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

Sponsor
Queen Mary University of London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06038045
Collaborator
(none)
80
15

Study Details

Study Description

Brief 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. 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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    PROSPER- Electronic Patient Reported OutcomeS to Empower Patients rEcoveR
    Anticipated Study Start Date :
    Sep 20, 2023
    Anticipated Primary Completion Date :
    Oct 20, 2024
    Anticipated Study Completion Date :
    Dec 20, 2024

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Queen Mary University of London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Queen Mary University of London
    ClinicalTrials.gov Identifier:
    NCT06038045
    Other Study ID Numbers:
    • 318066
    First Posted:
    Sep 14, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2023