PAINAD Scale for Painful Dementia

Recruiting at 1 trial location

Overseen By Principal Investigator

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Under 65, No hip pain, No dementia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1899 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the PAINAD EHR Prompt, PAINAD Scale, Pain Assessment in Advanced Dementia Scale treatment?

Research shows that the PAINAD scale is effective in assessing pain in patients with advanced dementia, providing results similar to other pain assessment tools and requiring less time to administer. This suggests it is a useful tool for identifying and managing pain in non-verbal patients. ^{1 2 3 4 5}

Is the PAINAD Scale safe for use in humans?

The PAINAD Scale is a tool used by healthcare workers to assess pain in people with advanced dementia, and there is no indication of safety concerns for its use in humans. ^{1 3 5 6 7}

How is the PAINAD EHR Prompt treatment different from other treatments for painful dementia?

The PAINAD EHR Prompt is unique because it uses the PAINAD scale to assess pain in dementia patients who cannot communicate verbally, focusing on five specific behaviors: breathing, vocalization, facial expression, body language, and consolability. This approach allows healthcare workers to evaluate pain quickly and effectively in less than five minutes, which is particularly important for patients with advanced dementia who struggle to express their pain. ^{2 3 5 6 8}

Research Team

Teresita M Hogan, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for people living with dementia, such as Alzheimer's disease, who are experiencing pain and need emergency care. It aims to help emergency department staff better assess and treat their pain.

Inclusion Criteria

History of dementia by past medical history or problem list in EMR

I am 65 years old or older.

I went to the emergency department because of hip pain.

Exclusion Criteria

Patients do not meet inclusion criteria

Timeline

Pre-implementation

Baseline data collection for patients with hip pain and dementia in the year preceding the implementation of the PAINAD EHR prompt

12 months

Implementation

Implementation of the PAINAD EHR prompt for assessing pain in patients with dementia upon ED arrival and one hour after first pain treatment

10 months

Follow-up

Prospective evaluation of EHR data to assess the effectiveness of the PAINAD scale in improving pain management

4 weeks

Treatment Details

Interventions

• PAINAD EHR Prompt

Trial Overview The study is testing whether a Pain in Advanced Dementia (PAINAD) scale prompt within the electronic health record can improve how emergency staff evaluate and manage pain in patients with dementia.

Participant Groups

Group I: Post-implementation Experimental Treatment 1 Intervention

PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt

Group II: Pre-implementation Active Control 1 Intervention

PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt

PAINAD EHR Prompt is already approved in United States, European Union for the following indications:

Approved in United States as PAINAD Scale for:

• Pain assessment in patients with advanced dementia

Approved in European Union as PAINAD Scale for:

• Pain assessment in patients with advanced dementia

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Findings from Research

The study assessed pain in 30 elderly patients with advanced dementia using the PAINAD and ABBEY scales, showing that both scales provide equivalent results for pain assessment, indicating their reliability in this population.

The PAINAD scale is quicker to administer than the ABBEY scale, making it a more efficient tool for nurses in geriatric settings to identify and manage pain in patients with global aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparison study between two pain assessment scales for hospitalized and cognitively impaired patients with advanced dementia]. Storti, M., Dal Santo, P., Zanolin, ME.[2009]

The study involved 12 non-communicative dementia patients, averaging 84.3 years old, and assessed pain behavior using the PAINAD scale before and after analgesic treatment, showing a significant reduction in pain behavior after medication.

Results indicated that continued pain medication led to sustained low PAINAD scores, confirming that the PAINAD scale effectively measures pain in patients with advanced dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of pain in advanced dementia. Construct validity of the German PAINAD]. Basler, HD., Hüger, D., Kunz, R., et al.[2018]

The PAINAD scale is a specific tool designed to evaluate pain levels in patients with dementia, helping caregivers and healthcare providers understand and manage pain effectively.

Using the PAINAD scale can improve the quality of care for dementia patients by ensuring that their pain is recognized and addressed, which is crucial since these patients may have difficulty communicating their discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calculated Decisions: Pain assessment in advanced dementia (PAINAD) scale Goldberg, R.[2020]

The Brazilian Portuguese version of the Pain Assessment in Advanced Dementia (PAINAD) scale was successfully adapted and validated for use, demonstrating good psychometric properties such as validity and inter-rater agreement among 63 inpatients unable to self-report pain.

The scale is practical for daily use in clinical settings, with a short application time and clear instructions, although special attention is needed for interpreting facial expressions and consolability during pain assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural adaptation and reproducibility validation of the Brazilian Portuguese version of the Pain Assessment in Advanced Dementia (PAINAD-Brazil) scale in non-verbal adult patients. Pinto, MC., Minson, FP., Lopes, AC., et al.[2022]

The PAINAD scale is a reliable tool for assessing pain intensity in elderly patients with advanced dementia, showing strong internal reliability (α = 0.90) and concurrent validity (Kendall's τ = 0.73) when compared to the numerical rating scale (NRS).

In a study of 600 elderly patients, the PAINAD scale demonstrated better inter-rater agreement (κ = 0.74) than the NRS, making it a preferred method for pain assessment in cognitively impaired individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the pain assessment in advanced dementia scale compared to self assessment of pain in elderly patients. Mosele, M., Inelmen, EM., Toffanello, ED., et al.[2022]

The PAINAD scale is an effective tool for assessing pain in older adults with severe dementia, focusing on five indicators: breathing, vocalization, facial expression, body language, and consolability.

Using the PAINAD scale allows trained healthcare workers to evaluate pain in less than five minutes, addressing the challenge of treating pain in patients who may have difficulty communicating verbally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain assessment in people with dementia. Horgas, A., Miller, L.[2021]

The PAINAD-G scale, designed to assess pain in advanced dementia, shows strong reliability with a Cronbach's alpha of 0.85 and high inter-rater stability (r = 0.80), making it a dependable tool for evaluating pain in nursing home residents.

The scale effectively differentiates between residents with and without pain, indicating its validity in measuring pain behaviors, although the level of pain did not always align with PAINAD-G scores, particularly in those with greater cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the German "Pain Assessment in Advanced Dementia Scale" (PAINAD-G) in nursing home residents. Schuler, MS., Becker, S., Kaspar, R., et al.[2022]

The Spanish version of the PAINAD scale (PAINAD-Sp) was validated for use in hospitalized patients with neurological disorders and end-of-life cancer patients, demonstrating good psychometric properties including a reliability score of 0.80 and a Cronbach's alpha greater than 0.70.

The PAINAD-Sp scale effectively measures pain sensitivity, showing a greater mean difference in pain assessment during movement compared to rest, indicating its utility in capturing pain levels in patients who cannot self-report.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Spanish Version of the Pain Assessment in Advanced Dementia Scale (PAINAD-Sp) in Hospitalized Patients with Neurologic Disorders and Oncologic Patients Unable to Self-Report Their Pain. Muñoz-Narbona, L., Cabrera-Jaime, S., Lluch-Canut, T., et al.[2020]

References

1. Italy pubmed.ncbi.nlm.nih.gov

[A comparison study between two pain assessment scales for hospitalized and cognitively impaired patients with advanced dementia]. [2009]

2. Germany pubmed.ncbi.nlm.nih.gov

[Assessment of pain in advanced dementia. Construct validity of the German PAINAD]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Calculated Decisions: Pain assessment in advanced dementia (PAINAD) scale [2020]

4. Brazil pubmed.ncbi.nlm.nih.gov

Cultural adaptation and reproducibility validation of the Brazilian Portuguese version of the Pain Assessment in Advanced Dementia (PAINAD-Brazil) scale in non-verbal adult patients. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Psychometric properties of the pain assessment in advanced dementia scale compared to self assessment of pain in elderly patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pain assessment in people with dementia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Psychometric properties of the German "Pain Assessment in Advanced Dementia Scale" (PAINAD-G) in nursing home residents. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Validation of the Spanish Version of the Pain Assessment in Advanced Dementia Scale (PAINAD-Sp) in Hospitalized Patients with Neurologic Disorders and Oncologic Patients Unable to Self-Report Their Pain. [2020]