Clinical trial NCT04164160: An Integrated Care Model for Chronic Patients
Official title: Effectiveness of the Integrated Care Model Salut+Social in Patients With Chronic Conditions: a Mixed Methods Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Integrated Care
Keywords: Integrated care
Health and social care
Chronic disease
Primary Health Care
Quality of life
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Department of Health, Generalitat de Catalunya
First posted: 2019-11-15
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in life quality
timeFrame: change from life quality at 6, 9 and 12 months after the beginning of the study.
measure: Change in caregiver burden
timeFrame: change from Zarit Caregiver Burden Inventory at 6, 9 and 12 months after the beginning of the study.
measure: Change in adherence to treatment
timeFrame: change from Morisky and Green test at 6, 9 and 12 months after the beginning of the study.
measure: Change in patient experience about his/her care
timeFrame: change from IEXPAC at 6, 9 and 12 months after the beginning of the study
Secondary outcomes:
measure: Sociodemographic characteristics of the patients
timeFrame: baseline (pre intervention period)
measure: Caregiver characteristics: caregiver with family relationship
timeFrame: baseline (pre intervention period)
measure: Caregiver characteristics: caregiver relationship
timeFrame: baseline (pre intervention period)
measure: Caregiver characteristics: hours of support
timeFrame: baseline (pre intervention period)
Other outcomes:
Locations:
city: Tortosa
country: Spain
facility: Institut Català de la Salut
state: Tarragona
Study officials:
References:
citation: Gavalda-Espelta E, Del Mar Lleixa-Fortuno M, Baucells-Lluis J, Ferre-Ferrate M, Mora-Lopez G, Tomas-Navarro B, Curto-Romeu C, Lucas-Noll J, Aguilar Martin C, Goncalves AQ, Ferre-Grau C. Effectiveness of the integrated care model Salut+Social in patients with chronic conditions: A mixed methods study protocol. Medicine (Baltimore). 2020 May;99(19):e19994. doi: 10.1097/MD.0000000000019994.