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Codesigned STAIR OF KNOWLEDGE intervention to prevent pressure ulcers, malnutrition, poor oral health and falls in
Merita Neziraj1, Christine Kumlien2,3, Malin Axelsson2
1Department of Care Science, Malmö University, Malmö, Sweden merita.neziraj@mau.se.
Objectives:
This external pilot study aimed to evaluate whether a definitive trial of the STAIR OF KNOWLEDGE intervention is warranted. The specific outcomes concerned the trial procedure, including the recruitment, randomisation and retention of nursing homes and the clinical outcomes required for a definitive trial.
Design:
The study is an external pilot cluster randomised controlled trial.
Setting:
Swedish nursing homes participated.
Participants:
The inclusion criteria for participation in the study were nursing homes working with in the Swedish national quality registry Senior Alert. Data from 309 older persons were extracted from the registry. Of these, 214 were women and 95 men, ages 65-102 years.
Intervention:
The intervention aims to support nursing staff in providing preventive care regarding pressure ulcers, malnutrition, poor oral health and falls to older persons in nursing homes.
Outcome Measures:
Following the Medical Research Council and the Knowledge to Action frameworks and guided by predefined progression criteria, we conducted an external pilot study to determine whether to proceed with a definitive trial. The outcome measures concerned testing nursing homes' recruitment and randomisation procedures, their retention and the selection of the most appropriate primary outcome measures.
Results:
We recruited eight nursing homes and randomised four to each study arm. All participating nursing homes completed the study, supporting its overall feasibility. The data collection and analysis for the intended clinical outcomes were also feasible. A total of 309 older persons were included in the study sample and were identified as being at risk of pressure ulcers, malnutrition, poor oral health and falls. Among these, actions were planned for 299 (96.8%). Of those for whom actions were planned, actions were implemented on 270 older persons (90.3%). After 12 months, a reduction in implemented actions was observed.
Conclusion:
Conducting the current pilot study was a critical step towards preparing for a future definitive trial. The predefined progression criteria were successfully met, demonstrating the feasibility of the specific objectives-including the recruitment, randomisation and retention of nursing homes-as well as the data collection and analysis of intended clinical outcomes. The results of this external pilot study support proceeding with a definitive trial.
Trial Registration Number:
NCT05308862.
