Clinical trial NCT03111004: BeyondSilos - More Personalised and Coordinated Care and Improved Outcomes for Elderly Patients
Official title: BeyondSilos - Integrated Care Leading to a More Personalised and Coordinated Care, Improving Outcomes for Elderly Patients, Delivering More Effective Care and Support, and Provide More Cost Efficient Health and Social Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Stroke
COPD
Diabetes
Keywords: information technology
telemedicine
integrated care
MAST framework
organizational change
social care
elderly patients
Lead sponsor: Him SA
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 1840
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly living independently at home with diagnosed chronic disease(s).

Brief summary: The study evaluates the impact of the new organisational models developed in the framework of the BeyondSilos pilot service in order to provide ICT supported integrated health and social care to elderly patients

Detailed description: The overall aim of the evaluation carried out in BeyondSilos is to identify the differences introduced by implementing ICT supported integrated care in different domains according to the MAST evaluation framework, including safety, clinical and social outcomes, resource use and cost of care, user/carer experience and organisational changes.

The focus of the evaluation will be the impact of so called "horizontal" integration, which is the integration between social care and health care, and the changing organisational models for elderly patients.

The hypothesis in this study is that integrated care (IC) will lead to a more personalised and coordinated care, improve outcomes for elderly patients, deliver more effective care and support, and provide more cost efficient health and social services.

Eligibility criteria: Potential participants are selected by screening electronic healthcare and social care records or/and the hospital / national databases and/or during long term condition annual reviews in the community setting. If necessary, candidates are informed about the nature and the objectives of the evaluation. If a candidate passes the inclusion/exclusion criteria and signs the informed consent form, if necessary, they participate in the evaluation.

Inclusion Criteria:

* Age ≥65 years.
* Presence of health needs specified as: Presence of heart failure, stroke, COPD or diabetes (diagnosed at hospital or at specialist visit) plus at least one additional chronic disease / condition included in the Charlson Comorbidity Index (CCI).
* Presence of social needs based on Barthel Index of Activities of Daily Living and Instrumental Activities of Daily Living (IADL).
* Reasonable expectation of permanence in the BeyondSilos project for the whole data collection period (18 months).
* Informed consent, signed if necessary (by the subject or his/her delegate).
* Capability to handle ICT equipment / devices alone, or with the help from a delegate.
* Presence of good/reliable communication connection at home (internet, telephone or what is needed for the ICT connection).

Exclusion Criteria:

Subjects who have been registered with an active cancer diagnosis and undergoing treatment, has undergone an organ transplant, or is undergoing dialysis prior to enrolment.

* Subjects in a terminal state
* People with an AIDS diagnose.

Primary outcomes:
measure: Change in length of the hospital stay
timeFrame: Days between admission and discharge of patient's admission episodes, measured based on follow up during whole length of study and accumulated at END of study (at month 18)
Secondary outcomes:
measure: Re-hospitalisation period
timeFrame: Days between last discharge of patient and her/his re-hospitalization, measured based on follow up during whole length of study and accumulated at END of study (at month 18)
measure: Patient encounters
timeFrame: Number of registered encounters/contacts between patient and GP, Specialists, Nurse, other involved healthcare providers within the timeframe based on total count in period between start (month 0) end (month 18) of study
measure: Weight
timeFrame: Weight measured in kilo grams (kg) at baseline (month 0) and at end (month 18) of study duration
measure: Blood pressure
timeFrame: Blood pressure measured in mmHg at baseline (month 0) and at end (month 18) of study duration
measure: Heart rate
timeFrame: Heart rate measured in beats per minute (bpm) at baseline and at end of study duration
measure: Oxygen saturation
timeFrame: Oxygen saturation measured in SpO2 (or %) based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: Blood glucose
timeFrame: Blood glucose measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: HbA1c
timeFrame: HbA1c measured in percentage (%) based on measurement at baseline and at end of study duration
measure: Creatinine
timeFrame: Creatinine measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: Charlson Comorbidity Index (CCI)
timeFrame: Charlson Comorbidity Index (CCI) measured in (a) ICD-10-CM and (b) CCI scale based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: Barthel index
timeFrame: Barthel index measured in index scale based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: Self-maintaining and instrumental activities of daily living (IADL)
timeFrame: Self-maintaining and instrumental activities of daily living (IADL) measured in (IADL) scale based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: Geriatric Depression Scale (GDS Short Form)
timeFrame: GDS measured in GDSsf-scale based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: Anxiety and depression based on HADS
timeFrame: Anxiety and depression according to HADS-scale measurements based on measurement at baseline (month 0) and at end (month 18) of study duration
measure: PIRU questionnaire on user experience (selected questions) of Integrated Care (IC)
timeFrame: User experience (PIRU) measurements based on PIRU-scale measurement at baseline and at end of study duration
measure: End user perception of service utility according to eCCIS (selected questions)
timeFrame: End user perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
measure: Carer perception of service utility according to eCCIS (selected questions)
timeFrame: Carer perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
Other outcomes:
Locations:
Study officials:
affiliation: Him SA
name: Panos A Stafylas
role: STUDY_DIRECTOR
References:
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citation: Piera-Jimenez J, Daugbjerg S, Stafylas P, Meyer I, Muller S, Lewis L, da Col P, Folkvord F, Lupianez-Villanueva F. BeyondSilos, a Telehealth-Enhanced Integrated Care Model in the Domiciliary Setting for Older Patients: Observational Prospective Cohort Study for Effectiveness and Cost-Effectiveness Assessments. JMIR Med Inform. 2020 Oct 6;8(10):e20938. doi: 10.2196/20938.