Palliative Care Costs for Outpatient Setting Management in Catalunya (CoCPAC)

March 16, 2023 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Palliative Care Costs for Oncologic and Non-oncologic Patients Under Different Outpatient Management in Catalunya

Cost-of-illness studies in palliative care (PC) are a growing area of interest in health economics activity. They are, in part, stakeholders' basis for deciding the allocation of the scarce public and private economic resources. There is no standard methodology to capture the formal and informal costs and expenses that health services and patients and their caregivers make during the PC attention period due to non-standard health services, and data capture approaches.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Methods / Analysis Prospective study on the burden of disease of PC on the outpatient/domiciliary attention. Proposed in three phases: Phase I: Systematic Review of Literature to identify de types of costs and proposed methodologies to identify and determine de economic burden of PC. With collected data, create a questionnaire to register the costs of services covered by the healthcare system and those covered by patients/caregivers (PROSPERO CRD42021250086). Phase II: Questionnaire piloting. Phase III: Transversal study of costs, collecting data from public healthcare billing and patient/caregivers payments to cover PC on selected patients. Final methodologic proposal to study billing/costs of outpatient/domiciliary PC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a history of breast, lung, and colorectal neoplasm or Chronic Heart Failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD), managed in the outpatient/domiciliary scenarios and their families/caregivers.

Description

Inclusion criteria:

  • Clinical diagnosis of breast, lung, and colorectal neoplasm or Chronic Heart Failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD).
  • Patient and caregivers must be able to maintain a 1-hour telephonic interview.
  • Patient and caregivers must allow one (1) more telephone call to revise data.

Exclusion Criteria:

  • Cases with an open legal process.
  • Family/caregivers of patients that can't communicate in fluent Spanish or Catalan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of economic burden (costs) of palliative care in the outpatient context.
Time Frame: 6 months
Calculation and report the economic burden (i.e., total costs) of outpatient palliative care services, medications and procedures covered and financed by the healthcare system alongside with those covered by the patients and their families/caregivers during the last six (6) months of life (in adult patients with lung, colorectal and breast neoplasms and with terminal cardiac heart failure [CHF] and chronic obstructive pulmonary disease [COPD]).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Type of costs.
Time Frame: 6 months
Direct, sanitary and non-sanitary costs covered by healthcare system, sanitary and non-sanitary costs covered by patients and families/caregivers and productivity losses due to the patients and families/caregivers to register and measure in a study of costs/economic burden of outpatient palliative care.
6 months
Differentiate and compare costs.
Time Frame: 6 months -1 year
To differentiate and compare direct, sanitary and non-sanitary costs and productivity losses of outpatient palliative care in oncologic and non oncologic patients.
6 months -1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22/006-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In case the obtained database gives data of public interest, can be used to make parallel analyses, supervised/directed by one of the headline authors.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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