The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures

February 26, 2019 updated by: Joshua Adkinson, Indiana University

The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures: a Single-blinded, Prospective, Randomized Controlled Trial

This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phone Call
Subjects in this study arm receive a post-operative phone call by a physician.
The intervention is a phone call on the day following surgery.
No Intervention: No Phone call
Subjects in this study arm do not receive an additional post-operative phone call by a physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Michigan Hand Questionnaire Score Difference
Time Frame: 1 month postoperatively.
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.
1 month postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient compliance with treatment recommendations
Time Frame: 1 month postoperatively
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.
1 month postoperatively
Patient satisfaction with their overall care
Time Frame: 1 month postoperatively.
Patient satisfaction with their overall care, as determined on a 5 point Likert scale. 1 is strongly satisfied whereas 5 is strongly dissatisfied.
1 month postoperatively.
Patient complication
Time Frame: 1 month postoperatively
Patient either has a complication or does not (values can be 0 or 1), i.e., their physician states that they had a complication.
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Joshua M Adkinson, M.D., Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1712309601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on Postoperative phone call

3
Subscribe