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

PROMs Clinical Trial

— PROMs & PREMs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272552
• Other study ID #: PI21-00026
• Secondary ID: 2021/10182/I
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: October 2027

Study information

• Verified date: February 2024
• Source: Parc de Salut Mar
• Contact: Olatz Garin, PhD
• Phone: +34 636210255
• Email: ogarin[@]researchmar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Implementation Research
• PROMs

Intervention

Other:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital del Mar Reseach Institute	Barcelona	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Health-related quality of life	Measured with the EQ-5D-5L in all patients that participate.	At recruitment and at 1 year intervals