Clinical trial NCT01399567: Nursing Home Pain Management Algorithm Clinical Trial
Official title: Nursing Home Pain Management Algorithm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: pain
depression
nursing homes
diffusion of innovations
clinical trial
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 396
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Change from Baseline in Pain at 3 months
timeFrame: 3 months
measure: Change from Baseline in Pain at 6 months
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Change from Baseline in Mobility at 3 months
timeFrame: 3 months
measure: Change from Baseline in Agitation at 6 months
timeFrame: 6 months
measure: Change from Baseline Adherence to Best Practices at 3 months
timeFrame: 3 months
measure: Change from Baseline in Depression at 3 months
timeFrame: 3 months
measure: Change from Baseline in Depression at 6 months
timeFrame: 6 months post intervention
measure: Change from Baseline in Mobility at 6 months
timeFrame: 6 months post-intervention
measure: Change from Baseline in Adherence to Best Practices at 6 months
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: University of Pennsylvania
name: Mary Ersek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.1526-4637.2009.00787.x. Epub 2010 Jan 15.
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.
citation: Ersek M, Neradilek MB, Herr K, Jablonski A, Polissar N, Du Pen A. Pain Management Algorithms for Implementing Best Practices in Nursing Homes: Results of a Randomized Controlled Trial. J Am Med Dir Assoc. 2016 Apr 1;17(4):348-56. doi: 10.1016/j.jamda.2016.01.001. Epub 2016 Feb 17.
citation: Ersek M, Polissar N, Pen AD, Jablonski A, Herr K, Neradilek MB. Addressing methodological challenges in implementing the nursing home pain management algorithm randomized controlled trial. Clin Trials. 2012 Oct;9(5):634-44. doi: 10.1177/1740774512454243. Epub 2012 Aug 9.