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

NCT06272552 | Recruiting

• 2 other identifiers: PI21-000262021/10182/I
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

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

Keywords

PRMs Implementation; Implementation Research; Implementation evaluation; PROMs; PREMs; Impact evaluation; RCT; Health Services Research

Outcome Measures

Primary Outcomes (2)

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

  The PRMIAT measures the perceptions of the patients and healthcare professionals about the implementation of PROMs and PREMs in routine clinical care

  At recruitment and at 1 year intervals

• Health-related quality of life

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

  At recruitment and at 1 year intervals

Study Arms (4)

PROMs and PREMs

EXPERIMENTAL

Other: PROMs and PREMs

PREMs

ACTIVE COMPARATOR

Other: PREMs

Control

ACTIVE COMPARATOR

Other: Control

Healthcare professionals

OTHER

Other: Healthcare professionals

Interventions

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.

PROMs and PREMs

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.

PREMs

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.

Control

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.

Healthcare professionals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Under 18 years of age

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital del Mar Reseach Institute

Barcelona, Catalonia, 08003, Spain

RECRUITING

MeSH Terms

Interventions

Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Olatz Garin, PhD

  Hospital del Mar Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olatz Garin, PhD

CONTACT

+34 636210255; ogarin@researchmar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 22, 2024
• Study Start: October 25, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

ES (1)