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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05412784
Other study ID # 22/006-P
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date March 31, 2024

Study information

Verified date May 2022
Source Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina Hospital Clinic of Barcelona

Outcome

Type Measure Description Time frame Safety issue
Primary 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]). 6 months
Secondary 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. 6 months
Secondary 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. 6 months -1 year
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