Digestive System DiseaseNCT05064163
SROI Project on the Surgical Waiting List Management System
An observational study of Digestive System Disease, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System Disease
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 16 May 2022
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients on the waiting list for surgery and diagnostic tests at the Hospital Punta de Europa, located in the Campo de Gibraltar West health management area, and referred to the "Clínica Virgen del Rosario" centre.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Return on Investment (SROI) Project of the Surgical Waiting List Management System
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.
Read more
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.
Read the detailed 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".
- Conditions
- Digestive System Disease
- Keywords
- Social Return on Investment (SROI), Surgical waiting list, Health Concerts, Diagnostic tests, Surgical procedures
- Medical subject headings
- Digestive System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Increase in resources
To know the increase in extraordinary resources to change waiting lists in terms of human and material resources.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Rate of return on investment (SROI)
Determine the social return for each surgical procedure and functional test.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Mar 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Gonzalez Munoz, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064163
- Sponsor's protocol ID
- SROI-LEQ2020
- Other IDs
- 113.21
- Status last verified
- Jun 2022
- First submitted
- 1 Sep 2021
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Return on Investment (SROI) Project of the Surgical Waiting List Management System
- ClinicalTrials.gov ID
- NCT05064163
- Acronym / sponsor ID
- SROI-LEQ2020
- Conditions
- Digestive System Disease
- Keywords
- Social Return on Investment (SROI), Surgical waiting list, Health Concerts, Diagnostic tests, Surgical procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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".
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on the waiting list for surgery and diagnostic tests at the Hospital Punta de Europa, located in the Campo de Gibraltar West health management area, and referred to the "Clínica Virgen del Rosario" centre.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Economic cost
Time frame: 4 months
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.
Increase in resources
Time frame: 4 months
To know the increase in extraordinary resources to change waiting lists in terms of human and material resources.
Prevalence of surgical procedures
Time frame: 4 months
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.
Quality-adjusted life years (QALYs)
Time frame: 4 months
Determine QALYs by multiplying the utility value associated with a given health state by the years lived in that state.
Rate of return on investment (SROI)
Time frame: 4 months
Determine the social return for each surgical procedure and functional test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Disease, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Economic cost (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.