Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia

Sponsor
Oslo Metropolitan University (Other)
Overall Status
Completed
CT.gov ID
NCT02945865
Collaborator
(none)
112
1
2
37.7
3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pain assessment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes
Actual Study Start Date :
Jan 26, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Mar 17, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. 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

  1. Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group [12 weeks]

  2. Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group [4, 8, 12 weeks]

  3. 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]

  4. Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group. [12 weeks]

  5. 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]

  6. 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]

  7. Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group [12 weeks]

  8. Validity and reliability of the Doloplus-2 pain scale. [12 weeks]

  9. Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior. [Baseline - 12 weeks]

  10. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Helath Science, Department of Nursing and Health Promotion Oslo PB 4 Saint Olavs Plass Norway N-0130

Sponsors and Collaborators

  • Oslo Metropolitan University

Investigators

  • Principal Investigator: Liv Halvorsrud, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liv Halvorsrud, Associate Professor, PhD, Oslo Metropolitan University
ClinicalTrials.gov Identifier:
NCT02945865
Other Study ID Numbers:
  • REK 2014/1431
First Posted:
Oct 26, 2016
Last Update Posted:
Apr 30, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2019