Impact Evaluation, Implementation Research, PREMs, PROMs
Conditions
Keywords
PRMs Implementation, Implementation Research, Implementation evaluation, PROMs, PREMs, Impact evaluation, RCT, 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' and health professionals' experiences on health care, as well as improve patients' health.
Interventions
OTHERPROMs 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.
OTHERPREMs
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.
OTHERControl
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.
OTHERHealthcare 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.
Sponsors
Instituto de Salud Carlos III
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals | At recruitment and at 1 year intervals | The PRMIAT measures the perceptions of the patients and healthcare professionals about the implementation of PROMs and PREMs in routine clinical care |
| Health-related quality of life | At recruitment and at 1 year intervals | Measured with the EQ-5D-5L in all patients that participate. |
Countries
Spain
Contacts
Primary ContactOlatz Garin, PhD
Outcome results
None listed