Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000998741
Ethics application status
Approved
Date submitted
6/09/2013
Date registered
9/09/2013
Date last updated
9/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of text messaging to improve attendance in internal medicine outpatient clinic: A randomized controlled trial in a teaching hospital in Saudi Arabia
Scientific title
The effectiveness in patients with appointment for outpatient visit to Internal Medicine outpatient clinic of text messaging reminder of the appointment for the intervention group compared to no text messaging reminder in the control group to reduce non-attendance.
Secondary ID [1] 283148 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non- attendance of outpatient clinic appointment 290007 0
Condition category
Condition code
Other 290397 290397 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients whose mobile number were documented in the hospital electronic database and were due to attend an appointment to the IM outpatient clinic during the following week were eligible to be included in the study. Because the SMS reminder messages will be sent in Arabic, non-Arabic speaking patients were excluded from the study. Patients younger than 18 years were also excluded. Each week a list of patients with appointment for the following week was retrieved from the hospital electronic database. A random sample of 20 patients was selected from the list of each day of the week. Using computer generated random number, these 20 patient appointments were then randomly allocated to either receive a reminder text message or to not receive such a reminder (10 appointments per group). This process continued over the study period (3 months) until the required sample size was collected. A standard text message reminder was sent manually to the intervention group using one of the phone service providers in Saudi Arabia 48 hours before the scheduled appointment. It started by a greeting at the beginning of the message followed by a reminder of the date, clinic name, and the hospital name. The text message did not has patient’s name. Within one week of the appointment, we conducted a telephone survey of a group of participants in the intervention group regarding their perception toward the SMS reminder. Other data collected from the electronic database included: patient age, sex, nationality, type of visit (new/follow-up) and whether the patient attended the scheduled appointment (show/no-show). The sequence of the randomization was concealed from the IT individual who provided the appointment list. The statistician was also blinded to the patient group.
Intervention code [1] 287885 0
Treatment: Other
Comparator / control treatment
No SMS reminder
Control group
Active

Outcomes
Primary outcome [1] 290412 0
Non-attendance of the outpatient clinic appointment was assessed by checking the hospital administrative database if the patient showed up in intended appointment
Timepoint [1] 290412 0
Date of outpatient appointment
Secondary outcome [1] 304469 0
Patient satisfaction with SMS reminder system was assessed by telephone interview among participants who received the SMS reminder .
Timepoint [1] 304469 0
Within one week of the appointment date

Eligibility
Key inclusion criteria
1. Patients who have outpatient appointment within a week
2. Arabic speaking
3. Have a registered phone number
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years old
Non- Arabic speaking patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients whose mobile number were documented in the hospital electronic database and were due to attend an appointment to the IM outpatient clinic during the following week were eligible to be included in the study. Because the SMS reminder messages will be sent in Arabic, non-Arabic speaking patients were excluded from the study. Patients younger than 18 years were also excluded. Each week a list of patients with appointment for the following week was retrieved from the hospital electronic database. A random sample of 20 patients was selected from the list of each day of the week. Using computer generated random number, these 20 patient appointments were then randomly allocated to either receive a reminder text message or to not receive such a reminder (10 appointments per group). This process continued over the study period until the required sample size was collected. A standard text message reminder was sent manually to the intervention group using one of the phone service providers in Saudi Arabia 48 hours before the scheduled appointment. It started by a greeting at the beginning of the message followed by a reminder of the date, clinic name, and the hospital name. The text message did not have patient’s name. The sequence of the randomization was concealed from the IT individual who provided the appointment list. The statistician was also blinded to the patient group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
The statistical analysis was performed using Stata 11 (Stata Corporation, College Station, TX. USA). The primary outcome for the study was non-attendance rate. Patients were considered non-attenders if they were registered in the electronic system as “no-show” for their scheduled appointment. The non-attendance status was calculated based on intention-to-treat analysis. The non-attendance rate in the SMS reminded group was compared with those in the non-SMS group using chi-squared test. To better control for confounding factors, multivariate logistic regression was conducted with attendance status as the dependent variable (Yes/No) and SMS reminder (Yes/No) as the main exposure factor. Other factors controlled for in the model included patient age, nationality (Saudi/Arab non-Saudi), type of visit (new/follow-up).For the odds ratio (OR) calculation the non SMS reminder group was used as the reference group. The OR and 95% confidence intervals are presented. P-value =0.05 was considered to be statistically significant. The multivariate logistic regression will also allow for hypothesis generation regarding types of patients more likely to not attend their appointment.

Sample size:
For two arm RCT, 151 per group is required to be able to detect 15% reduction due to SMS reminder with a power of 80% and a=5%. For a power of 90%, 198 per group were needed. However, we were able to include a larger number in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2011
Actual
5/04/2011
Date of last participant enrolment
Anticipated
4/07/2011
Actual
4/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
502
Accrual to date
Final
Recruitment outside Australia
Country [1] 5390 0
Saudi Arabia
State/province [1] 5390 0
Eastern Provience

Funding & Sponsors
Funding source category [1] 287903 0
Self funded/Unfunded
Name [1] 287903 0
Country [1] 287903 0
Saudi Arabia
Primary sponsor type
Individual
Name
Adel Youssef
Address
College of Applied Medical Sciences
University of Dammam
P.O. Box 2435
Dammam - 31441
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 286630 0
None
Name [1] 286630 0
Address [1] 286630 0
Country [1] 286630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289856 0
HIMT Research Project Committee
Ethics committee address [1] 289856 0
Ethics committee country [1] 289856 0
Saudi Arabia
Date submitted for ethics approval [1] 289856 0
Approval date [1] 289856 0
16/02/2011
Ethics approval number [1] 289856 0
HIMT-GP-2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42702 0
A/Prof Adel Youssef
Address 42702 0
Department of Health Information Management & Technology
College of Applied Medical Sciences
University of Dammam
P.O.Box 2435
Dammam - 31441
Saudi Arabia
Country 42702 0
Saudi Arabia
Phone 42702 0
+966560603410
Fax 42702 0
Email 42702 0
[email protected]
Contact person for public queries
Name 42703 0
Adel Youssef
Address 42703 0
Department of Health Information Management & Technology
College of Applied Medical Sciences
University of Dammam
P.O.Box 2435
Dammam - 31441
Saudi Arabia
Country 42703 0
Saudi Arabia
Phone 42703 0
+966560603410
Fax 42703 0
Email 42703 0
[email protected]
Contact person for scientific queries
Name 42704 0
Adel Youssef
Address 42704 0
Department of Health Information Management & Technology
College of Applied Medical Sciences
University of Dammam
P.O.Box 2435
Dammam - 31441
Saudi Arabia
Country 42704 0
Saudi Arabia
Phone 42704 0
+966560603410
Fax 42704 0
Email 42704 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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