NCT01933139

Brief Summary

To determine whether the addition of audio-visual presentations to standard physician interaction improves patient comprehension as it relates to the information provided during the informed consent process in patients undergoing hysterectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

August 26, 2013

Last Update Submit

August 26, 2015

Conditions

HysterectomyInformed Consent

Keywords

Informed consentpreoperative counselinghysterectomy

Outcome Measures

Primary Outcomes (1)

  • Patient comprehension

    the effectiveness of an audio-visual presentation in conjunction with the standard physician-patient interaction on patient comprehension as it pertains to the informed consent process prior to undergoing hysterectomy

    6 weeks

Secondary Outcomes (3)

  • Patient satisfaction

    1 day

  • Physician efficiency

    1 day

  • Adequacy and quality of the physician-directed informed consent process

    1 day

Study Arms (2)

Audio-visual presentation

EXPERIMENTAL

The intervention group will watch a 10-minute scripted video explaining the procedure, risks, benefits, expectations, and long term complications that relate to hysterectomies before face-to-face interaction with the surgeon. Patients in both arms will then sign the same standard pre-surgical informed consent form before undergoing the procedure.

Other: Audio-visual presentation

Control

NO INTERVENTION

standard physician interaction (control arm)

Interventions

Audio-visual presentationOTHER
Audio-visual presentation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult female patients undergoing vaginal, abdominal, or laparoscopic hysterectomy with or without salpingo-oophorectomy for benign indications

You may not qualify if:

  • malignant indication for the surgery
  • vision- and/or hearing-impairment
  • unwilling or unable to provide consent
  • under age 18
  • not primarily English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2013

First Posted

September 2, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations

US(1)