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SurgeryPROSPERNCT06038045

Measuring the Recovery of Barts Health Patients With Electronic Follow-up

An observational study of Surgery and Critical Illness, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

More and more people are surviving emergency, life-threatening illnesses. However, survival often comes at a cost to patients' wellbeing. Many suffer from being so ill in ways not necessarily related to their original illness. Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Surgery, Critical Illness, Trauma
How many people
314 participants
Where
1 siteUnited Kingdom
Study dates
20 Oct 2023to 28 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

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 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will be patients that are admitted to the critical care wards with any indication, and those above the age of 18 years and able to consent for the study. The PI will adopt a purposive sampling method to ensure that age, gender and ethnicity is equally represented in the population. Furthermore, the health care staff including clinicians, and follow- up clinic staff, physiotherapists, dieticians/nutritionist alike and staff involved in healthcare will be interviewed for their feedback on the questionnaires.

Who may be able to join

  • Patients undergoing emergency laparotomy, regardless of admission to the Adult Critical Care Unit.
  • Patients requiring Level 3 care admitted to the Adult Critical Care Unit with length of stay of >56 hours
  • Clinical staff involved in the pathway of care affected by the ePRO.
  • Purposive sampling to include patients based on age, gender, ethnicity, language spoken, digital literacy and reason for admission

Who cannot join

  • Those patients <18 years of age
  • Those not expected to survive 3 months post discharge; as per clinical decision making
  • Patients unable to consent to and without carers able to consent;

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Royal London Hospital

    London, E1 1FR

Other trials in United Kingdom

About this study

Official title: PROSPER- Electronic Patient Reported OutcomeS to Empower Patients rEcoveR

More and more people are surviving emergency, life-threatening illnesses. However, survival often comes at a cost to patients' wellbeing. Many suffer from being so ill in ways not necessarily related to their original illness. Patients struggle with their normal activities of daily living or to do the job they did before. They struggle to live independently, to enjoy a normal diet, or to be pain-free. This leads to a decrease in their quality of life, placing a burden on families. Investigators don't have a good method of highlighting and representing the issues faced by these patients. Investigators have recently implemented a service innovation project, using an an app-based questionnaire in two groups (patients that survive emergency surgery, and those who survive critical illness) to highlight these problems early, so that individuals are offered the right help and services to return to living their lives as fully as possible. Patients will be asked to fill in an electronic (on-line) questionnaire while in hospital, and at 1 and 6 months afterwards.

Along side this investigators intend to perform a qualitative assessment of the value and acceptability of this project. Investigators will interview patients approximately 2-3 weeks after the questionnaire completion at 1 and 6 months to determine how easy it was to use, how acceptable the process was and how well it described and highlighted their problems.

If this system works, it would become part of routine care, extended to patients admitted as emergencies to hospital, and used to develop a national program for all UK hospital patients

Read the detailed description

This is a qualitative study, with data collected through semi-structured interviews with patients and clinical staff with experience of using the ePRO system. Topic guides for both patients and clinicians have been developed based upon previous similar studies and with input from our study PPI group.

The patients for qualitative study will be consented by the coordinator. This will be done when the patients are invited to participate in the PROSPER study. The ePRO project is a service evaluation project registered with the Clinical Effectiveness Unit (CEU). The sample for qualitative study will be based on age, gender, ethnicity, language spoken, digital literacy and reason for admission. Patients who consent to participate will be interviewed twice about their experience of using the ePRO system. Interviews will be done approximately 2-3 weeks after the ePRO questionnaire completion time points of 1 and 6 months respectively. Interviews will follow the interview topic guide, with semi-structured questions exploring both the research objectives as above, will be conducted on the telephone and will be audio recorded and transcribed. Clinicians and health care staff will also be interviewed to assess their perception of usefulness of the electronic questionnaires.

Medical subject headings
Critical Illness, Wounds and Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. This is a qualitative study exploring the feasibility and acceptability of the electronic HRQoL

    Purposive sampling will be carried out on the patient population those filling in online questionnaires and health care staff involved in patient care. Their views will be recorded to assess the suitability and acceptability of the digital questionnaires. The outcome will be responses to the semi structured interview. These data will be analysed to derive themes, using the saturation method.

    Since August 2024, we have introduced an online questionnaire based on the feedback of a few patients.

    Measured: 6 months to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start20 Oct 2023
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038045
Sponsor's protocol ID
318066
Acronym
PROSPER
Status last verified
Mar 2025
First submitted
31 Aug 2023
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van Der Wees PJ, Nijhuis-Van Der Sanden MW, Ayanian JZ, Black N, Westert GP, Schneider EC. Integrating the use of patient-reported outcomes for both clinical practice and performance measurement: views of experts from 3 countries. Milbank Q. 2014 Dec;92(4):754-75. doi: 10.1111/1468-0009.12091.

    PubMed 25492603

  • Puthucheary Z, Brown C, Corner E, Wallace S, Highfield J, Bear D, Rehill N, Montgomery H, Aitken L, Turner-Stokes L. The Post-ICU presentation screen (PICUPS) and rehabilitation prescription (RP) for intensive care survivors part II: Clinical engagement and future directions for the national Post-Intensive care Rehabilitation Collaborative. J Intensive Care Soc. 2022 Aug;23(3):264-272. doi: 10.1177/1751143720988708. Epub 2021 Feb 1.

    PubMed 36033242

  • Major ME, van Nes F, Ramaekers S, Engelbert RHH, van der Schaaf M. Survivors of Critical Illness and Their Relatives. A Qualitative Study on Hospital Discharge Experience. Ann Am Thorac Soc. 2019 Nov;16(11):1405-1413. doi: 10.1513/AnnalsATS.201902-156OC.

    PubMed 31394924

  • Law J, Welch C, Javanmard-Emamghissi H, Clark M, Bisset CN, O'Neil P, Moug SJ; ELF study group. Decision-making for older patients undergoing emergency laparotomy: defining patient and clinician values and priorities. Colorectal Dis. 2020 Nov;22(11):1694-1703. doi: 10.1111/codi.15165. Epub 2020 Jun 21.

    PubMed 32464712

  • Vilches-Moraga A, Rowley M, Fox J, Khan H, Paracha A, Price A, Pearce L. Emergency laparotomy in the older patient: factors predictive of 12-month mortality-Salford-POPS-GS. An observational study. Aging Clin Exp Res. 2020 Nov;32(11):2367-2373. doi: 10.1007/s40520-020-01578-0. Epub 2020 May 24.

    PubMed 32449105

  • Poulton TE, Moonesinghe R, Raine R, Martin P; National Emergency Laparotomy Audit project team. Socioeconomic deprivation and mortality after emergency laparotomy: an observational epidemiological study. Br J Anaesth. 2020 Jan;124(1):73-83. doi: 10.1016/j.bja.2019.08.022.

    PubMed 31860444

  • Ray S, Laur C, Golubic R. Malnutrition in healthcare institutions: a review of the prevalence of under-nutrition in hospitals and care homes since 1994 in England. Clin Nutr. 2014 Oct;33(5):829-35. doi: 10.1016/j.clnu.2013.10.017. Epub 2013 Nov 1.

    PubMed 24238787

  • McNelly AS, Rawal J, Shrikrishna D, Hopkinson NS, Moxham J, Harridge SD, Hart N, Montgomery HE, Puthucheary ZA. An Exploratory Study of Long-Term Outcome Measures in Critical Illness Survivors: Construct Validity of Physical Activity, Frailty, and Health-Related Quality of Life Measures. Crit Care Med. 2016 Jun;44(6):e362-9. doi: 10.1097/CCM.0000000000001645.

    PubMed 26974547

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Critical Illness, run by Queen Mary University of London at 1 site in United Kingdom.

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 3 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: finished, as of the sponsor's last update on 24 Mar 2025. 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

This is a qualitative study exploring the feasibility and acceptability of the electronic HRQoL (time frame: 6 months to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06038045, which also lists 8 linked publications.

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 24 Mar 2025.

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