Pilot Study on Clinical Decision Support Tools for Referral for Dementia Consultation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adhesion of patients to remote monitorization with Brain on Track
研究概览
简要总结
The goal of this interventional study is to implement and evaluate the adhesion to two types of interventional strategies for assessing cognitive function, at Family Health Units (FHU), providing primary care clinicians (PCCs) 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 MoCA/MMSE -and the class I digital medical device web-based Brain on Track - group Brain on Track/MoCA/MMSE -, 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 interventional 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 interventional groups and, according to the respective results and other criteria used during the consultation, PCCs 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 interventional 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 interventional study groups with the Control Group, to see if there is an improvement on the referral process in the interventional groups, compared with the Control Group .
详细描述
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 six Portuguese FHU from Matosinhos. 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 two FHU in each group.
In each FHU, all PCCs will be invited to participate and all eligible patients will be proposed to be included in the study. The PCCs 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 PCCs. 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 MoCA/MMSE: a training session about dementia management and standardized criteria for referral will be provided to the participant PCCs, complemented with training in the administration of MMSE and MoCA, provided also to resident clinicians 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
The pilot study 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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults who are native from Portugal and fluent in Portuguese, have not already been diagnosed with dementia, have no motor, visual and/or hearing limitations and present to PCCs with cognitive complaints
- •In group Brain on Track/MoCA/MMSE, 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
排除标准
- •Motor, visual and hearing limitations
结局指标
主要结局
Adhesion of patients to remote monitorization with Brain on Track
时间窗: 12 months
Number of remote monitorization sessions with Brain on Track accomplished by each patient allocated to the follow-up period of 12 months/4
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
时间窗: 12 months
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
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
时间窗: 24 months
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
Proportion of new cases diagnosed with dementia, in the different stages of progression: mild, moderate and severe
时间窗: 18 months
To determine the proportion of incident cases of dementia, from early to severe stages, among the patients referred to specialized care
Referrals decided by PCCs in all study groups
时间窗: 24 months
Number of referrals decided by PCCs in each study group of patients who are eligible and accept to participate in the study, per month
Number of referrals decided by PCCs based mainly on the result of the cognitive intervention administered/Total number of decisions of referral * 100
时间窗: 24 months
Evaluation of the impact of the result obtained from the cognitive interventions administered on the clinical decision of referral made by PCCs
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
时间窗: 36 months
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
Positive predictive value of the implemented interventional strategies
时间窗: 18 months
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
Adhesion of PCCs to the three cognitive interventions implemented
时间窗: 12 months
Number of MoCA/MMSE/Brain on Track tests prescribed by PCCs to the recruited patients (with inclusion criteria and who accept to participate in the study) per month
次要结局
- Adhesion to interventional strategies by health professionals(At one-year of recruitment)
- Adhesion to Brain on Track by patients allocated to remote follow-up(At the end of the remote monitoring period of 12 months with Brain on Track)