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Trial registered on ANZCTR


Registration number
ACTRN12617000563369
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
21/04/2017
Date last updated
21/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
CogChamps: Using Cognition Champions to embed a new model of care for hospitalised older patients with cognitive impairment
Scientific title
CogChamps: Efficacy of using Cognition Champions to embed a new model of hospital care for hospitalised older patients.
Secondary ID [1] 291643 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 302784 0
Delirium 302785 0
Cognitive Impairment 302861 0
Condition category
Condition code
Neurological 302288 302288 0 0
Dementias
Public Health 302341 302341 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was implemented across 6 wards (2 surgical, 4 medical) at the Princess Alexandra Hospital (PAH; The Intervention Hospital) , Brisbane. Experienced nurses (with more than two years clinical experience), and (a) a specific interest in dementia and delirium, or (b) leadership skills, were identified to become Cognition Champions (CogChamps). CogChamps are nurses who will champion best practice care for older patients with cognitive impairment (CI) including dementia and delirium in hospital. They were provided with comprehensive dementia and delirium education and training (Workshop 1) and education about leadership and change management skills (Workshop 2) to facilitate changing care practices, through two full days of Workshops.

Workshop 1 topics included:
Project Overview (presented by Catherine Travers, PhD., Chief Investigator)
Dementia versus delirium (presented by PAH's Clinical Nurse Consultant (CNC) - Dementia and Delirium & a PAH Geriatrician),
Important issues associated with CI in hospital (presented by PAH's CNC - Dementia and Delirium),
Behavioural and psychological symptoms of dementia (presented by PAH's CNC - Dementia and delirium),
The assessment of delirium using the Confusion Assessment Method (CAM), This 2 hour session included a demonstration of the CAM by the hospital's CNC - Dementia and delirium, practice using the CAM by the CogChamps in pairs, as well as supervised real-life practice by each CogChamp on their home ward. Supervision was provided by either a hospital Geriatrician or a nurse well versed in use of the CAM, who observed each CogChamp administer the CAM and interpret the results (with discussion and feedback);
Delirium prevention and management (presented by one of the Investigators - Dr Judy McCrow who developed a validated online learning package for nurses about delirium);
Pharmaceuticals (presented by PAH's Pharmacist);
Implementing change in the workplace: Participants were introduced to the modified Knowledge Translation (KT) framework. The model outlines four steps for effective knowledge translation: awareness, agreement, adoption, and adherence. Participants were asked to complete a homework activity that involved considering which KT stage both they and their ward were at, and outline the steps required to transition from that stage to the next stage in the continuum (presented by one of the project's Investigators - a Nursing Professor with extensive geriatric nursing experience) . The activity was completed prior to, and in preparation for, Workshop 2.

Workshop 2 topics included:
What is a Cognition Champion? (presented by the Chief Investigator)
Elements of change and how to influence it (presented by PAH's Nurse Educator),
Development of a ward specific Action Plan by the CogChamps (2 hour session - small group activity), This activity was facilitated by three of the project's Investigators,
Communication skills including assertive communication, setting clear expectations, and tools and strategies for providing feedback (presented by PAH's Nurse Educator)..

Both workshops were delivered face-to-face and were presented twice to ensure the CogChamps were able to attend with a maximum of 20 participants per Workshop. All participants received continuing practice development points and a certificate for participation.

A key component of Workshop 2 was the development of ward specific Action Plans by the CogChamps who were asked to identify areas in their home wards where the care of patients with CI could be improved, and develop specific plans to make those improvements. This ensured that the specific interventions to be adopted addressed the local needs of each ward and the preferences of the CogChamps working on those wards. Examples of the Action items included the development of checklists for nurses to use when managing a patient who appears to have delirium; and the provision of education about delirium and its assessment for ward nurses.

The CogChamps were supported by the Research team and project facilitators (at least weekly face-to-face contact ranging from 10 minutes to 1 hour) to implement their Action Plans over a 5 month period (June - October 2016).. The aims of the meetings were to:
Mentor CogChamps to implement their Action Plans,
Ascertain and document progress towards the implementation of each ward’s Action plan,
Identify any barriers to progress, and guide CogChamps to identify possible solutions,
Provide feedback to CogChamps regarding their progress, and
Assist CogChamps to develop processes essential to effective project implementation (e.g. systems for communicating between CogChamps on each ward who work differing rosters).

The impact and effectiveness of the CogChamps project was assessed by collecting the same outcome data from 2 wards (a medical and a surgical ward) at a comparable site, located nearby (approximately 10 kilometers away) - he Control hospital
Intervention code [1] 297723 0
Prevention
Comparator / control treatment
Nursing care as usually provided
Control site - Two wards (1 medical and 1 surgical) ward at the Queen Elizabeth 2 hospital - a hospital comparable to the Intervention hospital comparable insofar as nursing staff have been exposed to the same educational modules for dementia and delirium as IH nurses and they have similar patient profiles
Control group
Active

Outcomes
Primary outcome [1] 301695 0
Primary outcome - Observational/ audit assessment (quantitative data) of evidence-based nursing care practices to prevent, manage and treat delirium in older hospitalised patients [as detailed in key documents including the Clinical Practice Guidelines for the Management of Delirium in Older People (Melbourne: Victorian Government Department of Human Services; 2006)].
An audit/ observational tool was developed to assess this outcome (based on the Practice Guidelines) and included questions relating to cognitive assessment, pain assessment and management (e.g. Was a pain assessment undertaken? Had analgesia been administered within the last 24 hours?), and antipsychotic / benzodiazepine use (Was the patient prescribed or administered any PRN antipsychotic / benzodiazepine medication within the past 24 hours?).
Items requiring direct observation include aspects of the environment (e.g. Was there a clock set to the correct time, that the patient could see from his/ her bed?); nutrition (Was adequate assistance provided to the patient if the patient had difficulty eating or drinking); restraint use (Was the patient restrained?); use of indwelling catheters (IDC; Did the patient have an IDC in situ?), communication (If the patient exhibited confusion / dis-orientation, did the nurse say anything to re-orient the patient?), and patient activity (What was the patient doing when you entered the room?).
The tool was initially developed by the chief investigator (CT) and subsequently revised by the research team until consensus regarding the included items was reached. Most items required an objective Yes/ No/ Not applicable answer.
Timepoint [1] 301695 0
Timepoint 1 - following CogChamps receiving dementia / delirium education (April 2016)
Primary outcome [2] 301696 0
Composite primary outcome - nurses’ knowledge of cognitive impairment (CI; dementia and delirium) and self-confidence in nursing patients with CI,
Delirium knowledge was assessed using 15 True/ False items relating to delirium features and risk factors. As no well validated tools for assessing nurse’s delirium knowledge were identified, the 15 items common to the Delirium Knowledge Questionnaire (Hare et al., 2008) and an assessment tool developed by Wand and colleagues (Wand et al., 2014) were selected.

Nurses' self-confidence in recognizing delirium and caring for patients with dementia / confusion was assessed using two single item statements answered using a 1 – 5 scale where 1=not at all confident and 5 = very confident..
Timepoint [2] 301696 0
Timepoint 2 - following implementation of Action Plans (October 2016)
Primary outcome [3] 301697 0
The number of nurses who are proficient in assessing and documenting dementia and delirium;
CogChamps were directly observed by the Chief Investigator performing a delirium assessment (CAM) to a patient and interpreting it. They were signed off as being proficient when observed to be able to administer and interpret the CAM correctly.
Timepoint [3] 301697 0
Timepoint 3 - follow-up (3 months following implementation of the Action Plans) - January 2017
Secondary outcome [1] 333798 0
Number of adverse events experienced by patients with cognitive impairment when hospitalised (i.e. falls, antipsychotic use). These data will be extracted from the hospital's administrative database.
Timepoint [1] 333798 0
Timepoint 2 - following implementation of the Action Plans (Oct 2016)

Eligibility
Key inclusion criteria
Patients - patients admitted to one of the study wards aged 65 years and older with a documented diagnosis of dementia or delirium, or report of confusion, memory problems or other cognitive impairment (e.g. memory problems, mild cognitive impairment) in the patient’s chart, or reported verbally by the Charge Nurse.

CogChamps - .. CogChamps were required to have over two years clinical experience and (a) a specific interest in dementia and delirium, or (b) have leadership skills.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient exclusion criteria - patients aged less than 65 years,
CogChamps exclusion criteria - less than 2 years of nursing experince

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Data collection time-points coincided with key phases of the project in order to evaluate which component(s) accounted for project outcomes. data was collected at baseline (pre-intervention); timepoint 1 (following CogChamps receiving dementia/ delirium education); timepoint 2 (following implementation of Action Plans); and at timepoint 3 (3 months following timepoint 2).
Statistical analyses include descriptive analyses of the CogChamps and patients; Group differences will be assessed using the Student’s t-test for continuous data (e.g. changes on knowledge outcomes), and non-parametric tests (Chi-squared statistic; Wilcoxon signed rank test) for categorical data (e.g. changes in nurses self-confidence in nursing patients with dementia/ delirium. Regression analyses will be sued to assess the importance of the intervention and its components in effecting changes in nursing care practices (e.g. was the patient assessed for pain).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/10/2015
Date of last participant enrolment
Anticipated
Actual
25/01/2017
Date of last data collection
Anticipated
Actual
25/01/2017
Sample size
Target
300
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7841 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7842 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 15780 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 15781 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 296136 0
Government body
Name [1] 296136 0
Commonwealth Department of Social Services
Country [1] 296136 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St, Brisbane Qld 4000
Country
Australia
Secondary sponsor category [1] 295037 0
None
Name [1] 295037 0
Address [1] 295037 0
Country [1] 295037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297388 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 297388 0
Ethics committee country [1] 297388 0
Australia
Date submitted for ethics approval [1] 297388 0
14/07/2015
Approval date [1] 297388 0
24/08/2015
Ethics approval number [1] 297388 0
HREC/15/QPAH/451
Ethics committee name [2] 297392 0
Queensland Univerisy of Technology Human Research Ethics Committee
Ethics committee address [2] 297392 0
Ethics committee country [2] 297392 0
Australia
Date submitted for ethics approval [2] 297392 0
24/08/2015
Approval date [2] 297392 0
24/08/2015
Ethics approval number [2] 297392 0

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

Contacts
Principal investigator
Name 73890 0
Dr Catherine Travers
Address 73890 0
Dementia Collaborative Research Centre
Level 6, N Block
Queensland University of Technology,
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country 73890 0
Australia
Phone 73890 0
+61 07 3138 3057
Fax 73890 0
Email 73890 0
catherine.travers@qut.edu.au
Contact person for public queries
Name 73891 0
Catherine Travers
Address 73891 0
Dementia Collaborative Research Centre
Level 6, N Block
Queensland University of Technology,
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country 73891 0
Australia
Phone 73891 0
+61 07 3138 3057
Fax 73891 0
Email 73891 0
catherine.travers@qut.edu.au
Contact person for scientific queries
Name 73892 0
Catherine Travers
Address 73892 0
Dementia Collaborative Research Centre
Level 6, N Block
Queensland University of Technology,
Victoria Park Rd.,
Kelvin Grove Qld 4059
Country 73892 0
Australia
Phone 73892 0
+61 07 3138 3057
Fax 73892 0
Email 73892 0
catherine.travers@qut.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCogChamps: impact of a project to educate nurses about delirium and improve the quality of care for hospitalized patients with cognitive impairment.2018https://dx.doi.org/10.1186/s12913-018-3286-4
EmbaseTurning education into action: Impact of a collective social education approach to improve nurses' ability to recognize and accurately assess delirium in hospitalized older patients.2018https://dx.doi.org/10.1016/j.nedt.2017.12.026
N.B. These documents automatically identified may not have been verified by the study sponsor.