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Multimorbidity Management Supported by a Digital Platform

Primary Purpose

Chronic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
METHIS Platform
Goal-Oriented Care Training Program
Sponsored by
Universidade Nova de Lisboa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring Primary Health Care, Information Management, Research Design, Telemedicine, Digital Health, Patient-Centered Care, Goal-Oriented Care

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • inability to: provide informed consent, to read or write, inability to access an email or electronic device, even when helped by an informal caregiver

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    METHIS Intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Health related quality of life
    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.

    Secondary Outcome Measures

    Mental health status
    Participants will be asked to complete the Hospital Anxiety and Depression Scale questionnaire (HADS-A and HADS-D, respectively). The investigators will calculate the mean difference in the variation (delta) in HADS-A and HADS-D between baseline and 12 months. Although HADS was designed for inpatients it was posteriorly validated in the primary care outpatient setting. A minimum important difference of 1.5 has been reported in other chronic disorders.
    Physical activity
    Physical activity will be monitored through the number of steps walked daily. To assess the number of steps per day, a smart band with a triaxial Accelerometer will be used in both arms of the trial. Although traditional step counters use pedometers to detect daily step counts, accelerometers are more accurate and sensitive to lower force accelerations (e.g., slow walking) being considered the current standard for collecting physical activity data. Sedentary older adults and individuals living with disability and chronic illness benefit from a physically active lifestyle, with approximately 4,600- 5,500 daily steps. The lowest median values for steps/day found is in disabled older adults (1214 steps/day) and by people living with COPD (2237 steps/day).
    Number of serious adverse events (clinician-reported)
    These will be the safety outcomes chosen for this trial. In both trial arms, data about patient mortality will be collected and combined with data on occurrence of emergency department visits and hospital admissions as a proxy for serious adverse events. This information is available through the Portuguese common EHR. Due to legal requirements, after death, the information about hospital admissions and other contacts with healthcare organisations ceases to be available to the attending physician.
    Number of potentially missed diagnoses (clinician-reported)
    These will be a second safety outcome. The investigators will ask clinicians in the intervention arm if they are aware of any serious diagnosis that might have been missed due to the intervention.

    Full Information

    First Posted
    October 3, 2022
    Last Updated
    May 15, 2023
    Sponsor
    Universidade Nova de Lisboa
    Collaborators
    Administração Regional de Saúde de Lisboa e Vale do Tejo, Portugal, Universidade Lusófona de Humanidades e Tecnologias, NOVA Medical School, NOVA School of Science and Technology ı FCT NOVA, University Hospital, Geneva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05593835
    Brief Title
    Multimorbidity Management Supported by a Digital Platform
    Official Title
    Protocol for a Cluster Randomised Trial of a Goal-Oriented Care Approach for Multimorbidity Patients Supported by a Digital Platform
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidade Nova de Lisboa
    Collaborators
    Administração Regional de Saúde de Lisboa e Vale do Tejo, Portugal, Universidade Lusófona de Humanidades e Tecnologias, NOVA Medical School, NOVA School of Science and Technology ı FCT NOVA, University Hospital, Geneva

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Disease
    Keywords
    Primary Health Care, Information Management, Research Design, Telemedicine, Digital Health, Patient-Centered Care, Goal-Oriented Care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster Randomised Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1380 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    METHIS Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    METHIS Platform
    Other Intervention Name(s)
    Goal-Oriented Care Information System, GOC Information System
    Intervention Description
    The METHIS platform is a digital healthcare platform, supported by three databases using PostreSQL (based in relational SQL). One of the databases allows adequate internal testing before production. Another database of production (secured with unique access codes) will be created to retrieve data from the practices' and the last database for the research data, where pseudonymised production data can be analysed for research purposes. The platform is integrated (via FCCN Scientific Computation Unit of the Portuguese Fundação para a Ciência e a Tecnologia) with the Software Zoom® to allow encrypted teleconsultations, with a guarantee that each patient connection is unique. The digital platform is web-based, and it can be used in multiple devices.
    Intervention Type
    Other
    Intervention Name(s)
    Goal-Oriented Care Training Program
    Other Intervention Name(s)
    GOC Training Program
    Intervention Description
    The training program will have three stages: initial face-to-face training, which will happen before the data collection, followed by remote, asynchronous training during a 12-month period, and a final seminar to discuss the results and inquire about the usability of the GOC model and the METHIS platform. The course will be offered to the intervention group one month before the start of patient recruitment, and for the control group at least one month after the end of data collection.
    Primary Outcome Measure Information:
    Title
    Health related quality of life
    Description
    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.
    Time Frame
    Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.
    Secondary Outcome Measure Information:
    Title
    Mental health status
    Description
    Participants will be asked to complete the Hospital Anxiety and Depression Scale questionnaire (HADS-A and HADS-D, respectively). The investigators will calculate the mean difference in the variation (delta) in HADS-A and HADS-D between baseline and 12 months. Although HADS was designed for inpatients it was posteriorly validated in the primary care outpatient setting. A minimum important difference of 1.5 has been reported in other chronic disorders.
    Time Frame
    Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.
    Title
    Physical activity
    Description
    Physical activity will be monitored through the number of steps walked daily. To assess the number of steps per day, a smart band with a triaxial Accelerometer will be used in both arms of the trial. Although traditional step counters use pedometers to detect daily step counts, accelerometers are more accurate and sensitive to lower force accelerations (e.g., slow walking) being considered the current standard for collecting physical activity data. Sedentary older adults and individuals living with disability and chronic illness benefit from a physically active lifestyle, with approximately 4,600- 5,500 daily steps. The lowest median values for steps/day found is in disabled older adults (1214 steps/day) and by people living with COPD (2237 steps/day).
    Time Frame
    Participants will wear the SmartBand for 12 months.
    Title
    Number of serious adverse events (clinician-reported)
    Description
    These will be the safety outcomes chosen for this trial. In both trial arms, data about patient mortality will be collected and combined with data on occurrence of emergency department visits and hospital admissions as a proxy for serious adverse events. This information is available through the Portuguese common EHR. Due to legal requirements, after death, the information about hospital admissions and other contacts with healthcare organisations ceases to be available to the attending physician.
    Time Frame
    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.
    Title
    Number of potentially missed diagnoses (clinician-reported)
    Description
    These will be a second safety outcome. The investigators will ask clinicians in the intervention arm if they are aware of any serious diagnosis that might have been missed due to the intervention.
    Time Frame
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: inability to: provide informed consent, to read or write, inability to access an email or electronic device, even when helped by an informal caregiver
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luís V. Lapão, PhD
    Phone
    +351 937234449
    Email
    luis.lapao@nms.unl.pt
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruno Heleno, PhD
    Phone
    +351 218803000
    Ext
    26045
    Email
    bruno.heleno@nms.unl.pt
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luís V. Lapão, PhD
    Organizational Affiliation
    Universidade Nova de Lisboa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The complete research dataset will be stored in an encrypted and secure location with the purpose of being accessed for secondary analyses or comparative studies or per request of the patients involved or the Research and Ethics Committee. For legal reasons, the investigators will not disclose the database or grant access for data reproduction. However, processed data may be made available upon request to the research team, with appropriate justification.
    IPD Sharing Time Frame
    After the study ends and for 5 years.
    IPD Sharing Access Criteria
    The trial protocol, the main paper with the trial results and a short paper with the results of the final physician survey will be published in peer-review journals.
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