Nursing Home Pain Management Algorithm Clinical Trial

This study has been completed.
Sponsor:
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01399567
First received: June 23, 2011
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Pain
Behavioral: Algorithm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nursing Home Pain Management Algorithm Clinical Trial

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Change from Baseline in Pain at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report

  • Change from Baseline in Pain at 6 months [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report


Secondary Outcome Measures:
  • Change from Baseline in Mobility at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Functional independence measure - locomotion

  • Change from Baseline in Agitation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pittsburgh Agitation Scale

  • Change from Baseline Adherence to Best Practices at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain Management Chart audit Tool; 17 item tool evalauting staff adherence to recommended pain assessment and management practices

  • Change from Baseline in Depression at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Cornell Scale for Depression in Dementia

  • Change from Baseline in Depression at 6 months [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Cornell Scale for Depression in Dementia

  • Change from Baseline in Mobility at 6 months [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Functional independence measure - locomotion

  • Change from Baseline in Adherence to Best Practices at 6 months [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Pain Management Chart audit Tool; 17 item tool evalauting staff adherence to recommended pain assessment and management practices


Enrollment: 396
Study Start Date: September 2006
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Behavioral: Algorithm
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.
Active Comparator: Control
Control sites received staff education for pain assessment and management comprised of four one-hour classes
Behavioral: Algorithm
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399567

Locations
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98014
Sponsors and Collaborators
Swedish Medical Center
Investigators
Principal Investigator: Mary Ersek, PhD University of Pennsylvania
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Ersek PhD, RN, University of Pennsylvania School of Nursing
ClinicalTrials.gov Identifier: NCT01399567     History of Changes
Other Study ID Numbers: 5R01NR009100
Study First Received: June 23, 2011
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
pain
depression
nursing homes
diffusion of innovations
clinical trial

ClinicalTrials.gov processed this record on April 22, 2014