Nursing Home Pain Management Algorithm Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nursing Home Pain Management Algorithm Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Algorithm<br>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 | Behavioral: Algorithm<br>* The NH pain management algorithm is a series of decision-making tools that begin with regular, comprehensive pain assessment matched to residents' cognitive status and proceed through analgesic therapy appropriate to the character, severity, and pattern of pain.<br>|
| Active Comparator: Control<br>Control sites received staff education for pain assessment and management comprised of four one-hour classes | Behavioral: Algorithm<br>* The NH pain management algorithm is a series of decision-making tools that begin with regular, comprehensive pain assessment matched to residents' cognitive status and proceed through analgesic therapy appropriate to the character, severity, and pattern of pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Pain at 3 months | Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report | 3 months | 
| Change from Baseline in Pain at 6 months | Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report | 6 months post intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, depression, nursing homes, diffusion of innovations, clinical trial