Nursing Home Pain Management Algorithm Clinical Trial

Phase 2

Completed

• Conditions: Pain
• Interventions: Behavioral: Algorithm

• Registration Number: NCT01399567
• Lead Sponsor: Swedish Medical Center

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 Timeline

• Study Start: 2006-09
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Study First Submitted: 2011-06-23
• Status Verified: 2011-07
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

• long-term nursing home residents,
• 65 years and older,
• with moderate or greater pain in the week prior to screening,
• residing in a participating facility,
• who consent to participate (or whose surrogate decisionmaker consents to participation)

Exclusion Criteria

• short-term stay patients,
• persons less than 65 years,
• residents on hospice

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Algorithm	Algorithm	The NH pain management algorithm is a series of decision-making tools that begins with regular, comprehensive pain assessment matched to residents' cognitive status and proceed through analgesic therapy appropriate to the character, severity, and pattern of pain. The algorithm is coupled with intense diffusion strategies (e.g., education, consultation, boosters) to increase adoption of these evidence-based practices
Control	Algorithm	Control sites received staff education for pain assessment and management comprised of four one-hour classes

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Pain at 3 months	3 months	Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report
Change from Baseline in Pain at 6 months	6 months post intervention	Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Mobility at 3 months	3 months	Functional independence measure - locomotion
Change from Baseline in Agitation at 6 months	6 months	Pittsburgh Agitation Scale
Change from Baseline in Depression at 6 months	6 months post intervention	Cornell Scale for Depression in Dementia
Change from Baseline in Mobility at 6 months	6 months post-intervention	Functional independence measure - locomotion
Change from Baseline in Depression at 3 months	3 months	Cornell Scale for Depression in Dementia
Change from Baseline Adherence to Best Practices at 3 months	3 months	Pain Management Chart audit Tool; 17 item tool evalauting staff adherence to recommended pain assessment and management practices
Change from Baseline in Adherence to Best Practices at 6 months	6 months post-intervention	Pain Management Chart audit Tool; 17 item tool evalauting staff adherence to recommended pain assessment and management practices

Trial Locations

Locations (1)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States