Preoperative Education in Hand Surgery

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standardized Preoperative Education

Standard of care

Preoperative and postoperative questionnaires

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring ORIF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any patient over the age of 18 years with a closed distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent
1. All closed distal radius fracture AO classification types are eligible for inclusion
2. Surgical technique will be standardized and will involve either a volar locking plate or dorsal spanning plate

Exclusion Criteria:

Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the distal radius fracture. Patients with open fractures. Patients who undergo surgical management with a technique other than a volar locking plate or dorsal spanning plate (e.g. Kirschner wires, external fixator). Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs).
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 be eligible for inclusion. All study documents and the educational video will be available in both English and Spanish. Informed consent will be obtained with the assistance of a licensed Spanish language interpreter through Grady's language line.

Sites / Locations

Grady Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10

Change in oral morphine equivalents consumed from day of surgery to postoperative day 10 (POD 10). The total amount of morphine equivalents consumed between the 2 study arms will be compared.

Secondary Outcome Measures

Total opioid consumption during the postoperative course

Total opioid consumption in mg during the postoperative course taken from the pain diary and postoperative questionnaire.

Total number of opioid refills in the postoperative period

Number of opioid refills in the postoperative period based on postoperative questionnaire and prescription drug monitoring program (PDMP) database.

Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms

Average visual analog scale (VAS) pain score will be collected for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period from the pain diary, and results will be compared between both study arms. Total score ranges between 1-10 and 10 correlates with worse pain.

Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery

UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital

Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery

UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital. The reason will be collected from the day of surgery until 30 days after surgery.

Change in results of Pain Management quiz after education

Change in results of Pain Management Quiz before and after education. Answers to the questions on the quiz are either correct or incorrect. Total number questions are 11. It will be measured as total number of correct answers/total number of questions (number of correct/11). This will be converted to a percentage correct. Range of score will be 0% - 100% correct. Higher change in percentage correct is a better outcome. Change in percentage correct from preoperative appointment to day of surgery will help determine the effectiveness of the educational protocol.

Postoperative Satisfaction score with education

Based on the postoperative questionnaire, participants will answer a question about satisfaction with 5 possible answers: Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied and Very dissatisfied. Results will be in percentage, based on number of participants in each category. "Very satisfied" correlates with better outcome with lower level of satisfaction until "very dissatisfied" that correlates with worse outcome.

Percentage of participants with adequate postoperative pain control

Based on the postoperative questionnaire, participants will answer a question about pain control: "Do you feel like your pain was adequately controlled after surgery?" Possible answers include:Yes, No and Somewhat. Number of participants who answer "Yes" will be counted per randomization group. A higher result correlates with better outcome (better pain control).

Full Information

NCT ID

NCT05237531

First Posted

January 24, 2022

Last Updated

March 28, 2023

Sponsor

Emory University

Collaborators

American Society for Surgery of the Hand

1. Study Identification

Unique Protocol Identification Number

NCT05237531

Brief Title

Preoperative Education in Hand Surgery

Official Title

Preop Education and Opioid Use After Distal Radius Open Reduction and Internal Fixation (ORIF): A Randomized Controlled Trial at a County Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

American Society for Surgery of the Hand

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distal Radius Fracture

Keywords

ORIF

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

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.

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standardized Preoperative Education

Intervention Description

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

Intervention Name(s)

Standard of care

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Preoperative and postoperative questionnaires

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10

Description

Change in oral morphine equivalents consumed from day of surgery to postoperative day 10 (POD 10). The total amount of morphine equivalents consumed between the 2 study arms will be compared.

Time Frame

Day of surgery, postoperative day 10

Secondary Outcome Measure Information:

Title

Total opioid consumption during the postoperative course

Description

Total opioid consumption in mg during the postoperative course taken from the pain diary and postoperative questionnaire.

Time Frame

Up to postoperative day 10

Title

Total number of opioid refills in the postoperative period

Description

Number of opioid refills in the postoperative period based on postoperative questionnaire and prescription drug monitoring program (PDMP) database.

Time Frame

Up to postoperative day 10

Title

Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms

Description

Average visual analog scale (VAS) pain score will be collected for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period from the pain diary, and results will be compared between both study arms. Total score ranges between 1-10 and 10 correlates with worse pain.

Time Frame

Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10

Title

Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery

Description

UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital

Time Frame

Up to 30 days after surgery

Title

Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery

Description

UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital. The reason will be collected from the day of surgery until 30 days after surgery.

Time Frame

Up to 30 days after surgery

Title

Change in results of Pain Management quiz after education

Description

Change in results of Pain Management Quiz before and after education. Answers to the questions on the quiz are either correct or incorrect. Total number questions are 11. It will be measured as total number of correct answers/total number of questions (number of correct/11). This will be converted to a percentage correct. Range of score will be 0% - 100% correct. Higher change in percentage correct is a better outcome. Change in percentage correct from preoperative appointment to day of surgery will help determine the effectiveness of the educational protocol.

Time Frame

Preoperative, day of surgery

Title

Postoperative Satisfaction score with education

Description

Based on the postoperative questionnaire, participants will answer a question about satisfaction with 5 possible answers: Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied and Very dissatisfied. Results will be in percentage, based on number of participants in each category. "Very satisfied" correlates with better outcome with lower level of satisfaction until "very dissatisfied" that correlates with worse outcome.

Time Frame

Postoperative (up to 2 weeks after surgery)

Title

Percentage of participants with adequate postoperative pain control

Description

Based on the postoperative questionnaire, participants will answer a question about pain control: "Do you feel like your pain was adequately controlled after surgery?" Possible answers include:Yes, No and Somewhat. Number of participants who answer "Yes" will be counted per randomization group. A higher result correlates with better outcome (better pain control).

Time Frame

Postoperative (Up to 2 weeks after surgery)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Any patient over the age of 18 years with a closed distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent All closed distal radius fracture AO classification types are eligible for inclusion Surgical technique will be standardized and will involve either a volar locking plate or dorsal spanning plate Exclusion Criteria: Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the distal radius fracture. Patients with open fractures. Patients who undergo surgical management with a technique other than a volar locking plate or dorsal spanning plate (e.g. Kirschner wires, external fixator). Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs). 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 be eligible for inclusion. All study documents and the educational video will be available in both English and Spanish. Informed consent will be obtained with the assistance of a licensed Spanish language interpreter through Grady's language line.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul Ghareeb, MD

Phone

404-686-8143

Email

paul.ghareeb@emory.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Samuel H Payne, MD

Email

samuel.houston.payne@emory.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Ghareeb, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grady Memorial Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paul Ghareeb, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

Anyone who wishes to access the data Any purpose Data will be available indefinitely

Distal Radius Fracture

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial