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

Not Applicable

Recruiting

• Conditions: Impact Evaluation; PROMs; Implementation Research; PREMs

• Registration Number: NCT06272552
• Lead Sponsor: Parc de Salut Mar

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: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-25
• Status Verified: 2024-02
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-21
• Last Update Submitted: 2024-02-21
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1440

Inclusion Criteria

• 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

Exclusion Criteria

• Under 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals	At recruitment and at 1 year intervals	The PRMIAT measures the perceptions of the patients and healthcare professionals about the implementation of PROMs and PREMs in routine clinical care
Health-related quality of life	At recruitment and at 1 year intervals	Measured with the EQ-5D-5L in all patients that participate.

Trial Locations

Locations (1)

Hospital del Mar Reseach Institute; 🇪🇸 Barcelona, Catalonia, Spain