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| ID | Type | Description | Link |
|---|---|---|---|
| 2021/10182/I | Other Identifier | CEIm Parc de Salut Mar |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROMs and PREMs | Experimental |
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| PREMs | Active Comparator |
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| Control | Active Comparator |
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| Healthcare professionals | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMs and PREMs | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Under 18 years of age
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olatz Garin, PhD | Contact | +34 636210255 | ogarin@researchmar.net |
| Name | Affiliation | Role |
|---|---|---|
| Olatz Garin, PhD | Hospital del Mar Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar Reseach Institute | Recruiting | Barcelona | Catalonia | 08003 | Spain |
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.
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| ID | Term |
|---|---|
| D006282 | Health Personnel |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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| PREMs | Other | 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. |
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| Control | Other | 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. |
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| Healthcare professionals | Other | 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. |
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