryazarlığı Sorensen ve ark. (2012) tarafından içeriği geliştirilerek bireylerin günlük yaşantılarında sağlıkları/sağlık durumları ile ilgili karar almak, sağlıklarını korumak ve geliştirmek amacıyla yaşam kalitelerini yükseltmek ve sürdürmek için ihtiyaç duyulan sağlık bilgisine ulaşma, ulaşılan bilgiyi anlama, anlaşılan bilgiyi değerlendirme ve değerlendirilen bilgiyi uygun şekilde kullanmayı sağlayan bilgi, güdülenme ile sosyal ve bilişsel yeterlilik olarak tanımlanmıştır (6).…”