PROMsPROMs & PREMsNCT06272552
Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact
A study testing PROMs and PREMs, PREMs and Healthcare professionals in people with PROMs and PREMs, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PROMs, PREMs, Implementation Research
- What is being tested?
- PROMs and PREMs, PREMs and Healthcare professionals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar Reseach Institute
Barcelona, Catalonia, 08003
Olatz Garin, +34 636210255, ogarin@research.net
Olatz Garin
About this study
Official title: 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.
Read more
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.
- Conditions
- PROMs, PREMs, Implementation Research, Impact Evaluation
- Being tested
- PROMs and PREMs, PREMs, Control, Healthcare professionals
- Keywords
- PRMs Implementation, Implementation Research, Implementation evaluation, PROMs, PREMs, Impact evaluation, RCT, Health Services Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMs and PREMsOther
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.
PREMsOther
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.
ControlOther
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.
Healthcare professionalsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PROMs and PREMs | Experimental | Not described Receives: Other: PROMs and PREMs |
| PREMs | Active comparator | Not described Receives: Other: PREMs |
| Control | Active comparator | Not described Receives: Other: Control |
| Healthcare professionals | Other | Not described Receives: Other: Healthcare professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At recruitment and at 1 year intervals
Health-related quality of life
Measured with the EQ-5D-5L in all patients that participate.
Measured: At recruitment and at 1 year intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start25 Oct 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROMsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Olatz Garin, PhD, Principal investigator, Hospital del Mar Research Institute (IMIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272552
- Sponsor's protocol ID
- PI21-00026
- Other IDs
- 2021/10182/I
- Acronym
- PROMs & PREMs
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.
- ClinicalTrials.gov ID
- NCT06272552
- Acronym / sponsor ID
- PROMs & PREMs / PI21-00026
- Conditions
- PROMs, PREMs, Implementation Research, Impact Evaluation
- Keywords
- PRMs Implementation, Implementation Research, Implementation evaluation, PROMs, PREMs, Impact evaluation, RCT, Health Services Research
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PROMs and PREMs | Experimental | Other: PROMs and PREMs |
| PREMs | Active comparator | Other: PREMs |
| Control | Active comparator | Other: Control |
| Healthcare professionals | Other | Other: Healthcare professionals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMs and PREMsParticipants 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. | Other | PROMs and PREMs |
| PREMsParticipants 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. | Other | PREMs |
| ControlAt 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 | Control |
| Healthcare professionalsHealthcare 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. | Other | Healthcare professionals |
Primary outcome
Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals
Time frame: 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
Time frame: At recruitment and at 1 year intervals
Measured with the EQ-5D-5L in all patients that participate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olatz Garin, PhD principal investigator
Hospital del Mar Research Institute (IMIM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMs and PREMs, PREMs and Healthcare professionals in people with PROMs and PREMs, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olatz Garin, PhD (+34 636210255, ogarin@researchmar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation quesionnaire (PRMIAT) of the implementation to be completed by all patients and healthcare professionals (time frame: At recruitment and at 1 year intervals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.