Effects of a clinical medication review focused on personal goals, quality of life, and health problems in older persons with polypharmacy: A randomised controlled trial (DREAMeR-study)

PLoS Med. 2019 May 8;16(5):e1002798. doi: 10.1371/journal.pmed.1002798. eCollection 2019 May.

Abstract

Background: Clinical medication reviews (CMRs) are increasingly performed in older persons with multimorbidity and polypharmacy to reduce drug-related problems (DRPs). However, there is limited evidence that a CMR can improve clinical outcomes. Little attention has been paid to patients' preferences and needs. The aim of this study was to investigate the effect of a patient-centred CMR, focused on personal goals, on health-related quality of life (HR-QoL), and on number of health problems.

Methods and findings: This study was a randomised controlled trial (RCT) performed in 35 community pharmacies and cooperating general practices in the Netherlands. Community-dwelling older persons (≥70 years) with polypharmacy (≥7 long-term medications) were randomly assigned to usual care or to receive a CMR. Randomisation was performed at the patient level per pharmacy using block randomisation. The primary outcomes were HR-QoL (assessed with EuroQol [EQ]-5D-5L and EQ-Visual Analogue Scale [VAS]) and number of health problems (such as pain or dizziness), after 3 and 6 months. Health problems were measured with a self-developed written questionnaire as the total number of health problems and number of health problems with a moderate to severe impact on daily life. Between April 2016 and February 2017, we recruited 629 participants (54% females, median age 79 years) and randomly assigned them to receive the intervention (n = 315) or usual care (n = 314). Over 6 months, in the intervention group, HR-QoL measured with EQ-VAS increased by 3.4 points (95% confidence interval [CI] 0.94 to 5.8; p = 0.006), and the number of health problems with impact on daily life decreased by 12% (difference at 6 months -0.34; 95% CI -0.62 to -0.044; p = 0.024) as compared with the control group. There was no significant difference between the intervention group and control group for HR-QoL measured with EQ-5D-5L (difference at 6 months = -0.0022; 95% CI -0.024 to 0.020; p = 0.85) or total number of health problems (difference at 6 months = -0.30; 95% CI -0.64 to 0.054; p = 0.099). The main study limitations include the risk of bias due to the lack of blinding and difficulties in demonstrating which part of this complex intervention (for example, goal setting, extra attention to patients, reducing health problems, drug changes) contributed to the effects that we observed.

Conclusions: In this study, we observed that a CMR focused on personal goals improved older patients' lives and wellbeing by increasing quality of life measured with EQ-VAS and decreasing the number of health problems with impact on daily life, although it did not significantly affect quality of life measured with the EQ-5D. Including the patient's personal goals and preferences in a medication review may help to establish these effects on outcomes that are relevant to older patients' lives.

Trial registration: Netherlands Trial Register; NTR5713.

Publication types

  • Multicenter Study
  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Aging / psychology*
  • Community Pharmacy Services*
  • Cost of Illness
  • Female
  • Goals*
  • Health Status
  • Humans
  • Male
  • Medication Therapy Management*
  • Multimorbidity
  • Netherlands
  • Patient Preference
  • Polypharmacy*
  • Quality of Life*
  • Self Report
  • Time Factors

Associated data

  • NTR/NTR5713

Grants and funding

This study received unconditional grants from the Royal Dutch Pharmacists Association (‘Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie’ KNMP) and from Service Apotheek as part of the total PhD project of SV. The funders of the study had no role in the data management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Patients received no fee for their participation. Pharmacists received standard reimbursement for the clinical medication reviews from the health insurance companies and a small administrative fee for mailings of questionnaires.