Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorParc de Salut Mar
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PROMs and PREMs
Other interventionParticipants 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 interventionParticipants 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 interventionAt 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 interventionHealthcare 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.
Treatment groups
1,440 Participants
are divided into 4 treatment groupsGroup A: PROMs and PREMsExperimental treatment 1 intervention
Group B: PREMsActive comparator 1 intervention
Group C: ControlActive comparator 1 intervention
Group D: Healthcare professionalsOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
At recruitment and at 1 year intervals2
Health-related quality of life
Measured with the EQ-5D-5L in all patients that participate.
Time frame
At recruitment and at 1 year intervalsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Parc de Salut Mar
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Source ClinicalTrials.gov