Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

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 details
    PROMs
    PREMs
    Implementation Research
    Impact Evaluation

NCT06272552

Parc de Salut Mar

8 March 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.