protocolSection identificationModule nctId: NCT06272552, orgStudyIdInfo id: PI21-00026, secondaryIdInfos id: 2021/10182/I, type: OTHER, domain: CEIm Parc de Salut Mar, briefTitle: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact, acronym: PROMs & PREMs, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Parc de Salut Mar, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: 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\&#39; and health professionals\&#39; experiences on health care, as well as improve patients\&#39; health., conditionsModule conditions: PROMs, conditions: PREMs, conditions: Implementation Research, conditions: Impact Evaluation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1440, type: ESTIMATED, armsInterventionsModule interventions name: PROMs and PREMs, interventions name: PREMs, interventions name: Control, interventions name: Healthcare professionals, outcomesModule primaryOutcomes measure: Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals, primaryOutcomes measure: Health-related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital del Mar Reseach Institute, status: RECRUITING, city: Barcelona, state: Catalonia, zip: 08003, country: Spain, contacts name: Olatz Garin, role: CONTACT, phone: +34 636210255, email: ogarin@research.net, contacts name: Olatz Garin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False