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

Surgery Clinical Trial

— PROSPER  

Official title:

PROSPER- Electronic Patient Reported OutcomeS to Empower Patients rEcoveR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038045
• Other study ID #: 318066
• Status: Recruiting
• Start date: October 20, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: December 2023
• Source: Queen Mary University of London
• Contact: Jai Vairale, MBBS MPH
• Phone: +44 (0)20 3594 0351
• Email: j.vairale[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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;

Related Conditions & MeSH terms

• Critical Illness
• Surgery
• Trauma

Locations

Country	Name	City	State
United Kingdom	The Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months to one year