A Patient Education Video Program for Post-Operative Recovery After Upper Extremity Surgery

NCT ID: NCT03366805

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-06-12

Brief Summary

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Adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity. The effect of this educational program on pain medications used, pain control efficacy, and other measures of satisfaction and recovery will be assessed.

Detailed Description

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Four hundred (400) adult patients undergoing elective outpatient, upper extremity, orthopedic surgeries will be recruited by the surgeon-investigators. Patients will be randomized to view one of two educational programs: 1) a 2-video series regarding post-operative pain management or 2) a video regarding wound care and activity.

These patients will be encouraged to review the video online in the week before surgery. An intake enrollment form will be completed by an investigator using demographic information available in the chart.

Participants in both arms will complete their Patient Education Study Diary daily, for 7 days following their surgery. There are two versions of this diary: the Wound Education Version asks patients to report daily pain mediation use. The Pain Education Version does not include this section as patients in the pain management arm of the study record this information in their Recovery Diary.

The patient will be contacted again by phone and/or mail 1 year after surgery (12-14 months) using the contact information available in EPIC to determine the self-reported prevalence of chronic pain and pain medication use.

Conditions

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Analgesics, Opioid Orthopedic Surgery Ambulatory Surgery Education, Patient Injuries and Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
Care provider is not informed of which patient education video(s) the patient was provided, unless that patient initiates a conversation with the provider regarding the video.

Study Groups

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Wound Care Video

Wound Care Patient Education Video

Group Type ACTIVE_COMPARATOR

Wound Care Patient Education Video

Intervention Type BEHAVIORAL

Patient education video that were created in-house specifically for this project.

Pain Management Video Group

Pain Management Patient Education Video

Group Type EXPERIMENTAL

Pain Management Patient Education Video

Intervention Type BEHAVIORAL

Patient education video that were created in-house specifically for this project.

Interventions

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Pain Management Patient Education Video

Patient education video that were created in-house specifically for this project.

Intervention Type BEHAVIORAL

Wound Care Patient Education Video

Patient education video that were created in-house specifically for this project.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult patients planning elective outpatient orthopedic surgery procedures by a Carilion Clinic hand surgeon will be eligible for the study.

Exclusion Criteria

1. Patients unable or unwilling to provide informed consent
2. Patients unable to unwilling to participate in the trial (poor English language skills, blindness, cognitively disadvantaged, poor literacy skills, other barriers to participation)
3. Patients who are or suspect they may be pregnant.
4. Patients for whom the medical provider, in his professional judgment, does not feel that the study protocol would be appropriate. (to be tracked)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carilion Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cassandra Mierisch

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cassandra Mierisch, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

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Institute for Orthopedics and Neurosciences

Roanoke, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2266

Identifier Type: -

Identifier Source: org_study_id

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