BeyondSilos - More Personalised and Coordinated Care and Improved Outcomes for Elderly Patients (BeyondSilos)

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Stroke; Diabetes; COPD
• Intervention / Treatment: Other: New Care

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.

• Study Type: Observational
• Enrollment (Actual): 1840

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elderly living independently at home with diagnosed chronic disease(s).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; The Study Group receives 'new care' (integrated health and social care)	Other: New Care; All settings that are in any way relevant to the provision of health and social care are integrated, including: out-of-hospital (community) services as well as hospitals, GPs' offices, community nurses, and any type of care practitioners, users' homes and volunteer service providers' offices; Other Names: integrated health care and social care
Comparator Group; The comparator group receives usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in length of the hospital stay	Change in the duration of hospitalization (calculated from admission date and discharge date) measured in days	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-hospitalisation period	Re-hospitalisation within 30 days (calculate from admission date and discharge date) measured in days	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)
Patient encounters	Encounters and contacts between patient and GP, Specialists, Nurse, other involved healthcare providers	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
Weight	Weight as disease specific health status measurement	Weight measured in kilo grams (kg) at baseline (month 0) and at end (month 18) of study duration
Blood pressure	Blood pressure as disease specific health status measurement	Blood pressure measured in mmHg at baseline (month 0) and at end (month 18) of study duration
Heart rate	Heart rate pressure as disease specific health status measurement	Heart rate measured in beats per minute (bpm) at baseline and at end of study duration
Oxygen saturation	Oxygen saturation pressure as disease specific health status measurement	Oxygen saturation measured in SpO2 (or %) based on measurement at baseline (month 0) and at end (month 18) of study duration
Blood glucose	Blood glucose pressure as disease specific health status measurement	Blood glucose measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
HbA1c	HbA1c pressure as disease specific health status measurement	HbA1c measured in percentage (%) based on measurement at baseline and at end of study duration
Creatinine	Creatinine pressure as disease specific health status measurement	Creatinine measured in mg/dl based on measurement at baseline (month 0) and at end (month 18) of study duration
Charlson Comorbidity Index (CCI)	Charlson Comorbidity Index (CCI) as a generic health related / functional quality of life	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
Barthel index	Barthel index as a generic health related / functional quality of life	Barthel index measured in index scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Self-maintaining and instrumental activities of daily living (IADL)	Self-maintaining and instrumental activities of daily living (IADL) as a generic health related / functional quality of life	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
Geriatric Depression Scale (GDS Short Form)	Geriatric Depression Scale (GDS Short Form) as a psychological measure	GDS measured in GDSsf-scale based on measurement at baseline (month 0) and at end (month 18) of study duration
Anxiety and depression based on HADS	Anxiety and depression (according to HADScale) as a psychological measure	Anxiety and depression according to HADS-scale measurements based on measurement at baseline (month 0) and at end (month 18) of study duration
PIRU questionnaire on user experience (selected questions) of Integrated Care (IC)	PIRU questionnaire on user experience of IC as a user perspectives measure	User experience (PIRU) measurements based on PIRU-scale measurement at baseline and at end of study duration
End user perception of service utility according to eCCIS (selected questions)	End user perception of service utility (eCCIS) as a user perspectives measure	End user perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration
Carer perception of service utility according to eCCIS (selected questions)	Carer perception of service utility (eCCIS) as a user perspectives measure	Carer perception of service utility based on eCCIS-scale measurement at baseline (month 0) and at end (month 18) of study duration

Collaborators and Investigators

• Sponsor: Him SA
• Investigators: Study Director: Panos A Stafylas, Him SA

Publications and helpful links

General Publications

• Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
• Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Int J Surg. 2014 Dec;12(12):1500-24. doi: 10.1016/j.ijsu.2014.07.014. Epub 2014 Jul 18.
• Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health. 2012 Mar-Apr;15(2):217-30. doi: 10.1016/j.jval.2011.12.010.
• 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.

Helpful Links

• Project Website BeyondSilos

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: telemedicine; integrated care; elderly patients; information technology; MAST framework; organizational change; social care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: BeyondSilos_CIP_No.621069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No