Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272552
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-12
Brief Title:
Implementing PROMs and PREMs in Routine Clinical Care Assessment of Requirements and Impact
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Implementing PROMs and PREMs in Routine Clinical Care Assessment of Requirements and Impact
Status:
RECRUITING
Status Verified Date:
2024-02
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:
PROMs PREMs
Brief Summary:
There has been increasing interest in the use of patient-reported outcomes and experience measures PROMs and PREMs in clinical practice yet few empirical studies have been conducted to evaluate the usefulness of such implementation
Objective To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management
Design Randomized control trial Setting In and outpatient departments of a public hospital in Spain
Participants 1440 adult patients managed for breast cancer prostate cancer chronic kidney disease or bariatric surgery
Intervention Patients will monthly complete through an App from their smartphones PROMs and PREMs arm A n480 or only PREMs arm B n480 Responses to PROMs will be transformed into a graphic summary accessible for physicians and patients at the follow-up visits of the project 9 and 18 months after recruitment
Main outcome measures Comparison of change among arms on the assessment variables - such as health-related quality of life EQ-5D-5L satisfaction with care or patient-professionals communication These constructs will be measured at recruitment and at follow up visits for all patients regardless of their arm allocation arm C would only be administered these questionnaires without intervention n480
Expected results Incorporating PROMs and PREMs in routine clinical care may improve patients39 and health professionals39 experiences on health care as well as improve patients39 health
Objective To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management
Design Randomized control trial Setting In and outpatient departments of a public hospital in Spain
Participants 1440 adult patients managed for breast cancer prostate cancer chronic kidney disease or bariatric surgery
Intervention Patients will monthly complete through an App from their smartphones PROMs and PREMs arm A n480 or only PREMs arm B n480 Responses to PROMs will be transformed into a graphic summary accessible for physicians and patients at the follow-up visits of the project 9 and 18 months after recruitment
Main outcome measures Comparison of change among arms on the assessment variables - such as health-related quality of life EQ-5D-5L satisfaction with care or patient-professionals communication These constructs will be measured at recruitment and at follow up visits for all patients regardless of their arm allocation arm C would only be administered these questionnaires without intervention n480
Expected results Incorporating PROMs and PREMs in routine clinical care may improve patients39 and health professionals39 experiences on health care as well as improve patients39 health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 202110182I | OTHER | CEIm Parc de Salut Mar | None |