Implementation of observational pain management protocol to improve pain management for long-term institutionalized older care residents with dementia: study protocol for a cluster-randomized controlled trial

BACKGROUND Systematic use of observational pain tools has been advocated as a means to improve pain management for care home residents with dementia. Pain experts suggest that any observational tool should be used as part of a comprehensive pain management protocol, which should include score interpretation and verification with appropriately suggested treatments. The Observational Pain Management Protocol (Protocol) was therefore developed. This study aims to investigate the extent to which the implementation of this Protocol can improve pain management in care home residents with dementia. METHODS/DESIGN In this two-group, single-blinded, cluster-randomized controlled trial, 122 care home residents with dementia and pain-related diagnoses will be recruited from eight care homes (that is 15 to 16 residents from each care home). Invitations will be sent to all local care homes who meet the home selection criteria. The eight care homes will be randomly selected from all care homes that agree to join this trial. They will then be randomized to either the control or experimental conditions. Participants from each care home will be placed into their home's corresponding group to avoid 'contamination' effects across participants. Each intervention cycle will take 16 weeks (that is, baseline assessment and care home staff training for 4 weeks and Protocol implementation for 12 weeks). The Protocol will guide the pain management of the participants in the experimental care homes. Meanwhile, the control care homes will continue their usual pain management strategies. Intervention effects will be measured weekly during the protocol implementation period and compared with the baseline measurements, as well as between the experimental and control conditions. DISCUSSION Although similar pain protocols have been suggested previously, the recommendations were based on experts' opinions rather than evaluation of research studies. The feasibility and effectiveness of this kind of pain management protocol, tailored to older people with dementia, remains unknown. The findings of this trial will offer strong evidence that better strategies for pain management should be used in the care home daily routine. TRIAL REGISTRATION The Chinese University of Hong Kong, Centre for Clinical Trials: CUHK-CCT00367.