Effect of Standardized Consent for Urogynecological Procedures on Patient Satisfaction
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Women's Studies, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2018 |
| Start Date: | December 2014 |
| End Date: | August 2018 |
The investigators aim is to augment the current process for surgical consent for patients
undergoing urogynecological procedures by incorporating visual media. We propose that visual
media will be an effective and efficient addition to the standard of care in urogynecological
consents and will improve patient understanding and satisfaction. Our randomized controlled
trial will investigate the effect of standardizing the consent for three urogynecologic
procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using
visual media, on patients' understanding of, and satisfaction with, their procedure. Our
primary outcome will be patient's knowledge score at the end of the pre-operative clinic
visit, and secondary outcomes include patients' satisfaction, subjective understanding of
their procedure, immediate pre-operative and post-operative knowledge, and number of
post-operative encounters. Participants will be followed up to their post-operative clinic
visit.
undergoing urogynecological procedures by incorporating visual media. We propose that visual
media will be an effective and efficient addition to the standard of care in urogynecological
consents and will improve patient understanding and satisfaction. Our randomized controlled
trial will investigate the effect of standardizing the consent for three urogynecologic
procedures (vaginal hysterectomy, robotic sacrocolpopexy, and sub-urethral sling) using
visual media, on patients' understanding of, and satisfaction with, their procedure. Our
primary outcome will be patient's knowledge score at the end of the pre-operative clinic
visit, and secondary outcomes include patients' satisfaction, subjective understanding of
their procedure, immediate pre-operative and post-operative knowledge, and number of
post-operative encounters. Participants will be followed up to their post-operative clinic
visit.
Background
The current standard of care for consenting patients undergoing urogynecological procedures
involves counseling patients on the procedures, other treatment options, risks, benefits, and
pre-op and post-op periods. This counseling is routinely done verbally and may not be
consistently standardized across patients. Pre-operatively, patients may undergo testing and
post-operatively, patients may be admitted to the hospital and/or discharged with a urinary
catheter following a voiding trial. Patients may also experience pain and constipation
post-operatively at the hospital or at home and in the long term may experience recurrence of
their symptoms and require reoperation.
The existing literature cites many examples of quality improvement initiatives and studies
focused on improving the surgical consent process, patients' understanding and satisfaction.
Several systematic reviews include prospective and randomized controlled trials using various
patient counseling interventions including videos, computer programs, electronic
presentation, websites, powerpoint, and written information have found improved patient
comprehension and knowledge but did not consistently affect satisfaction (Farrell et al.
Patient Education and Counseling. 2012;94:20-32. Nehme et al. Surg Innov. 2013;20(1):13-23.
Schenker et al. Med Decis Making. 2011;31:151-173.). Most trials reported outcomes including
overall satisfaction, knowledge score, perceived understanding (Hoppe et al. J Shoulder Elbow
Surg. 2014;23:e134-e139. Johannes et al. Ann Surg Oncol. 2013;20:15-23. Bollschweiler et al.
Ann Surg. 2008;258:205-211.). However, there has not been any such prospective randomized
controlled trial for improving the consent process using media aid for urogynecological
procedures. A related prospective study reported patients' understanding of sacrocolpopexy
without any intervention and found deficiencies with mean knowledge score of less than 70 out
of 100 (Adams et al. Female Pelvic Med Reconstr Surg. 2012;18(6):352-356.).
In our study, we hope to incorporate and assess the effectiveness of standardized visual
presentation in addition to the standard of care. We hope to use the results of our study to
inform our clinical practice and improve our patients' understanding and satisfaction.
Design and Overview
Our randomized controlled trial will investigate the effect of standardizing the consent for
three urogynecologic procedures (vaginal hysterectomy, robotic sacrocolpopexy, and
sub-urethral sling) using visual media, on patients' understanding of, and satisfaction with,
their procedure.
Eligible patients will be recruited by a member of the research team at their pre-operative
clinic visits. Participants who decline to enroll will not have access to the additional
materials, but will receive the same standard level of care as the enrolled participants.
Currently, the standard of care for consenting patients for these three procedures involves
verbally counseling patients on what the procedures involves, other treatment options, risks,
benefits, and what to expect in the pre-op and post-op periods. In this study, for each of
the three surgical procedures, we will use a computer-generated scheme to allocate
participants in a 1:1 ratio using block randomization. Participants will be randomized to one
of two study arms:
1. Participants will receive the standard counseling described above
2. Participants will receive the same counseling as described above and will then review a
standardized visual presentation for the procedure they will undergo.
Each participant will be first provided the standard of care that they would have received at
a pre-operative clinic visit. Then, participants in the intervention arm will view a visual
presentation that will address what type of procedure they will undergo, the risks and
benefits of the procedure (i.e. injury to nearby organs, risks of infection and bleeding,
risk of re-operation), alternative treatments to the procedure, what to expect during the
pre-operative period, and what to expect in the post-operative period (i.e. urinary catheter,
constipation, pain management, hospital stay). Time spent viewing the visual presentation
will be recorded to assess for the efficiency of this quality improvement intervention. At
the end of the clinic visit, all participating patients will receive the same survey to
evaluate their understanding of their procedure, pre-operative and post-operative
expectations, and satisfaction with their experience. A similar survey will be repeated
before their surgery and at their post-operative clinic visit at approximately 1-2 weeks
following the surgery.
Outcome Ascertainment
Our primary outcome will be patient's knowledge score at the end of the pre-operative clinic
visit, and secondary outcomes include patients' satisfaction, subjective understanding of
their procedure, immediate pre-operative and post-operative knowledge, and number of
post-operative encounters. Participants will be followed up to their post-operative clinic
visit.
The current standard of care for consenting patients undergoing urogynecological procedures
involves counseling patients on the procedures, other treatment options, risks, benefits, and
pre-op and post-op periods. This counseling is routinely done verbally and may not be
consistently standardized across patients. Pre-operatively, patients may undergo testing and
post-operatively, patients may be admitted to the hospital and/or discharged with a urinary
catheter following a voiding trial. Patients may also experience pain and constipation
post-operatively at the hospital or at home and in the long term may experience recurrence of
their symptoms and require reoperation.
The existing literature cites many examples of quality improvement initiatives and studies
focused on improving the surgical consent process, patients' understanding and satisfaction.
Several systematic reviews include prospective and randomized controlled trials using various
patient counseling interventions including videos, computer programs, electronic
presentation, websites, powerpoint, and written information have found improved patient
comprehension and knowledge but did not consistently affect satisfaction (Farrell et al.
Patient Education and Counseling. 2012;94:20-32. Nehme et al. Surg Innov. 2013;20(1):13-23.
Schenker et al. Med Decis Making. 2011;31:151-173.). Most trials reported outcomes including
overall satisfaction, knowledge score, perceived understanding (Hoppe et al. J Shoulder Elbow
Surg. 2014;23:e134-e139. Johannes et al. Ann Surg Oncol. 2013;20:15-23. Bollschweiler et al.
Ann Surg. 2008;258:205-211.). However, there has not been any such prospective randomized
controlled trial for improving the consent process using media aid for urogynecological
procedures. A related prospective study reported patients' understanding of sacrocolpopexy
without any intervention and found deficiencies with mean knowledge score of less than 70 out
of 100 (Adams et al. Female Pelvic Med Reconstr Surg. 2012;18(6):352-356.).
In our study, we hope to incorporate and assess the effectiveness of standardized visual
presentation in addition to the standard of care. We hope to use the results of our study to
inform our clinical practice and improve our patients' understanding and satisfaction.
Design and Overview
Our randomized controlled trial will investigate the effect of standardizing the consent for
three urogynecologic procedures (vaginal hysterectomy, robotic sacrocolpopexy, and
sub-urethral sling) using visual media, on patients' understanding of, and satisfaction with,
their procedure.
Eligible patients will be recruited by a member of the research team at their pre-operative
clinic visits. Participants who decline to enroll will not have access to the additional
materials, but will receive the same standard level of care as the enrolled participants.
Currently, the standard of care for consenting patients for these three procedures involves
verbally counseling patients on what the procedures involves, other treatment options, risks,
benefits, and what to expect in the pre-op and post-op periods. In this study, for each of
the three surgical procedures, we will use a computer-generated scheme to allocate
participants in a 1:1 ratio using block randomization. Participants will be randomized to one
of two study arms:
1. Participants will receive the standard counseling described above
2. Participants will receive the same counseling as described above and will then review a
standardized visual presentation for the procedure they will undergo.
Each participant will be first provided the standard of care that they would have received at
a pre-operative clinic visit. Then, participants in the intervention arm will view a visual
presentation that will address what type of procedure they will undergo, the risks and
benefits of the procedure (i.e. injury to nearby organs, risks of infection and bleeding,
risk of re-operation), alternative treatments to the procedure, what to expect during the
pre-operative period, and what to expect in the post-operative period (i.e. urinary catheter,
constipation, pain management, hospital stay). Time spent viewing the visual presentation
will be recorded to assess for the efficiency of this quality improvement intervention. At
the end of the clinic visit, all participating patients will receive the same survey to
evaluate their understanding of their procedure, pre-operative and post-operative
expectations, and satisfaction with their experience. A similar survey will be repeated
before their surgery and at their post-operative clinic visit at approximately 1-2 weeks
following the surgery.
Outcome Ascertainment
Our primary outcome will be patient's knowledge score at the end of the pre-operative clinic
visit, and secondary outcomes include patients' satisfaction, subjective understanding of
their procedure, immediate pre-operative and post-operative knowledge, and number of
post-operative encounters. Participants will be followed up to their post-operative clinic
visit.
Inclusion Criteria:
- Undergoing vaginal hysterectomy, robotic sacrocolpopexy, or sub-urethral sling
- English speaking
- Written, informed consent
Exclusion Criteria:
We found this trial at
1
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