NCT01836107

Brief Summary

The purpose of this study is to make a Spanish version of a score that evaluates the characteristics of a good quality clinical note for the purpose of physician communication. The score is an instrument, originally made in English. Due to the score will be used in a different country, language and culture of the original protocol, it is necessary apply a process of translation and adaptation to the context where the score is going to be applied. The process of validation implies to evaluate if the instrument produces the same results under similar conditions and if the instrument maintains the ability to measure the same features or characteristics according to the original design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

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

April 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 24, 2015

Status Verified

April 1, 2013

Enrollment Period

5 months

First QC Date

April 8, 2013

Last Update Submit

March 22, 2015

Conditions

Validation StudiesCross-Cultural ComparisonMedical RecordsTotal Quality Management

Keywords

Clinical notesCommunication between physiciansQualityCross-cultural adaptation

Outcome Measures

Primary Outcomes (1)

  • Cross cultural validity of a score

    Evaluation of criterion validity (Gold Standard vs the use of the adapted score)

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical notes (admission notes, progress notes and discharge summaries) will be included in the study following the original research.

You may qualify if:

  • For every phase, the clinical notes will be randomly and stratified selected. The clinical notes must belong to patients hospitalized at Internal Medicine area in Hospital Italiano de Buenos Aires (HIBA) without any referral to or from other medical areas. The length of stay expected should be at least three days, and the Electronic Health Record (EHR) has to contain the admission notes, progress notes and discharge summaries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Study Officials

  • Sonia E Benitez, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 24, 2015

Record last verified: 2013-04

Locations

AR(1)