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

Stroke Clinical Trial

— BeyondSilos  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111004
• Other study ID #: BeyondSilos_CIP_No.621069
• Status: Completed
• Start date: September 1, 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: August 2018
• Source: Him SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1840
• Est. completion date: October 1, 2017
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Diabetes
• Heart Failure
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Him SA

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	HbA1c	HbA1c pressure as disease specific health status measurement	HbA1c measured in percentage (%) based on measurement at baseline and at end of study duration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Project Website BeyondSilos