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Completed

NCT Number: NCT01399567

Nursing Home Pain Management Algorithm Clinical Trial

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Swedish Medical Center

Seattle, Washington, 98014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algorithm

Behavioral

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.

Primary outcomes

  1. Change from Baseline in Pain at 3 months

    Time frame: 3 months

    Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report

  2. Change from Baseline in Pain at 6 months

    Time frame: 6 months post intervention

    Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report

Secondary outcomes

  1. Change from Baseline in Mobility at 3 months

    Time frame: 3 months

    Functional independence measure - locomotion

  2. Change from Baseline in Agitation at 6 months

    Time frame: 6 months

    Pittsburgh Agitation Scale

  3. Change from Baseline Adherence to Best Practices at 3 months

    Time frame: 3 months

    Pain Management Chart audit Tool; 17 item tool evalauting staff adherence to recommended pain assessment and management practices

  4. Change from Baseline in Depression at 3 months

    Time frame: 3 months

    Cornell Scale for Depression in Dementia

  5. Change from Baseline in Depression at 6 months

    Time frame: 6 months post intervention

    Cornell Scale for Depression in Dementia

  6. Change from Baseline in Mobility at 6 months

    Time frame: 6 months post-intervention

    Functional independence measure - locomotion

  7. Change from Baseline in Adherence to Best Practices at 6 months

    Time frame: 6 months post-intervention

    Pain Management Chart audit Tool; 17 item tool evalauting staff adherence to recommended pain assessment and management practices

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jul 22, 2011
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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