Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More (DOLEVA75)

October 6, 2014 updated by: University Hospital, Clermont-Ferrand

The pain of the elderly is even often unrecognized or trivialized and ignored in spite of its big 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.

So in the elderly, the noxious character of the pain is more pregnant than at the young adult. The echo on the acts of the everyday life is fast, the activities decrease, coming to deteriorate the isolation and the dependence: the echo on the psychic state is frequent and the pain is a part of the cause of a confusional state. Finally, the presence of a pain distorts considerably the quality of life and can modify the state general as the desire of life.

The evaluation of the 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 with the real age. For that purpose, the investigators have first of all scale of self-assessment as the numerical scale which is adapted to estimate the acute and chronic pains but this scale presents a bias because, certain patients do not express spontaneously their pain and this one must be attentively looked for in case of modification of behavior.

So scales of hetero-evaluation were elaborated to solve the difficulties of detection and to care the pain of the elderly. One of these is the scale Algoplus® (5 items which allow within one minute a good quality evaluation whatever is the place of care) whose objective is the observation of the behavioral changes caused by the acute pain in elderly having communication disorders.

Due to the demographic evolution, emergency departments are more and more frequently a place of consultation of the elderly. Indeed, the elderly represent approximately 10 to 20 % of all the passages in emergency department and 50 % of the patients hospitalized during the passage in the reception of Emergency department are elderly. Elderly care is difficult for a certain number of reasons (vulnerability, accumulation of pathologies and treatments). So, in this context, the evaluation of the presence of pain and its care are difficult in particular at the elderly with communication disorders.

In a preliminary study in the emergency department of the Hospital of Clermont-Ferrand, on 700 patients of more than 75 years old admitted in April 2012, 32 % had a prescription of analgesic while 13 % only had a real quotation of the pain.

The aim of the investigators study is to analyze if the systematic introduction of the scale Algoplus® in the evaluation of elderly during its entrance to emergency department could modify the prescription of analgesic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

First period of the study :

Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and then taken care according to the usual practice of the emergency department.

A Clinical Research Associate will collect the quotation of pain by numerical scale and the analgesics treatments prescribed and their posology and route of administration.

This data collection must be realized for 100 elderly patients of 75 or more years old admitted the Emergency department during one month.

Training period :

Training of the emergency physicians in the use of the Algoplus® scale.

Second period of the study :

Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and by Algoplus® scale then taken care according to the usual practice of the emergency department.

A Clinical Research Associate will collect the quotation of pain by numerical scale and by Algoplus® scale and the analgesics treatments prescribed and their posology and route of administration.

This data collection must be realized for 100 elderly patients of 75 or more years old admitted the Emergency department during one month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

elderly patients

Description

Inclusion Criteria:

  • Patients admitted in emergency department for any pathologies,
  • Patients of 75 or more years old

Exclusion Criteria:

  • Patients of less than 75 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
numerical scale
Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and then taken care according to the usual practice of the emergency department.
Other: pain in elderly patients
algoplus scale
Evaluation of the pain of elderly patient admitted in the emergency department by numerical scale and by Algoplus® scale then taken care according to the usual practice of the emergency department.
Other: pain in elderly patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Collection of the rate of prescription of analgesic treatments
Time Frame: at day 1
at day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Collection of the score of quotation of pain by numerical scale (score from 0 to 10)
Time Frame: at day 1
at day 1
Collection of prescription of analgesic
Time Frame: at day 1
at day 1
Collection of the prescription of analgesic by class according to the scale of the WHO
Time Frame: at day 1
at day 1
Collection of the score of the scale Algoplus®
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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