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Trial registered on ANZCTR


Registration number
ACTRN12613000997752
Ethics application status
Approved
Date submitted
3/09/2013
Date registered
9/09/2013
Date last updated
9/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Assessment and Management of the Cognitively Impaired Older Person Presenting to Emergency Departments with suspected long bone fracture
Scientific title
For patients over 64 years of age with suspected long bone fractures and cognitive impairment, does the use of The Pain Assessment in Advanced Dementia (PAINAD) screening tool compared to standard ED pain assessment (verbal analogue scales), improve the time to analgesia and pain score at 60 minutes.
Secondary ID [1] 283132 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain assessment of patients over 64 years of age with cognitive impairment who present to the emergency department with suspected long bone fracture. 289983 0
Condition category
Condition code
Injuries and Accidents 290362 290362 0 0
Fractures
Musculoskeletal 290363 290363 0 0
Other muscular and skeletal disorders
Neurological 290364 290364 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is no nationally accepted tool, in emergency departments, for assessing pain in patients with cognitive impairment. Current Australasian practice is for emergency nurses to assess a patient’s pain using the verbal analogue scales (0-10 pain scale score). However, a verbal analogue scale does not meet the needs of the older person with cognitive impairment and or communication barriers. Given the lack of an appropriate screening tool, pain assessment and timely analgesic intervention is made more difficult for older persons with cognitive impairment.

The Pain Assessment in Advanced Dementia (PAINAD) screening tool has features that most closely resemble an ‘ideal’ tool for ED clinicians for pain assessment of cognitively impaired patients. PAINAD comprises five behavioural categories: breathing, vocalization, facial expression, body language and consolability. The PAINAD tool uses a ten point score scale which is assigned by the clincian as a result of responses given by the patient. PAINAD is similar to the verbal analogue scale (0-10 scale) emergency clinicians currently use for pain assessment. Furthermore, in a time poor environment such as the ED the PAINAD tool is quick, relatively simple to use and allows for measuring pain assessment trends over time.

Our randomised blinded prospective study will be conducted in four emergency departments: two departments were randomized to use the Pain Assessment in Advanced Dementia (PAINAD) tool and two departments to continue standard care using the verbal analogue scale. A convenience sample of patients with suspected long bone fracture in the control sites (two) will be examined for cognitive impairment using the SIS cognitive screening tool and continue to routinely be assessed for pain using current pain assessment scales (verbal analogue scale).

In the intervention sites (two) a convenience sample of patients with suspected long bone fracture will be screened for cognitive impairment using the SIS and if the score is less than four (cognitive impairment), patients will be screened for pain using the PAINAD tool.

Intervention code [1] 287853 0
Diagnosis / Prognosis
Intervention code [2] 287854 0
Early detection / Screening
Comparator / control treatment
Standard treatment: The control group is a convenience sample of patients with suspected long bone fractures (>64years) in two control sites. Patients will be examined for cognitive impairment using the SIS cognitive screening tool and continue with routine pain assessment care. Whereby nurses will use the standard verbal analogue scale (current practice).
Control group
Active

Outcomes
Primary outcome [1] 290393 0
Primary Outcome 1: Time to analgesia for older persons (65+) with suspected long bone fracture and cognitive impairment using the PAINAD scale compared to standard treatment.
Timepoint [1] 290393 0
Time point measure is from ED arrival (Triage) to first analgesic dose documented in the patient’s medical record.
Secondary outcome [1] 304397 0
Secondary outcome 1: Analgesic documentation (type of analgesia, dose of anagelsia and time analgesia adminsitered) of older persons (65+) with suspected long bone fracture and cognitive impairment using the PAINAD scale and type of analgesic administered.
Timepoint [1] 304397 0
Time point measure is from ED arrival (Triage) and first analgesic type documented in the patient’s medical record.
Secondary outcome [2] 304398 0
Secondary outcome 2: Pain assessment documentation of older persons (65+) with suspected long bone fracture and cognitive impairment using the PAINAD scale at 60 minutes.
Timepoint [2] 304398 0
Time point measure is first pain score documented in the patient’s medical record and then pain score at 60minutes.
Secondary outcome [3] 304399 0
Secondary outcome 3: Analgesic documentation (type of analgesia, dose of anagelsia and time analgesia adminsitered) of older persons (65+) with suspected long bone fracture and cognitive impairment using the PAINAD compared to standard care and type of analgesic administered.
Timepoint [3] 304399 0
Time point measure is from ED arrival (Triage) and first pain score and analgesic type documented in the patient’s medical record across all sites.
Secondary outcome [4] 304400 0
Secondary outcome 4: Verbal pain score documentation of older persons (65+) with suspected long bone fracture compared with the SIS scale and type of analgesic administered.
Timepoint [4] 304400 0
Time point measure is from ED arrival (Triage) and first pain score, SIS score and analgesic documented in the patient’s medical record in control sites.
Secondary outcome [5] 304401 0
Secondary outcome 5: Verbal pain score documentation of older persons (65+) with suspected long bone fracture compared with the SIS scale score and PAINAD score.
Timepoint [5] 304401 0
Time point measure is from ED arrival (Triage) and first pain score or PAINAD and SIS score documented in the patient’s medical record.

Eligibility
Key inclusion criteria
People over 64 years of age who present to the Emergency Department with suspected long bone fracture.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Triage Category 1, multi-trauma and haemodynamic or respiratory instability.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients over 64 years with a suspected long bone fracture will be eligible for enrolment in the study. Subject and treatment allocation is not concealed with only the site randomised to the intervention. However, Clinicians are blinded to the outcome study measures. In this trial two of the four sites were randomly allocated to use the PAINAD tool or standard treatment pain assessment (verbal analogue scale). The allocation to intervention will not be concealed from subjects (emergency nurses) as they will complete the PAINAD tool and obtain a pain score. The PAINAD score provides the nurse with a pain assessment scale (0-10). Once the nurse obtains a PAINAD score they will apply their standard pain management treatment regimes. Clinicians will not be blinded to the PAINAD score, but are blinded to its purpose (time to analgesia). The time to analgesia will be collected from the medical record independently of the nurse administering the analgesic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of coin tossing was used in this trial to allocate the PAINAD tool or standard pain assessment (verbal analogue scale) treatment to each site. The four sites were broken into geographical areas: south Sydney and north Sydney. Each hospital was assigned either heads or tails. The called side, such as heads, was allocated to the intervention, the other side was allocated to the control group. At all sites a convenience sample of participants with suspected long bone fracture over the age of 64years will be used in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using IBM SPSS v.19. Descriptive statistics will be calculated, followed by comparisons of cognitively and non-cognitively impaired patient groups using the t-test and X2 test. Univariate analysis for the effect of each measured variable will be assessed using a Chi-squared test. Age will be considered as an ordered categorical variable. Variables with P<0.25 on univariate analysis will be included in a baseline multivariate logistic regression model. Backward elimination of variables which are not significant and show no evidence of confounding will be used to obtain a final model. Chi-squared analysis and a multivariate logistic regression models will be applied to determine significant relationships.

Our target sample size is 484 [121 per site]. The sample size estimates are based on various assumptions. All are assuming a mean of 185 (SD 167) minutes in the control sites based on the prior prevalence data. The ICC determines the inflation factor for the clustering effect. An ICC of 0.1 is more realistic but gives an IF of 5.9. I have given the target time of cognitively normal patients as 80 minutes, with a power of 0.8 or 80%. Based upon these power calculations we would require a total number of 472 patients or 118 per site.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
Date of last participant enrolment
Anticipated
24/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
484
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1472 0
St George Hospital - Kogarah
Recruitment hospital [2] 1473 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 1474 0
Manly Hospital - Manly
Recruitment hospital [4] 1475 0
Mona Vale Hospital - Mona Vale
Recruitment postcode(s) [1] 7306 0
2217 - Kogarah
Recruitment postcode(s) [2] 7307 0
2031 - Randwick
Recruitment postcode(s) [3] 7308 0
2095 - Manly
Recruitment postcode(s) [4] 7309 0
2103 - Mona Vale

Funding & Sponsors
Funding source category [1] 287884 0
Government body
Name [1] 287884 0
Emergency Care Institute NSW
Country [1] 287884 0
Australia
Primary sponsor type
Hospital
Name
Research and Practice Development Unit, Northern Sydney Local Health District
Address
Research and Practice Development Unit,
Nursing and Midwifery Directorate
Northern Sydney Local Health District
Level 7 Kolling Building,
Royal North Shore Hospital
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 286611 0
None
Name [1] 286611 0
Address [1] 286611 0
Country [1] 286611 0
Other collaborator category [1] 277599 0
Individual
Name [1] 277599 0
Professor Lynn Chenoweth,

Centre for Healthy Brain Ageing
Faculty of Medicine
University of New South Wales
Address [1] 277599 0
Centre for Healthy Brain Ageing
NPI, Euroa Centre, Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country [1] 277599 0
Australia
Other collaborator category [2] 277600 0
Individual
Name [2] 277600 0
Associate Professor Glenn Arendts,

Centre for Medical Research,
Faculty of Medicine, Dentistry and Health Sciences
The University of Western Australia
Address [2] 277600 0
Centre for Medical Research, UWA (CMR)
The University of Western Australia (M516)
35 Stirling Highway
CRAWLEY WA 6009
Country [2] 277600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289825 0
Northern Sydney Local Health District Human Ethics Committee
Ethics committee address [1] 289825 0
Ethics committee country [1] 289825 0
Australia
Date submitted for ethics approval [1] 289825 0
Approval date [1] 289825 0
20/12/2012
Ethics approval number [1] 289825 0
1212-430M

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42606 0
Prof Margaret Fry
Address 42606 0
Research and Practice Development,
Nursing and Midwifery Directorate
Northern Sydney Local Health District
Level 7 Kolling Building,
Royal North Shore Hospital
St Leonards NSW 2065
Country 42606 0
Australia
Phone 42606 0
+61(2) 9926 4693
Fax 42606 0
Email 42606 0
[email protected]
Contact person for public queries
Name 42607 0
Casimir MacGregor
Address 42607 0
University of Technology Sydney /
Research and Practice Development,
Nursing and Midwifery Directorate
Northern Sydney Local Health District
Level 7 Kolling Building,
Royal North Shore Hospital
St Leonards NSW 2065
Country 42607 0
Australia
Phone 42607 0
+61 2 99264653
Fax 42607 0
Email 42607 0
[email protected]
Contact person for scientific queries
Name 42608 0
Margaret Fry
Address 42608 0
Research and Practice Development,
Nursing and Midwifery Directorate
Northern Sydney Local Health District
Level 7 Kolling Building,
Royal North Shore Hospital
St Leonards NSW 2065
Country 42608 0
Australia
Phone 42608 0
+61(2) 9926 4693
Fax 42608 0
Email 42608 0
Margaret.Fry@ health.nsw.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



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