Nursing Home Pain Management Algorithm Clinical Trial

Pain Clinical Trial

Official title:

Nursing Home Pain Management Algorithm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399567
• Other study ID #: 5R01NR009100
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2011
• Last updated: July 21, 2011
• Start date: September 2006
• Est. completion date: January 2010

Study information

• Verified date: July 2011
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ersek M, Herr K, Neradilek MB, Buck HG, Black B. Comparing the psychometric properties of the Checklist of Nonverbal Pain Behaviors (CNPI) and the Pain Assessment in Advanced Dementia (PAIN-AD) instruments. Pain Med. 2010 Mar;11(3):395-404. doi: 10.1111/j — View Citation

Ersek M, Polissar N, Neradilek MB. Development of a composite pain measure for persons with advanced dementia: exploratory analyses in self-reporting nursing home residents. J Pain Symptom Manage. 2011 Mar;41(3):566-79. doi: 10.1016/j.jpainsymman.2010.06.009. Epub 2010 Nov 20. — View Citation

Jablonski A, Ersek M. Nursing home staff adherence to evidence-based pain management practices. J Gerontol Nurs. 2009 Jul;35(7):28-34; quiz 36-7. doi: 10.3928/00989134-20090428-03. — View Citation

Jablonski AM, DuPen AR, Ersek M. The use of algorithms in assessing and managing persistent pain in older adults. Am J Nurs. 2011 Mar;111(3):34-43; quiz 44-5. doi: 10.1097/10.1097/01.NAJ.0000395239.60981.2f. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Pain at 3 months	Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report	3 months	No
Primary	Change from Baseline in Pain at 6 months	Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report	6 months post intervention	No
Secondary	Change from Baseline in Mobility at 3 months	Functional independence measure - locomotion	3 months	No
Secondary	Change from Baseline in Agitation at 6 months	Pittsburgh Agitation Scale	6 months	No
Secondary	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	No
Secondary	Change from Baseline in Depression at 3 months	Cornell Scale for Depression in Dementia	3 months	No
Secondary	Change from Baseline in Depression at 6 months	Cornell Scale for Depression in Dementia	6 months post intervention	No
Secondary	Change from Baseline in Mobility at 6 months	Functional independence measure - locomotion	6 months post-intervention	No
Secondary	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	No