Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia

Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes

It is estimated that 45-80 % of nursing home residents have substantial pain at any given time. Residents with impaired cognition have been found to report chronic pain more often, more frequent and more severe, compared to residents with normal cognition. Approximately 3/4 of permanent residents in nursing homes in Norway have developed dementia. The burden of dementia is often compounded by painful conditions. Despite over a decade of research on the subject, inadequate pain assessment and management remain significant problems among institutionalized older adults, with and without dementia. The poor pain management in patients with dementia has been attributed, at least in part, to difficulties with, and lack of, pain assessment in this population. Therefore, this study seek to determine the effect of regular pain assessment.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Dementia
• Intervention / Treatment: Other: Pain assessment

Detailed Description

The aim of the study is to determine the effect of regular pain assessment on pain management interventions applied and patient outcomes among patient with severe dementia.

A cluster randomized controlled trial will be conducted. A cluster is defined as a single independent nursing home. The clusters will be randomly assigned to either the experimental or control condition. Appropriate information will be given to both the intervention and the control group. All nurses in the experimental conditions will be taught how to administer the DOLOPLUS-2. The study will start after the initial education session. During the 3-month study period, the participating nursing staff will be asked to complete the DOLOPLUS-2 regularly. The control groups will receive standard methods of care. Data collection at baseline and at 4, 8 and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • PB 4 Saint Olavs Plass
    • Oslo, PB 4 Saint Olavs Plass, Norway, N-0130
      • Faculty of Helath Science, Department of Nursing and Health Promotion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 65 years old
• Dementia diagnosis
• Severe language impairment/non-communicative
• Clinically significant pain and/or behavioral symptoms: a score of at least 44 on the Norwegian version of the Cohen-Mansfield Agitation Inventory (CMAI),
• or a score of at least 4 (frequency × severity) on items of the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH),
• or an indication of clinically significant pain (≥ 5) according to the DOLOPLUS-2 at baseline

Exclusion Criteria:

• Short term stay, < 4 weeks
• Primary psychiatric diagnosis
• Delirium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITreatment arm: Pain Assessment; Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.	Other: Pain assessment; Pain assessment with assessment tools
No Intervention: Control arm: No treatment; Treatment us usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in analgesic intake measured in Defined Daily Dose (DDD) or a similar measure from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.	12 weeks
Change in pain score on the Dolplus-2 pain scale, and change in proportion scoring ≥ 5 on the Doloplus-2 scale from baseline to 12 week. Will be assessed in both the Intervention and Control group.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group	12 weeks
Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group	4, 8, 12 weeks
Change in agitation measured with Brief Agitation Rating Scale (BARS) from baseline to 4 to 8 to 12 weeks. Will be assessed in both the Intervention and Control group.	4, 8, 12 weeks
Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.	12 weeks
Change in personal activity of daily living measured with the Physical Self Management Scale from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.	12 weeks
Nurses evaluation of systematic pain assessment tools by using a questionnaire developed for this study. Will be assessed in both the Intervention and Control group	12 weeks
Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group	12 weeks
Validity and reliability of the Doloplus-2 pain scale.	12 weeks
Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior.	Baseline - 12 weeks
Association between variables; pain, agitation, NPS, depression, ADL, QoL, analgesic use, psychotropic use Will be assessed in both the Intervention and Control group.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Investigators: Principal Investigator: Liv Halvorsrud, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): March 17, 2018

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: REK 2014/1431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO