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

Diabetes Clinical Trial

— CAREWELL  

Official title:

CareWell - Multi-level Integration for Patients With Complex Needs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03042039
• Other study ID #: CareWell_EC_Grant No. 620983
• Status: Active, not recruiting
• Phase: N/A
• First received: January 24, 2017
• Last updated: August 8, 2017
• Start date: January 1, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: August 2017
• Source: Him SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Frail elderly patients are characterised as having complex health and social care needs; they are at risk of hospital or residential care home admission, and require a range of high level interventions due to their frailty and multiple chronic conditions. A growing proportion of the population in OECD countries are age 65 and over: 15% in 2010, and expected to reach 22% by 2030. More than half of all older people have at least three chronic conditions, and a significant proportion have five or more.

A recent US study indicates that more than 95% of Medicare patients with a chronic disease such as congestive heart failure, depression, or diabetes have at least one other chronic condition, and the majority (80%, 71%, and 56%, respectively) have four or more chronic conditions. The CareWell project deals with multimorbid frail patients. Typically these patients have several diagnoses, the most frequent ones are:

• Chronic Obstructive Pulmonary Disease (COPD),

• Diabetes and

• Congestive Heart Failure (CHF).

The main objective of the CareWell study is to explore the data collection and analysis of health services' use. All sites are requested to upload their available data regarding service use, their flow chart on recruitment, and the demographic characteristics of end users. The evaluation has been conducted using the MAST multi-dimensional evaluation methodology adapted to the needs of CareWell project focusing on integrated healthcare.

MAST includes assessment of the outcomes of telemedicine applications divided into the following seven domains:

1. health problem and characteristics of the application;

2. safety;

3. clinical effectiveness;

4. patient perspectives;

5. economic aspects;

6. organisational aspects and

7. socio-cultural, ethical and legal aspects. Each domain will be addressed and studied through a range of methodological approaches, quantitative, qualitative and modelling.

Patients distributed in six sites will be recruited and assessed at baseline and be followed up during a period of six months. Data is to be collected from different sources, including administrative databases, questionnaires and personal interviews.

All 6 CareWell sites are to conduct cohort studies, which means that a group of people with similar characteristics are followed over a period of time. Potential participants are selected by screening electronic healthcare records and/or the hospital / national databases and/or during long term condition annual reviews in the community setting.

Candidates are informed about the nature and the objectives of the evaluation. Once candidates have signed the informed consent form, if necessary, they participate in the evaluation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1712
• Est. completion date: October 1, 2017
• Est. primary completion date: April 30, 2016
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age =65 years.

2. 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).

3. Fulfilling local/national/organisational criteria of frailty: increased vulnerability, complex health needs, and at high risk of hospital or care home admission.

4. Participants have to be able to understand and to comply with study instructions and requirement, either independently or with help from a carer.

Exclusion Criteria:

1. 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.

2. Subjects who are candidates for palliative care (with life expectancy less than one year, clinically evaluated).

3. People with an AIDS diagnosis.

4. 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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Chronic Obstructive Pulmonary Disease
• Diabetes
• Frail Elderly Syndrome
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Croatia	Higher or Secondary Education Establishments	Zagreb
Italy	Agenzia Regionale Sanitaria Pugliese	Bari
Poland	Urzad Marszalkowski Wojewodztwa Dolnoslaskiego	Wroclaw
Spain	Servicio Vasco de Salud Osakidetza	Vitoria-Gasteiz
United Kingdom	Bronllys Hospital	Bronllys

Sponsors (1)

Lead Sponsor	Collaborator
Him SA

Countries where clinical trial is conducted

Croatia,  Italy,  Poland,  Spain,  United Kingdom, 

References & Publications (7)

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. — View Citation

Hiligsmann M, Gathon HJ, Bruyère 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. — 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

Kopec JA, Finès 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. Review. — View Citation

Lega F, DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy. Health Policy. 2005 Nov;74(3):261-81. Review. — View Citation

Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI)	Charlson Comorbidity Index (CCI)	Change in CCI between baseline and after (approximately) 12 months (=end of study)
Secondary	Change in Generic health related/functional quality of life (2) by assessing Barthel index	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)
Secondary	Change in Psychological measures (1) by assessing Geriatric Depression Scale	Geriatric Depression Scale (GDS Short Form)	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)
Secondary	Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale	Hospital Anxiety and Depression Scale (HADS 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)
Secondary	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	Policy Research Unit in Policy Innovation Research (PIRU) questionnaire on user experience of Integrated Care (IC)	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)
Secondary	Changes in User perspectives (3) by measuring Carer perspectives of integration according to eCCIS	Carer perspectives of integration according to eCCIS	Changes in User perspectives as assessed based on eCCIS measurements of CARERS between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
Secondary	Changes in User perspectives (4) by measurement of NHS LTC6 Questionnaire	National Health Services (NHS) LTC6 Questionnaire	Changes in NHS-LTC6 measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
Secondary	Economic aspects (1) as measured based on the total of Efforts related to service development & implementation during the study (between start and 12 months)	Efforts related to service development & implementation	Economic aspects as assessed based on measurements of total efforts related to Development and Implementation of Services during the period between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Economic aspects (2) as measured based on the total of Efforts related to service during the operation or use of the study (between starts and 12 months)	Efforts related to service operation or use	Economic aspects as assessed based on measurements of total efforts related to Service Operations during the period between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Economic aspects (3) as measured based on the total of Equipment costs during the project, between start and after 12 months	Equipment costs	Economic aspects as assessed based on measurements of total of Costs of Equipment during the period between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Economic aspects (4) based on measurements of Service effectiveness benefits during study (between start and 12 months)	Service effectiveness benefits	Total of Benefits in Effectiveness of Services during the period between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in of Economic aspects (5) based on measurements of Service efficiency benefits during study (between start and 12 months)	Service efficiency benefits	Economic aspects as assessed based on measurements of total of Benefits in Efficiency of Services during the period between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Economic aspects (6) based on changes in measurements Changes Willingness to pay between start en end of study (12 months)	Changes Willingness to pay	Economic aspects as assessed based on measurements of Changes in Willingness To Pay for Services between baseline and after (approximately) 12 months (=end of study)
Secondary	Impact on Organisational aspects (1) as measured with impact on staff between start and study end (after 12 months)	Impacts on staff	Total of Services' Impact On Staff during the period between baseline after (approximately) 12 months (=end of study)
Secondary	Impact on Organisational aspects (2) as measured with impact on involved organisations between start study and end (12 months)	Impacts on organisation	Total of Services' Impact On Organisations during the period between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Overall service effectiveness and specific outcome measures (1) as measured with Admission-Discharge Duration of admissions between start and study end	Admission-Discharge Duration	Changes in Overall service effectiveness and specific outcome assessed based on change between Average of Duration of each Admission throughout study between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Overall service effectiveness and specific outcome measures (2) as measured with Indication for hospitalisation of all admissions between start and study end (12 months)	Indication for hospitalisation	Changes in Overall service effectiveness and specific outcome by recording of Admission Indication throughout study between baseline and after (approximately) 12 months (=end of study)
Secondary	Changes in Overall service effectiveness and specific outcome measures (3) as measured with Re-hospitalisation rates within 30 days after dismissal between start and end study (12 months)	Re-hospitalisation within 30 days	Changes in Overall service effectiveness and specific outcome as assessed based on change between measurements of total of re-hospitalization within 30 days after last admission throughout study between baseline and after (approx.) 12 months (=study end)
Secondary	Change in Overall service effectiveness and specific outcome measures (4) as assessed with Origin before Admission of all admissions between start and end of study (12 months)	Origin before Admission	Changes in Overall service effectiveness and specific outcome by recording of Origin ad each Admission throughout study between baseline and after (approximately) 12 months (=end of study)
Secondary	Change in Overall service effectiveness and specific outcome measures (5) as assessed with Discharge destiny of all discharges between start and end of study (12 months)	Discharge destiny	Changes in Overall service effectiveness and specific outcome by recording of Destiny after each discharge throughout study between baseline and end of study (12 months)
Secondary	Change in Disease specific health status measurement (1) as measured with HbA1c of diabetes patients between start and end of study (12 months)	HbA1c	Changes in Disease specific health status based on measurements of HbA1c between baseline and after (approximately) 12 months (=end of study)
Secondary	Change in Disease specific health status measurement (2) as measured with blood glucose levels of all diabetes patients between start and end of study (12 months)	Blood glucose	Changes in Disease specific health status based on measurements of Blood Glucose between baseline and after (approximately) 12 months (=end of study)
Secondary	Change in Disease specific health status measurement (3) as measured with heart rate measurements of all chronic heart failure patients between start and study end (12 months)	Heart rate	Changes in Disease specific health status based on measurements of Heart Rate between baseline and after (approximately) 12 months (=end of study)
Secondary	Change in Disease specific health status measurement (4) as measured with blood pressure of all patients with chronic heart failure between start and end of study (12 months)	Blood pressure	Changes in Disease specific health status based on measurements of blood Pressure between baseline and after (approximately) 12 months (=end of study)
Secondary	Change of Disease specific health status measurement (5) as measured with weight of all patients with chronic heart failure between start and end of study (12 months)	Weight	Changes in Disease specific health status based on measurements of Weight between baseline and after (approximately) 12 months (=end of study)
Secondary	Change in Disease specific health status measurement (6) as measured with BMI of all patients with chronic heart failure between start and end of study (12 months)	BMI	Changes in BMI between baseline and after (approximately) 12 months (=end of study)

External Links

•   Project Website CareWell