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Objectives: Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.
Design: Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation.
Setting: 72 general practices in Hesse, Germany.
Participants: 505 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.
Interventions: Intervention 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 measures: The 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.
Results: At 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).
Conclusions: The 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 behavioral sciences, including most of psychology, seek to explain and predict behavior with the help of theories and models that involve concepts (e.g., attitudes) that are subsequently translated into measures. Currently, some subdisciplines such as social psychology focus almost exclusively on measures that demand reflection or even introspection when administered to persons. We argue that such a focus hinders progress in explaining behavior. One major reason is that such an exclusive focus on reflections results in common method bias, which then produces spurious relations, or in other words, low discriminant validity. Without the valid measurement of theoretical concepts, theoretical assumptions cannot be tested, and hence, theory development will be hampered. We argue that the use of a greater variety of methods would reduce these problems and would in turn foster theory building. Using a representative sample of N = 472 participants (age: M = 51.0, SD = 17.7; 54% female), we compared the validity of a classical introspective attitude measure (i.e., the New Ecological Paradigm) with that of an alternative attitude measure (i.e., the General Ecological Behavior scale). The latter measure, which was based on self-reported behavior, showed substantially better validity that we argue could aid theory development.