NCT02710799

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,470

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2015

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

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

March 7, 2016

Last Update Submit

August 8, 2016

Conditions

Diabetes MellitusHypothyroidismHyperthyroidismGoiterThyroid NoduleObesity

Keywords

EndocrinologyReferral listTeleconsultationTelemedicineCluster randomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Number of consultations authorized

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

    1 year

Secondary Outcomes (3)

  • Number of new referrals for endocrinology

    1 year

  • Adherence to the state's protocols

    1 year

  • Usage of TelessaúdeRS teleconsultations

    1 year

Study Arms (2)

Control

ACTIVE COMPARATOR

Referrals will be evaluated through the state's protocols

Other: Protocol

Intervention

EXPERIMENTAL

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

Other: TeleconsultationOther: Protocol

Interventions

TeleconsultationOTHER

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
ProtocolOTHER

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

ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Secretaria Estadual da Saúde

Porto Alegre, Rio Grande do Sul, 90110-150, Brazil

Location

MeSH Terms

Conditions

Diabetes MellitusHypothyroidismHyperthyroidismGoiterThyroid NoduleObesity

Interventions

Remote ConsultationClinical Protocols

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesThyroid DiseasesThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care ManagementTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Erno Harzheim, MD

    Hospital de Clínicas de Porto Alegre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 17, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

BR(1)