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Trial registered on ANZCTR


Registration number
ACTRN12617001536358
Ethics application status
Approved
Date submitted
28/07/2017
Date registered
6/11/2017
Date last updated
6/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effetiveness of an new model of shared telephonic patient referral between primary health care and hospital health care.
Scientific title
Effectiveness of a new model of telephonic patient referral from primary health care to Internal Medicine consultation to reduce the waiting list period.
Secondary ID [1] 292550 0
NONE
Universal Trial Number (UTN)
U1111-1199-9475
Trial acronym
DETELCOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
INTERNAL MEDICINE DISEASES 304207 0
Condition category
Condition code
Cardiovascular 303544 303544 0 0
Other cardiovascular diseases
Inflammatory and Immune System 303545 303545 0 0
Other inflammatory or immune system disorders
Public Health 303653 303653 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients referrals were carreid out via telephone consultation so that the General Practitoners were able to consult directly the Internal Medicine doctors by telephone in order to obtain an early diagnosis. The time to access to the General Practitioner for the first consultation was from 1 to 3 days. During this first telephone consult between the General Practitioner and the Internal Medicine specialist, they both reached an agreement concerning the treatment, and the complementary tests and future check-up were scheduled. The timing for obtaining the results of the complementary tests was 17 days.
Intervention code [1] 298747 0
Diagnosis / Prognosis
Comparator / control treatment
Control groups patients were referrred to Internal Medicine consultation by the traditional way, which involves a waiting list of 51 days and having to be moved several times to the nearest hospital with Internal Medicine consultation (Riotinto Hospital), which is about one hour from the participants´ locations.
Control group
Active

Outcomes
Primary outcome [1] 302912 0
Change in waiting list time (number of days) from primary health care to internal consultation, assessed by review of medical records available at "Diraya" (institutional medical record system)
Timepoint [1] 302912 0
Baseline (first visit to the General Practitioner) and first visit to Internal Medicine Consultation
Secondary outcome [1] 337689 0
Patient´s acceptance of this new model of referral, which was assessed asking them about their reasons to abandon the trial.
Only 9 patients refused to participate in the trial because they preferred the traditional referral way.
Timepoint [1] 337689 0
Baseline (first visit to the General Practitioner consultation)
Secondary outcome [2] 337690 0
Doctors´ acceptance of this new model of referral, which was assessed asking them about their reasons to abandon the trial.
Only 8 doctors refused to participate in the trial because they thought this way would involve more dedication to each patient.
Timepoint [2] 337690 0
Baseline (first visit to General Practitioner consultation)

Eligibility
Key inclusion criteria
Every patient who needed to be referred to Internal Medicine Hospital Consultation according to the Geeral Practitioners´decision.
General Practitioners from the north area of Huelva (Spain) who agreed to participate in the trial.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Whenever the General Practitioner considered that a patient would not get significant benefit from the telephone referral.
Patients who refused to participate in the study
General Practitioners who refused to participate in the trial.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation: General Practitioners were randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
1.- DESCRIPTIVE ANALYSIS
2.- KRUSKALL-WALLIS TEST
3.- MANN-WHITNEY TEST (p= 0.01 CI 99%)
4.-HODGES-LEHMAN TEST FOR INDEPENDENT SAMPLES

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9111 0
Spain
State/province [1] 9111 0
SEVILLE

Funding & Sponsors
Funding source category [1] 297126 0
Self funded/Unfunded
Name [1] 297126 0
NOT APPLICABLE
Address [1] 297126 0
NOT APPICABLE
Country [1] 297126 0
Primary sponsor type
Individual
Name
LUIS MIGUEL AZOGIL LÓPEZ
Address
Centro de Salud de Valverde del Camino
Plaza de la Constitución, s/n
21600 - Huelva. Spain
Country
Spain
Secondary sponsor category [1] 296138 0
Individual
Name [1] 296138 0
ESTHER MARÍA MEDRANO SANCHEZ
Address [1] 296138 0
University of Seville. Faculty of Nursing, Physiotherapy and Podiatry.
Calle Avenzoar, 6
41009 SEVILLE
Country [1] 296138 0
Spain
Secondary sponsor category [2] 296139 0
Individual
Name [2] 296139 0
MARÍA DEL VALLE CORONADO VÁZQUEZ
Address [2] 296139 0
Departamento de Sanidad. Gobierno de Aragón
Edificio Vía Universitas
Vía Universitas, 36 - 8ª planta
50071 Zaragoza (Spain)
Country [2] 296139 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298300 0
Fundación Andaluza Beturia para la Investigación en Salud (F.A.B.I.S.)
Ethics committee address [1] 298300 0
4ª Planta Hospital Juan Ramón Jiménez
Ronda Norte s/n 21005. Huelva
T: 959.016.760 - F: 959.016.804/5

http://www.fabis.org
Ethics committee country [1] 298300 0
Spain
Date submitted for ethics approval [1] 298300 0
10/04/2015
Approval date [1] 298300 0
21/09/2015
Ethics approval number [1] 298300 0

Summary
Brief summary
Aim: The purpose of this study is to find out whetheror not telephone referral from Primary Health Care to Internal Medicine Consult manages to reduce waiting days as compared to traditional referral. This study also aims to know how acceptable is the telephone referral to general practitioners and their patients.
Design: No blind randomized controlled clinical trial. Setting Northern Huelva Health District. Participant 154 patients. Interventions Patients referrals from intervention clinicians were sent via telephone consultation, whereas patients referrals from control clinicians were sent by the traditional method for a face-to-face consultation,
Measurements: Number of days from referral request to Internal Medicine Consult; Number of telephone and traditional referrals; Number of doctors and patients denied; Denial reasons.
Results: A statistically significant difference was found between groups, with an average of 27 (21-34) days. Among General Practitioners, 8 of the first 58 total doctors after randomization and, subsequently, 6 of the 20 doctors of the test group refused to engage in the trial because they considered “excessive time and effort consuming”. 50 % of patients referred by the 14 General Practitioners finally randomized to the intervention group were denied referral by telephone due to patient’s complexity.
Conclusions: Telephone referral significantly reduces waiting days for internal medicine consult. This type of referral did not mean an “excessive time and effort consuming” to General Practitioners and was not all that beneficial to complex patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76638 0
Mr LUIS MIGUEL AZOGIL LÓPEZ
Address 76638 0
BALTASAR DE ALCAZAR ST, Nº 4, 1ºC
41008 SEVILLE

AFFILIATION: ANDALUSIAN HEALTH CARE PUBLIC SYSTEM (SISTEMA ANDALUZ DE SALUD)
Country 76638 0
Spain
Phone 76638 0
+ 34 646 500 778
Fax 76638 0
+34 954 486 527
Email 76638 0
luismiazogil@gmail.com
Contact person for public queries
Name 76639 0
Dr ESTHER MARÍA MEDRANO SANCHEZ
Address 76639 0
DIEGO ANGULO IÑIGUEZ ST. Nº 6, BLOCK 3, 1º C
41018 SEVILLE

AFFILIATION: UNIVERSITY OF SEVILLE
Country 76639 0
Spain
Phone 76639 0
+34 609 076 282
Fax 76639 0
+34 954 486 527
Email 76639 0
emedrano@us.es
Contact person for scientific queries
Name 76640 0
Dr ESTHER MARIA MEDRANO SANCHEZ
Address 76640 0
DIEGO ANGULO IÑIGUEZ ST. Nº 6, BLOCK 3, 1º C
41018 SEVILLE

AFFILIATION: UNIVERSITY OF SEVILLE
Country 76640 0
Spain
Phone 76640 0
+34 609 076 282
Fax 76640 0
+ 34 954 486 527
Email 76640 0
emedrano@us.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary