Pilot study to test the feasibility of a trial design and complex intervention on PRIoritising MUltimedication in Multimorbidity in general practices (PRIMUMpilot)
| Autor: | Christiane Muth, Rafael Perera, André Knottnerus, Lorenz Uhlmann, Martin Beyer, Justine Rochon, Antje Erler, Jose M Valderas, Walter E. Haefeli, Corina Güthlin, Ferdinand M. Gerlach, Marjan van den Akker, Birgit Fullerton, Sebastian Harder |
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| Přispěvatelé: | RS: CAPHRI - R6 - Promoting Health & Personalised Care, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Family Medicine, RS: CAPHRI - R5 - Optimising Patient Care, Bureau FHML |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Program evaluation
Male General Practice Psychological intervention Pilot Projects 030204 cardiovascular system & hematology complex intervention 0302 clinical medicine Germany Surveys and Questionnaires Health care Outcome Assessment Health Care Medicine 030212 general & internal medicine Geriatrics Aged 80 and over Health services research General Medicine Checklist comorbidity Female General practice / Family practice Adult medicine.medical_specialty 03 medical and health sciences Quality of life (healthcare) Medication Reconciliation Nursing General Practitioners Humans Patient participation polypharmacy Aged Physician-Patient Relations business.industry Research Multimorbidity Reproducibility of Results Decision Support Systems Clinical drug therapy computer-assisted Chronic Disease medication adherence Physical therapy Feasibility Studies Patient Participation business Program Evaluation |
| Zdroj: | BMJ Open, 6(7):e011613. BMJ Publishing Group BMJ Open |
| ISSN: | 2044-6055 9969-1973 |
| Popis: | ObjectiveTo improve medication appropriateness and adherence in elderly patients with multimorbidity, we developed a complex intervention involving general practitioners (GPs) and their healthcare assistants (HCA). In accordance with the Medical Research Council guidance on developing and evaluating complex interventions, we prepared for the main study by testing the feasibility of the intervention and study design in a cluster randomised pilot study. Setting20 general practices in Hesse, Germany. Participants100 cognitively intact patients ≥65 years with ≥3 chronic conditions, ≥5 chronic prescriptions and capable of participating in telephone interviews; 94 patients completed the study. InterventionThe HCA conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision-support system (CDSS), the GPs discussed medication intake with patients and adjusted their medication regimens. The control group continued with usual care. Outcome measuresFeasibility of the intervention and required time were assessed for GPs, HCAs and patients using mixed methods (questionnaires, interviews and case vignettes after completion of the study). The feasibility of the study was assessed concerning success of achieving recruitment targets, balancing cluster sizes and minimising drop-out rates. Exploratory outcomes included the medication appropriateness index (MAI), quality of life, functional status and adherence-related measures. MAI was evaluated blinded to group assignment, and intra-rater/inter-rater reliability was assessed for a subsample of prescriptions. Results10 practices were randomised and analysed per group. GPs/HCAs were satisfied with the interventions despite the time required (35/45 min/patient). In case vignettes, GPs/HCAs needed help using the CDSS. The study made no patients feel uneasy. Intra-rater/inter-rater reliability for MAI was excellent. Inclusion criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results. ConclusionsIntervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions. Trial registration numberISRCTN99691973; Results. |
| Databáze: | OpenAIRE |
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