Clinical trial NCT06735404: RAPIDE: The Feasibility of a Hybrid Care Model
Official title: Regular and Unplanned Care Adaptive Dashboard for Cross-border Emergencies (RAPIDE): The Feasibility of a Hybrid Care Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Heart Failure
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Rationale: During cross-border health emergencies, such as seen with the COVID-19 pandemic, health and care services are rapidly being overwhelmed by high numbers of patients requiring care, leading to stretches in the whole healthcare system. Delays and backlogs in regular care, as the result of the stretched health care services, leave millions of patients with regular care needs unattended, resulting in disastrous healthcare outcomes. If disastrous healthcare outcomes across the population are to be avoided, healthcare systems must become more robust, resilient, and flexible in the face of future health emergencies and allow for rapid changes in the care delivery services.

Objective: To evaluate the feasibility of delivering a hybrid care model alongside care as usual through observations, and questionnaires and interviews on patient reported views, opinions, and experiences. This hybrid care model aims to reduce the burden on health and care systems during a health emergency, decrease the need to scale down regular care, and ensure patient safety and quality of care.

Study design: One year cohort study, using observations, questionnaires, and interviews.

Study population: Patients with type 2 diabetes and/or chronic heart failure with comorbidities and/or having a high care consumption according to the treating general practitioner.

Intervention: The hybrid care model will consist of a combination of digital tools and/or task shifting of certain healthcare providers. Examples are:

* Telemonitoring: patients perform self-measurements through e.g. sensors, wearables, or (mobile) applications to get insight in their health status (supporting self-management) and report this to their healthcare provider(s), when relevant
* Teleconsultation: patients communicate with their healthcare provider(s) remotely
* Personal health portals and self-management applications
* Online prescription requests: patients request prescription online Main study parameters/endpoints: The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Evaluating the feasibility of this hybrid care model will only be done through observations, questionnaires, and interviews at home (during three home visits at baseline, after six months, and after one year). No invasive (physical) procedures will be performed.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Patients with type 2 diabetes mellitus, WITH:

* At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND
* A high number of medical consultations at the GP practice and/or referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.

Patients with chronic heart failure, WITH:

* At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND
* A high number of medical consultations at the GP practice and/or referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.

Exclusion Criteria:

* Terminally ill patients
* Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)
* Patients who are cognitively impaired

Primary outcomes:
measure: The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs), using the PaRIS questionnaire.
timeFrame: At enrolment, at six months after enrolment, and at twelve months after enrolment.
Secondary outcomes:
measure: Episodes of care consumption, using patient chart reviews
timeFrame: At baseline and 12 months after enrolment
Other outcomes:
measure: Acceptability and feasibility from the perspective of patients, informal caregivers, and healthcare professionals, using observations and interviews
timeFrame: Six and twelve months after enrolment.
measure: Implementation feasibility, using observations and interviews
timeFrame: Six and twelve months after enrolment.
measure: Changes in practice organisation and care delivery, using observations and interviews
timeFrame: Six and twelve months after enrolment.
Locations:
city: Verona
country: Italy
facility: Accademia Italiana Cure Primarie
city: Valletta
country: Malta
facility: University of Malta
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Ljubljana
country: Slovenia
facility: Community Health Centre Ljubljana
Study officials:
References: