Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06272552

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

Led by Parc de Salut Mar · Updated on 2024-02-22

1440

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Parc de Salut Mar

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in routine clinical care to see if they improve health outcomes and satisfaction with health management. This randomized control trial involves 1,440 adult patients receiving care for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery at a public hospital in Spain. The study aims to assess the impact of incorporating these measures on patients' quality of life and communication with healthcare professionals. Participants are divided into three groups: one group completes both PROMs and PREMs monthly via a smartphone app, with their PROMs results summarized graphically for use by patients and doctors at 9 and 18 months; a second group completes only PREMs; and a control group completes evaluation questionnaires without additional interventions. Healthcare professionals also participate by completing questionnaires before and two years after implementation to assess their perspectives. During the study, patients complete evaluation questionnaires at recruitment and yearly to measure health-related quality of life (using EQ-5D-5L), satisfaction with care, and patient-professional communication. PROMs and PREMs are administered mainly via email using the REDCap platform. Participant responses help track the study's impact over two years, with safety monitoring and follow-up visits planned throughout this period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service
  • Having an email account and basic knowledge of how to manage emails
  • Having access to a smartphone, computer, or tablet with internet
  • Being fluent and able to read Spanish
Not Eligible

You will not qualify if you...

  • Under 18 years of age

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation Period

Duration - 2 years

Participants complete PROMs and/or PREMs surveys by email and attend clinic visits to answer evaluation questionnaires at recruitment and annually for two years to assess the impact of these measures in routine clinical care.

Clinic visits at recruitment and annually for 2 years; PROMs and PREMs surveys by email as scheduled

Trial Site Locations

Total: 1 location

1

Hospital del Mar Reseach Institute

Barcelona, Catalonia, Spain, 08003

Actively Recruiting

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Research Team

O

Olatz Garin, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

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