Denise Van Der Nat

Introduction

Patient safety is an important global healthcare issue that needs to be addressed, especially by increasing medication safety. As adverse drug events are a leading cause of avoidable harm in healthcare, activities to avoid, prevent, or correct medication errors are important to decrease the occurrence of these events. A method to reduce the number of medication errors is to identify medication discrepancies, defined as unexplained differences between the list of medications in the medical record (referred to as recorded medications) and what a patient actually takes based on medication packages and/or self-reports. As most of the medication discrepancies are detected (and subsequently resolved) with medication reconciliation (MR) (the process of identifying the most accurate list of patient’s current medicines), it is recommended to perform MR with each in- and outpatient. However, the current implementation of MR is hampered by several factors. Because of this, we wanted to explore the applicability of PHRs used by patients for MR in usual care. Besides organizational and economic advantages, a PHR may also increase patient empowerment 5–7. Although PHRs used for MR have been investigated in several studies 5,8–12, the inconclusive results about the appropriateness, feasibility and adoption of PHRs, make it difficult to assess whether PHRs used by patients can be (safely) applied to perform MR in standard care. Therefore, in this thesis we aimed to explore the applicability of PHRs used by patients for MR in usual care. As implementation of PHRs in patient healthcare depends on a good validity, usability and utility of the system, these aspects were investigated in this thesis 13.

Validity and correctness of identified medication discrepancies with an online personal health record used by patients

In Chapter 2, we performed a prospective cohort study in the Netherlands to assess the level of agreement between identified medication discrepancies between the gold standard, MR performed by a healthcare professional, and a PHR used by patients. Furthermore, the correctness of performing MR using a PHR was investigated.

In total, 155 (of the 488 approached) patients who both used a PHR and had received MR, were included. We observed that MR performed by a pharmacy technician identified overall more medication discrepancies (on average 6.2 (SD 4.3) medication discrepancies per patient) compared to patients who used a PHR (on average 4.7 (SD 3.7) medication discrepancies per patient). However, there was no significant difference between the number of identified clinically relevant medication discrepancies between the gold standard and the PHR. Besides that, the correctness of the drug information reported in the PHR was high: 82.1% of the drug information noted by the patient in the PHR was correct compared to the drug list generated with the gold standard and 98.6% had no clinically relevant differences between the lists. Altogether, the results of this study indicate that patients who use an online PHR can relatively accurately record a list of their medication.

Risk factors for clinically relevant deviations in an online personal health record used for medication reconciliation

After we concluded that most patients were capable to correctly report their drug information in a PHR (in Chapter 2), we wanted to explore which patients were best potential candidates for MR by making use of a PHR. In Chapter 3 we performed a prospective cohort study to asses which patient-, setting-, and medication-related factors were associated with the occurrence of a clinically relevant deviation in a patient’s drug list composed with a PHR (used by patients) compared to the gold standard, MR performed by a healthcare professional.

In total, 24 clinically relevant deviations were observed among 155 included patients. We observed that patients who used individual multi-dose packaging (aOR 14.8; 95% CI 2.02–110) and patients who used a higher number of medications (aOR 1.15; 95% CI 1.01–1.32) were positively associated with the presence of a clinically relevant deviation in a patient’s medication list generated with a PHR compared to MR performed by a pharmacy technician. We observed that the risk for the occurrence of a clinically relevant deviation was highest when patients used eight or more different medications (sensitivity 0.71; specificity 0.62; area under the curve 0.64; 95% CI 0.52–0.76). Therefore, MR performed by a healthcare professional remains the preferred method to identify medication discrepancies for patients with an individual multi-dose packaging and/or patients who used eight or more drugs. Patients without those characteristics should be capable to check their drug list in an online PHR by themselves.

Patients’ experienced usability and utility of an online personal health record

According to the technology acceptance model, adoption of a device depends on its usability and perceived usefulness 14. In Chapter 4, we performed a multicenter cross-sectional study to access the usability and perceived usefulness of an online PHR used for MR at both the in- and outpatient clinics. Besides that, we assessed the association between patient-, clinical-, hospital-, and ICT-related factors and the usability and perceived usefulness.

One month after their hospital visit, PHR-users were asked to rate usability (using the System Usability Scale (SUS) questionnaire) and perceived usefulness on a 5-point Likert scale. Subsequently, the usability and perceived usefulness of the 255 (of the 743 invited) PHR-users were classified according to the adjective rating scale of Bangor et al.

We observed that the majority of the patients (78% inpatients and 83% outpatients) indicated that the usability of the PHR was good, excellent or best imaginable. There were no patient-, clinical-, hospital-, and ICT-related factors significantly associated with usability. Also, the majority of the patients (57% inpatients and 67% outpatients) classified the perceived usefulness of the PHR as good, excellent, or best imaginable. Outpatients who also used the PHR for other drug related purposes reported a higher perceived usefulness (aOR 20.0; 95% CI 2.36–170). Other associations between perceived usefulness and patient-, clinical-, hospital-, and ICT-related factors were not found.

Altogether, the results of this study demonstrated that the majority of the patients indicate that the PHR for MR is useful and easy to use, but that there is still room for improvement.

Patients’ barriers and facilitators for using an online personal health record for medication reconciliation

To improve the usage of PHRs in the MR process and to better understand usability and perceived usefulness of PHRs by patients, the barriers and facilitators of PHRs used for MR were investigated. In Chapter 5, we performed a qualitative study to provide insight into patients’ barriers and facilitators for the usage of a PHR for MR prior to an in- or outpatient visit.

Ten PHR users and ten PHR non-users were interviewed. In total 14 barriers and 10 facilitators were identified. These barriers and facilitators were categorized in four domains: context, patient, application and process. To effectively develop and implement PHRs for MR, these identified barriers and facilitators need to be addressed.

Figure 1: Overview of the barriers and facilitators for using a personal health record (PHR) for medication reconciliation reported by PHR users and non-users.

BARRIERS:
- Context: Lack of data exchange and connectivity between applications; Healthcare professionals do not use the requested data.
- Patient: Privacy concerns; Limited (health) literacy and/or computer skills; Poor memory.
- Application: Limited perceived usefulness and/or motivation; Insufficient information provision (necessity, process, application); Concerns about data safety; Practical and technical issues; No computer/smartphone; Poor usability; Missing functionalities.
- Process: Ambiguity about who is responsible, the patient or the healthcare provider; Bad timing of invitations and reminders.

FACILITATORS:
- Context: Integration of different applications; Information provision by healthcare providers; Support of professionals and/or family.
- Patient: Perceived importance and perceived usefulness; Target patients who benefit most and/or have sufficient skills.
- Application: Improve usability; Add functionalities.
- Process: Check by healthcare providers; More frequent medication list update; Place and time independent.

Added value of medication reconciliation in the outpatient clinics

In Chapter 1 we reported the clinical impact of performing MR in several inpatient settings. However, the added value of MR in the outpatient setting was unknown. Therefore, in Chapter 6, we performed a cross-sectional observational study at the outpatient rheumatology department to get insight into the proportion of outpatient visits in which the patient provided essential drug information in addition to the existing digital information (including the electronic medical record and Nationwide Medication Record System) during MR that was required for the rheumatologist to perform drug-related actions.

The study design consisted of four steps:
1. MR was performed with the patient (by telephone or online using a PHR).
2. A pharmacy technician observed the visits and reported all drug-related actions performed by the rheumatologist.
3. The rheumatologists were asked (after the visit) which drug information (the presence of a drug, drug strength and/or drug frequency) he/she had used to perform each of the drug-related actions.
4. An expert panel consisting of two rheumatologists and two pharmacists scored which drug-related information was necessary for the drug-related actions that had been performed during the visits.

Subsequently, a researcher determined whether the required information was also available in the following sources:
• Electronic medical record: contains (drug) data from patients, as well in the electronic prescribing system as in the physician’s medical notes; and
• Nationwide Medication Record System: a digital nationwide network which exchanges medication dispensing data from all pharmacies in the Netherlands (provided that the patient has given permission for this data to be shared) 15,16.

The information required for rheumatologists (indicated by themselves) to perform a drug-related action was available in the digital drug sources for all observed outpatient visits. In other words, in none of the 83 observed outpatient visits the patient provided additional information during MR compared to the digital sources that was required to perform a drug-related action. According to the assessment of the expert panel, the patient provided in 14% of the outpatient visits additional information to perform a drug-related action that was not available in digital sources. Compared to the electronic medical record alone, patient’s input during MR resulted in additional information (compared to the digital sources) required to perform a drug-related action in 8% and 29% of the outpatient visits according to the assessment of the rheumatologists and expert panel, respectively.

Furthermore, we observed that the added value of patient’s input during MR depended on the type of performed drug-related action and was highest when a new drug was started or a drug-related problem was discussed. Based on these results, it may be considered to stop performing MR prior to an outpatient visit. Instead, in clinical practice, it may be considered that a physician only performs MR during the visit if he/she prescribes a new drug and/or the patient experiences a DRP. Herewith a more targeted and consequently more efficient implementation of MR at the outpatient clinics will be achieved.

Main conclusions of this thesis

This thesis presents a series of studies related to the applicability of PHRs used by patients for MR in usual care. First, we concluded that PHRs used by patients for MR have a good validity as the majority of the patients can accurately record their medication list in a PHR. Furthermore, we observed that the validity of the PHR depends on patient characteristics: patients with an individual multi-dose packaging and/or patients who used eight or more drugs were at highest risk for having a clinically relevant medication deviation in their drug list generated with a PHR compared to MR performed by a healthcare professional. So, patients without those characteristics should be capable to check their drug list in an online PHR by themselves. Second, we demonstrated that the majority of the patients indicated that the PHR was useful and easy to use, but the reported barriers and facilitators have to be addressed to further increase the implementation and consequently the adoption of PHRs in the MR process. Finally, the added value of performing MR (using a PHR) in the outpatient setting was investigated. The added value of patient’s input during MR was limited in the outpatient setting and depended on the type of performed drug-related action.