Matteo Balestrieri1, Davide Sisti2, Marco Rocchi2, Paola Rucci3, Gregory Simon4, Ricardo Araya5,6, Giovanni de Girolamo7. 1. Unit of Psychiatry, DAME, University of Udine, Udine, Italy. 2. Department of Biomolecular Sciences-Unit of Medical Statistic and Biometry, University of Urbino 'Carlo Bo', Urbino, Italy. 3. Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy. 4. Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA. 5. Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London. 6. Centre for Global Mental Health and Primary Care Research, Health Service and Population Research (PO36), IoPPN, David Goldberg Centre, King's College London, London, UK. 7. Unit of Psychiatric Epidemiology and Evaluation, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Abstract
BACKGROUND:Computerized Clinical Decision Support Systems (CCDSS) are information technology tools, designed to improve clinical decision-making. Telemedicine is a health care service delivery using videoconferencing, telephone or messaging technologies. OBJECTIVES: Our project aimed at testing the effectiveness of a composite CCDSS and telemedicine approach designed to treat depression in primary care. METHODS: This cluster randomized trial involved four GP clinics located in Northern Italy. Two clinics were assigned to the experimental protocol, and two served as controls. The study compared the telemedicine group (TG), in which GPs had access to a CCDSS platform, with the control group (CG) in which GPs provided treatment as usual (TAU). Patients scoring ≥11 on Patient Heath Questionnaire and ≥26 on the Inventory of Depressive Symptomatology-Self-Report were eligible for participation. Patients were also administered the World Health Organization Quality of Life-BREF to assess quality of life and Medical Interview Satisfaction Scale 21 to assess satisfaction with the medical interview. RESULTS: Overall, 2810 patients were screened and 66 in the experimental group and 32 in the CG passed the screening stages and met inclusion criteria. The percentage of remitters at 6 months was significantly higher in the TG than in the CG group (24.1% versus 3.1%, χ 2 = 6.6, P = 0.01). This difference remained significant after adjusting for baseline confounders. Physical and psychological quality of life improved significantly from baseline in both groups. Patients reported, on average, good satisfaction with the medical interview. CONCLUSIONS: Our study showed that a combined CCDSS and telemedicine approach may be more effective than the TAU offered by GPs to patients with depression. TRIAL REGISTRATION: The trial was registered on https://clinicaltrials.gov/ on 5 October 2012 with identifier: NCT01701791. The first participant was enrolled on 5 May 2014 and the study was completed on May 2016.
RCT Entities:
BACKGROUND: Computerized Clinical Decision Support Systems (CCDSS) are information technology tools, designed to improve clinical decision-making. Telemedicine is a health care service delivery using videoconferencing, telephone or messaging technologies. OBJECTIVES: Our project aimed at testing the effectiveness of a composite CCDSS and telemedicine approach designed to treat depression in primary care. METHODS: This cluster randomized trial involved four GP clinics located in Northern Italy. Two clinics were assigned to the experimental protocol, and two served as controls. The study compared the telemedicine group (TG), in which GPs had access to a CCDSS platform, with the control group (CG) in which GPs provided treatment as usual (TAU). Patients scoring ≥11 on Patient Heath Questionnaire and ≥26 on the Inventory of Depressive Symptomatology-Self-Report were eligible for participation. Patients were also administered the World Health Organization Quality of Life-BREF to assess quality of life and Medical Interview Satisfaction Scale 21 to assess satisfaction with the medical interview. RESULTS: Overall, 2810 patients were screened and 66 in the experimental group and 32 in the CG passed the screening stages and met inclusion criteria. The percentage of remitters at 6 months was significantly higher in the TG than in the CG group (24.1% versus 3.1%, χ 2 = 6.6, P = 0.01). This difference remained significant after adjusting for baseline confounders. Physical and psychological quality of life improved significantly from baseline in both groups. Patients reported, on average, good satisfaction with the medical interview. CONCLUSIONS: Our study showed that a combined CCDSS and telemedicine approach may be more effective than the TAU offered by GPs to patients with depression. TRIAL REGISTRATION: The trial was registered on https://clinicaltrials.gov/ on 5 October 2012 with identifier: NCT01701791. The first participant was enrolled on 5 May 2014 and the study was completed on May 2016.
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