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Trial registered on ANZCTR


Registration number
ACTRN12611001032943
Ethics application status
Approved
Date submitted
27/09/2011
Date registered
28/09/2011
Date last updated
28/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evidence-based care of people with suspected cognitive impairment (or dementia) in general practice: a cluster randomised control trial.
Scientific title
A theory based intervention, compared to usual care, to facilitate evidence-based care by general practitioners in the detection and diagnosis of people with cognitive impairment/dementia.
Secondary ID [1] 263107 0
Nil.
Universal Trial Number (UTN)
Trial acronym
IRIS: Investigating Research Implementation Strategies for care of people with suspected cognitive impairment (or dementia).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia(s) 270864 0
Cognitive impairment 270865 0
Condition category
Condition code
Neurological 271040 271040 0 0
Dementias
Mental Health 279055 279055 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating GPs from practices randomised to the intervention arm will receive a targeted, theory-based intervention designed to address the modifiable barriers to implementing recommendations from an evidence-based guideline when diagnosing and managing patients in whom they suspect cognitive impairment/dementia.

The intervention will comprise 6 hours of interactive workshops – offered either as a full day workshop or spread across two sessions – led by trained facilitators and opinion leaders. When the workshop is spread across two sessions these will be held in the evening. GP participants attending these evening sessions will be asked to attend two sessions no more than three weeks apart.

The behaviour change techniques utilised in the workshop will include: (a) persuasive communication; (b) information provision; (c) information regarding behaviour, outcome; (d) feedback; (e) social processes of encouragement, pressure and support; (f) self-monitoring; (g) modelling/demonstration of behaviour by others; (h) environmental changes; (i) increasing skills; (j) coping skills; (k) rehearsal of relevant skills; (l) prompts, triggers and cues.

The workshops will be supported by a DVD with evidence-based resources for the management of people with dementia. The DVD will be distributed to all GPs in the intervention arm, including those that cannot attend the workshops.
Intervention code [1] 269452 0
Behaviour
Comparator / control treatment
Standard treatment/care: Participating GPs from practices randomised to the comparator arm will receive written evidence-based information about the management of patients with dementia.
Control group
Active

Outcomes
Primary outcome [1] 279694 0
Percentage of cognitively impaired patients who have a Mini Mental State Examination (MMSE) completed (measured via Clinical Audit Tool (CAT) automated search of electronic medical records for 'active' patients aged 70 years and over in whom the GP suspects cognitive impairment).

* For the purposes of this study, 'active' patients are defined as patients who have visited their general practitioner at least 3 times in the previous two years.
Timepoint [1] 279694 0
6 months post-workshop delivery.
Primary outcome [2] 279695 0
Percentage of cognitively impaired patients who are screened for co-morbid depression using a validated scale - either the Geriatric Depression Scale (GDS), Hamilton Rating Scale for Depression (HRDS) or the Even Briefer Assessment Scale for Depression (EBAS-DEP) - (measured via CAT automated search of electronic medical records for 'active' patients aged 70 years and over in whom the GP suspects cognitive impairment).
Timepoint [2] 279695 0
6 months post-workshop delivery.
Secondary outcome [1] 294230 0
Referral to specialist for further management (measured via CAT automated search of electronic medical records for 'active' patients aged 70 years and over in whom the GP suspects cognitive impairment).
Timepoint [1] 294230 0
6 months post-workshop delivery.
Secondary outcome [2] 294231 0
Referral for CT scan (measured via CAT automated search of electronic medical records for 'active' patients aged 70 years and over in whom the GP suspects cognitive impairment).
Timepoint [2] 294231 0
6 months post-workshop delivery.
Secondary outcome [3] 294232 0
Recorded suspicion of cognitive impairment (measured via CAT automated search of electronic medical records for 'active' patients aged 70 years and over).
Timepoint [3] 294232 0
6 months post-workshop delivery
Secondary outcome [4] 294233 0
Recorded dementia diagnosis (measured via CAT automated search of electronic medical records for 'active' patients aged 70 years and over).
Timepoint [4] 294233 0
6 months post-workshop delivery
Secondary outcome [5] 294234 0
GP's intention to practice in concordance with CPG recommendations (measured via self-reported behaviour in response to patient vignettes in GP questionnaire).

Behaviours include:
Diagnosis related: a) Complete a formal cognitive assessment using validated scale (MMSE) in individuals with suspected cognitive impairment; b) Assess co-morbid depression using a validated scale (eg, Geriatric Depression Scale (GDS) or others); c) Referral to a specialist for access to dementia-modifying medication; d) Referral for head/brain CT scan; e) Complete a review of current medication (prescription and over the counter (OTC) that may cause cognitive impairment); f) Complete pathology tests.

Management related: a) Disclose or reinforce a diagnosis of dementia (once confirmed by a specialist); b) Give carers information on available education and training resources; c) Provide information on activities to promote cognitive stimulation; d) Provide information on recreational activities to enhance quality of life and well being; e) Promote awareness of changing driving capacity as disease progresses; f) Discussion of legal issues (e.g. power of attorney, guardianship); g) Give advice re respite care.
Timepoint [5] 294234 0
Baseline and 6 months post-workshop delivery.
Secondary outcome [6] 294235 0
Behavioural construct domains related to key recommendations (attitudes, beliefs and intentions; measured via GP questionnaire).
Timepoint [6] 294235 0
Baseline and 6 months post-workshop delivery.

Eligibility
Key inclusion criteria
General practices: General practices will be eligible for inclusion in the trial if the following criteria are met: (i) at least one GP within the practice provides written informed consent; (ii) the practice utilises CAT-compatible software (either Medical Director or Best Practice) to routinely record their clinical patient encounters.
Minimum age: 18 years. Maximum age: No limit.

Patient cohort: The study will not recruit patient participants. Rather, patients’ electronic records are accessed via the CAT automated searches and de-identified records will be provided to the investigators. Patient informed consent will not be required.

The CAT automated search parameters will render patient records eligible for inclusion if the following criteria are met: (i) the patient is defined as ‘active’ i.e. they have a minimum of three visits recorded in the clinical software within the last two years; (ii) the patient is aged 70 years and over; (iii) the patient’s GP has recorded a suspicion of cognitive impairment; (iv) the patient visits the GP in the follow-up period (6 months post-workshop delivery).
Minimum age: 70 years. Maximum age: No limit.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General practices/practitioners: General practices are ineligible to participate in the trial if: (i) they are a non-computerised practices or are a practice that does not routinely use an electronic medical record system/program to capture clinical encounters; (ii) the practice principal or practice manager refuse to participate.

Individual GPs may be excluded if they work at more than one of the general practices included in the trial, and the practices are randomised to different trial arms.

Patient cohort: No exclusion criteria in addition to not meeting inclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Practices meeting the inclusion criteria will be randomly allocated to receive either the intervention or control. Restricted randomisation will be used to reduce the probability of baseline imbalance. Within stratum, one-half of the practices will be randomised to the intervention group, and the other half to the control using computer-generated random numbers. Four strata will be defined by the location of practice (rural or metropolitan) and the number of GPs in the practice. A statistician independent of the study will implement the randomisation. They will be provided with only practice codes and stratification variables. Randomisation of practices will be undertaken at one time. Allocation will be concealed from the investigators until baseline data has been collected from practitioners.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number will be generated using the statistical package Stata/MP 12 for Windows (StataCorp. 2011. Stata Statistical Software: Release 12. College Station, TX: StataCorp LP). Within stratum, practices will be sorted by the random number. The first half of the practices within each stratum will be allocated to the intervention, and the second half to the control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4523 0
3004 (site of recruitment)
Recruitment postcode(s) [2] 4524 0
recruiting across all postcodes in Victoria that include a general practice.

Funding & Sponsors
Funding source category [1] 269934 0
Government body
Name [1] 269934 0
National Health and Medical Research Council
Address [1] 269934 0
Street address:
Level 1,
16 Marcus Clarke Street,
Canberra ACT 2601

Postal address: National Health and Medical Research Council,
GPO Box 1421,
Canberra ACT 2601
Country [1] 269934 0
Australia
Primary sponsor type
University
Name
School of Public Health and Preventive Medicine, Monash University
Address
Level 6, The Alfred Centre,
99 Commercial Road,
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 268935 0
None
Name [1] 268935 0
Address [1] 268935 0
Country [1] 268935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271901 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 271901 0
Human Ethics,
Monash Research Office,
Building 3E, Room 111,
Monash University (Clayton campus),
Wellington Road,
Clayton VIC 3008
Ethics committee country [1] 271901 0
Australia
Date submitted for ethics approval [1] 271901 0
Approval date [1] 271901 0
04/07/2011
Ethics approval number [1] 271901 0
CF11/0727 - 2011000192

Summary
Brief summary
The number of Australians with dementia is increasing and so is the frequency of people with dementia presenting to general medical practice. This project aims to improve the care of people with suspected cognitive impairment in general practice. We have conducted interviews with 30 GPs from urban and rural settings in Victoria, Australia to determine their clinical behaviours and knowledge with respect to the detection, diagnosis and management of cognitive impairment and dementia and their perceived barriers to implementing evidence-based recommendations. A national survey is currently being conducted to further explore GPs’ current clinical practice in this area. Using this information we have designed a targeted theory-based intervention to implement these evidence-based recommendations into clinical practice once cognitive impairment is suspected by the GP. We will conduct a cluster randomised controlled trial to test the effect of this targeted intervention and establish if the intervention is effective in increasing the number of cognitively impaired patients in whom the GP undertakes the recommendations to formally diagnose or exclude dementia. Automated search strategies will be developed to extract evidence-based recommendations from de-identified patient electronic medical files including completion of a Mini-Mental State Examination and a screen for co-morbid depression using a validated scale. General practices (n= 126) will be randomised to receive either the targeted theory-based intervention, or to a control group receiving access to the evidence-based clinical practice guideline alone. This project will contribute to the body of knowledge about how to bring about practice change. The outcomes of the study have the potential to improve the detection and diagnosis of people with suspected dementia in primary care.
Trial website
http://www.cochrane.org.au/projects/iris.php
Trial related presentations / publications
IRIS Publications

2010
Workman B, Dickson F and Green S “Early dementia: optimal management in general practice”. Australian Family Physician 2010; 39:722-726.

2009
Dickson F, Green S and Workman B. “Post diagnosis management of dementia”. Geriatric Medicine in General Practice 2009; 3:26-27.

Workman B, Dickson F and Green S. “Diagnosing dementia and Clinical Practice Guidelines”. Geriatric Medicine in General Practice 2009; 1:6-7.

IRIS Conference Presentations

2011
Browning, C on behalf of IRIS Study Group. Implementing evidence-based dementia guidelines: Using the views of GPs to inform behaviour change interventions. Alzheimer’s Australia National Conference May 2011.

2009
Green, S, Dickson F on behalf of IRIS Study Group. Exploring the barriers and enablers in general practice to the uptake of evidence-based clinical practice guidelines in care of people with dementia. Alzheimer’s Australia National Conference June 2009.

Green S on behalf of the IRIS Study Group. Implementing an evidence-based clinical practice guideline for care of people with dementia in general practice: the design of a cluster randomised controlled trial. Paper Abstract. 2009 General Practice & Primary Health Care Research Conference, July 2009.
Public notes

Contacts
Principal investigator
Name 33201 0
Address 33201 0
Country 33201 0
Phone 33201 0
Fax 33201 0
Email 33201 0
Contact person for public queries
Name 16448 0
Ms Lana Kluchareff
Address 16448 0
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 16448 0
Australia
Phone 16448 0
+61 3 9903 0069 (for Melbourne, Australia)
Fax 16448 0
+61 3 9903 0556 (‘ATTN IRIS Study’)
Email 16448 0
lana.kluchareff@monash.edu
Contact person for scientific queries
Name 7376 0
Professor Sally Green or Dr Simon French
Address 7376 0
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country 7376 0
Australia
Phone 7376 0
Professor Green: +61 3 9903 0366; Dr French: +61 3 9903 0063
Fax 7376 0
+61 3 9903 0556 (‘ATTN IRIS Study’)
Email 7376 0
sally.green@monash.edu , simon.french@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results