- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05412784
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
Not yet recruiting
Conditions
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
Observational
Enrollment (Anticipated)
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
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
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
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.
Collaborators
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)
April 1, 2023
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
March 31, 2024
Study Registration Dates
First Submitted
May 31, 2022
First Submitted That Met QC Criteria
June 7, 2022
First Posted (Actual)
June 9, 2022
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID 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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