PAINAD Scale for Painful Dementia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Teresita M Hogan, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Disqualifiers: Under 65, No hip pain, No dementia

No Placebo Group

Approved in 2 Jurisdictions

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Chicago Chicago, IL

University of North Carolina at Chapel Hill Chapel Hill, NC

Who Is Running the Clinical Trial?

University of Chicago Lead Sponsor

National Institute on Aging (NIA) Collaborator

University of North Carolina, Chapel Hill Collaborator

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] The management of pain in a elderly patients with advanced dementia is a very frequently problem in geriatric wards. The pain in patients with advanced dementia whose verbal fluency is declining is underestimated and poorly treated and this is mainly due to the lack of availability of proper tools able to recognise and to assess this disease symptom in those patients. During recent years major progress has taken place, and valid scales that allow for the assessment of the pain also in those kind of patients have been developed. The objective of this research is to verify the pertinence of the PAINAD and ABBEY scales throughout the assessment of pain in a 30 resident patients in care of a geriatric setting. The thirty elderly were average age 86 years (18 female and 12 male) with vascular dementia or late stage Alzheimer's disease, completely dependant on ADLs and with global aphasia. After 48 hours from the acceptance to hospital the pain has been identified. The pain assessment was carried out by administering the PAINAD (already validate in italian) and ABBEY scales by the nurse responsible for the patient and by a second nurse, for an amount of four surveys for each patients. Results show that both scales give equivalent results for the pain assessment (K=0.68), with concordance asset moderately good between the exams taken by the two nurses (Cohen K rate between 0.49 and 0.58). The PAINAD scale requires an administering time far lower than the ABBEY scale (p 0.001) and both can be used for the assessment of pain in those patients, also in the hospital.

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

[Assessment of pain in advanced dementia. Construct validity of the German PAINAD]. [2018] The observation scale PAINAD (pain assessment in advanced dementia) is composed of five behavioral categories: breathing, vocalization, facial expression, body language, and consolability. The present study investigates the construct validity of the German version.

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

Calculated Decisions: Pain assessment in advanced dementia (PAINAD) scale [2020] The PAINAD scale is used to assess pain in patients with dementia.

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] To adapt the Pain Assessment in Advanced Dementia (PAINAD) scale to Brazilian Portuguese with respect to semantic equivalence and cultural aspects, and to evaluate the respective psychometric properties (validity, feasibility, clinical utility and inter-rater agreement).

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] The aims of the present study were to report on the psychometric properties of the Pain Assessment in Advanced Dementia (PAINAD) scale by comparing it with the gold standard method of self-reporting on a numerical rating scale (NRS), and to provide a categorical version of the PAINAD scale comparable with the verbal descriptor scale of the NRS.

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

Pain assessment in people with dementia. [2021] Pain in older adults is very often undertreated, and it may be especially so in older adults with severe dementia. Changes in a patient's ability to communicate verbally present special challenges in treating pain, and unrelieved pain can have serious consequences, including declines in physical function and diminished appetite. The Pain Assessment in Advanced Dementia (PAINAD) scale has been designed to assess pain in this population by looking at five specific indicators: breathing, vocalization, facial expression, body language, and consolability. A trained nurse or other health care worker can use the scale in less than five minutes of observation. For an online video showing nurses using the PAINAD scale and other pain-assessment tools, go to http://links.lww.com/A251.

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] The study aims to evaluate the psychometric properties of the German version of a scale for the assessment of pain in advanced dementia (PAINAD-G).

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] Pain has a significant impact on hospitalized patients and is a quality indicator for nursing care. The Pain Assessment in Advanced Dementia (PAINAD) scale measures pain in people with communication disorders and advanced dementia, but it has not been validated in any other population.