Multimorbidity Management Supported by a Digital Platform

November 28, 2023 updated by: Universidade Nova de Lisboa

Protocol for a Cluster Randomised Trial of a Goal-Oriented Care Approach for Multimorbidity Patients Supported by a Digital Platform

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: METHIS Platform
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.
Other Names:
  • Goal-Oriented Care Information System
  • GOC Information System
Other: Goal-Oriented Care Training Program
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.
Other Names:
  • GOC Training Program
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: 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.
Participants will be asked to fill in the SF-12 questionnaire at baseline and at 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental health status
Time Frame: Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.
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.
Participants will complete the HADS-A and HADS-D questionnaire at baseline and at 12 months.
Physical activity
Time Frame: Participants will wear the SmartBand for 12 months.
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).
Participants will wear the SmartBand for 12 months.
Number of serious adverse events (clinician-reported)
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.
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.
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.
Number of potentially missed diagnoses (clinician-reported)
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Collaborators

University Hospital, Geneva
NOVA Medical School
Administração Regional de Saúde de Lisboa e Vale do Tejo, Portugal
Universidade Lusófona de Humanidades e Tecnologias
NOVA School of Science and Technology ı FCT NOVA

Investigators

  • Principal Investigator: Luís V. Lapão, PhD, Universidade Nova de Lisboa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METHIS_CRTMB2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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