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Trial registered on ANZCTR


Registration number
ACTRN12617000989347
Ethics application status
Approved
Date submitted
28/06/2017
Date registered
10/07/2017
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain assessment and management for older people with dementia in hospitals
Scientific title
Nursing practice of pain assessment and management for older people with dementia in hospitals
Secondary ID [1] 292302 0
None
Universal Trial Number (UTN)
U1111-1198-4495
Trial acronym
OPWD
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Pain 303838 0
Dementia 303839 0
Condition category
Condition code
Neurological 303206 303206 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Undermanaged pain among older patients with dementia continues to be of concern. The reviewed evidence indicated that pain has not been well assessed and pain assessment tool has not been routinely used for patients with dementia. This requires an attention among the health care professionals in pain and dementia care, in particular for older patients with dementia who may have difficulty report their pain through verbal communication.

The aims of this study are to explore if older people with dementia self-report pain while hospitalised and to examine whether routinisation of pain assessment by nurses has an effect on pain management for older patients with dementia in acute care settings.
The study will be conducted in two local health district hospitals (Gosford and Wyong). Four units will be randomly assigned into two for intervention units and two for control units.

The study will use both quantitative and qualitative methods. A quasi-experimental design will be employed as quantitative methodology. The study will conduct auditing of patients' medical records, surveying nurses, and delivering the information sessions, An individual interview and document analysis will be employed as qualitative approaches. The study will use a developed pain checklist for conducting an audit, Tool for Evaluating the ways Nurse Assess Pain (TENAP) for nurses' survey, ASK 4 brochures and ASK 4 portable cards for the information sessions and in nurses' daily practice.

The study comprises three stages: pre-intervention stage, intervention stage, and post-intervention stage. In pre-intervention stage, the study will audit of patients’ medical records (Document analysis) using a developed pain checklist. Nurses' survey (TENAP) will be distributed to all the participation units. For the intervention stage, the study will held several Information/education sessions. The information sessions will take place in every week throughout 6 weeks of the intervention program, and it will take about 20-30 minutes for each information session. The nurses (n=30-40) who work in the two intervention units will be invited to attend the information sessions for the entire 6 weeks of the intervention program. The intervention 'ASK 4' algorithm will be introduced. The ASK 4 comprised 4 simple steps that prompt nurses to initiate a pain assessment when caring for patients with dementia. The Ask 4 includes 1.DO YOU HAVE PAIN? 2. DOCUMENT THE SCORE 3. PROVIDE NURSING ACTION 4. REASSESS and ENTER in nursing progress notes. Nurses attending the information sessions will be informed about how to implement ‘ASK 4’ into their routine vital sign round including 1). the importance of patient’s self-report pain, 2). utilise the pain assessment tools including self-report and observation pain tools into routine practice, 3). take action into pain management, 4). reassessment, and documentation. The designed ASK 4 cards will be distributed as a reminder of the everyday practice of pain in dementia. The researcher who is an experienced Registered Nurse and PhD candidate will deliver the information sessions. The dementia care providers are the Registered Nurses (RNs) who work regularly in the participantion units. Those RNs include senior, experienced, and new graduated nurses on the wards. The care provided is part of their routine practice. There is no direct contact to the patients with dementia. After the intervention stage, the study will conduct auditing of medical records, TENAP nurses' survey again and interview of the individual nurses..





Intervention code [1] 298478 0
Behaviour
Intervention code [2] 298479 0
Treatment: Other
Comparator / control treatment
Four participation units will be randomly assigned into two for intervention units and two for control units. The nurses who work in the intervention units have a choice of whether to participate in the intervention program. For nurses who work in the control units will not receive information session for the 'ASK 4' intervention. There is no direct contact with patients. The auditing of patient's medical records will be recruited according to inclusion criteria which are patients with dementia and age 65 and over.
The study will compare the differences between the intervention groups and the control groups, and the group differences between the pre and post of the intervention program.
Control group
Active

Outcomes
Primary outcome [1] 302584 0
The primary outcome measure of the study is to measure if patients with dementia self-reported pain. Both control and intervention units' patient medical records will be assessed for self-pain reports in patient with dementia by measuring the use of Numeric rating scale (NRS), Visual analogue scale (VAS), FACE scale, and Face, Legs, Activities, Cry, Cosolidation (FLACC) pain tools. The pain tools used and the level of pain score documented will be recorded into Stata 14 to examine if the proportion of patients with dementia are able to self report their pain while hospitalised.
Timepoint [1] 302584 0
the timepoint for measuring the primary outcome will be evaluated in 4 weeks in pre-intervention stage and 4 weeks after the intervention
Primary outcome [2] 302621 0
An additional primary outcome of the study is to test if nominalising a pain assessment as 5th vital sign has an effect on nurses' pain management for older people with dementia. By auditing patients’ medical records using the developed pain checklist before and after the intervention program, we will be able to measure the difference before and after the intervention program in nurses' everyday pain practice in patients with dementia.
Timepoint [2] 302621 0
This will be evaluated 4 weeks before and after the intervention program
Primary outcome [3] 302671 0
The nurses’ knowledge, attitude, report pain practice before and after the intervention program will be measured by TENAP survey. The data drawn from the individual interview will also provide a deep understanding about nurses knowledge and experience in the process of implementation .
Timepoint [3] 302671 0
This will be evaluated 4 weeks before and 4 weeks after the intervention program
Secondary outcome [1] 336432 0
The study will generate secondary outcome about if there are any incident report is related to pain issue in patient with dementia. This will be measured by document analysis of the qualitative data from the pain checklist. The study will record the cause of the incident report in patients with dementia to measure if pain is correlated to the incident report (types of incident) during hospitalisation.
Timepoint [1] 336432 0
The secondary timepoint will be measured 4 weeks in pre-intervention stage and 4 weeks after the intervention program
Secondary outcome [2] 336542 0
The study will also reveal the pain prevalence among hospitalised older patients with dementia by aggregation the numbers of pain report in patients with dementia. Pain has been defined as ''whatever the experiencing person says it is, existing whenever the experiencing person say it does ” (McCaffery, 1968, p.95.). Thus the pain report from the pain score documented will reveal that if patient has pain during the admission. Pain score other than 0 is considering the perception of pain.
Timepoint [2] 336542 0
This will be measured 4 weeks in pre-intervention stage and 4 weeks after the intervention stage.
Secondary outcome [3] 336721 0
The secondary outcome of the study will also reveal if pain is related to an extended hospital stay. By document analysis of the patients' medical records, we shall be able to assess what is the causes for the patients with dementia to stay in the hospital longer than its primary diagnosis. We will measure how many of the patients with dementia extending the hospitalisation because of the pain issue.
Timepoint [3] 336721 0
This will be measured 4 weeks in pre-intervention stage and 4 weeks after the intervention stage.

Eligibility
Key inclusion criteria
Patients:
Patients aged 65 years and over who have a diagnosis of dementia will be included in the study. Dementia diagnosis is confirmed with a structured clinical assessment based on international DSM-IV criteria, and or had a clear documented dementia diagnosis in the electronic medical record system (EMR).
Nurses:
The Registered Nurses (RNs) who work in the participation units on a regular basis and have a direct involvement in the care of older patients with dementia will be recruited.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without dementia diagnosis and documented
All Registered Nurses in the participation units will be included

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data
All quantitative data will be entered into password-protected excel spreadsheet and import into Stata 14 (StataCorp. 2015. Stata Statistical Software) for analysis. Descriptive statistics will be used to report the participants’ (nurses and patients) demographic data. Patients’ types of dementia behaviours, types of incident report and extended of hospitalisation that were correlated to pain will be summarised with descriptive statistic using mean, median and standard deviation (SD). For the patient groups, we are comparing two independent samples (patients are likely to be different before and after the intervention program due to fast hospital admissions and discharges. And it will be the different sample group between the intervention groups and the control groups). Assuming that the data are normally distributed, a parametric test of two independent sample t-test will be used (or if, non-parametric test). For the nurse groups, we are comparing two dependent sample (RN survey participants), a one sample dependent t-test will be used. The categorical data such as types of pain tool used, types of dementia, types of pain medication prescribed and administered between the groups will be tested with Chi-square test. Those variable differences between the groups will be examined by Logistic regression.

Qualitative data
For the qualitative data, the interview will be audio recorded and transcribed verbatim. All qualitative data will be analysed using direct content analysis with NPT to identify themes and underlying meaning of the text (Graneheim & Lundman, 2004; Potter & Levine-Donnerstein, 1999). The process will be a series of moving back and forth to achieve saturation, including reading transcripts several times, coding the data, generating the themes among each independent researchers (Ngulube, 2015; Streubert & Carpenter, 2011). The qualitative data will be recorded in word document and use NVivo 11 (QSR International's NVivo 11 Software) to facilitate data analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial Ceased
Date of first participant enrolment
Anticipated
17/07/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
1/08/2018
Actual
2/04/2018
Date of last data collection
Anticipated
1/09/2018
Actual
Sample size
Target
200
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296847 0
University
Name [1] 296847 0
The university of Newcastle
Country [1] 296847 0
Australia
Primary sponsor type
Individual
Name
Sarah Jeong
Address
The University of Newcastle
Ourimbah campus
10 Chittaway Road
Ourimbah NSW 2258
Australia
Country
Australia
Secondary sponsor category [1] 295845 0
None
Name [1] 295845 0
Address [1] 295845 0
Country [1] 295845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298076 0
Hunter New England Local Health District (HNELHD) Human Research Ethics Committee (HREC)
Ethics committee address [1] 298076 0
Hunter New England Local Health district, Locked Bag 1, New
Lambton, NSW, 2305
Ethics committee country [1] 298076 0
Australia
Date submitted for ethics approval [1] 298076 0
01/12/2016
Approval date [1] 298076 0
16/12/2016
Ethics approval number [1] 298076 0
HNEHREC Reference No: 16/12/14/5.09 NSW HREC Reference No: LNR/16/HNE/578
Ethics committee name [2] 298077 0
Central Coast Local Health District (CCLHD) Site Specific Assessment
Ethics committee address [2] 298077 0
RESEARCH - Central Coast Local Health District
Holden St, level 1 health service building, Gosford NSW 2250
Ethics committee country [2] 298077 0
Australia
Date submitted for ethics approval [2] 298077 0
31/01/2017
Approval date [2] 298077 0
28/04/2017
Ethics approval number [2] 298077 0
0117-009C

Summary
Brief summary
Undermanaged pain among older patient with dementia continues to impact on patient centre care provided among acute care settings. As the dementia population continues to grow, there is a need to address this issue by finding the solution for a better outcome. The challenges in assessing pain in dementia play a major barrier for nurses in conducting effective pain management (Bruneau & Benjamin, 2014; Coker et al., 2008; De Witt Jansen et al., 2017; Laflamme et al., 2012; Rantala, Kankkunen, Kvist, & Hartikainen, 2014b). This intervention study aims to investigate if nurses’ daily pain assessment and management for older patients with dementia can be improved by a simple and routinised intervention program. The project will introduce an innovative intervention program, which prompts nurse participants to undertake pain assessment during their routine vital sign round, that is, pain become embedded as a fifth vital sign.

The study aims:
1). To explore if older people with dementia provide self-report of pain while hospitalised; 2). To examine whether routinisation of pain assessment and subsequent management by nurses has an effect on pain management in older people with dementia in hospital settings.

Study hypothesis:
H0: 1. There are no differences before and after the intervention program in the level of self-reported pain by older patients with dementia between two groups; intervention groups and control groups.
2. There are no effect on nurses’ practice in the routinisation of pain assessment and management for older patients with dementia before and after the intervention program between two groups; intervention groups and control groups.
Ha: 1. There are differences before and after the intervention program in the level of
self-reported pain by older patients with dementia between two groups; intervention groups and control groups.
2. There are effect on nurses’ practice in routinisation of pain assessment and management for older patients with dementia before and after the intervention program between two groups; intervention groups and control groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75914 0
A/Prof Sarah Jeong
Address 75914 0
The University of Newcastle
Ourimbah Campus
10 Chittaway Road
Ourimbah NSW 2258
Australia
Country 75914 0
Australia
Phone 75914 0
+61 2 4349-4535
Fax 75914 0
Email 75914 0
[email protected]
Contact person for public queries
Name 75915 0
Sharyn Hunter
Address 75915 0
The University of Newcastle
Callaghan Campus
University Drive, Callaghan
NSW 2308, Australia
Country 75915 0
Australia
Phone 75915 0
+61 2 4921 5957
Fax 75915 0
Email 75915 0
[email protected]
Contact person for scientific queries
Name 75916 0
Yvette Tsai
Address 75916 0
The University of Newcastle
Ourimbah Campus
10 Chittaway Road
Ourimbah NSW 2258
Australia
Country 75916 0
Australia
Phone 75916 0
+61 451115318
Fax 75916 0
Email 75916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.