Medication Review in patients with Polypharmacy in primary care: Effects of the Clinical Rules Engine and the Outcome Prioritisation Tool on Patient and Clinical Outcomes: CRE-OPT study

Polypharmacy * the use of five or more chronic medications * is widely
recognized as a serious health problem. For health care professionals, patients
with complex multimorbidity (meerdere chronische ziekten, met tegenstrijdige
adviezen in ziekte specifieke richtlijnen) unrelated multiple chronic diseases,
with contradictory advice resulting from disease specific clinical guidelines)
are difficult to manage. For patients, having to meet a complex medication
regime with many different medicines can seriously burden them and can decrease
satisfaction with prescribed medication. This *treatment satisfaction* is
associated with treatment-related behaviours such as medication adherence, and
hence indirectly with successful treatment outcomes and fewer adverse events.
Dutch studies incorporating patients with different chronic diseases reported
medication adherence between 25% and 99%, with higher percentages in RCTs
compared to observational studies, indicating there is a lot to gain here.
In the Netherlands, about 180 patients per general practice have polypharmacy.
In 2012, the Multidisciplinary Guideline Polypharmacy (MDR) was introduced to
support the care for patients with complex multimorbidity who often receive
care from different medical specialists. The Dutch Health Care Inspectorate
(IGZ) has even decreed the implementation of this guideline. However, IGZ has
adapted the MDR criteria to reduce the number of yearly medication reviews from
700,000 Dutch inhabitants to an estimated 220,000: GPs and pharmacists should
perform regular medication reviews at least for all patients aged over 75, who
use seven or more chronic medicines, with a decreased kidney function.
Nevertheless, these adapted criteria seem highly pragmatic and lack evidence.
Limiting the population in this way might result in a large group of patients
being exposed to medication errors and adverse events.

Using an intelligent guideline-based software programme (e.g. using clinical
guidelines and STOPP/START criteria) that could identify possible medication
issues in the medical record (based on diagnoses, patient characteristics such
as age and sex, laboratory test results and medication) could decrease the time
to prepare the actual review. Moreover, it would standardize the process of
medication review, providing a method that is consistent, objective and always
alert.
The doctor-patient conversation on treatment preferences may be supported by a
simple decision support tool, like the *Outcome Prioritization Tool* (OPT;
www.OPTool.nl). OPT combines four visual analogue scales, on four universal
health values *Extend life*, *Preserve independence', *Reduce or eliminate
pain', and 'Reduce or eliminate other symptoms', respectively. Research has
shown that older people with multimorbidity can make a meaningful rank of the
relative importance of these values, which might support GPs in patient-centred
clinical decision-making.

It is hypothesized that the CRE-OPT will result in better treatment
satisfaction with prescribed medication, fewer or less medication alerts from
CRE, changes in medication prescription, better medication adherence, lower
drug burden index and increased quality of life compared to usual care.

In the proposed project we evaluate the potential benefits and feasibility of
including (a) a decision support system, *Clinical Rules Engine* (CRE) and (b)
patient preferences, using the *Outcome Prioritization Tool* (OPT) in a
comprehensive integrated multidisciplinary medication review as compared to
usual care. The joined intervention will be further indicated as CRE-OPT.

This results in two research questions:
1. Does the application of CRE-OPT in patients with complex multimorbidity and
polypharmacy result in:
a. better treatment satisfaction with prescribed medication as compared to
usual care?
b. fewer or less serious medication alerts from CRE, different changes in
medication prescriptions ,better medication adherence, lower drug burden index,
and increased quality of life as compared to usual care?
2. What is the perceived added value and feasibility of including CRE-OPT in
the medication review?
a. Patient perspective: Do patients experience that their preferences are heard
and taken into account in the medication review? How do patients evaluate OPT?
Do patients experience difficulties using OPT?
b. GP / nurse practitioner / pharmacist perspective: Does CRE-OPT support the
GPs / pharmacists in their medication review? Do GPs and pharmacists consider
the inclusion of CRE-OPT an added value to the medication review? Do GPs, nurse
practitioners and pharmacists consider CRE-OPT a feasible tool to implement in
daily practice?

Cluster randomized clinical trial. Randomization is at practice level
stratified to region (Maastricht/Groningen). Per treatment arm 9 practices
together with their preferred pharmacist will recruit 180 patients (total 360
patients).

Intervention: integral medication review including a consultation with GP,
augmented with sophisticated medication review software (*Clinical Rules
Engine* (CRE)) and including an explicit assessment of patient preferences
using a feasible tool (*Outcome Prioritization Tool* (OPT)). Patients in the
control group receive care as usual; GPs are roughly informed about the
intervention and are stimulated to evaluate the prescribed medication of the
patients participating in the study, in their usual way.

At the beginning of the study patient will receive a questionnaire. Thereafter
the patient will visit the general practitioner at least one time. After one
year the patient will receive the same questionnaire. It is expected that
patients will be involved in the medication prescription and wil expierence
less adverse events en side effects. In the end patiets will therfore receive a
more optimalised version of standard care.