Improving the Follow up Rate for Pediatric Patients

NCT04837534 | Completed DMC

• 1 other identifier: BEH/ERB/761/2020 P
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

Follow-up of pediatric patients is important for their regular ocular morbidity monitoring, especially for amblyopia management. An observatory data of 1st week (1st to 7th) of January 2019 revealed that the follow-up compliance was very low (22%) among children aged 0-16 years in the pediatric department of Bharatpur Eye Hospital. A problem tree analysis showed a lack of awareness in children and their parents regarding the importance of follow-up and patients forgetting regarding the follow-up visit, usually when there is the long duration of follow up are the major contributing factors for poor adherence to follow-up. So, an intervention study was aimed at finding the effectiveness of counseling and reminders through SMS and phone calls to improve the follow-ups. All pediatric patients 0-16 years of age with ocular conditions requiring at least 3 follow-ups in the study period (January 2021 to April 2021) will be included. Two hundred and sixty-four participants will be equally distributed to three groups: routine standard care, counseling, and reminders with SMS and phone calls. In the routine care group, children will undergo routine care as per existing practice in the hospital and there will be no additional intervention. In counseling group, in addition to routine care parents/guardians along with the child will receive counseling from a trained counselor as per the set counseling protocol in every follow-up visits and will also be provided with the disease-specific information leaflets as additional information material before the child is discharged from the department. In the SMS and phone call reminder group, in addition to routine care, parents/guardians of children will receive reminders through short messaging text (SMS) 3 days and phone calls one day prior to the scheduled visit. Compliance to follow up Participants completing all the three follow-up visits as per the schedule within the window period of +/-2 days will be considered as a complaint to follow up. However, the follow-ups of all the participants will be recorded although that is beyond the window period. The primary outcome will be measured by the proportion of children completing all three scheduled follow-ups. The ethical approval has been obtained from the Institutional Review Committee of NHRC (ERB protocol registration number 761/2020 P). Informed consent will be taken from parent and child. Conclusion: If interventions improve the follow-up rate and are cost-effective, this can be applied in all the departments of the hospital.

Conditions

CNLDO - Congenital Nasolacrimal Duct Obstruction; Amblyopia; Conjunctivitis; Eye Injuries; Corneal Ulcer; Strabismus

Keywords

Follow up; Counselling; SMS and phone calls; intervention study; Children; Peadiatric eye conditions

Outcome Measures

Primary Outcomes (1)

• Proportion of children completing all three follow up visits

  The primary outcome is the proportion of children completing all three follow up visits in routine standard care group, counseling group and reminders through SMS and phone call group.

  4 months

Secondary Outcomes (2)

• Factors affecting compliance to follow-up

  2 months

• Cost-effectiveness of the intervention

  1 month

Study Arms (3)

Counseling group

EXPERIMENTAL

In this group after the children have been examined, treatment plan and follow up schedule been advised by a pediatric ophthalmologist, parents/guardians along with the child will receive counseling from a trained counselor as per the set counseling protocol in every follow-up visits and will also be provided with the disease-specific information leaflets as an additional information material before the child is discharged from the department.

Behavioral: Counseling group

SMS and phone call reminder group:

EXPERIMENTAL

In this group after the children have been examined, treatment plan and the follow-up schedule been advised, they will be discharged from the department but later they will receive reminders through short messaging text (SMS) and phone calls as per the set protocol

Behavioral: SMS and phone call reminder group

Routine standard care group

NO INTERVENTION

In this group, the children will undergo ocular examination, and treatment plan. They will be discharged from the department and advised accordingly including a routine follow-up schedule as per hospital protocol.

Interventions

Counseling group BEHAVIORAL

In this group after the children have been examined, treatment plan and follow up schedule been advised by a pediatric ophthalmologist, parents/guardians along with the child will receive counseling from a trained counselor as per the set counseling protocol in every follow-up visits and will also be provided with the disease-specific information leaflets as an additional information material before the child is discharged from the department.

Counseling group

SMS and phone call reminder group BEHAVIORAL

In this group after the children have been examined, treatment plan, and the follow-up schedule been advised, they will be discharged from the department but later they will receive reminders through short messaging text (SMS) and phone calls as per the set protocol.

SMS and phone call reminder group:

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all pediatric patients 0-16 years age advised for at least 3 follow up visits within 4 months period (January 2021 to April 2021) at Bharatpur Eye Hospital
• Patients who require weekly, bi-weekly (fortnight), or monthly follow up visits,
• In certain conditions, some severe cases require earlier follow up than the scheduled follow up schedule, those cases will be included,
• Parents/guardians of children who own a mobile phone or have daily access to a phone and are able to use the SMS (Short Message Sending) feature on these phones,
• Parents of children willing to enroll their children in the study

You may not qualify if:

• Children who require less than 3 follow up visits,
• Ocular conditions requiring daily follow up visits will be excluded because it is not feasible to send the reminder phone call and SMS for daily follow up
• Children who have already been treated and under regular follow up,
• Children with ocular conditions requiring to follow up beyond four months,
• Children whose follow up schedules fall beyond the study duration,
• Parents/ guardians of the children not willing to participate in the study.

Sponsors & Collaborators

• Seva Foundation: lead
• Bharatpur Eye Hospital: collaborator
• Indian Institute of Public Health, India: collaborator
• Seva Canada Society: collaborator
• Queen's University, Belfast: collaborator

Study Sites (1)

Bharatpur Eye Hospital

Bharatpur, Chitwan, Nepal

Location

Related Publications (2)

• Shrestha M, Bhandari G, Kamalakannan S, Murthy GVS, Rathi SK, Gudlavalleti AG, Agiwal V, Pant H, Pandey B, Ghimire R, Ale D, Kayastha S, Karki R, Chaudhary DS, Byanju R; Operational Research Capacity Building Study Group. Evaluating the Effectiveness of Interventions to Improve the Follow-up Rate for Children With Visual Disabilities in an Eye Hospital in Nepal: Nonrandomized Study. JMIR Pediatr Parent. 2023 Feb 23;6:e43814. doi: 10.2196/43814.

  PMID: 36821366 DERIVED

• Shrestha M, Bhandari G, Rathi SK, Gudlavalleti AG, Pandey B, Ghimire R, Ale D, Kayastha S, Chaudhary DS, Byanju R; Operational Research Capacity Building Study Group. Improving the Follow-up Rate for Pediatric Patients (0-16 years) of an Eye Hospital in Nepal: Protocol for a Public Health Intervention Study. JMIR Res Protoc. 2021 Oct 8;10(10):e31578. doi: 10.2196/31578.

  PMID: 34521615 DERIVED

MeSH Terms

Conditions

Amblyopia; Conjunctivitis; Eye Injuries; Corneal Ulcer; Strabismus

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Conjunctival Diseases; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Eye Infections; Infections; Keratitis; Corneal Diseases; Ocular Motility Disorders; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Dr Manisha Shrestha

  Bharathpur Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Primary Purpose: Our primary objectives are a) to determine if parental counseling has an impact on adherence to follow-up, b) To determine if reminders through phone calls and SMS increase the follow-up rate in pediatric patients. Assessing the cost-effectiveness of counseling and reminder SMS and phone calls, and determining the role of counselors and their sustainability are our secondary objectives. We hypothesize that counseling will increase the follow-up rate from 22% to 50% and reminders through phone calls and SMS from 22% to 25% of pediatric patients attending Bharatpur Eye Hospital

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: February 15, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Locations

NE (1)