Improving the Referral of Patients With Suspected Cognitive Impairment and Early Dementia

Study Overview
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Brief Summary
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The goal of this interventional study is to implement and evaluate the adhesion to two types of intervention strategies for assessing cognitive function, at Family Health Units (FHU), providing primary care clinicians (PCC) with support to the decision process, regarding the referral of patients suspected of having mild cognitive impairment (MCI) or early dementia to the specialized consultation of Neurology at the public hospital services. The defined intervention strategies are the paper version of the cognitive tests MMSE and MoCA -group MMSE/MoCA-and the digital web-based platform Brain on Track - group Brain on Track/MMSE/MoCA -, which will be compared with the regular clinical practice as the Control Group. The main question it aims to answer is: • the impact on the referral process of the implemented cognitive assessment strategies in the two intervention study groups compared with the Control Group. Trained health professionals, at FHU, will administer the cognitive tests mentioned above to the eligible patients suspected of having MCI or early dementia, in the intervention groups and, according to the respective results and other criteria used during the consultation, PCC will decide about the need of referral to the Neurology consultation. In the Control Group, health professionals will provide the regular clinical assistance practised in the respective FHU. If the referral occurs, the Neurology specialist will perform a complete clinical neuropsychological assessment of the referred patients and will validate the suspected diagnosis made at FHU. Eligible patients with suspected MCI or early dementia will perform the cognitive tests according to the intervention study group, at the FHU or remotely. In the Control Group, eligible patients will be assisted through the daily clinical practice in the respective FHU. The research team will compare the intervention study groups, MMSE/MoCA and Brain on Track/MMSE/MoCA, with the Control Group, to see if there is an improvement on the referral process in the intervention groups, compared with the Control Group .

Detailed Description
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The pilot study has an exploratory quasi-experimental design. It is single blinded in the perspective of the Neurology consultation, regarding the origin and method of referral of each patient with a suspected diagnosis of MCI or early dementia from primary care. The study will be implemented at 12 Portuguese FHU, six from Santa Maria da Feira and six from Matosinhos. In each geographic region, FHU will be similar in size, demographic composition, annual average of patients with cognitive complaints suspected of a diagnosis of MCI or early dementia, and annual average of referrals of patients with suspected MCI or early dementia to specialized care. FHU will be randomly allocated to the three study groups, existing four FHU in each group, two from each geographic region. A sample size of 12 FHU is considered statistically adequate for a pilot study. In each FHU, all PCC, Nurses and Psychologists will be invited to participate and all eligible patients will be proposed to be included in the study. The PCC will assess the patient during a normal consultation and, whenever considered relevant, will decide to apply the referral strategy based on the support tools available. This will be a non-probabilistic consecutive sampling process of the general population, carried out by PCC. An average of 20 to 30 patients are expected to be referred to the specialized care, after one year of recruitment, in each group. The study groups are characterized as the following: i) Group MMSE/MoCA: a training session about dementia management and standardized criteria for referral will be provided to the participant PCC, complemented with training in the administration of MMSE and MoCA, provided also to participant health professionals responsible for administration of the tests. MMSE will be administered if the patient has three to four years of schooling, and the MoCA will be used if the patient has more than four years of schooling. Patients with less than three years of education will be evaluated through regular clinical practice. ii) Group Brain on Track/MMSE/MoCA: a training session about dementia management and standardized criteria for referral will be provided to the participant PCC, complemented with training in the administration of Brain on Track, MMSE, and MoCA, provided also to participant health professionals responsible for administration of the tests. Brain on Track is a web-based platform, used to remotely monitor cognitive function: https://neuroinova.com/brain-on-track/. The first assessment will occur at the FHU, administered by a health professional. Depending on the score obtained, patients will be immediately referred to a specialized consultation or will be followed up during a period of 12 months with remote self monitorization, every three months. According to the total score from the four self-assessments, PCC will decide whether to refer or not. Patients who are illiterate will be evaluated through regular clinical practice, or MMSE or MoCA tests, according to years of schooling, if they are literate, but do not gather the inclusion criteria for the administration of Brain on Track. iii) Control group: regular clinical practice complemented with the provision of standardized criteria for referring patients with a suspected diagnosis of MCI or early dementia to PCC. In each study group, the participating health professionals will receive adequate training from the research team. All referred patients will undergo a comprehensive neuropsychological assessment and a complete etiological study, performed by Neurologists from the reference hospitals associated with the participating FHU. This assessment will validate the PCC clinical decision of referral as correct or incorrect, in all three groups. Concerning the validation of the clinical decision of non-referral, all the patients not referred will be contacted by phone, one year after the participation in the study, to check if the diagnosis changed during that period of time and the patient is being followed up or will start to be followed up by a Neurologist. Additionally, Focus Groups will be performed in two different moments: i) the first at baseline, with health professionals from all participating FHU, to understand the current barriers and facilitators to the management of dementia, and ii) the second, at the end of the period of patients´ recruitment of one year, with health professionals from FHU allocated to intervention groups, and at the end of the one-year follow-up period with Brain on Track, with patients who were allocated to this follow-up. The aim of the second qualitative study is to perceive the experience of both health professionals and patients on using the respective intervention strategies. The success of the implementation of the study will be quantified by quality indicators of two types, indicators of adhesion and indicators of referral, which will be constructed upon data collected by PCC in specific forms designed by the research team and integrated on the local computer network of FHU. At the end of the study a questionnaire about the experience of usability of Brain on Track will be applied to the patients allocated to the one-year monitoring and to the health professionals who administered it at the FHU, to evaluate the global adhesion to the digital intervention. The statistical analysis of will be performed using SPSS statistical software and will consist of a comparison of the primary endpoints between the three study groups, using an adequate statistical test for independent samples, namely a Qui-Square test or a T-test. The significance level will be fixed at 5%. Concerning the secondary endpoint related to the adhesion to the intervention strategies implemented, models of logistic regression will be used to assess the associations between patients and health professionals sociodemographic and professional characteristics, and the level of adhesion to the intervention. Odds ratio with 95% confidence intervals will be computed using logistic regression. The qualitative data obtained from Focus Groups will be analyzed using NVivo software and all the information collected will be transcribed verbatim, and a thematic analysis and data triangulation will be performed subsequently.

Official Title
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Pilot Study on Clinical Decision Support Tools for Referral for Dementia Consultation

Conditions
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Cognitive Dysfunction, Mild Cognitive Impairment

Intervention / Treatment
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* Diagnostic Test: Mini Mental State Examination
* Diagnostic Test: Montreal Cognitive Assessment
* Device: Brain on Track (version BOT.0.0.0 03.03.2023)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who are fluent in Portuguese, have not already been diagnosed with dementia, have no motor, visual and/or hearing limitations and present to PCC with cognitive complaints In group Brain on Track/MMSE/MoCA, related to Brain on Track: have a computer and/or tablet at home, with internet access, and have minimal computer literacy, in addition to the previous referred inclusion criteria Exclusion Criteria: Less than 18 years old, with a previous diagnosis of dementia (independently of the stage) and not fluent in Portuguese

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The unit of study is the FHU. The 12 FHU recruited will be randomly allocated to the three study groups and each FHU will belong to the same group during the total period of the study. The study will be conducted simultaneously in all the groups, in each geographic region.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group MMSE/MoCA (Interventional Group)<br>A training session about dementia management and standardized criteria for referral will be provided to the participant PCC, complemented with training in the administration of MMSE and MoCA, provided also to participant health professionals responsible for administration of the tests. MMSE will be administered if the patient has three to four years of schooling, and the MoCA will be used if the patient has more than four years of schooling. Patients with less than three years of education will be evaluated through regular clinical practice. | Diagnostic Test: Mini Mental State Examination<br>* MMSE is a clinically validated cognitive test, broadly used in healthcare and scientific settings, and is administered to individuals with cognitive complaints suspected of cognitive decline whose educational literacy is of three to four years of schooling.<br>* Other names: MMSE;Diagnostic Test: Montreal Cognitive Assessment<br>* MoCA is a clinically validated cognitive test, broadly used in healthcare and scientific settings, and is administered to individuals with cognitive complaints suspected of cognitive decline whose educational literacy is, at least, of four years of schooling.<br>* Other names: MoCA;|
| Experimental: Group Brain on Track/MMSE/MoCA (Interventional Group)<br>The training sessions mentioned in group MMSE/MoCA will be similarly provided to participant health professionals in this group. Brain on Track is a web-based platform, used to remotely monitor cognitive function: https://neuroinova.com/brain-on-track/. The first assessment will occur at the FHU, administered by a health professional. Depending on the score obtained, patients will be immediately referred to a specialized consultation or will be followed up during a period of 12 months with remote self monitorization, every three months. According to the total score from the four self-assessments, PCC will decide whether to refer or not. Patients who are illiterate will be evaluated through regular clinical practice, or MMSE or MoCA tests, according to years of schooling, if they are literate, but do not gather the inclusion criteria for the administration of Brain on Track. | Diagnostic Test: Mini Mental State Examination<br>* MMSE is a clinically validated cognitive test, broadly used in healthcare and scientific settings, and is administered to individuals with cognitive complaints suspected of cognitive decline whose educational literacy is of three to four years of schooling.<br>* Other names: MMSE;Diagnostic Test: Montreal Cognitive Assessment<br>* MoCA is a clinically validated cognitive test, broadly used in healthcare and scientific settings, and is administered to individuals with cognitive complaints suspected of cognitive decline whose educational literacy is, at least, of four years of schooling.<br>* Other names: MoCA;Device: Brain on Track (version BOT.0.0.0 03.03.2023)<br>* Brain on Track is a class 1 web-based software medical device, accessible on most platforms, including desktops and laptops. It is designed to allow periodic self-administered cognitive tests to be performed, enabling a cognitive assessment and continuous monitoring of the cognitive state of the patient remotely. It is based on the classic tests of neuropsychological assessment and allows assessing the main areas of cognition through a test lasting approximately 22 minutes. The stimuli that integrate each subtest are randomized between sessions, which reduces the effect of learning and allows the accomplishment of serial assessments.The test is available in three versions, adapted to different levels of schooling: 1-4 years, 5-9 years and 10+ years. The performance in each test is compared with normative population data and performance over time. For each test performed, Brain on Track presents a cumulative risk score for the presence of cognitive impairment.<br>* Other names: BOT;|
| No Intervention: Control Group<br>Regular clinical practice complemented with the provision of standardized criteria for referring patients with a suspected diagnosis of MCI or early dementia to PCC. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of the implemented intervention strategies | To determine the capacity of MMSE, MoCA and Brain on Track of detecting the true positive cases of MCI among the total positive cases of suspected cognitive impairment | 18 months | 
| Proportion of new cases diagnosed with dementia, in the different stages of progression: mild, moderate and severe | To determine the proportion of incident cases of dementia, from early to severe stages, among the patients referred to specialized care | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers and facilitators to the management of dementia by health professionals | Description of the opinions and experiences of health professionals from FHU concerning the management of patients suspected of having dementia in the daily clinical practice, through Focus Groups | Before beginning the recruitment of patients - at baseline | 
| Adhesion of PCCs to the three cognitive interventions implemented | Number of MoCA/MMSE/Brain on Track tests prescribed by PCCs per month | 12 months | 
| Adhesion to intervention strategies by health professionals | Description of the experiences from health professionals, concerning the application of interventions from groups MMSE/MoCA and Brain on Track/MMSE/MoCA, through Focus Groups | At one-year of recruitment | 
| Usability of Brain on Track by health professionals | Assessment of the usability of Brain on Track by health professionals at FHU, during one year, through a questionnaire designed by the research team | At the end of the period of one-year of recruitment | 
| Adhesion of patients to remote monitorization with Brain on Track | Number of remote monitorization sessions with Brain on Track accomplished by each patient allocated to the follow-up period of 12 months/4 | 12 months | 
| Usability of Brain on Track by patients allocated to remote follow-up | Assessment of the usability of Brain on Track by patients allocated to self-monitoring during one year, through a questionnaire designed by the research team | At one-year of remote monitoring with Brain on Track | 
| Adhesion to Brain on Track by patients allocated to remote follow-up | Description of the experiences from patients allocated to self-monitoring with Brain on Track during one year, through Focus Groups | At the end of the remote monitoring period of 12 months with Brain on Track | 
| Average number of MoCA/MMSE/Brain on Track tests prescribed by PCCs in the 12-month period of implementation/Average number of MoCA/MMSE/Brain on Track tests prescribed by PCCs at baseline | Evaluation of the adhesion to the cognitive tests implemented during the 12-month period of the study in comparison to the adhesion existent before the implementation of the study | 12 months | 
| Referrals decided by PCCs in all study groups | Number of referrals decided by PCCs in each study group per month | 24 months | 
| Average number of referrals decided by PCCs in each group of the study in the total temporal period of the study/Average number of referrals decided by PCCs at baseline | Evaluation of the impact of the implemented interventions on the quantity of referred patients suspected of a diagnosis of MCI or early dementia, during the 12-month period of implementation, taking into account the comparison to the same average quantity before the implementation of the study | 24 months | 
| Number of referrals decided by PCCs based mainly on the result of the cognitive intervention administered/Total number of decisions of referral * 100 | Evaluation of the impact of the result obtained from the cognitive interventions administered on the clinical decision of referral made by PCCs | 24 months | 
| Number of correct referrals decided by PCCs based mainly on the result of the cognitive intervention administered/Number of correct referrals decided by PCCs in the Control group * 100 | Evaluation of the impact of the cognitive interventions administered and their result on the clinical decision of referral made by PCCs in comparison to the impact of regular clinical practice on the same type of clinical decision | 36 months | 
| Relative frequency of each diagnosed stage of dementia | Determination of the distribution of each of the three possible diagnosed stages of dementia among the patients referred to specialized care | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment, early dementia, timely diagnosis, primary care, referral process