SurgeryNCT03966469
What is the Impact of the Presence of a Support Person on Informed Consent
An observational study of Surgery and Knowledge, Attitudes, Practice, run by Hartford Hospital at 1 site in United States.
Trial summary
In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Surgery, Knowledge, Attitudes, Practice, Prolapse, Vaginal
- What is being tested?
- Preoperative support person present and Patient Present Only
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 25 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women planning to undergo pelvic organ prolapse surgery with our Urogynecology team.
Who may be able to join
- Scheduled to undergo a 23-hr observation or inpatient surgery for pelvic organ prolapse
- Able to understand English
- Able/willing to sign the informed consent document
Who cannot join
- Surgery canceled
- Inability to provide consent
- Resident of a long-term care facility or utilization of a home health service
- Scheduled for outpatient surgery
- non-English speaking
- unable/unwilling to sign informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter
In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators are exploring if having a support person present during this consent process impacts anxiety, satisfaction, knowledge, and preparedness for surgery.
Read the detailed description
Introduction:
In practice, the investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators hypothesize that having a family member or close friend present will decrease patient anxiety and improve patient satisfaction and recall regarding the risks/benefits/ alternatives of surgery.
Study Objectives The primary objective is to assess the impact of having a support person present during the patient's preoperative visit on patient anxiety regarding informed consent for surgery. The secondary objective is to assess the impact of a support person on patient satisfaction, self-assessment of understanding, knowledge, time spent with patient, and pre- and post-operative phone calls.
Hypotheses HO: For women with a support person present during their preoperative visit, there is no difference in the patient-reported anxiety regarding informed consent for surgery compared with women without a support person present.
HA: For women with a support person present during their preoperative visit, there is a difference in the patient-reported anxiety regarding informed consent for surgery compared with women without a support person present.
Research Questions
The research questions to be answered as a part of this study are:
Does having a support person present at the pre-operative visit affect anxiety, satisfaction, preparedness and knowledge regarding their surgery? Does having a support person present impact utilization of clinic resources including preoperative phone calls, and postoperative phone calls?
Study Design and Methods This study will be a prospective cohort study. All women scheduled to undergo vaginal pelvic reconstructive surgery will be recruited from the Urogynecology clinics of the Hartford Hospital Medical Group at the time of their pre-operative appointment. Patients who qualify for inclusion and consent to participate will be enrolled in the study.
Participants will be assigned to one of two arms:
the "support person present" arm, or the "patient present only" arm.
Participants will answer questionnaires prior to their appointment with the physician, after the appointment, 2-3 days prior to surgery via telephone, and at their postoperative appointment.
Risks/Benefits to Patients This is a minimal-risk study. The only research element, and therefore introduction of potential risk(s) beyond standard-of-care treatment, comprises administration of several surveys and data collection.
- Being tested
- Preoperative support person present, Patient Present Only
- Keywords
- informed consent, support person
- Medical subject headings
- Behavior, Uterine Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative support person presentOther
Participants who bring a support person to their preoperative appointment.
Patient Present OnlyOther
Patient presents to their preoperative appointment without a support person.
| Study group | Role | What they receive |
|---|---|---|
| Support Person Present | Participants who bring a support person with them to their preoperative appointment. Receives: Other: Preoperative support person present | |
| Patient Present Only | Participants who present by themselves to their preoperative appointment. Receives: Other: Patient Present Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety
We will measure anxiety with the Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire. Score ranges from 20 to 80 with higher values indicating higher anxiety.
Measured: Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.
Secondary outcomes (10)
Patient satisfaction immediately after the preoperative appointment: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire
We will measure satisfaction with the SDS-PFD questionnaire. The SDS-PFD is composed of 6 individual items graded from 1 to 5, with higher scores indicating higher satisfaction.
Measured: Patient satisfaction measured immediately after the preoperative appointment prior to leaving the clinic.
Patient satisfaction prior to surgery: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire
We will measure satisfaction with the SDS-PFD questionnaire. The SDS-PFD is composed of 6 individual items graded from 1 to 5, with higher scores indicating higher satisfaction.
Measured: Patient satisfaction measured via telephone 2-3 days prior to surgery.
Preparedness at the preoperative appointment
We will measure preparedness with the preoperative preparedness questionnaire. This is an 11 item questionnaire graded from 1 to 6, with lower scores indicating higher preparedness.
Measured: Immediately after the preoperative appointment, the preparedness questionnaire will be provided
Preparedness 2-3 days prior to surgery
We will measure preparedness with the preoperative preparedness questionnaire. This is an 11 item questionnaire graded from 1 to 6, with lower scores indicating higher preparedness.
Measured: 2-3 days prior to scheduled surgery, participants will be called and a preparedness questionnaire asked.
Knowledge after the preoperative appointment
We will measure knowledge with a knowledge questionnaire. This is a 14 item questionnaire graded in a yes/no format with lower scores indicating lower knowledge.
Measured: Immediately after the the preoperative appointment involving informed consent.
Knowledge 2-3 days prior to surgery
We will measure knowledge with a knowledge questionnaire. This is a 14 item questionnaire graded in a yes/no format with lower scores indicating lower knowledge.
Measured: 2-3 days prior to surgery, participants will receive a phone call where we will ask questions regarding knowledge (complete the knowledge questionnaire)
Phone calls.
We will monitor the incidence of phone calls prior to and after surgery by chart review.
Measured: From time of enrollment up to the participants 3-5 week postoperative appointment.
Postoperative satisfaction: questionnaire
We will measure postoperative satisfaction with a postoperative satisfaction questionnaire. This is a 7 item questionnaire with lower scores indicating higher satisfaction/preparedness.
Measured: At the 3-5 week postoperative appointment.
Impression of improvement at postoperative appointment
We will measure impression of improvement with a Patient Global Impression of Improvement Questionnaire. This is a 1 item questionnaire graded from 1 to 7, with lower scores indicating greater postoperative improvement condition.
Measured: At the 3-5 week postoperative appointment, patients will be provided the PGI-I questionnaire
Anxiety prior to surgery
We will call participant several days prior to surgery and ask Spielberger State-Trait Anxiety Inventory (STAI-6) over the phone. Score ranges from 20 to 80 with higher values indicating higher anxiety.
Measured: 2-3 days prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start17 May 2019
- Primary completion26 Jan 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Sappenfield, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966469
- Sponsor's protocol ID
- HHC-2018-0251
- Status last verified
- Apr 2020
- First submitted
- 17 May 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not available to other researchers.
Publications
Sappenfield EC, O'Sullivan DM, Steinberg AC. The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):27-32. doi: 10.1097/SPV.0000000000001059.
PubMed 34978544
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Consent for Pelvic Reconstruction: Does Having a Support Person Matter
- ClinicalTrials.gov ID
- NCT03966469
- Acronym / sponsor ID
- HHC-2018-0251
- Keywords
- informed consent, support person
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In practice, the Investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators are exploring if having a support person present during this consent process impacts anxiety, satisfaction, knowledge, and preparedness for surgery.
Detailed description
Introduction:
In practice, the investigators recommend that patients bring a family member or close friend to their pre-operative appointment to help with patient anxiety, comprehension, and informed decision-making. However, there is limited literature to support this recommendation. The investigators hypothesize that having a family member or close friend present will decrease patient anxiety and improve patient satisfaction and recall regarding the risks/benefits/ alternatives of surgery.
Study Objectives The primary objective is to assess the impact of having a support person present during the patient's preoperative visit on patient anxiety regarding informed consent for surgery. The secondary objective is to assess the impact of a support person on patient satisfaction, self-assessment of understanding, knowledge, time spent with patient, and pre- and post-operative phone calls.
Hypotheses HO: For women with a support person present during their preoperative visit, there is no difference in the patient-reported anxiety regarding informed consent for surgery compared with women without a support person present.
HA: For women with a support person present during their preoperative visit, there is a difference in the patient-reported anxiety regarding informed consent for surgery compared with women without a support person present.
Research Questions
The research questions to be answered as a part of this study are:
Does having a support person present at the pre-operative visit affect anxiety, satisfaction, preparedness and knowledge regarding their surgery? Does having a support person present impact utilization of clinic resources including preoperative phone calls, and postoperative phone calls?
Study Design and Methods This study will be a prospective cohort study. All women scheduled to undergo vaginal pelvic reconstructive surgery will be recruited from the Urogynecology clinics of the Hartford Hospital Medical Group at the time of their pre-operative appointment. Patients who qualify for inclusion and consent to participate will be enrolled in the study.
Participants will be assigned to one of two arms:
the "support person present" arm, or the "patient present only" arm.
Participants will answer questionnaires prior to their appointment with the physician, after the appointment, 2-3 days prior to surgery via telephone, and at their postoperative appointment.
Risks/Benefits to Patients This is a minimal-risk study. The only research element, and therefore introduction of potential risk(s) beyond standard-of-care treatment, comprises administration of several surveys and data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support Person Present | – | Other: Preoperative support person presentParticipants who bring a support person with them to their preoperative appointment. |
| Patient Present Only | – | Other: Patient Present OnlyParticipants who present by themselves to their preoperative appointment. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women planning to undergo pelvic organ prolapse surgery with our Urogynecology team.
Key inclusion criteria (3 listed)
- Scheduled to undergo a 23-hr observation or inpatient surgery for pelvic organ prolapse
- Able to understand English
- Able/willing to sign the informed consent document
Key exclusion criteria (6 listed)
- Surgery canceled
- Inability to provide consent
- Resident of a long-term care facility or utilization of a home health service
- Scheduled for outpatient surgery
- non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative support person presentParticipants who bring a support person to their preoperative appointment. | Other | Support Person Present |
| Patient Present OnlyPatient presents to their preoperative appointment without a support person. | Other | Patient Present Only |
Primary outcome
Change in Anxiety
Time frame: Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.
We will measure anxiety with the Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire. Score ranges from 20 to 80 with higher values indicating higher anxiety.
10 secondary outcomes
Patient satisfaction immediately after the preoperative appointment: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire
Time frame: Patient satisfaction measured immediately after the preoperative appointment prior to leaving the clinic.
Patient satisfaction prior to surgery: the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) questionnaire
Time frame: Patient satisfaction measured via telephone 2-3 days prior to surgery.
Preparedness at the preoperative appointment
Time frame: Immediately after the preoperative appointment, the preparedness questionnaire will be provided
Preparedness 2-3 days prior to surgery
Time frame: 2-3 days prior to scheduled surgery, participants will be called and a preparedness questionnaire asked.
Knowledge after the preoperative appointment
Time frame: Immediately after the the preoperative appointment involving informed consent.
Knowledge 2-3 days prior to surgery
Time frame: 2-3 days prior to surgery, participants will receive a phone call where we will ask questions regarding knowledge (complete the knowledge questionnaire)
Phone calls.
Time frame: From time of enrollment up to the participants 3-5 week postoperative appointment.
Postoperative satisfaction: questionnaire
Time frame: At the 3-5 week postoperative appointment.
Impression of improvement at postoperative appointment
Time frame: At the 3-5 week postoperative appointment, patients will be provided the PGI-I questionnaire
Anxiety prior to surgery
Time frame: 2-3 days prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 34978544Sappenfield EC, O'Sullivan DM, Steinberg AC. The Value of a Support Person During the Surgical Consent Process: A Prospective Cohort Study. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):27-32. doi: 10.1097/SPV.0000000000001059.
- Individual participant dataSharing planned: No. Individual participant data is not available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Knowledge, Attitudes, Practice, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety (time frame: Immediately prior to the preoperative visit with the physician and immediately after the preoperative appointment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.