Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT04960735
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation, Effectiveness and Impact of a Value Based Intervention for Patients with Breast or Lung Cancer
Sponsor:
Biosistemak Institute for Health Systems Research
Organization:
Study Overview
Official Title:
Value-based Healthcare for Outcomes in Breast and Lung Cancer in Europe
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOICE
Brief Summary:
VOICE project aims to guide health services in their reorganization towards the provision of the highest value care for the patient at the best cost. VOICE is targeted to patients with breast and lung cancer. The purpose is to offer a new innovative strategic framework based on value-based healthcare model to these patients in Europe. VOICE Community consists of 13 hospitals across Europe working collaboratively to implement this approach.
The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.
The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.
The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.
The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.
The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.
The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.
Detailed Description:
VOICE is a Europe-wide Hospital Community pioneering in the assessment of value-based healthcare outcomes related to breast and lung cancer. The VOICE Community members have extended experience in value-based healthcare paradigm as they founded the community in 2018 in continuity with in the All.Can initiative launched by International Consortium for Health Outcome Measurements (ICHOM).
VOICE aims to implement the innovative value based healthcare approach for patients with breast cancer or lung cancer in routine practice to transform care provision and place the patient at the centre of the system. The project will assess the implementation process, the effectiveness of clinical practice and its impact on costs grouped by process for an intervention-based measurement of outcome values for patients with breast or lung cancer. As a result is expected to (i) analyse the effectiveness of an intervention based on measuring outcome values for patients in order to improve patient empowerment, shared decision-making, and physician-patient communication; (ii) assess the impact of an intervention based on measuring outcome values for patients on costs grouped by clinical process, and in the organisation of healthcare by processes and (iii) integrate the measurement of value-based health outcomes in everyday clinical practice for organisations both systematically and long term.
This study duration will be three years and a half.
* Preparation period (July-December 2018): the intervention was defined; the data battery to be collected was designed; the systems required for that purpose were developed; and professionals participating in the study were recruited and trained.
* Intervention period (January 2019-June 2020): all processes set forth were activated; patient recruitment and follow-up, as well as data collection started.
* Analysis and benchmarking period (June 2020-June 2023): data collected will be analysed and outcomes will be compared among organisations participating in the study and corresponding dissemination.
More than 1,000 patients were progressively recruited in 13 pilot sites (European Hospitals) when diagnosed with breast or lung cancer. Patients who met the eligibility criteria described below were invited to take part in the study once diagnosed at the hospital. Medical professionals (gynaecology, oncology, pneumology and thoracic surgery consultants) explained the study and provided the patients with the information sheet and informed consent form.
Recruitment was conducted in the first six months and patients were monitored for at least six months or until death, if that occurred first. Intervention outcomes were monitored at different times: at the start (on recruitment which coincided with diagnosis); at 6 months in breast cancer; and at the start (on recruitment which coincided with diagnosis), at 3 months; and after 6 months in lung cancer.
This multicentre prospective study combines an implementation research component and an effectiveness component, using quantitative and qualitative methods for data collection and analysis. Quantitative analysis includes a descriptive analysis of all variables included in the study. Categorical variables will be shown using frequencies and percentages, n (%). Continuous variables with normal distribution will be shown as standard deviation (SD). Continuous variables with non-normal distribution will be shown as median and first and third quartiles (Q1, Q3). Pre and post intervention differences between categorical variables will be calculated with McNemar's test used on paired data. In continuous variables, the Student´s t test will be used on paired data; or the Wilcoxon rank sum test for variables with normal and non-normal distributions, respectively. Moreover, regression models for the pre/post difference will be proposed to assess whether that difference varies from 0. Models will be adjusted by possible determinant factors such as gender and other socio-demographic elements.
The qualitative analysis to be carried out at the end of the intervention will include semi-structured interviews and focus groups methods. Analyses will be performed at individual level (patient) and at organisational level (costs).
Data management will meet the current European Union (EU) General Data Protection Regulations (GDPR) and shall include detailed information on the procedures in terms of data collection, conservation, protection, reuse and/or destruction. The project will only obtain essential data, and will never share patients' personal data or raw anonymous data. Data obtained will be used for assessment purposes, impact valuation and to increase the empirical base. Templates are based on ICHOM data dictionary for breast cancer and lung cancer where each variable is coded and responses are typified.
VOICE will follow the procedures indicated in the new general data protection regulation No 2016/679 that has been recently applied in Europe for the data access, protection and sharing.
The Community partners have signed an agreement to access and to share data.
VOICE aims to implement the innovative value based healthcare approach for patients with breast cancer or lung cancer in routine practice to transform care provision and place the patient at the centre of the system. The project will assess the implementation process, the effectiveness of clinical practice and its impact on costs grouped by process for an intervention-based measurement of outcome values for patients with breast or lung cancer. As a result is expected to (i) analyse the effectiveness of an intervention based on measuring outcome values for patients in order to improve patient empowerment, shared decision-making, and physician-patient communication; (ii) assess the impact of an intervention based on measuring outcome values for patients on costs grouped by clinical process, and in the organisation of healthcare by processes and (iii) integrate the measurement of value-based health outcomes in everyday clinical practice for organisations both systematically and long term.
This study duration will be three years and a half.
* Preparation period (July-December 2018): the intervention was defined; the data battery to be collected was designed; the systems required for that purpose were developed; and professionals participating in the study were recruited and trained.
* Intervention period (January 2019-June 2020): all processes set forth were activated; patient recruitment and follow-up, as well as data collection started.
* Analysis and benchmarking period (June 2020-June 2023): data collected will be analysed and outcomes will be compared among organisations participating in the study and corresponding dissemination.
More than 1,000 patients were progressively recruited in 13 pilot sites (European Hospitals) when diagnosed with breast or lung cancer. Patients who met the eligibility criteria described below were invited to take part in the study once diagnosed at the hospital. Medical professionals (gynaecology, oncology, pneumology and thoracic surgery consultants) explained the study and provided the patients with the information sheet and informed consent form.
Recruitment was conducted in the first six months and patients were monitored for at least six months or until death, if that occurred first. Intervention outcomes were monitored at different times: at the start (on recruitment which coincided with diagnosis); at 6 months in breast cancer; and at the start (on recruitment which coincided with diagnosis), at 3 months; and after 6 months in lung cancer.
This multicentre prospective study combines an implementation research component and an effectiveness component, using quantitative and qualitative methods for data collection and analysis. Quantitative analysis includes a descriptive analysis of all variables included in the study. Categorical variables will be shown using frequencies and percentages, n (%). Continuous variables with normal distribution will be shown as standard deviation (SD). Continuous variables with non-normal distribution will be shown as median and first and third quartiles (Q1, Q3). Pre and post intervention differences between categorical variables will be calculated with McNemar's test used on paired data. In continuous variables, the Student´s t test will be used on paired data; or the Wilcoxon rank sum test for variables with normal and non-normal distributions, respectively. Moreover, regression models for the pre/post difference will be proposed to assess whether that difference varies from 0. Models will be adjusted by possible determinant factors such as gender and other socio-demographic elements.
The qualitative analysis to be carried out at the end of the intervention will include semi-structured interviews and focus groups methods. Analyses will be performed at individual level (patient) and at organisational level (costs).
Data management will meet the current European Union (EU) General Data Protection Regulations (GDPR) and shall include detailed information on the procedures in terms of data collection, conservation, protection, reuse and/or destruction. The project will only obtain essential data, and will never share patients' personal data or raw anonymous data. Data obtained will be used for assessment purposes, impact valuation and to increase the empirical base. Templates are based on ICHOM data dictionary for breast cancer and lung cancer where each variable is coded and responses are typified.
VOICE will follow the procedures indicated in the new general data protection regulation No 2016/679 that has been recently applied in Europe for the data access, protection and sharing.
The Community partners have signed an agreement to access and to share data.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: