Clinical trial NCT02174744: Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales
Official title: Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain in Elderly Patients Having Communication Disorders.
Keywords: Pain in elderly patients having communication disorders
Numerical scale
Algoplus® scale
Doloplus® scale
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-1405 - Main investigator - Coordinating center
name: Ms Joëlle DEVOT - Collaborator
name: Dr Patrice RAT - Investigator
name: Dr Chandra COLOM - Investigator
name: Mr Dieudonné ENDOUGOU - Collaborator
name: Dr Cyril GUILLAUME - Investigator
name: Ms Nathalie ROUX - Collaborator
name: Dr Yves PASSADORI - Investigator
name: Ms Nathalie DANNENBERGER - Collaborator
name: Dr Micheline MICHEL - Investigator
name: Dr Sylvie CHAPIRO- Investigator
name: Dr Jean-François VILLARD - Investigator
name: Dr Bernard WARY- Investigator
name: Dr Anne-Cécile BOURJAL - Investigator
name: Dr Catherine BLUNTZ - Investigator
name: Dr Françoise CAPRIZ - Investigator
name: Dr Marie FLOCCIA - Investigator
name: Dr Jérôme BOHATIER - Investigator
name: Ms Linh NGUYEN PHUONG - Collaborator
First posted: 2014-06-26
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients

Brief summary: The pain of the elderly is often trivialized and ignored in spite of its high frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in institution and 80 % of this population at the end of life.

The evaluation of pain appeals to the same strategy as to the younger subject but with some specificities, related more to the pathologies associated with the ageing than to the real age. For that purpose, the investigators have self-assessment scales as the Numeric Pain Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a bias because, some patients do not express spontaneously their pain.

So behavioural scales were elaborated to solve the difficulties of detection and to care the pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be completed) whose objective is the observation of behavioural changes caused by the acute pain in elderly having communication disorders. The Doloplus® scale (30 items which allow in few minutes a good evaluation of pain) whose objective is the observation of behavioural changes caused by the chronic pain in elderly having communication impairments.

In practice, because of its popularity, the Algoplus® scale is widely used out of the specificity in which it has been validated. Practitioners, worried about this misuse, suggested to Doloplus® group, to test the concordance between the two behavioural scales in order to develop recommendations more targeted. The risk is that the use of the Algoplus® scale may underestimate pain that would have been detected by Doloplus® scale, and lead to under-treatment or non-treatment of pain in elderly having communication disorders.

This study aims to establish the concordance between these two scales to generate advices and recommendations to assess efficiently the pain in this vulnerable population.

The main objective of this study is to assess whether the use of Algoplus® scale is in good concordance with Doloplus® scale.

The secondary objective of this study is to assess the concordance with different levels of Algoplus® pain scale: (0-1), (2-3), (4-5).

Detailed description: The physician investigator will identify and include patients in the study according to the inclusion criteria. Management of patients do not differ from the usual care in the service concerned. During the usual patient care, several pain assessments will be performed: Numeric Pain Rating Scale, MMSE score if the patient is able to communicate, Algoplus® scale and Doloplus® scale will be performed by doctors and/or caregivers without patient's participation. The patient will be assessed by two doctors and or caregivers (the time interval between the two assessments must be as short as possible).

In a first step, 48 hours after patient admission in the care service, a first doctor/caregiver will assess pain with Numeric Pain Rating Scale and evaluate MMSE score if it is possible and then assess pain with the Algoplus® scale. The results of the Numeric Pain Rating Scale, the Algoplus® scale and the MMSE score will be recorded in the medical record and in the study Case Report Form.

In a second step, less than 3 hours after the first assessment, a second doctor/caregiver will assess pain with the Doloplus® scale and the result will be recorded in the medical record and in the study Case Report Form.

The Case Report Form (containing demographic data, the history of pain, analgesics treatment, scores of Numeric Pain Rating Scale, MMSE, Algoplus® scale and Doloplus® scale) will be faxed to the Coordinating Center at Clermont-Ferrand in the day.

Eligibility criteria: Inclusion Criteria:

* Patients of 65 or more years old
* Patients having communication disorders
* Hospitalization for at least 48 hours

Exclusion Criteria:

* Patients of less than 65 years

Primary outcomes:
measure: Pain scores on Algoplus® and Doloplus® pain scales
timeFrame: at 48 hours after patients' admission in the care service.
Secondary outcomes:
measure: Different levels of Algoplus® pain scale: (0-1), (2-3), (4-5)
timeFrame: at 48 hours after patients' admission in the care service.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References: