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

June 23, 2011
July 21, 2011
September 2006
November 2009   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01399567 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Nursing Home Pain Management Algorithm Clinical Trial
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Pain
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.
  • 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
    Intervention: Behavioral: Algorithm
  • Active Comparator: Control
    Control sites received staff education for pain assessment and management comprised of four one-hour classes
    Intervention: Behavioral: Algorithm

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
January 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01399567
5R01NR009100
Yes
Mary Ersek PhD, RN, University of Pennsylvania School of Nursing
Swedish Medical Center
Not Provided
Principal Investigator: Mary Ersek, PhD University of Pennsylvania
Swedish Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP