Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia

NCT ID: NCT02945865

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-26
• Study Completion Date: 2018-03-17

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.

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.

Conditions

Pain; Dementia; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ITreatment arm: Pain Assessment

Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.

Group Type: EXPERIMENTAL

Pain assessment

Intervention Type: OTHER

Pain assessment with assessment tools

Control arm: No treatment

Treatment us usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pain assessment

Pain assessment with assessment tools

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Liv Halvorsrud

Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liv Halvorsrud, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Faculty of Helath Science, Department of Nursing and Health Promotion

Oslo, PB 4 Saint Olavs Plass, Norway

Countries

Norway

Other Identifiers

REK 2014/1431

Identifier Type: -

Identifier Source: org_study_id