Implementation of Community-based Collaborative Management of Complex Chronic Patients

NCT02956395 | Completed

• 1 other identifier: Nextcare_CCP
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background/Aims: Large scale adoption of integrated care for chronic patients constitutes a key milestone to accelerate adaptation of current healthcare systems to the evolving needs triggered by population ageing and high prevalence of chronic conditions. Lessons learnt from deployment experiences are being disseminated as "good practices". But, there is need for further assessment of implementation strategies in real world scenarios. Moreover, progresses achieved in disease-oriented integrated care cannot be automatically transferred to management of complex chronic patients (CCP). The protocol addresses five aims: 1) implementation of two integrated care interventions using a collaborative and adaptive case management (ACM) approach (i) Community-based management of CCP; and, ii) Integrated care for patients under long-term oxygen therapy (LTOT)); 2) adoption of information and communication technologies (ICT) required to support collaborative ACM; 3) to evaluate the impact of enhanced clinical health risk assessment and stratification; 5) to generate a roadmap for regional adoption of the CCP program. Methods/Design: the CCP program will be deployed in three healthcare sector of Barcelona-Esquerra (AISBE) (520 k citizens) and in two other areas of Catalonia: Badalona Serveis Assistencials (BSA) (420 k citizens) and Lleida (366 k citizens) following Plan-Do-Study-Act iterative cycles, using the Model for Assessment of Telemedicine for evaluation purposes. The study also addresses the steps for scale-up of integrated care in the entire Catalan region (7.5 M citizens). Observational studies with matched controls have been planned for both Community-based management of CCP (n=3.000) and for Integrated care for patients under LTOT (n=500). Moreover, clustered randomized controlled trials (RCT) are planned on top of the observational studies to test specific questions (i.e. performance of the ICT platform providing ACM functionalities). Main components of CCP program are: a) patient stratification; b) comprehensive assessment strategies; c) ICT supported adaptive Case management; d) Roadmap for regional adoption. Hypothesis: the CCP program will generate guidelines for large scale deployment of the CCP program, including transferability analysis, facilitating adoption of integrated care services for management of multi-morbidity.

Conditions

Chronic Disease; Integrated Care; Telemedicine

Keywords

adaptive case management approach; Transitional Care; multimorbidity

Outcome Measures

Primary Outcomes (1)

• Reduction of early hospital-related events after hospital discharge

  Hospital re-admissions

  30 and 90 days and 12 months

Study Arms (2)

Integrated care group

ACTIVE COMPARATOR

Integrated care intervention is implemented by a multidisciplinary team from the hospital and from the Primary Care in three healthcare sectors: Barcelona-Esquerra, Lleida and Badalona.

Other: Integrated care intervention

Conventional care group

NO INTERVENTION

Patients assigned to the control group will be from other healthcare sectors in Catalonia with similar characteristics.

Interventions

Integrated care intervention OTHER

Integrated care intervention is implemented by a multidisciplinary team from the hospital and from the Primary Care. The intervention after hospital discharge a) Phone call at 24 hours; b) Home visit at 72 hours after discharge by one member of the transitional care team, if is needed; During this visit, the therapeutic plan for each patient will be customized to their individual frailty factors and shared with the primary care team. Reinforcement of the logistics for treatment of co-morbidities and social support will be done accordingly; c) Accessibility to the point of care available 24 hours/day ; d) Accessibility to the individualized PHF, as self-management tool ; d) appointment at 1m after discharge and after 12 m

Integrated care group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients and LACE index ≥7.

You may not qualify if:

• Severe psychiatric disorders

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Badalona Serveis Assistencials: collaborator
• Institut de Recerca Biomèdica de Lleida: collaborator

Study Sites (1)

Hospital Clinic de Barcelona. Integrated Care Unit

Barcelona, 08036, Spain

Location

Related Publications (1)

• Vela E, Tenyi A, Cano I, Monterde D, Cleries M, Garcia-Altes A, Hernandez C, Escarrabill J, Roca J. Population-based analysis of patients with COPD in Catalonia: a cohort study with implications for clinical management. BMJ Open. 2018 Mar 6;8(3):e017283. doi: 10.1136/bmjopen-2017-017283.

  PMID: 29511004 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carme Hernandez, RN

  Hospital Clinic of Barcelona

  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: Director Integrated Care Unit

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 7, 2016
• Study Start: February 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: January 15, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

ES (1)