Volume 23, Number 1 (Spring 2017)                   IJPCP 2017, 23(1): 108-117 | Back to browse issues page

DOI: 10.18869/nirp.ijpcp.23.1.108

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Pad B, Alavi K, Hajebi A. A Randomized Controlled Trial of Telephone Follow-Up in Patients With Severe Mental Illness: Study Protocol. IJPCP. 2017; 23 (1) :108-117
URL: http://ijpcp.iums.ac.ir/article-1-2344-en.html

Psychiatrist ,Associate professor Research Center for Addiction & Risky Behaviors, School of Behaviors( ReCARB) Sciences & Mental Health (Tehran Psychiatric Institute), Iran University of Medical Sciences , Email: hajebi.ahmad@gmail.com
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Extended Abstract
1. Introduction
Patient absenteeism for follow-up visits in outpatient clinics is different in different disciplines of medicine [2 ,1]. Evidence suggests that in the UK, the number of patient absentees in psychiatric clinics is twice than most medical disciplines  .[3]Several factors including stigma caused by the disease have an effect on the presence or absence of these patients in clinics [5].
Studies show that every year up to 30% of the world's population suffers from a kind of psychiatric disorder and that at least two-thirds of them, even in advanced countries, do not receive services [6]. In Iran also , the most common approach in the care for patients with severe psychiatric disorder is passive care, in which the patients are only asked to visit the clinic or the office to follow their treatment by themselves. In most cases, patients experience frequent relapses and admissions. Providing active and persistent services after discharge of these patients may reduce relapse and readmission. This may also result in clinical improvement, reduction in the burden of mental disorders, and an increase in the cost-effectiveness of interventions. The current study has been conducted to determine the effectiveness of telephone follow-up in patients with severe psychiatric disorders in comparison with regular services provided for these patients after being discharged from hospital. 
2. Method
This study is a randomized controlled clinical trial. In this study, participants were randomized into two intervention and control groups with an equal number of subjects . Patients aged 18 to 65 years and suffering from schizophrenia and Bipolar I disorder (BID) were selected for the study. In addition, the patient should have had at least one of his/her family members or relatives living with them in order to be included in the study. Patients suffering from a physical or severe neurological illness or intellectual disability were excluded from the study. Informed written consent was obtained from each patient and his/her family member or relative living with them for participation in this study .
Based on the study protocol, telephone follow-up was performed to check the presence of the patients belonging to the intervention group in the clinic. To do so, the time of visit was determined based on the prescriptions by physicians such that the patient and his/her family member or relative were informed to attend the outpatient clinic a day before the visit. On the day after the visit, another call was made to ensure the patient’s attendance in the clinic. The patients in the control group were similarly evaluated, but they did not receive the phone call service and were received only the hospital's usual care services which was an appointment for one or two weeks after discharge and then monthly visits. These visits were not followed up via the telephone nor was there any other reminder. 
In this study, the data was collected from both the groups at the time of admission, discharge, and also at 6 and 12 months after discharge at the outpatient clinic. To collect data, instruments such as the Positive and Negative Symptom Scale (PANSS) [20], Young Mania Rating Scale (YMRS) [21], and the Hamilton Depression Scale [22] were used in all the four evaluation steps. In addition to these tools, evaluations after discharge, frequency of re-admission and the length of the next hospitalization were carefully evaluated.
Non-randomized convenience sampling method was used in a sequential manner. Sample size was calculated based on the duration of the stay during re-readmission within a year after the initial discharge. The number of individuals in intervention and control groups was considered equal (1=1). Sample size was calculated to be 26 for each group based on the following formula, considering α=0.05, β=0.2 and the effect size (d) of 0.8, which is considered to be powerful. To compensate for the possible loss of attendance during the different stages of follow-up, 35% was added to this figure, and the final sample size was 36 in each group. 
In this study, raw and relative frequency and cumulative frequency were used for describing qualitative variables, and mean, standard deviation, median, and variance were used for describing quantitative variables. In the case of normal distribution of quantitative data, first, individual and clinical backgrounds were compared using T test for independent samples. In the case of no significant difference between the two groups at the beginning of the study, frequency of re-admission within a year was compared using Mann-Whitney test and the duration of the re-admission was compared with T test for independent samples. Also, the trend of changes in severity of psychopathology was assessed based on PANSS, YMRS, HDRS, and repeated measure ANOVA Test. In the case that some individual and clinical characteristics of the two groups were different at the beginning of the study, the variable with a significant difference between the two groups entered the analysis of covariance as the covariant. P<0.05 was considered statistically significant. This study was approved by the ethics committee of Iran University of Medical Sciences having code 24729-19/6/93.
4. Discussion and Conclusion
This article presents a controlled and randomized clinical trial protocol of telephone follow-up for patients with severe mental disorders in an outpatient clinic. Researchers know that the study will have several operational limitations. In this study, there is no possibility for researchers and raters to be blind. Sample size has been calculated by the given quantitative variables and based on the effect size of 0.8, which is remarkable; therefore, the effect size in this study may not be statistically significant. 
Determining the effectiveness of this intervention on re-hospitalization of patients, duration of hospitalization as well as the severity of their psychopathology can guide policy-makers, clinicians, and other service providers in designing and planning interventions.
The Research Deputy and Mental Health Research Center of Iran University of Medical Sciences have financially supported the present study.
Conflict of Interest
The authors declared no conflicts of interest.
Type of Study: Original Research | Subject: General
Received: 2016/08/1 | Accepted: 2017/01/12

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