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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064163
Other study ID # SROI-LEQ2020
Secondary ID 113.21
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date May 16, 2022

Study information

Verified date June 2022
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The waiting lists for surgery and diagnostic tests registered in the health management area of Campo de Gibraltar West are very high, and this is compounded by the lack of resources that prevent them from being managed efficiently. The aim of the study is to know, quantify and communicate the measurement of the social impact, also known as social return on investment, which is presented as a tool for decision making on the intervention of the management of health concerts in comparison with the current system in Andalucia. In addition, other objectives will be studied, such as the health and non-health benefits derived from applying the intervention of the concerts compared to the current system of waiting list management from the economic, social and environmental points of view, the economic cost of the interventions by the health concerts and the Andalusian public health system, the cost of the increase in extraordinary health resources, determining the most prevalent surgeries from highest to lowest and specifying the highest number of surgeries that are established in the concerts and in the SSPA. The method used will be an economic evaluation of the different healthcare technologies in which the investigators compare the healthcare agreements of the most prevalent procedures and those that collect data in both groups through the SROI tool. A cross-sectional and prospective design will be carried out with a time horizon of 2021 and 2022, and for the statistical analysis the investigators will use the SSPS V25 and JASP programmes. The investigators consider it necessary to carry out this research study as there is no specific bibliography on the healthcare technology used in healthcare agreements as a new healthcare technology compared with the current system for managing surgical waiting lists in the Andalusian public healthcare system in terms of return on investment.


Description:

The main objective of the study is to carry out a SROI (social return on investment) project as a decision-making tool for clinical and health management of waiting lists in Campo de Gibraltar. In addition, the investigators consider it necessary to carry out this research study as there is no specific bibliography on the healthcare want to achieve other more specific objectives such as: - To know the economic cost of the interventions by the extraordinary health concert and the ordinary activity of the Andalusian Public Health System (APHS) of the surgical waiting list and diagnostic tests of certain surgical and functional procedures. - To know the increase in extraordinary resources to reduce waiting lists in terms of human and material resources. - To describe socio-demographic data and the prevalence of surgical interventions and diagnostic tests in the extraordinary agreement and the Andalusian Public Health System (APHS). - To find out how the patient's life is affected in different areas. - Specify the patient's willingness to pay to improve their quality of life. - To determine the social return for each surgical procedure and functional test. The methodology of the study, a questionnaire will be carried out with the aim of analysing the effect that the waiting list for surgery and diagnostic tests has on the lives of the people who suffer from it, this questionnaire will include, among others, the following sections: - Socio-demographic characteristics, employment situation and family environment. - Type of procedures and pathology - Effect of the waiting list for surgery and diagnostic tests on different areas of the patient's life. - Willingness to pay to improve aspects of their life affected since diagnosis. - Use of health resources in the last year linked to the pathology. The number of visits that the patient will have to make will only be once, prior to their diagnostic or surgical procedure, to which they will be given the information sheet, informed consent and questionnaires. Extraordinary visits will not be made. The alternative procedures or treatments that may exist for the subject and their significant potential risks and benefits. The duration of the study will be 1 year, from April 2021 to March 2022. The number of participants will be the patients included in the surgical waiting list and diagnostic tests of the Hospital Punta de Europa located in the health management area Campo de Gibraltar West and referred to the centre "Clínica Virgen del Rosario".


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date May 16, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion criteria: - Patients undergoing surgery and diagnostic tests at Hospital Punta Europa in ordinary activity. - Patients undergoing surgery and diagnostic tests in external health care agreement at the Clínica Virgen del Rosario in Algeciras. Exclusion criteria: - Urgent surgical interventions -Urgent diagnostic tests. - Patients who have signed the revocation of informed consent. - Absence at the surgical appointment - Lack of collaboration - Resolution of the illness causing the surgical appointment. No presentation of illness - Refusal by the physician - Allergies

Study Design


Locations

Country Name City State
Spain Clinica Virgen Del Rosario Algeciras Cadiz

Sponsors (1)

Lead Sponsor Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Economic cost To ascertain the economic cost of interventions under the extraordinary healthcare agreement and of the ordinary activity of the Andalusian Public Health System (APHS) of the surgical waiting list and of diagnostic tests for certain surgical and functional procedures. 4 months
Primary Increase in resources To know the increase in extraordinary resources to change waiting lists in terms of human and material resources. 4 months
Primary Prevalence of surgical procedures Calculate by dividing the total number of individuals with a surgical procedure at the time of the study by the population at that point in time. 4 months
Primary Quality-adjusted life years (QALYs) Determine QALYs by multiplying the utility value associated with a given health state by the years lived in that state. 4 months
Primary Rate of return on investment (SROI) Determine the social return for each surgical procedure and functional test. 4 months
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