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PainPhase 2NCT01399567

Nursing Home Pain Management Algorithm Clinical Trial

A Phase 2 study testing Algorithm in people with Pain, run by Swedish Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Pain
What is being tested?
Algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
1 siteUnited States
Study dates
Sep 2006to Jan 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Swedish Medical Center

    Seattle, Washington, 98014

Other trials in United States

About this study

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.

Read the 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.

Conditions
Pain
Being tested
Algorithm
Keywords
pain, depression, nursing homes, diffusion of innovations, clinical trial
Medical subject headings
Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlgorithmBehavioural

    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.

Study groups in NCT01399567
Study groupRoleWhat they receive
AlgorithmExperimentalThe 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
Receives: Behavioral: Algorithm
ControlActive comparatorControl sites received staff education for pain assessment and management comprised of four one-hour classes
Receives: Behavioral: Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Pain at 3 months

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

    Measured: 3 months

  2. Change from Baseline in Pain at 6 months

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

    Measured: 6 months post intervention

Secondary outcomes (7)

  1. Change from Baseline in Mobility at 3 months

    Functional independence measure - locomotion

    Measured: 3 months

  2. Change from Baseline in Agitation at 6 months

    Pittsburgh Agitation Scale

    Measured: 6 months

  3. 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

    Measured: 3 months

  4. Change from Baseline in Depression at 3 months

    Cornell Scale for Depression in Dementia

    Measured: 3 months

  5. Change from Baseline in Depression at 6 months

    Cornell Scale for Depression in Dementia

    Measured: 6 months post intervention

  6. Change from Baseline in Mobility at 6 months

    Functional independence measure - locomotion

    Measured: 6 months post-intervention

  7. 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

    Measured: 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2011 (estimated)
  2. Study startSep 2006
  3. Primary completionNov 2009
  4. Study completionJan 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01399567
Sponsor's protocol ID
5R01NR009100
Status last verified
Jul 2011
First submitted
23 Jun 2011
Last updated
22 Jul 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21346465

  • 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.

    PubMed 21094018

  • 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.

    PubMed 20088854

  • 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.

    PubMed 19650621

  • 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.

    PubMed 26897592

  • 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.

    PubMed 22879574

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Algorithm in people with Pain, run by Swedish Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Pain at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01399567, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.

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