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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02710799
Other study ID # 32981014.0.0000.5327
Secondary ID U1111-1179-2949
Status Completed
Phase N/A
First received March 7, 2016
Last updated August 8, 2016
Start date June 2015
Est. completion date June 2016

Study information

Verified date August 2016
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3470
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Intervention

Other:
Teleconsultation
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.
Protocol
The informations provided in the referral list will be evaluated through the state's referrals protocols.

Locations

Country Name City State
Brazil Secretaria Estadual da Saúde Porto Alegre Rio Grande do Sul

Sponsors (4)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Programa de Pesquisa e Pós-Graduação em Epidemiologia da UFRGS, Secretaria Estadual da Saúde do Estado do Rio Grande do Sul, TelessaúdeRS / UFRGS

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of consultations authorized Number of consultations authorized after the evaluation by the control and intervention strategies. 1 year No
Secondary Number of new referrals for endocrinology Total number of new referrals performed by the county. 1 year No
Secondary Adherence to the state's protocols Number of new referrals for endocrinology with adequate informations according to the state's protocols. 1 year No
Secondary Usage of TelessaúdeRS teleconsultations Total number of calls to TelessaúdeRS hotline (available to every primary care physician working in brazilian public health system) 1 year No
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