Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorPortsmouth Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consent form 1- Adult patients who have the capacity to consent for themselves.
Female adult aged 18years or above
Diagnosed with early invasive breast cancer suitable for breast conserving surgery
Undergoing Wide Local Excision of the breast and sentinel lymph node biopsy.
Disqualifiers
Unable to consent for themselves or do not wish to participate.
Patients who need an interpreter.
Trial population
Women over 18yrs old with early invasive breast cancer who are undergoing "wide local excision and sentinel lymph node biopsy" operation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Proportion of patients who respond to the feedback questionnaire
Calculate the proportion of patients who respond to the feedback questionnaire
Time frame
6 months2
Final attrition rate
Calculate the final attrition rate. This is the proportion of patients who fail to respond to the email questionnaire and telephone call.
Time frame
6 monthsSecondary outcomes
1
Quoted risks in the consent to the incidence of complications
Compare the quoted risks in the consent to the incidence of complications reported by the patients.
Time frame
6 months2
Frequency of PRC and CRCs (Consent Form Reported Complications)
Review the monthly department CGM (Clinical Governance Meeting) data for the study period and correlate the frequency of PRC and CRCs.
Time frame
6 months3
Understanding of consent
Calculate the proportion of patients that feedback that they have understood the consent form.
Time frame
6 months4
Language used in patient reported complications
Examine the language used by patients in the free-text box for reporting complications and whether this matches to that use in their consent form.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Portsmouth Hospitals NHS Trust
Lead sponsor
University of East Anglia
Collaborator
Source ClinicalTrials.gov