Dementia, Pain, Quality of Life
Conditions
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.
Interventions
OTHERPain assessment
Pain assessment with assessment tools
Sponsors
Oslo Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group | 12 weeks |
| Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group | 12 weeks |
Countries
Norway
Outcome results
None listed