Implementation of Observational Pain Management Protocol for Residents With Dementia: A Cluster-RCT

To investigate whether the implementation of the Observational Pain Management Protocol (Protocol) can improve pain management for nursing home residents with dementia.

A two-group, single-blinded, cluster-randomized controlled trial.

Seventeen nursing homes.

Hundred and twenty eight recruited residents with advanced dementia and pain-related diagnoses were allocated to either the control or the experimental conditions based on the randomized group allocated to their home.

The Protocol, which includes assessing, interpreting, and verifying the participants' observed pain scores, initiating pain-relieving interventions according to the observed pain scores, and reassessment, was implemented in the experimental homes for 12 weeks to guide the pain management of the participants. Meanwhile, the control homes continued to employ their usual pain management strategies.

These included the use of pain medications (measured by the Medication Quantification Scale) and non-pharmacological pain treatments in terms of types and frequency, as well as the participants' observational pain scores (assessed by Chinese-Pain Assessment IN Advanced Dementia).

A significant increase in the frequency (95% CI: -0.13 to -0.09, P < .01) and type (95% CI: -0.05 to -0.02, P < .01) of non-pharmacological interventions used was seen in the experimental homes in comparison with the control homes. However, no statistically significant difference in the use of pain medications was observed. A significant reduction in the observational pain score (95% CI: -0.26 to -0.17, P < .001) was obtained only in the experimental home.

This study supports the view that the Protocol is of clinical utility in enhancing the use of non-pharmacological pain-relieving interventions among residents with advanced dementia, leading to a reduction in their observational pain-related behaviors. However, the Protocol did not have any effect on the use of pain medications.