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

Parc de Salut Mar

Status: Enrolling

Conditions: Implementation Research; Impact Evaluation; PROMs; PREMs

Treatments: Other: Control; Other: PREMs; Other: PROMs and PREMs; Other: Healthcare professionals

Study type: Interventional

Funder types: Other

Identifiers

NCT06272552

2021/10182/I (Other Identifier)

PI21-00026

Details and patient eligibility

About

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.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,440 participants in 4 patient groups

PROMs and PREMs

Experimental group

Treatment:

Other: PROMs and PREMs

PREMs

Active Comparator group

Treatment:

Other: PREMs

Control

Active Comparator group

Treatment:

Other: Control

Healthcare professionals

Other group

Treatment:

Other: Healthcare professionals