NCT01399567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

3.2 years

First QC Date

June 23, 2011

Last Update Submit

July 21, 2011

Conditions

Pain

Keywords

paindepressionnursing homesdiffusion of innovationsclinical trial

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Pain at 3 months

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

    3 months

  • Change from Baseline in Pain at 6 months

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

    6 months post intervention

Secondary Outcomes (7)

  • Change from Baseline in Mobility at 3 months

    3 months

  • Change from Baseline in Agitation at 6 months

    6 months

  • Change from Baseline Adherence to Best Practices at 3 months

    3 months

  • Change from Baseline in Depression at 3 months

    3 months

  • Change from Baseline in Depression at 6 months

    6 months post intervention

  • +2 more secondary outcomes

Study Arms (2)

Algorithm

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Control sites received staff education for pain assessment and management comprised of four one-hour classes

Behavioral: Algorithm

Interventions

AlgorithmBEHAVIORAL

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.

AlgorithmControl

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • long-term nursing home residents,
  • 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)

You may not qualify if:

  • short-term stay patients,
  • persons less than 65 years,
  • residents on hospice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98014, United States

Location

Related Publications (6)

  • 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.

    PMID: 21346465BACKGROUND

  • 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.

    PMID: 21094018BACKGROUND

  • 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.

    PMID: 20088854RESULT

  • 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.

    PMID: 19650621RESULT

  • 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.

    PMID: 26897592DERIVED

  • 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.

    PMID: 22879574DERIVED

MeSH Terms

Conditions

PainDepression

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

  • Mary Ersek, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2011

First Posted

July 22, 2011

Study Start

September 1, 2006

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

US(1)