An Integrated Care Model for Chronic Patients

Not Applicable

• Conditions: Integrated Care
• Interventions: Other: integrated-care-model benefiting group

• Registration Number: NCT04164160
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief Summary

Integrated care models aim to promote the coordination and communication between services. The present study aim to evaluate the effectiveness of a new integrated care model (Salut+Social model) which will promote the coordination and communication between social and healthcare services in southern Catalonia (Spain) for the improvement of quality of life of chronic patients, adherence to treatment, access to medical services and caregiver overload. Also, we will evaluate the experience of health and social professionals with the new model implemented.

Detailed Description

A clinical trial with mixed methodology will be carried out. The intervention consists of the promotion and coordination between the social and health sectors, for 6 months, through the use of information and communication technology (ICT) tools that operate as an interface for the integrated care model. The study subjects are chronic patients with health and social conditions that are susceptible to be treated in a collaborative and coordinated way in the field of primary health care. A sample size of 141 patients was estimated. Questionnaires will be used at baseline and at 6, 9 and 12 months after the beginning of the study for the evaluation of quality of life, treatment adherence, medical service and caregiver overload. The principal variable is the quality of life. For statistical analysis, comparisons of means and proportions at different time points will be performed. One discussion group will be performed with the aim of improving the care model according to professionals' opinions. A thematic content analysis will be carried out.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-10
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• Adult patients with at least one health and one social condition, as below specified:

  1. health condition, according to diagnosis of the electronic medical history: complex chronic patient; advanced chronic disease; patient in the home care program; dementia; neurodegenerative diseases; stroke; others chronic disease.
  2. social condition, according to social service workstation from Ribera d'Ebre district: dependence grade; home social service assistance; teleassistance systems assigned by home support.

• Knowledgement of Spanish or Catalan.

• Accepting participation in the study (with informed consent signed by the patient or by the caregiver).

Exclusion Criteria

• Institutionalized patients.
• Users with difficulties filling out or respond a questionnaire.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
integrated-care-model benefiting group	integrated-care-model benefiting group	Chronic patients whose clinical and social data will be added in the integrated care model application software.

Primary Outcome Measures

Name	Time	Method
Change in patient experience about his/her care	change from IEXPAC at 6, 9 and 12 months after the beginning of the study	Be evaluated with the IEXPAC (Instrument for the Evaluation of the Chronic Patient's Experience). Each of the 11 items will be measured with 5-point Likert scale. The global punctuation is an average of the score of the each of the items: 0 (worst experience) to 10 (best experience).
Change in life quality	change from life quality at 6, 9 and 12 months after the beginning of the study.	to be evaluated with the EuroQol- 5 Dimension (EQ-5D). It will be measured by a scale Likert: 0 (worst) to 1 (best).
Change in caregiver burden	change from Zarit Caregiver Burden Inventory at 6, 9 and 12 months after the beginning of the study.	to be evaluated with the Zarit Caregiver Burden Inventory. It will be measured by a scale Likert: 22 (best) to 110 (worst).
Change in adherence to treatment	change from Morisky and Green test at 6, 9 and 12 months after the beginning of the study.	be evaluated with the Morisky and Green test. It will be measured with a dichotomic variable: compliant (if response for the 4 questions is: No/Yes/No/No); noncompliant (if response for the 4 questions is different for: No/Yes/No/No).

Secondary Outcome Measures

Name	Time	Method
Sociodemographic characteristics of the patients	baseline (pre intervention period)	age, sex, level of education, civil status, job situation, nationality
Caregiver characteristics: caregiver relationship	baseline (pre intervention period)	To be evaluated with an ad hoc questionnaire (1. Couple; 2. Mother; 3. Father; 4. Son; 5. Others).
Caregiver characteristics: hours of support	baseline (pre intervention period)	To be evaluated with an ad hoc questionnaire (quantitative variable).
Caregiver characteristics: caregiver with family relationship	baseline (pre intervention period)	To be evaluated with an ad hoc questionnaire (yes/no type)

Trial Locations

Locations (1)

Institut Català de la Salut; 🇪🇸 Tortosa, Tarragona, Spain