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Completed

NCT Number: NCT06038045

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

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

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal London Hospital

London, E1 1FR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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;

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months to one year

    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.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

PROSPER- Electronic Patient Reported OutcomeS to Empower Patients rEcoveR

Acronym: PROSPER

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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