Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01399567
Brief Summary:
Pain assessment and management deficiencies in nursing homes (NHs) are well documented. Unrelieved pain in this setting results in poorer resident outcomes, including depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled with intense diffusion strategies in improving pain, physical function and depression among NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.
Detailed Description:
Inadequate pain management in nursing homes (NHs) is well documented. Unrelieved pain in this setting results in depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm delivered using intense diffusion strategies. Outcomes are facility pain practices and residents' pain, physical function and depression. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.
Study:
NCT01399567
Study Brief:
Protocol Section:
NCT01399567