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NCT Number: NCT06272552

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

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.

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Key information

Conditions

PROMs Impact Evaluation Implementation Research PREMs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar Reseach Institute

Barcelona, Catalonia, 08003, Spain

Location status: Recruiting

Location contact

Olatz Garin

CONTACT

[email protected]

+34 636210255

Olatz Garin

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROMs and PREMs

Other

Participants are administered PROMs and PREMs at a given timeline adequate to each participant conditions for a duration of 2 years. The administration of PROMs is done by email using the REDCap platform. The research team and health care professionals have access to their patient's results to aid in the patients clinical care.

Participants are administered a PREM once a year for two years. Only health care administrators, department heads and researchers will have access to the PREMs data, and this data will always be aggregated data to avoid identification of the patients. The administration of the PREM is done by email using the REDCap platform.

At recruitment and once a year, participants answer an evaluation questionnaire to measure the impact of completing PROMs and PREMs. This questionnaire is completed during a clinic visit.

PREMs

Other

Participants are administered a PREM once a year for two years. Only health care administrators, department heads and researchers will have access to the PREMs data, and this data will always be aggregated data to avoid identification of the patients. The administration of the PREM is done by email using the REDCap platform.

At recruitment and once a year, participants answer an evaluation questionnaire to measure the impact of completing PROMs and PREMs. This questionnaire is completed during a clinic visit.

Control

Other

At recruitment and once a year, participants answer an evaluation questionnaire to measure the impact of completing PROMs and PREMs. This questionnaire is completed during a clinic visit.

Healthcare professionals

Other

Healthcare professionals participating in the study answer an evaluation questionnaire before the implementation starts at their service and two years later to measure their perceptions about the implementation.

Primary outcomes

  1. Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals

    Time frame: 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

  2. Health-related quality of life

    Time frame: At recruitment and at 1 year intervals

    Measured with the EQ-5D-5L in all patients that participate.

Study contacts

Contact information is provided by the study sponsor or research team.

Olatz Garin, PhD

CONTACT

[email protected]

+34 636210255

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: PROMs & PREMs

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2024
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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