Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementation of Community-based Collaborative Management of Complex Chronic Patients (Nextcare_CCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956395
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Badalona Serveis Assistencials
Institut de Recerca Biomèdica de Lleida
Information provided by (Responsible Party):
Carme Hernandez, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
Chronic Disease Integrated Care Telemedicine Other: Integrated care intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Protocol for Regional Implementation of Community-based Collaborative Management of Complex Chronic Patients (CCP)
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Integrated care group
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

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


No Intervention: Conventional care group
Patients assigned to the control group will be from other healthcare sectors in Catalonia with similar characteristics.



Primary Outcome Measures :
  1. Reduction of early hospital-related events after hospital discharge [ Time Frame: 30 and 90 days and 12 months ]
    Hospital re-admissions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Hospitalized patients and LACE index ≥7.

Exclusion Criteria:

Severe psychiatric disorders


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956395


Contacts
Layout table for location contacts
Contact: Carme Hernandez, RN +34932275747 chernan@clinic.ub.es
Contact: Miriam Hillenius, Bsc +34932275747 mhillen@clinic.ub.es

Locations
Layout table for location information
Spain
Hospital Clinic de Barcelona. Integrated Care Unit Recruiting
Barcelona, Spain, 08036
Contact: Carme Hernandez, RN    +34932275747    chernan@clinic.ub.es   
Contact: Miriam Hillenius, Bsc    +34932275747    mhillen@clinic.ub.es   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Badalona Serveis Assistencials
Institut de Recerca Biomèdica de Lleida
Investigators
Layout table for investigator information
Principal Investigator: Carme Hernandez, RN Hospital Clinic of Barcelona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Carme Hernandez, Director Integrated Care Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02956395     History of Changes
Other Study ID Numbers: Nextcare_CCP
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carme Hernandez, Hospital Clinic of Barcelona:
adaptive case management approach
Transitional Care
multimorbidity
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Disease
Disease Attributes
Pathologic Processes