Evaluation of the Effects of Teleconsultations on a Endocrinology Referral List

Evaluation of the Effectivity of Teleconsultations for Improving the Referrals From Primary Care to Specialized Care of Patients With Chronic Endocrinological Conditions

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus; Hypothyroidism; Goiter; Hyperthyroidism; Thyroid Nodule
• Intervention / Treatment: Other: Protocol; Other: Teleconsultation

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.

• Study Type: Interventional
• Enrollment (Actual): 3470
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-150
      • Secretaria Estadual da Saúde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Referrals will be evaluated through the state's protocols	Other: Protocol; The informations provided in the referral list will be evaluated through the state's referrals protocols.
Experimental: Intervention; Referrals will be evaluated through the state's protocols associated with telephone-based teleconsultations.	Other: Protocol; The informations provided in the referral list will be evaluated through the state's referrals protocols.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of consultations authorized	Number of consultations authorized after the evaluation by the control and intervention strategies.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of new referrals for endocrinology	Total number of new referrals performed by the county.	1 year
Adherence to the state's protocols	Number of new referrals for endocrinology with adequate informations according to the state's protocols.	1 year
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

Collaborators and Investigators

• 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
• Investigators: Study Chair: Erno Harzheim, MD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Teleconsultation; Endocrinology; Cluster randomized clinical trial; Referral list
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Hypothyroidism; Hyperthyroidism; Thyroid Nodule
• Other Study ID Numbers: 32981014.0.0000.5327; U1111-1179-2949 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.