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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03557073
Other study ID # 1712309601
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2018

Study information

Verified date February 2019
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Postoperative phone call
The intervention is a phone call on the day following surgery.

Locations

Country Name City State
United States Eskenazi Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient compliance with treatment recommendations 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
Other Patient satisfaction with their overall care 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.
Other Patient complication 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
Primary 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. 1 month postoperatively.
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