PAINAD Scale for Painful Dementia

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the PAINAD scale can help doctors and nurses better treat pain in dementia patients visiting the emergency room. The scale uses a prompt in electronic health records to assist staff in accurately assessing and treating pain. The trial includes two groups: one before using the PAINAD tool and one after. Suitable participants have dementia, are 65 or older, and have visited the emergency room with hip pain. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pain management for dementia patients.

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 prior data suggests that the PAINAD EHR prompt is safe for improving pain care in dementia patients?

Research has shown that the PAINAD scale reliably assesses pain in people with severe dementia. Emergency rooms and other settings use it to gauge pain levels in patients who may struggle to communicate. Studies have found that this tool effectively observes and rates pain without harming patients. No reports of negative effects or safety issues have emerged from using the PAINAD scale. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAINAD EHR Prompt because it focuses on a more systematic and efficient way to assess pain in people living with dementia (PLWD), especially those experiencing conditions like hip pain. Unlike traditional methods that heavily rely on subjective assessments by healthcare providers, this prompt is integrated within electronic health records (EHR), ensuring consistent and timely evaluations. The PAINAD EHR Prompt aims to streamline pain management, potentially leading to quicker and more accurate interventions. By standardizing the assessment process, the hope is to improve overall patient care and outcomes for PLWD in emergency settings.

What evidence suggests that the PAINAD EHR prompt is effective for improving pain care in dementia?

Research has shown that the PAINAD scale reliably assesses pain in people with severe dementia. It is easy to use and effectively measures pain in patients who cannot communicate. This trial will compare two groups: one assessed using the PAINAD EHR prompt post-implementation, and the other assessed pre-implementation. Studies suggest the PAINAD scale can improve pain care in emergency settings for those with cognitive impairment. The PAINAD scale helps healthcare workers better understand pain levels, leading to more accurate and effective treatment. Initial findings support its use in emergency departments to enhance pain management for people living with dementia. ^{1 2 6 7 8}

Who Is on the Research Team?

Teresita M Hogan, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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 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 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-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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9828226/

Psychometric evaluation of the Pain Assessment in Advanced ... There was no correlation between PAINAD and a measure of behavioural and psychological symptoms of dementia, suggesting no evidence of convergent validity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06370572

Pragmatic Use of PAIN-Advanced Dementia Scale in ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2588994X18300332

The Pain Assessment in Advanced Dementia (PAINAD) scale The PAINAD has potential as an effective pain assessment tool for older people with cognitive impairment in emergency departments.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12807591/

Development and psychometric evaluation of the Pain ... The PAINAD is a simple, valid, and reliable instrument for measurement of pain in noncommunicative patients. Since the patient population used for its ...

5. mdpi.com mdpi.com/2624-8611/5/3/52

Multi-Center Validation of Pain Assessment in Advanced ... In conclusion, the PAINAD scale is a reliable observer-rated pain assessment tool for persons with severe dementia in Malaysia. It is also ...

6. geriatrictoolkit.missouri.edu geriatrictoolkit.missouri.edu/cog/painad.pdf

Pain Assessment in Advanced Dementia (PAINAD) Scale **Total scores range from 0 to 10 (based on a scale of 0 to 2 for five items), with a higher score indicating more severe pain (0="no pain" to ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30998888/

The Pain Assessment in Advanced Dementia (PAINAD) scale The PAINAD has potential as an effective pain assessment tool for older people with cognitive impairment in emergency departments.

8. interiorhealth.ca interiorhealth.ca/sites/default/files/PDFS/pain-assessment-advance-dementia-scale.pdf

Pain Assessment in Advanced Dementia (PAINAD) Scale Pain Assessment IN Advanced Dementia. PAINAD -- Item Definitions. Breathing: 1. Normal breathing: effortless, quiet, rhythmic (smooth) respirations.