Palliative CareCoCPACNCT05412784
Palliative Care Costs for Outpatient Setting Management in Catalunya
An observational study of Palliative Care and Cost and Cost Analysis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Cost and Cost Analysis, Outpatient
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Mar 2024
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Cases with an open legal process.
- Family/caregivers of patients that can't communicate in fluent Spanish or Catalan.
About this study
Official title: 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.
Read the 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.
- Conditions
- Palliative Care, Cost and Cost Analysis, Outpatient
- Keywords
- Palliative Care [MeSH], Cost and Cost Analysis [MeSH], Outpatients [MeSH]
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of economic burden (costs) of palliative care in the outpatient context.
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]).
Measured: 6 months
Secondary outcomes (2)
Type of costs.
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.
Measured: 6 months
Differentiate and compare costs.
To differentiate and compare direct, sanitary and non-sanitary costs and productivity losses of outpatient palliative care in oncologic and non oncologic patients.
Measured: 6 months -1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412784
- Sponsor's protocol ID
- 22/006-P
- Acronym
- CoCPAC
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Costs for Oncologic and Non-oncologic Patients Under Different Outpatient Management in Catalunya
- ClinicalTrials.gov ID
- NCT05412784
- Acronym / sponsor ID
- CoCPAC / 22/006-P
- Conditions
- Palliative Care, Cost and Cost Analysis, Outpatient
- Keywords
- Palliative Care [MeSH], Cost and Cost Analysis [MeSH], Outpatients [MeSH]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 9 Jun 2022 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Cases with an open legal process.
- Family/caregivers of patients that can't communicate in fluent Spanish or Catalan.
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
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]).
2 secondary outcomes
Type of costs.
Time frame: 6 months
Differentiate and compare costs.
Time frame: 6 months -1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Undecided. 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Cost and Cost Analysis, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Determination of economic burden (costs) of palliative care in the outpatient context. (time frame: 6 months). 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 17 Mar 2023.