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

NCT ID: NCT06272552

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2027-10-31

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.

Conditions

PROMs; PREMs; Implementation Research; Impact Evaluation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PROMs and PREMs

Group Type: EXPERIMENTAL

PROMs and PREMs

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

PREMs

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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

Group Type: OTHER

Healthcare professionals

Intervention Type: 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.

Interventions

PROMs and PREMs

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.

Intervention Type: OTHER

PREMs

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.

Intervention Type: OTHER

Control

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.

Intervention Type: OTHER

Healthcare professionals

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olatz Garin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar Research Institute

Locations

Hospital del Mar Reseach Institute

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Olatz Garin, PhD

Role: CONTACT

ogarin@researchmar.net

+34 636210255

Facility Contacts

Olatz Garin

Role: primary

ogarin@research.net

+34 636210255

Other Identifiers

2021/10182/I

Identifier Type: OTHER

Identifier Source: secondary_id

PI21-00026

Identifier Type: -

Identifier Source: org_study_id