Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945865
• Other study ID #: REK 2014/1431
• Status: Completed
• Phase: N/A
• Start date: January 26, 2015
• Est. completion date: March 17, 2018

Study information

• Verified date: April 2019
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 17, 2018
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Pain
• Quality of Life

Intervention

Other:
• Pain assessment
Pain assessment with assessment tools

Locations

Country	Name	City	State
Norway	Faculty of Helath Science, Department of Nursing and Health Promotion	Oslo	PB 4 Saint Olavs Plass

Sponsors (1)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group		12 weeks
Secondary	Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group		4, 8, 12 weeks
Secondary	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
Secondary	Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.		12 weeks
Secondary	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
Secondary	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
Secondary	Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group		12 weeks
Secondary	Validity and reliability of the Doloplus-2 pain scale.		12 weeks
Secondary	Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior.		Baseline - 12 weeks
Secondary	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