NCT06038045

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.4 years

First QC Date

August 31, 2023

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    6 months to one year

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal London Hospital

London, E1 1FR, United Kingdom

Location

Related Publications (8)

  • 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: 25492603BACKGROUND
  • 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: 36033242BACKGROUND
  • 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: 31394924BACKGROUND
  • 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: 32464712BACKGROUND
  • 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: 32449105BACKGROUND
  • 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.

    PMID: 31860444BACKGROUND
  • 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: 24238787BACKGROUND
  • 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: 26974547BACKGROUND

MeSH Terms

Conditions

Critical IllnessWounds and Injuries

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 14, 2023

Study Start

October 20, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations