Effectiveness of a complex intervention on Prioritising Multimedication in Multimorbidity (PRIMUM) in primary care: results of a pragmatic cluster randomised controlled trial

Abstract

ObjectivesInvestigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.DesignPragmatic, cluster randomised controlled trial with general practice as unit of randomisation.Setting72 general practices in Hesse, Germany.Participants505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.InterventionsIntervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.Outcome measuresThe primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months’ follow-up: quality of life, functioning, medication adherence, and so on.ResultsAt baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0–5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI −0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).ConclusionsThe intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.Trial registration number ISRCTN99526053. NCT01171339; Results.

The effects of clinical decision support system for prescribing medication on patient outcomes and physician practice performance: A systematic review and meta-analysis

“…Our study results are consistent with Olsson's study which suggest that CDSS for elderly people, who use multiple types of medicines, has no effect on important outcomes [86]. We think that the unexpected ndings of our research could be attributed to the lack of information for patients with serious infections who require immediate care and the lack of relevance of the checklist given for the drug problems of patients [45,48,49].…”

“…Analysis of the results of the reviewed studies shows that the use of CDSS in prescribing a number of drugs has no effect on the physician performance in outcomes such as drug prescription rates with drug suitability index, average functional status outcome, and drug complexity index [45,48,49]. Our study results are consistent with Olsson's study which suggest that CDSS for elderly people, who use multiple types of medicines, has no effect on important outcomes [86].…”

“…Also in another study, the average number of readmission days for each patient and the combination of re-hospitalization and emergency ward visits in the 30 days after hospital discharge was not different in the intervention group using Recommendation CDSS with control groups [47]. In some trials, there was no discrepancy between the outcomes of the dosage rate and the Modi ed Medication Appropriateness Index (MMAI), improper medication prescribing (p value = 0.48), the Medication Regimen Complexity Index, and the mean pain outcome difference after 6 months (p value = 0.13) and 9 months (p value = 0.78) between the intervention group using alert or reminder CDSS and the control group [48,49]. Table 9 shows the result brie y.…”

Integrated care for the management of ageing-related non-communicable diseases: current gaps and future directions

“…The reduction in costs is mainly due to a decrease in inpatient and outpatient admissions. However, it should be noted that much of the current evidence comes from clinical settings in the USA and there are limited well-designed trials in Europe, though results from studies such as the German-based PRIMUM trial [33] will soon help to provide a clearer picture of integrated care solutions within European settings.…”

Is My Patient Overwhelmed?

“…28 Second, on a research level, several recent trials aimed at testing new care models for multimorbid patients failed to demonstrate improvement in quality of life. [29][30][31] Among potential explanations that investigators invoked were the broad inclusion criteria that may have selected patients not likely to benefit from the interventions, which in turn may have "diluted the potential effectiveness of the approach." 32(p1) With the PASS, we offer the ability for researchers to develop interventions targeted at high-risk patients (ie, patients with burden-of-treatment levels above the PASS).…”