xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038045</url>
    </required_header>
    <id_info>
      <org_study_id>318066</org_study_id>
      <nct_id>NCT06038045</nct_id>
    </id_info>
    <brief_title>Measuring the Recovery of Barts Health Patients With Electronic Follow-up</brief_title>
    <acronym>PROSPER</acronym>
    <official_title>PROSPER- Electronic Patient Reported OutcomeS to Empower Patients rEcoveR</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Queen Mary University of London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Queen Mary University of London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        More and more people are surviving emergency, life-threatening illnesses. However, survival&#xD;
        often comes at a cost to patients' wellbeing. Many suffer from being so ill in ways not&#xD;
        necessarily related to their original illness. Patients struggle with their normal activities&#xD;
        of daily living or to do the job they did before. They struggle to live independently, to&#xD;
        enjoy a normal diet, or to be pain-free. This leads to a decrease in their quality of life,&#xD;
        placing a burden on families. Investigators don't have a good method of highlighting and&#xD;
        representing the issues faced by these patients. Investigators have recently implemented a&#xD;
        service innovation project, using an an app-based questionnaire in two groups (patients that&#xD;
        survive emergency surgery, and those who survive critical illness) to highlight these&#xD;
        problems early, so that individuals are offered the right help and services to return to&#xD;
        living their lives as fully as possible. Patients will be asked to fill in an electronic&#xD;
        (on-line) questionnaire while in hospital, and at 1 and 6 months afterwards.&#xD;
  &#xD;
        Along side this investigators intend to perform a qualitative assessment of the value and&#xD;
        acceptability of this project. Investigators will interview patients approximately 2-3 weeks&#xD;
        after the questionnaire completion at 1 and 6 months to determine how easy it was to use, how&#xD;
        acceptable the process was and how well it described and highlighted their problems.&#xD;
  &#xD;
        If this system works, it would become part of routine care, extended to patients admitted as&#xD;
        emergencies to hospital, and used to develop a national program for all UK hospital patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a qualitative study, with data collected through semi-structured interviews with&#xD;
        patients and clinical staff with experience of using the ePRO system. Topic guides for both&#xD;
        patients and clinicians have been developed based upon previous similar studies and with&#xD;
        input from our study PPI group.&#xD;
  &#xD;
        The patients for qualitative study will be consented by the coordinator. This will be done&#xD;
        when the patients are invited to participate in the PROSPER study. The ePRO project is a&#xD;
        service evaluation project registered with the Clinical Effectiveness Unit (CEU). The sample&#xD;
        for qualitative study will be based on age, gender, ethnicity, language spoken, digital&#xD;
        literacy and reason for admission. Patients who consent to participate will be interviewed&#xD;
        twice about their experience of using the ePRO system. Interviews will be done approximately&#xD;
        2-3 weeks after the ePRO questionnaire completion time points of 1 and 6 months respectively.&#xD;
        Interviews will follow the interview topic guide, with semi-structured questions exploring&#xD;
        both the research objectives as above, will be conducted on the telephone and will be audio&#xD;
        recorded and transcribed. Clinicians and health care staff will also be interviewed to assess&#xD;
        their perception of usefulness of the electronic questionnaires.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 20, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>This is a qualitative study exploring the feasibility and acceptability of the electronic HRQoL</measure>
      <time_frame>6 months to one year</time_frame>
      <description>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.</description>
    </primary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Surgery</condition>
    <condition>Critical Illness</condition>
    <condition>Trauma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will be patients that are admitted to the critical care wards with any&#xD;
          indication, and those above the age of 18 years and able to consent for the study.&#xD;
  &#xD;
          The PI will adopt a purposive sampling method to ensure that age, gender and ethnicity is&#xD;
          equally represented in the population.&#xD;
  &#xD;
          Furthermore, the health care staff including clinicians, and follow- up clinic staff,&#xD;
          physiotherapists, dieticians/nutritionist alike and staff involved in healthcare will be&#xD;
          interviewed for their feedback on the questionnaires.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing emergency laparotomy, regardless of admission to the Adult&#xD;
               Critical Care Unit.&#xD;
  &#xD;
            -  Patients requiring Level 3 care admitted to the Adult Critical Care Unit with length&#xD;
               of stay of &gt;56 hours&#xD;
  &#xD;
            -  Clinical staff involved in the pathway of care affected by the ePRO.&#xD;
  &#xD;
            -  Purposive sampling to include patients based on age, gender, ethnicity, language&#xD;
               spoken, digital literacy and reason for admission&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Those patients &lt;18 years of age&#xD;
  &#xD;
            -  Those not expected to survive 3 months post discharge; as per clinical decision making&#xD;
  &#xD;
            -  Patients unable to consent to and without carers able to consent;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jai Vairale, MBBS MPH</last_name>
      <phone>+44 (0)20 3594 0351</phone>
      <email>j.vairale@qmul.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zudin Puthucheary, MBBS B.Med.Sci FRCP FHEA FFICM</last_name>
      <email>z.puthucheary@qmul.ac.uk</email>
    </overall_contact_backup>
    <reference>
      <citation>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.</citation>
      <PMID>25492603</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>36033242</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31394924</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32464712</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32449105</PMID>
    </reference>
    <reference>
      <citation>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. Erratum In: Br J Anaesth. 2020 Mar;124(3):355.</citation>
      <PMID>31860444</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>24238787</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26974547</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038045
  org study id: 318066
  nct id: NCT06038045
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  observational model: Other
  time perspective: Prospective
  measure: This is a qualitative study exploring the feasibility and acceptability of the electronic HRQoL
  time frame: 6 months to one year
  description: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 110 Years
  healthy volunteers: No
  last name: Jai Vairale, MBBS MPH
  phone: +44 (0)20 3594 0351
  email: j.vairale@qmul.ac.uk
  last name: Zudin Puthucheary, MBBS B.Med.Sci FRCP FHEA FFICM
  email: z.puthucheary@qmul.ac.uk
  citation: 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.
  PMID: 25492603
  citation: 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.
  PMID: 36033242
  citation: 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.
  PMID: 31394924
  citation: 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.
  PMID: 32464712
  citation: 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.
  PMID: 32449105
  citation: 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. Erratum In: Br J Anaesth. 2020 Mar;124(3):355.
  PMID: 31860444
  citation: 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.
  PMID: 24238787
  citation: 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.
  PMID: 26974547
  responsible party type: Sponsor
  mesh term: Critical Illness
  sharing ipd: No