PROMs Clinical Trial
Official title:
Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.
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: 1,440 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, n=480), or only PREMs (arm B, n=480). 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, n=480). Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients' and health professionals' experiences on health care, as well as improve patients' health.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
| Completed |
NCT06060730 -
Measurement Properties of the Turkish Version of the Patellofemoral Pain and Osteoarthritis Subscale of the KOOS
|
||
| Completed |
NCT05274958 -
Effectiveness of Telepsychiatry With Randomized Waitlist Control Utilizing Patient Reported Outcome Measures
|
N/A | |
| Completed |
NCT04609137 -
Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)
|
N/A | |
| Recruiting |
NCT05224297 -
Patient Experience Data in Radiation Oncology
|
||
| Not yet recruiting |
NCT04393571 -
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
|
N/A | |
| Completed |
NCT02671812 -
Outcome After Dental Implant Treatment
|
||
| Active, not recruiting |
NCT04735744 -
Evaluation of Allied Healthcare in Patients Recovering From COVID-19
|
||
| Recruiting |
NCT05518643 -
Compliance With ERAS Protocol in Pancreatic Surgery, Stress Response and Outcomes
|
||
| Recruiting |
NCT06091397 -
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
|
||
| Completed |
NCT04816656 -
An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic
|
N/A | |
| Completed |
NCT03994861 -
Dutch Version Fear-Avoidance Component Scale (FACS)
|
N/A |