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

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.

Study Overview

• Status: Recruiting
• Conditions: PROMs; Implementation Research; PREMs; Impact Evaluation
• Intervention / Treatment: Other: PROMs and PREMs; Other: PREMs; Other: Control; Other: Healthcare professionals

• Study Type: Interventional
• Enrollment (Estimated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olatz Garin, PhD; Phone Number: +34 636210255; Email: ogarin@researchmar.net

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08003
      • Recruiting
      • Hospital del Mar Reseach Institute
      • Contact: Olatz Garin; Phone Number: +34 636210255; Email: ogarin@research.net
      • Principal Investigator: Olatz Garin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	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.
Other: Healthcare professionals	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.
Experimental: PROMs and PREMs	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.
Active Comparator: PREMs	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Olatz Garin, PhD, Hospital del Mar Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: RCT; Health Services Research; Implementation Research; PROMs; PRMs Implementation; Implementation evaluation; PREMs; Impact evaluation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: PI21-00026; 2021/10182/I (Other Identifier: CEIm Parc de Salut Mar)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be available upon request to outside institutions after data from all individual patients has been anonimized and once the study has finalized and main results have been published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No