Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service

• In possession of an email account and having basic knowledge of how to manage emails

• In possession of a smartphone, computer, or tablet with access to the Internet

• Fluent and able to read in Spanish

Locations
Other Locations
Spain
Hospital del Mar Reseach Institute
RECRUITING
Barcelona
Contact Information
Primary
Olatz Garin, PhD
ogarin@researchmar.net
+34 636210255
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2027-10
Participants
Target number of participants: 1440
Treatments
Experimental: PROMs and PREMs
Active_comparator: PREMs
Active_comparator: Control
Other: Healthcare professionals
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Parc de Salut Mar

This content was sourced from clinicaltrials.gov