Clinical trial NCT06272552: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact
Official title: Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PROMs
PREMs
Implementation Research
Impact Evaluation
Keywords: PRMs Implementation
Implementation Research
Implementation evaluation
PROMs
PREMs
Impact evaluation
RCT
Health Services Research
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2024-02-22
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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\&#39; and health professionals\&#39; experiences on health care, as well as improve patients\&#39; health.


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

Primary outcomes:
measure: Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals
timeFrame: At recruitment and at 1 year intervals
measure: Health-related quality of life
timeFrame: At recruitment and at 1 year intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar Reseach Institute
state: Catalonia
Study officials:
affiliation: Hospital del Mar Research Institute
name: Olatz Garin, PhD
role: PRINCIPAL_INVESTIGATOR
References: