RAPIDE: The Feasibility of a Hybrid Care Model

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

Terminally ill patients

Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)

Patients who are cognitively impaired

Trial design

Design model

Single group

Treatments tested in this trial

  • Hybrid care

    Other 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

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Hybrid careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs), using the PaRIS questionnaire.

Time frame
At enrolment, at six months after enrolment, and at twelve months after enrolment.

Secondary outcomes

1

Episodes of care consumption, using patient chart reviews

Time frame
At baseline and 12 months after enrolment

Other outcomes

1

Acceptability and feasibility from the perspective of patients, informal caregivers, and healthcare professionals, using observations and interviews

Through observations and interviews, the investigators will evaluate the extent to which the hybrid care model is acceptable and feasible for patients, informal care givers, and healthcare professionals.

Time frame
Six and twelve months after enrolment.
2

Implementation feasibility, using observations and interviews

Through observations and interviews, the investigators will evaluate the extent to which the new hybrid care model is practically feasible to implement (facilitators and barriers of implementation).

Time frame
Six and twelve months after enrolment.
3

Changes in practice organisation and care delivery, using observations and interviews

Through observations and interviews, the investigators will evaluate the extent to which the new hybrid care model initiates changes in practice organisation and care delivery.

Time frame
Six and twelve months after enrolment.

Sponsors and contacts

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