JMIR Publications

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 a complex intervention, i.e. a medication module within a patient-led electronic health record (www.infopat.eu) on patients’ health literacy.

Methods:

We conducted a randomized controlled study in community-dwelling patients with type 2 diabetes mellitus. Patients were recruited in primary care practices and after randomization, had either access to an internet-based medication module allowing them to store their medication, look up drug information, and print a medication schedule or they received an information brochure on the importance of medication schedules. After 4- 8 weeks, patients were invited to attend a structured medication review. Data were collected via questionnaires before start of the intervention and during the second visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessment of patients in the control and intervention group.

Results:

Of 116 recruited patients, 107 completed the follow-up assessments and were eligible for intention-to-treat analyses. Only 73 patients (thereof 29 in the intervention group) followed the study protocol and were eligible for per-protocol analysis. Differences in overall health literacy were observed neither in the intention-to-treat nor in the per-protocol cohort. Reasons for a null effect might be that our cohort was not particularly enriched with participants with low health literacy thus precluding measurable improvement (ceiling). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (randomization according to protocol, drop-out of 29 patients)and the actual interaction with the medication module was modest (drop-out of 9 patients).

Conclusions:

The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short duration, or insufficient efficacy of the intervention as such contributed to the null effect of this study. This clearly outlines value of piloting complex interventions and accompanying process evaluations.