Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351865
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-02
Brief Title:
Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
Sponsor:
Portsmouth Hospitals NHS Trust
Organization:
Portsmouth Hospitals NHS Trust
Study Overview
Official Title:
A Feasibility Study to Evaluate if Breast Cancer Patients Consented Using Digital Consent Reliably Provide Accurate Patient Reported Complication PRC Data Using Feedback Questionnaires
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRC
Brief Summary:
Patient report complication data to our best knowledge has not been studied yet in electronic consent This study is a feasibility study to assess whether patients will reliably report their complications the quality of this reporting and whether the information provided in the consent form matches up to their experience This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up PIFU model is effective or if it leads to underreporting of problems
Detailed Description:
At the time of consent patients are informed of possible post-operative complications It is often not known whether these complications actually occur whether there are others which go unreported and the extent both quantitatively and qualitatively of the complications Patient reported complication data to our best knowledge has not been previously studied
This study is a feasibility study to assess whether patients will reliably report their complications the quality of this reporting and whether the information provided in the consent form matches up to their experience In this case consent is to be sought digitally the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience
If PRC data collection is feasible and reliable this technique could be scaled to create a consent feedback loop enabling operative outcome data to be collected from all patients to be be used to improve the consent process for subsequent patients
Awareness of post-operative patient complications is important and it is an NHS National Health Service requirement that complications are discussed within regular clinical governance mortalitymorbidity audit departmental meetings Currently this process relies on clinicians obtaining and reporting these complications The move towards Patient Initiated Follow Up PIFU models may be leading to underreporting of problems Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures This in turn might help facilitate shared decision making and allow treatment decisions to be tailored to the individual patients
This study is a feasibility study to assess whether patients will reliably report their complications the quality of this reporting and whether the information provided in the consent form matches up to their experience In this case consent is to be sought digitally the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience
If PRC data collection is feasible and reliable this technique could be scaled to create a consent feedback loop enabling operative outcome data to be collected from all patients to be be used to improve the consent process for subsequent patients
Awareness of post-operative patient complications is important and it is an NHS National Health Service requirement that complications are discussed within regular clinical governance mortalitymorbidity audit departmental meetings Currently this process relies on clinicians obtaining and reporting these complications The move towards Patient Initiated Follow Up PIFU models may be leading to underreporting of problems Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures This in turn might help facilitate shared decision making and allow treatment decisions to be tailored to the individual patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None