Multi-level Integration for Patients With Complex Needs Facilitated by ICTs. A Shared Approach, Mutual Learning and Evaluation Are Expected to Create Synergies Among the Partners and to Bring Forward Integration of Care in Europe

NCT03042039 | Unknown DMC

• 1 other identifier: CareWell_EC_Grant No. 620983
• Study Type: observational
• Target: 1,712
• Locations: 5 countries
• Sites: 5

Brief Summary

CareWell will enable the delivery of integrated healthcare to frail elderly patients in a pilot setting through comprehensive multidisciplinary integrated care programmes where the role of ICTs can foster the coordination and patient centered delivery care. Carewell will focus in particular complex, multi-morbid elderly patients, who the patients most in need of health and social care resources (35% the total cost of Health Care System) and more complex interventions due to their frailty and comorbidities (health and social care coordination, monitoring, self-management of the patient and informal care giver). ICT platforms and communication channels that allow sharing information between healthcare and social care professionals involved in the delivery care of these patients, facilitating their coordination, increasing their resoluteness and avoiding duplicities when tackling patients´ diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based platforms can improve the adherence to treatment, enhance self-care and increase patient awareness about their health status , as well as, improve the empowerment of informal caregivers, who usually take care of these patients. According to this, it is hypothesized that the benefit of integrated care programmes based on (1) integrated care coordination and (2) patient empowerment \& home support pathways supported by ICT is greater and essential for these patients. Care pathways will cut across organisational boundaries and will activate the most appropriate resources across the entire spectrum of healthcare and social care services available for both scheduled and emergency care. CareWell aims to scale up the services in pioneer regions and share their approach, learning from and supporting the other pilot sites which are at different levels of maturity in respect to designing, developing and implementing new ways of providing integrated care services.

Conditions

Chronic Obstructive Pulmonary Disease; Diabetes; Chronic Heart Failure; Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (1)

• Total number of hospital admissions per participant measured at end of study (at approx 12 months)

  The total of (planned and unplanned) hospital admissions

  Total of hospital admissions as measured after (approximately) 12 months (= end of study)

Secondary Outcomes (26)

• Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI)

  Change in CCI between baseline and after (approximately) 12 months (=end of study)

• Change in Generic health related/functional quality of life (2) by assessing Barthel index

  Change in Generic health related/functional quality of life as assessed based on BARTHEL INDEX scores between baseline and (approximately) after 12 months (=end of study)

• Change in Psychological measures (1) by assessing Geriatric Depression Scale

  Changes in Psychological measures as assessed based on GDS-SF between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)

• Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale

  Changes in Psychological measures as assessed based on HADS measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)

• Changes in the User perspectives (1) by measuring PIRU questionnaire on user experience of Integrated Care (IC) by measuring Policy Research Unit in Policy Innovation Research questionnaire

  Changes in User perspectives as assessed based on PIRU scores between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)

Study Arms (1)

Study group 'New Care'

Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually.

Other: New Care

Interventions

New Care OTHER

New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).

Study group 'New Care'

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Frail elderly living in one of the 6 CareWell sites

You may qualify if:

• Age ≥65 years.
• Presence of at least two chronic diseases included in the Charlson Comorbidity Index (CCI) \[4\]. At least one of the comorbid conditions must be one of the following conditions: Chronic obstructive pulmonary disease (COPD), diabetes mellitus (both insulin-dependent and noninsulin-dependent) or chronic heart failure (CHF).
• Fulfilling local/national/organisational criteria of frailty: increased vulnerability, complex health needs, and at high risk of hospital or care home admission.
• Participants have to be able to understand and to comply with study instructions and requirement, either independently or with help from a carer.

You may not qualify if:

• Subjects who have either been registered with an active cancer diagnosis under treatment, have undergone an organ transplant, or are undergoing dialysis prior to enrolment.
• Subjects who are candidates for palliative care (with life expectancy less than one year, clinically evaluated).
• People with an AIDS diagnosis.
• People living in care homes where their daily health, care and wellbeing needs are met by staff (nurses and support staff) employed within the home.

Sponsors & Collaborators

• Him SA: lead

Study Sites (5)

Higher or Secondary Education Establishments

Zagreb, 10000, Croatia

Location

Agenzia Regionale Sanitaria Pugliese

Bari, 70126, Italy

Location

Urzad Marszalkowski Wojewodztwa Dolnoslaskiego

Wroclaw, 50-411, Poland

Location

Servicio Vasco de Salud Osakidetza

Vitoria-Gasteiz, Spain

Location

Bronllys Hospital

Bronllys, LD3 0LS, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 22617736 BACKGROUND

• Agha Z, Schapira RM, Maker AH. Cost effectiveness of telemedicine for the delivery of outpatient pulmonary care to a rural population. Telemed J E Health. 2002 Fall;8(3):281-91. doi: 10.1089/15305620260353171.

  PMID: 12419022 BACKGROUND

• Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.

  PMID: 19001484 BACKGROUND

• Kopec JA, Fines P, Manuel DG, Buckeridge DL, Flanagan WM, Oderkirk J, Abrahamowicz M, Harper S, Sharif B, Okhmatovskaia A, Sayre EC, Rahman MM, Wolfson MC. Validation of population-based disease simulation models: a review of concepts and methods. BMC Public Health. 2010 Nov 18;10:710. doi: 10.1186/1471-2458-10-710.

  PMID: 21087466 BACKGROUND

• Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.

  PMID: 14976904 BACKGROUND

• Hiligsmann M, Gathon HJ, Bruyere O, Ethgen O, Rabenda V, Reginster JY. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010 Jun-Jul;13(4):394-401. doi: 10.1111/j.1524-4733.2009.00687.x. Epub 2010 Jan 21.

  PMID: 20102558 BACKGROUND

• Lega F, DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy. Health Policy. 2005 Nov;74(3):261-81. doi: 10.1016/j.healthpol.2005.01.010.

  PMID: 16226138 BACKGROUND

• Mateo-Abad M, Gonzalez N, Fullaondo A, Merino M, Azkargorta L, Gine A, Verdoy D, Vergara I, de Manuel Keenoy E. Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country. BMC Health Serv Res. 2020 Jul 3;20(1):613. doi: 10.1186/s12913-020-05473-2.

  PMID: 32620116 DERIVED

Related Links

• Project Website CareWell

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Manager of KRONIKGUNE, the Basque Centre for Health Services Research and Chronicity.

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 3, 2017
• Study Start: January 1, 2015
• Primary Completion: April 30, 2016
• Study Completion: October 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); PL (1); CR (1); ES (1); GB (1)