Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001024336
Ethics application status
Approved
Date submitted
20/05/2017
Date registered
14/07/2017
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-attendance in paediatric outpatient clinics, text reminder versus conventional system; a randomised control trial
Scientific title
The effect of SMS appointment reminders on non-attendance rates in paediatric outpatient clinics
Secondary ID [1] 292333 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-attendance in Paediatric Clinics 303376 0
Condition category
Condition code
Public Health 302799 302799 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention - Parents of participants will receive SMS reminder 1 week prior to scheduled appointment. This SMS will be sent by a hired Research Assistant 1 week before the appointment. The content of this SMS will include date and time of the appointment in Malay language.

Intervention code [1] 298131 0
Behaviour
Comparator / control treatment
Parents of paediatric patients will receive no reminder in any form prior to their scheduled appointment
Control group
Active

Outcomes
Primary outcome [1] 302178 0
Attendance on the pro-forma will be recorded and confirmed with medical records.
Timepoint [1] 302178 0
On the day of the appointment
Secondary outcome [1] 336543 0
Effect of level of education, salary and types of clinic on non attendance in both intervention and control groups.
Timepoint [1] 336543 0
on the day of the appointment

Eligibility
Key inclusion criteria
1. Any patient that requires new appointment and pre-existing patients that require further appointments
2. Parents must have an active mobile phone number for contact purposes.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. frequent clinic defaulters
2. high risk patients e.g. poorly controlled asthma/epilepsy

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pearson Chi Square to assess categorical independent and outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/04/2017
Date of last participant enrolment
Anticipated
Actual
10/05/2017
Date of last data collection
Anticipated
Actual
13/05/2017
Sample size
Target
640
Accrual to date
Final
646
Recruitment outside Australia
Country [1] 8913 0
Malaysia
State/province [1] 8913 0
Kelantan

Funding & Sponsors
Funding source category [1] 296521 0
Self funded/Unfunded
Name [1] 296521 0
Azri Fikry
Country [1] 296521 0
Malaysia
Primary sponsor type
Individual
Name
Azri Fikry
Address
Paediatric Department,
Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
16150 Kota Bharu,
Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 295480 0
None
Name [1] 295480 0
Address [1] 295480 0
Country [1] 295480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297712 0
Jabatankuasa Etika Penyelidikan Manusia Universiti Sains Malaysia
Ethics committee address [1] 297712 0
Jabatankuasa Etika Penyelidikan Manusia,
Universiti Sains Malaysia Kampus Kesihatan,
Jalan Raja Perempuan Zainab 2,
16150 Kota Bharu,
Kelantan, Malaysia
Ethics committee country [1] 297712 0
Malaysia
Date submitted for ethics approval [1] 297712 0
18/01/2017
Approval date [1] 297712 0
13/04/2017
Ethics approval number [1] 297712 0
USM/JEPeM/17010057

Summary
Brief summary
This is a single blind randomised control trial conducted in Paediatric Clinic Hospital Universiti Sains Malaysia (Hospital USM). The main objectives are the determine the non-attendance rate in our Paediatric Clinics and to assess the non-attendance rate in the intervention group and the control group.

The respondents are the parents of paediatric patients. In the intervention group, they will receive an SMS reminder 1 week prior to the appointment and the control group will receive no reminder. A randomisation generated by a software will be used, and the primary investigator will be blinded by the allocation and outcome. A proforma containing an active mobile phone number including level of education and salary will be utilised for this study.

Pearson Chi Square will be used to evaluate the intervention with the outcome.

There is a 15.6% statistically significant reduction in the non-attendance rate in the intervention group. However the is no statistical significance in the level of education and salary to the non-attendance.

SMS reminder is an effective way to improve the non-attendance rate. The association of poor socioeconomic status with poor attendance in the previous trials was not reproducible in this trial.
Trial website
Trial related presentations / publications
1. George, A., & Rubin, G. (2003). Non-attendance in general practice: a systematic review and its implications for access to primary health care. Family Practice, 20(2), 178-184. doi: 10.1093/fampra/20.2.178
2. Jamil, M. T., Ismail, N. Z. A. N., Zulkifli, A. B., Majid, N. A., & Van Rostenberghe, H. (2011). Non-attendance to the paediatric clinics in a Malaysian tertiary hospital: A sizeable problem and identification of an efficacious intervention. Journal of paediatrics and child health, 47(6), 346-349.
3. Junod Perron, N., Dominicé Dao, M., Kossovsky, M. P., Miserez, V., Chuard, C., Calmy, A., & Gaspoz, J.-M. (2010). Reduction of missed appointments at an urban primary care clinic: a randomised controlled study. BMC Family Practice, 11(1), 79. doi: 10.1186/1471-2296-11-79(McLean et al., 2016)
4. (Hasvold & Wootton, 2011)Hasvold, P. E., & Wootton, R. (2011). Use of telephone and SMS reminders to improve attendance at hospital appointments: a systematic review. Journal of telemedicine and telecare, 17(7), 358-364.
5. McLean, S. M., Booth, A., Gee, M., Salway, S., Cobb, M., Bhanbhro, S., & Nancarrow, S. A. (2016). Appointment reminder systems are effective but not optimal: results of a systematic review and evidence synthesis employing realist principles. Patient preference and adherence, 10, 479.

Public notes

Contacts
Principal investigator
Name 74918 0
Dr Azri Fikry
Address 74918 0
Jabatan Paediatrik,
Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
16150, Kota Bharu,
Kelantan
Country 74918 0
Malaysia
Phone 74918 0
+6097673000
Fax 74918 0
+6097672351
Email 74918 0
[email protected]
Contact person for public queries
Name 74919 0
A/Prof Ariffin Nasir
Address 74919 0
Jabatan Paediatrik,
Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
16150, Kota Bharu,
Kelantan
Country 74919 0
Malaysia
Phone 74919 0
+6097673000
Fax 74919 0
+6097672351
Email 74919 0
[email protected]
Contact person for scientific queries
Name 74920 0
A/Prof Ariffin Nasir
Address 74920 0
Jabatan Paediatrik,
Hospital Universiti Sains Malaysia,
Jalan Raja Perempuan Zainab 2,
16150, Kota Bharu,
Kelantan
Country 74920 0
Malaysia
Phone 74920 0
+6097673000
Fax 74920 0
+6097672351
Email 74920 0
[email protected]

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No Supporting Document Provided



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