Study Design of the Empirical Evaluation of the AISBE Program in Catalonia

NCT03130283 | Completed DMC

• 1 other identifier: SELFIE-HH/ED
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care services; and, (iii) Population-based study on cost-effectiveness of integrated care services in the urban healthcare sector of Barcelona-Esquerra (540.000 inhabitants). The central hypothesis is that the approach will show safety and effectiveness with high level of user's acceptance and health value generation leading to sustainability of the service.The preliminary data indicate that HH/ED shows potential to strengthen care coordination between highly specialized hospital-based care and home-based services involving different levels of complexity. The need for appropriately designed transitional care services has been identified as the best option, not only for an efficient transference of patients from hospital to the community after hospital discharge, but as a way to overcome well identified limitations for generalization of community-based integrated care services. AISBE is a population-based health initiative aiming at deployment of integrated care in one urban healthcare sector (Barcelona-Esquerra, 540.000 inhabitants) in the city of Barcelona. Within this initiative, the HH/ED program carried out by Hospital Clinic provides home-based hospitalization. Moreover, the program aims to implement transitional care strategies for optimal discharge. The current document describes three studies: (Study 1) Analysis of the period 2006-2015; (Study 2) Program-based analysis of Home Hospitalization/Early Discharge (HH/ED) , and, (Study 3) Population-based analysis of cost-effectiveness of AISBE-based services. Study 2 is a program-based analysis of Home Hospitalization/Early Discharge (HH/ED). A quasi-experimental design. That is, a non-randomized intervention group (integrated care) will be compared with a control group (usual care) using propensity score matching wherein age, gender and health risk scoring will be main matching variables. The population-based evaluation will be done using registry data obtained from the Catalan Health Surveillance System (CHSS). The protocol evaluation follows a Triple Aim approach considering pre-defined outcome variables for: a) health and well-being, b) experience with care, and c) costs.

Conditions

Unrecognized Condition

Keywords

Acute patients; Exacerbated chronic patients

Outcome Measures

Primary Outcomes (1)

• Costs

  Health Care Cost

  30 days

Secondary Outcomes (2)

• Health and well-being

  30 days

• Experience with care

  30 days

Study Arms (2)

Home Hospitalization

ACTIVE COMPARATOR

Visit every day at home

Other: Home Hospitalization

Conventional Hospitalization

PLACEBO COMPARATOR

Review Clinical History

Other: Conventional Hospitalization

Interventions

Home Hospitalization OTHER

Visit every 24 hours

Home Hospitalization

Conventional Hospitalization OTHER

No intervention

Conventional Hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in his/her house within the healthcare sector
• Having caregiver during 24h per day
• Having phone at home
• Signing written acceptance to participate in the study

You may not qualify if:

• High risk of severe clinical deterioration not treatable at home, as assessed by best medical judgment
• Admission in a short stay unit; and, iii) severe psychiatric disorder

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic. Integrated Care Unit

Barcelona, 08036, Spain

Location

Related Publications (2)

• Hernandez C, Herranz C, Baltaxe E, Seijas N, Gonzalez-Colom R, Asenjo M, Coloma E, Fernandez J, Vela E, Carot-Sans G, Cano I, Roca J, Nicolas D. The value of admission avoidance: cost-consequence analysis of one-year activity in a consolidated service. Cost Eff Resour Alloc. 2024 Apr 15;22(1):30. doi: 10.1186/s12962-024-00536-1.

  PMID: 38622593 DERIVED

• Herranz C, Gonzalez-Colom R, Baltaxe E, Seijas N, Asenjo M, Hoedemakers M, Nicolas D, Coloma E, Fernandez J, Vela E, Cano I, Molken MR, Roca J, Hernandez C. Prospective cohort study for assessment of integrated care with a triple aim approach: hospital at home as use case. BMC Health Serv Res. 2022 Sep 7;22(1):1133. doi: 10.1186/s12913-022-08496-z.

  PMID: 36071439 DERIVED

Related Links

• NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016
• SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 EU project

Study Officials

• Carme Hernandez, PhD

  Hospital Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research IDIBAPS

Model Details: quasi experimental study design with propensity score matching

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 26, 2017
• Study Start: December 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: December 1, 2018
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)