NCT03557073

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

June 4, 2018

Last Update Submit

February 26, 2019

Conditions

Keywords

Hand injuriesHand traumaPatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • 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.

Other Outcomes (3)

  • Patient compliance with treatment recommendations

    1 month postoperatively

  • Patient satisfaction with their overall care

    1 month postoperatively.

  • Patient complication

    1 month postoperatively

Study Arms (2)

Phone Call

EXPERIMENTAL

Subjects in this study arm receive a post-operative phone call by a physician.

Behavioral: Postoperative phone call

No Phone call

NO INTERVENTION

Subjects in this study arm do not receive an additional post-operative phone call by a physician.

Interventions

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

Phone Call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Hand InjuriesWounds and InjuriesDisease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joshua M Adkinson, M.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Both the provider and the outcomes assessor are blinded to participant's study arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized to receiving a postoperative phone call or not receiving a postoperative phone call by a physician.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joshua Michael Adkinson

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 14, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations