Back to resultsThe Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures
Primary Purpose
Hand Injuries, Trauma, Hand Injuries and Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Postoperative phone call
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injuries focused on measuring Hand injuries, Hand trauma, Patient reported outcomes
Eligibility Criteria
Inclusion Criteria:
- Patients with isolated injuries of the hand who present to a specific level 1 trauma center in the Midwestern United States
- Patients who have planned surgical treatment by a pre-specified group of surgeons
Exclusion Criteria:
- Patients who have significant trauma to other organ systems proximal to the wrist
- Patients who have open ("compound") fractures (i.e., bone is exposed)
- Children
Sites / Locations
- Eskenazi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Phone Call
No Phone call
Arm Description
Subjects in this study arm receive a post-operative phone call by a physician.
Subjects in this study arm do not receive an additional post-operative phone call by a physician.
Outcomes
Primary Outcome Measures
Brief Michigan Hand Questionnaire Score Difference
A patient reported measure of hand function on a scale of 1 to 100. 100 indicates better hand function and 1 indicates worse hand function. The measure is obtained form a survey that has been published in multiple peer reviewed articles. This score can be subtracted from preoperative score to obtain a difference in score of preoperative compared to postoperative.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03557073
Brief Title
The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures
Official Title
The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures: a Single-blinded, Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.
Detailed Description
This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery. Patients who require operative treatment of hand and wrist fractures are randomly assigned to a group that receives a postoperative phone call or the control group that receives the standard postoperative care. Patient reported and medical outcomes are observed starting at 1 month postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Trauma, Hand Injuries and Disorders
Keywords
Hand injuries, Hand trauma, Patient reported outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to receiving a postoperative phone call or not receiving a postoperative phone call by a physician.
Masking
Care ProviderOutcomes Assessor
Masking Description
Both the provider and the outcomes assessor are blinded to participant's study arm.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phone Call
Arm Type
Experimental
Arm Description
Subjects in this study arm receive a post-operative phone call by a physician.
Arm Title
No Phone call
Arm Type
No Intervention
Arm Description
Subjects in this study arm do not receive an additional post-operative phone call by a physician.
Intervention Type
Behavioral
Intervention Name(s)
Postoperative phone call
Intervention Description
The intervention is a phone call on the day following surgery.
Primary Outcome Measure Information:
Title
Brief Michigan Hand Questionnaire Score Difference
Description
A patient reported measure of hand function on a scale of 1 to 100. 100 indicates better hand function and 1 indicates worse hand function. The measure is obtained form a survey that has been published in multiple peer reviewed articles. This score can be subtracted from preoperative score to obtain a difference in score of preoperative compared to postoperative.
Time Frame
1 month postoperatively.
Other Pre-specified Outcome Measures:
Title
Patient compliance with treatment recommendations
Description
Patient compliance with treatment as documented in their medical record. Patients are either compliant or not compliant (values can be 0 or 1), i.e., their physician states that they followed instructions or they did not.
Time Frame
1 month postoperatively
Title
Patient satisfaction with their overall care
Description
Patient satisfaction with their overall care, as determined on a 5 point Likert scale. 1 is strongly satisfied whereas 5 is strongly dissatisfied.
Time Frame
1 month postoperatively.
Title
Patient complication
Description
Patient either has a complication or does not (values can be 0 or 1), i.e., their physician states that they had a complication.
Time Frame
1 month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with isolated injuries of the hand who present to a specific level 1 trauma center in the Midwestern United States
Patients who have planned surgical treatment by a pre-specified group of surgeons
Exclusion Criteria:
Patients who have significant trauma to other organ systems proximal to the wrist
Patients who have open ("compound") fractures (i.e., bone is exposed)
Children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua M Adkinson, M.D.
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures
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