Protocol for a Cluster Randomised Trial of a Goal-Oriented Care Approach for Multimorbidity Patients Supported by a Digital Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,380
- 主要终点
- Health related quality of life
研究概览
简要总结
This study aims to assess whether the use of the METHIS digital platform using a patient-centered approach contributes to an improvement in the quality of life, mental health and physical activity of patients with multimorbidity followed up in Primary Health Care. Practices will be randomly allocated between: providing access to consultations through the METHIS platform (intervention) or following patients by the traditional method (control). They will complete questionnaires on quality of life, mental health and report the number of steps taken, at the beginning and end of the study.
详细描述
A superiority, cluster randomised trial will be conducted at Primary Health Care Practices (1:1 allocation ratio). All public practices in the Lisbon and Tagus Valley Region, Portugal, not involved in a previous pilot trial, will be eligible. The intervention combines a training programme and a customised Information System (METHIS). Both are designed to help clinicians to adopt a Goal-Oriented Care Model approach and to encourage patients and carers to play a more active role in autonomous healthcare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •community-dwelling people
- •aged 50 or older
- •with complex multimorbidity (co-occurrence of three or more chronic conditions affecting three or more different body systems)
- •with access to an Internet connection and a communication technology device
排除标准
- •inability to: provide informed consent, to read or write, inability to access an email or electronic device, even when helped by an informal caregiver
研究组 & 干预措施
METHIS Intervention
The METHIS intervention will consist of two components. The first component is a Goal-Oriented Care (GOC) Training Program for health professionals. The training program will include the concept of personalised care, methods of goal elation, implications of GOC in healthcare practice, and how METHIS platform can be used to support the application of GOC. The training will be implemented through a blended-learning, continuous education program that will be credited by Nova University of Lisbon. The second component is a GOC information system. This will be the digital platform METHIS, which will be designed to nudge clinicians to adopt a GOC and to encourage patients and caregivers to take an active role in healthcare. The investigators will adapt an existing platform that was developed for a pilot study during the COVID-19 pandemic, that promotes care coordination, optimises disease prioritisation, and patient self-management.
干预措施: METHIS Platform (Device)
METHIS Intervention
The METHIS intervention will consist of two components. The first component is a Goal-Oriented Care (GOC) Training Program for health professionals. The training program will include the concept of personalised care, methods of goal elation, implications of GOC in healthcare practice, and how METHIS platform can be used to support the application of GOC. The training will be implemented through a blended-learning, continuous education program that will be credited by Nova University of Lisbon. The second component is a GOC information system. This will be the digital platform METHIS, which will be designed to nudge clinicians to adopt a GOC and to encourage patients and caregivers to take an active role in healthcare. The investigators will adapt an existing platform that was developed for a pilot study during the COVID-19 pandemic, that promotes care coordination, optimises disease prioritisation, and patient self-management.
干预措施: Goal-Oriented Care Training Program (Other)
Control
The control group in this trial will be the best usual care, using the standard Electronic Health Records available to the practice. Our understanding of what "best usual care" is for people with multimorbidity is informed by qualitative research in an earlier stage of this project. Our results suggest that healthcare professionals often provide disease-driven care. When faced with multiple healthcare problems, they prioritise based on 1) patient complaints; 2) which condition is less well controlled; or 3) which condition is more likely to adversely impact on patient Health Related-Quality of life. General practitioners and primary care nurses are often not familiar with the Goal-Oriented Care model. However, they already try to implement some of its principles such as identifying patient goals and supporting shared decision making.
结局指标
主要结局
Health related quality of life
时间窗: Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.
Participants will be asked to fill in the SF-12 questionnaire which generates a physical component score (PCS) and a mental component score (MCS). The primary outcome will be the mean difference in the variation (delta) of the PCS of SF-12 between baseline and 12 months. The SF-12 can be filled in 2-4 minutes, and it is validated for the Portuguese population. Minimum important differences validated across large populations and multiple disease categories are a change in between 2 and 3 points from the population mean of 50.
次要结局
- Physical activity(Participants will wear the SmartBand for 12 months.)
- Number of serious adverse events (clinician-reported)(Family physicians will be asked, at 6 and 12 months after randomization, to check the life status of enrolled patients and whether patients in the trial were admitted to a hospital or had a visit to an emergency service since the randomization date.)
- Mental health status(Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.)
- Number of potentially missed diagnoses (clinician-reported)(Potentially missed diagnoses will be reported 6 months after the intervention phase. In this way a compromise between avoiding recall bias and allowing enough time for a missed diagnosis to become clinically apparent is achieved.)