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Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List

Primary Purpose

Diabetes Mellitus, Hypothyroidism, Hyperthyroidism

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Teleconsultation
Protocol
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring Endocrinology, Referral list, Teleconsultation, Telemedicine, Cluster randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients from counties with at least 5 endocrinology referrals waiting appointment.
  • Patients referred from primary care physicians
  • Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity).

Exclusion Criteria:

  • Patients from counties with more than one hundred endocrinology referrals waiting appointment.

Sites / Locations

  • Secretaria Estadual da Saúde

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Referrals will be evaluated through the state's protocols

Referrals will be evaluated through the state's protocols associated with telephone-based teleconsultations.

Outcomes

Primary Outcome Measures

Number of consultations authorized
Number of consultations authorized after the evaluation by the control and intervention strategies.

Secondary Outcome Measures

Number of new referrals for endocrinology
Total number of new referrals performed by the county.
Adherence to the state's protocols
Number of new referrals for endocrinology with adequate informations according to the state's protocols.
Usage of TelessaúdeRS teleconsultations
Total number of calls to TelessaúdeRS hotline (available to every primary care physician working in brazilian public health system)

Full Information

First Posted
March 7, 2016
Last Updated
August 8, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Secretaria Estadual da Saúde do Estado do Rio Grande do Sul, Programa de Pesquisa e Pós-Graduação em Epidemiologia da UFRGS, TelessaúdeRS / UFRGS
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1. Study Identification

Unique Protocol Identification Number
NCT02710799
Brief Title
Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List
Official Title
Evaluation of the Effectivity of Teleconsultations for Improving the Referrals From Primary Care to Specialized Care of Patients With Chronic Endocrinological Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Secretaria Estadual da Saúde do Estado do Rio Grande do Sul, Programa de Pesquisa e Pós-Graduação em Epidemiologia da UFRGS, TelessaúdeRS / UFRGS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is evaluate the effects of telephone teleconsultations to primary care physicians (compared to the state's referral protocol) in the referrals waiting list for endocrinological appointments.
Detailed Description
Rio Grande do Sul state's referral list for endocrinology evaluation in specialized care is highly overloaded. There is currently a referral protocol to select patients how should be referred. It will be evaluated if a intervention of telephone-based teleconsultations provided by the TelessaúdeRS to the primary care physicians can provide additional benefits. TelessaúdeRS is a telehealth program from the University of Rio Grande do Sul. This will be evaluated in a cluster randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid Nodule, Obesity
Keywords
Endocrinology, Referral list, Teleconsultation, Telemedicine, Cluster randomized clinical trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
3470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Referrals will be evaluated through the state's protocols
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Referrals will be evaluated through the state's protocols associated with telephone-based teleconsultations.
Intervention Type
Other
Intervention Name(s)
Teleconsultation
Intervention Description
The teleconsultations will be performed by medical doctors, mostly family physicians, but also internists and endocrinologists. The teleconsultations will follow a structured format to discuss some topics on the disease and access the relevant information (based on the state's protocols). The doubts from the primary care physician will be addressed.
Intervention Type
Other
Intervention Name(s)
Protocol
Intervention Description
The informations provided in the referral list will be evaluated through the state's referrals protocols.
Primary Outcome Measure Information:
Title
Number of consultations authorized
Description
Number of consultations authorized after the evaluation by the control and intervention strategies.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of new referrals for endocrinology
Description
Total number of new referrals performed by the county.
Time Frame
1 year
Title
Adherence to the state's protocols
Description
Number of new referrals for endocrinology with adequate informations according to the state's protocols.
Time Frame
1 year
Title
Usage of TelessaúdeRS teleconsultations
Description
Total number of calls to TelessaúdeRS hotline (available to every primary care physician working in brazilian public health system)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from counties with at least 5 endocrinology referrals waiting appointment. Patients referred from primary care physicians Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity). Exclusion Criteria: Patients from counties with more than one hundred endocrinology referrals waiting appointment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erno Harzheim, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Secretaria Estadual da Saúde
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90110-150
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We plan to publish trial results in an indexed medical journal. The results will be reported by the authors and the authorship criteria from ICMJE will be followed. After publishing the main results of the trial the unidentified dataset will be available by contacting the authors and providing an analyses plan which will be evaluated by the study's main investigator.

Learn more about this trial

Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List

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