PainDOLEVA75NCT02258503
Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More
An observational study of Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Pain
- What is being tested?
- pain in elderly patients
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly patients
Who may be able to join
- Patients admitted in emergency department for any pathologies,
- Patients of 75 or more years old
Who cannot join
- Patients of less than 75 years.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pain
- Being tested
- pain in elderly patients
- Keywords
- Numerical scale, Pain in elderly patients admitted in emergency department
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain in elderly patientsOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: pain in elderly patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of the rate of prescription of analgesic treatments
Measured: at day 1
Secondary outcomes (4)
Collection of the score of quotation of pain by numerical scale (score from 0 to 10)
Measured: at day 1
Collection of prescription of analgesic
Measured: at day 1
Collection of the prescription of analgesic by class according to the scale of the WHO
Measured: at day 1
Collection of the score of the scale Algoplus®
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258503
- Sponsor's protocol ID
- CHU-0211
- Acronym
- DOLEVA75
- Status last verified
- Oct 2014
- First submitted
- 3 Oct 2014
- Last updated
- 7 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of the Scale ALGOPLUS® on the Prescriptions of Analgesics in Emergency Department on Patients of 75 Years Old or More
- ClinicalTrials.gov ID
- NCT02258503
- Acronym / sponsor ID
- DOLEVA75 / CHU-0211
- Conditions
- Pain
- Keywords
- Numerical scale, Pain in elderly patients admitted in emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| numerical scale | – | Other: pain in elderly patientsEvaluation 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. |
| algoplus scale | – | Other: pain in elderly patientsEvaluation 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly patients
Key inclusion criteria (2 listed)
- Patients admitted in emergency department for any pathologies,
- Patients of 75 or more years old
Key exclusion criteria (1 listed)
- Patients of less than 75 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain in elderly patients | Other | algoplus scale, numerical scale |
Primary outcome
Collection of the rate of prescription of analgesic treatments
Time frame: at day 1
4 secondary outcomes
Collection of the score of quotation of pain by numerical scale (score from 0 to 10)
Time frame: at day 1
Collection of prescription of analgesic
Time frame: at day 1
Collection of the prescription of analgesic by class according to the scale of the WHO
Time frame: at day 1
Collection of the score of the scale Algoplus®
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of the rate of prescription of analgesic treatments (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.