Preoperative Education in Hand and Wrist Surgery

NCT ID: NCT05237531

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-06-16

Brief Summary

This study will compare opioid consumption in patients undergoing outpatient surgical fixation of distal radius fractures with and without standardized preoperative education at Grady Memorial Hospital.

Detailed Description

The proposed research aims to study the impact of preoperative education on postoperative pain control after outpatient surgery for traumatic wrist fractures. The impact of preoperative education will be studied through patient questionnaires and by tracking postoperative opioid consumption as well as instances of unscheduled healthcare contact after surgery. The study will be a randomized controlled trial. This study imposes no more than minimal risk to study participants. Loss of privacy and breach of confidentiality are risks of this study. All data will be stored securely on Microsoft One Drive, a password-protected, encrypted database which requires two-factor authorization. The study population will be patients aged 18-99 years who are undergoing outpatient surgical management of distal radius fractures at Grady Memorial Hospital. No vulnerable populations will be included. Contact will be made with potential study participants at their preoperative clinic visit. Written informed consent will be obtained. Data will not be publicly available. Data will be deidentified, and no members of the team will have access to the code that identifies patients. Data will be collected in the plastic surgery clinic, orthopedic surgery clinic, and preoperative area at Grady Memorial Hospital. The total respondent burden will be 30 minutes.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Patients in the experimental arm will receive standardized preoperative education in the form of a brief video, interactive quiz, and written handout.

All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects.

Group Type: EXPERIMENTAL

Standardized Preoperative Education

Intervention Type: BEHAVIORAL

The standardized preoperative education includes a brief video, an interactive quiz, and a written handout.

The video will provide information on the proper use and common side effects of opioid pain medications, the expected effects of a peripheral nerve block, and the concept of multimodal postoperative pain management with non-opioid medications and non-pharmaceutical pain management strategies. The interactive quiz will reinforce the critical components of the video in a question-and-answer format which requires active participation. The written handout will summarize the educational content in a form which can be easily referenced by patients at home.

Preoperative and postoperative questionnaires

Intervention Type: BEHAVIORAL

Preoperative questionnaire: Demographic questions plus specific questions about chronic pain, prior opioid use, and mental health diagnoses Postoperative questionnaire: Questions about pain control after surgery, satisfaction with pain control, healthcare contact since surgery, opioid consumption since surgery, and satisfaction with education

Control Arm

Patients in the control arm will receive education per the provider's preference (current standard of care).

All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: BEHAVIORAL

Education per provider preference (no standardization, current standard of care)

Preoperative and postoperative questionnaires

Intervention Type: BEHAVIORAL

Preoperative questionnaire: Demographic questions plus specific questions about chronic pain, prior opioid use, and mental health diagnoses Postoperative questionnaire: Questions about pain control after surgery, satisfaction with pain control, healthcare contact since surgery, opioid consumption since surgery, and satisfaction with education

Interventions

Standardized Preoperative Education

The standardized preoperative education includes a brief video, an interactive quiz, and a written handout.

The video will provide information on the proper use and common side effects of opioid pain medications, the expected effects of a peripheral nerve block, and the concept of multimodal postoperative pain management with non-opioid medications and non-pharmaceutical pain management strategies. The interactive quiz will reinforce the critical components of the video in a question-and-answer format which requires active participation. The written handout will summarize the educational content in a form which can be easily referenced by patients at home.

Intervention Type: BEHAVIORAL

Standard of care

Education per provider preference (no standardization, current standard of care)

Intervention Type: BEHAVIORAL

Preoperative and postoperative questionnaires

Preoperative questionnaire: Demographic questions plus specific questions about chronic pain, prior opioid use, and mental health diagnoses Postoperative questionnaire: Questions about pain control after surgery, satisfaction with pain control, healthcare contact since surgery, opioid consumption since surgery, and satisfaction with education

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Any patient over the age of 18 years with a closed carpal, metacarpal, or distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent.

Exclusion Criteria

• Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the carpal, metacarpal, or distal radius fracture. Patients with open fractures. Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs). Non-English speaking patients will be excluded.
• Adults who are unable to consent will not be included.
• Individuals who are not yet adults will not be included.
• Pregnant women will not be included.
• Prisoners will not be included.
• Cognitively impaired individuals or individuals with impaired decision-making capacity will not be included.
• Individuals who speak English will be included. Individuals who have limited English proficiency but speak Spanish as a primary language will not be eligible for inclusion. Spanish-speaking patients will be excluded because the components of the educational protocol (video, questionnaires, surveys) are not available in Spanish.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Surgery of the Hand

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Paul A Ghareeb, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Ghareeb, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

STUDY00003074

Identifier Type: -

Identifier Source: org_study_id