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Evidence-based care of people with suspected cognitive impairment (or dementia) in general practice: a cluster randomised control trial.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001032943
Acronym
IRIS: Investigating Research Implementation Strategies for care of people with suspected cognitive i
Enrollment
2520
Registered
2011-09-28
Start date
2011-10-10
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 leade

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.

Sponsors

School of Public Health and Preventive Medicine, Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 10, 2026