Improving the Follow up Rate for Pediatric Patients
Condition: CNLDO - Congenital Nasolacrimal Duct Obstruction; Amblyopia; Conjunctivitis; Eye Injuries; Corneal Ulcer; Strabismus
MeSH terms: Corneal Ulcer; Amblyopia; Strabismus; Eye Injuries; Conjunctivitis; Lacrimal Duct Obstruction
Study type: Interventional

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.
    

Detailed description: 
      Need: Childhood visual impairment and blindness remains an important public health issue. It
      is estimated that around 14 million children in the world are blind. Nepal Pediatric Ocular
      Disease study found that prevalence of blindness and visual impairment in the community was
      0.068% (95% CI 0.02%-0.12%) and 0.097% (95% CI 0.04%-0.15%) respectively. Increasing the
      global knowledge base for planning for childhood eye care services is a top priority in order
      for children with visual impairment to realize their full visual potential. Follow-up of
      pediatric patients is important for their regular ocular morbidity monitoring, especially for
      amblyopia management. A study done in India revealed distance and cost as major barriers, as
      was the inability of the eye care center to communicate the importance of follow-up. Another
      study done in Nepal found poor follow-up rates for post-cataract surgery patients which
      however improved after implementation of a post-operative follow-up program.

      Bharatpur Eye Hospital observed that there is poor adherence to follow-up visits. An
      observatory data of 1st week (1st to 7th) of January 2019 revealed that the follow-up
      compliance was very low among children aged 0-16 years in the pediatric department. Among the
      children advised for follow up only 22% were found to have come for at least one follow-up
      visit. Therefore, there was the need to implement measures to improve the follow-up rate.

      Potential impact: High-quality pediatric counseling service, follow-up program, tracking
      system, and cell phone reminders resulted in the improved follow-up of pediatric patients in
      Lumbini Eye Institute, Nepal.6 Many studies have compared different methods of reminder
      options like telephone calls, email, SMS in order to improve the compliance to
      followup.7,8,9,10. Bharatpur Eye Hospital aims to find the effectiveness of counseling and
      reminders through SMS and phone calls on improving the follow-up rates of pediatric patients.

      Bharatpur Eye Hospital assumes that with the proposed intervention the follow-up rate would
      increase to 50% considering the similar increase in follow-up rate in postoperative cataract
      surgery patients done in Lumbini Eye Institute (around 20% increase in follow up)6. In
      addition to it, another study done in London showed the use of SMS reminders for
      ophthalmology outpatient appointments reduced the non-attendance rates by 6.9%.18Improving
      follow-ups of patients is important to meet the treatment goal and provide effective and
      complete treatment for particular ocular problems. Adherence to follow-up is even more vital
      for children because the visual system is still in the developing phase in young children and
      loss of follow-up may lead to loss of vision. So, for quality treatment, patient satisfaction
      and improvement of the visual status of children, and revenue generation for the hospital it
      should be the priority area for the hospital to find ways for improving the existing low
      adherence to follow up in pediatric patients.

      Study site: Bharatpur, Chitwan is located in the central part of the country, which is 150 K
      M. west from Kathmandu and 130 K. M. east from Lumbini (Bhairahawa) with an area of 2218 sq.
      Kilometer. The hospital, named Bharatpur Eye Hospital is located in the delightful city of
      Bharatpur, the capital of Chitwan district, by the bank of Narayani River, a place of
      pilgrimage of the Hindus. It is a tertiary eye hospital that ranks first among the eye
      hospitals in Nepal.

      Study population: All pediatric patients 0-16 years of age attending the pediatric department
      of Bharatpur Eye Hospital from January 2021 to April 2021. In the pediatric department
      children aged 0-16 years are being examined as per the hospital policy although younger than
      18 years is considered as children as per WHO.

      Eligibility: Enrolment criteria: all pediatric patients 0-16 years age attending Bharatpur
      Eye Hospital and advised for at least 3 follow up visits within 4 months period (January 2021
      to April 2021)

      Sample size: A sample size of 264 (88 in each of the three groups) pediatric patients will be
      targeted with an adjusted significance level of 0.02, 80% power, and 10% loss to follow up.
      The sample size for comparison of two proportions using Bonferroni correction (level of
      significance=0.05/k=3 comparisons) was adopted. The proportion of attendance in counseling
      (p1) and reminder SMS/phone call(p2) are taken as 50% (0.5) and 25% (0.25) respectively.

      The sample size has been calculated as per the general objective that "To determine the
      effect of counseling and reminders through SMS and phone calls in improving the follow-up
      rates in pediatric patients". Hence this study is not exclusively looking at the difference
      between counseling and reminder through SMS and phone call with routine standard care group
      separately. That means the project is looking for overall improvement in follow-up rate based
      on the package of the interventions vs routing standard care group. For ease of understanding
      2 groups have been created among the intervention group.

      Randomization: None Program: The total costs involved in implementing the interventions will
      be compared with the attendance of follow-up patients and the revenue generated through their
      follow-ups. The intervention costs include the salary for the team members. In addition to
      the costs for the phone calls and reminder SMS telecommunication charges, the cost for
      equipment, stationary, and the charges for utility services like water and electricity will
      also be included as the cost for implementing interventions. Cost-effectiveness will be
      analyzed separately for counseling and reminders (phone &SMS) by calculating the total cost
      incurred per attendance of follow-up in each intervention group and the total revenue
      generated through the attendance.

      Data collection: Records of the participants from the first visit to all the follow-up visits
      will be maintained in the department by the Assistant of Pediatric Ophthalmologist. In order
      to obtain the required data from the participants, a proforma has been designed based on
      variables pertaining to sociodemographic and follow-up. Proforma has been developed in the
      English language, sequence of questions will be carefully looked into as well as skips
      pattern (if any). Questions pertaining to identification and socio-demographic information
      appeared first, then follow-up points.

      The record of the patients will be kept even if they come for follow-up beyond the set window
      period (+/- 2 days), however in this case they will not be considered compliant to follow up.

      The assistant will also assign the group to the patients (if they receive any intervention or
      not) as per the study procedure.

      Data management plan: A follow-up recording file (3 in number, one each for routine standard
      care, counseling, and reminders through SMS and phone call) will be maintained. These
      follow-up details will also be entered in the excel sheet on the same day as a backup in case
      the paper records are lost or destroyed. The entry of all the details from the proforma will
      be done in the excel sheet by the assistant and the status of record maintenance will be
      regularly monitored. The data entry program will be designed in the SPSS version (The latest
      version). Mr. Gopal, who is an optometrist and Co-PI in this study, will do the first and
      second data entries. Validation of the two data sets will be done. Corrections will be made
      where required by comparing the computer data file with the original proforma.

      The local statistician will also be part of this study

      Data analysis plan: Data will be processed and analyzed using SPSS latest version

      Descriptive analysis:

      In the first step descriptive analysis will be done, summarizing demographic variables by
      computing means with standard deviation for continuous variables and percentages for
      categorical variables. Amputation and intention to treat analysis will also be conducted (if
      required).

      Univariate analysis:

      Univariate logistic regression analysis will be conducted by comparing two variables for each
      variable of interest using odds ratio (OR) and their 95% confidence intervals (CI).
      Likelihood ratio test will be used to estimate odds ratio and 95% CI for odds ratio for all
      associations of interest.

      Multivariate analysis:

      Multivariate logistic regression analysis will be performed to adjust for simultaneous
      effects of multiple factors on the outcome variable. The criteria for inclusion of factors in
      the multivariate analysis are to include all variables from the univariate analysis with a
      p-value of <= 0.1 along with all the variables of known biological importance. To assess the
      importance of each variable included in the model, a Wald statistic for each variable will be
      used.

      Before conducting multivariate analysis, the association among independent variables will be
      checked by the chi-square test. For independent variables having more than two categories,
      dummy variables will be created. All the variables meeting the above selection criteria will
      be entered one by one, starting with the highly significant factor from the univariate
      analysis. The overall significance of independent variables in the model will be assessed by
      the likelihood ratio test (G statistic). The selection of the final model will be based on
      parsimony, biological interpretability, and statistical significance. The parameters of the
      logistic regression model will be estimated by the maximum likelihood method. The adjusted
      odds ratios (ORs) and their 95% confidence intervals (CIs) will be computed using the
      estimates of parameters of the final model. The dependent variable will be dichotomous,
      either follow-up rate increased or as it is (no difference). The final model will be tested
      for goodness-of-fit by Hosmer- Lemeshow chi-square (x2) statistic. P-values will be noted to
      assess the model fit.

      Monitoring: Supervision and monitoring will be done by PI and co-PI every week to check the
      study participants' enrolment, record keeping, and maintenance of data and ensure research
      activities are taking place as per the research protocol.

      Ethics and consent: The ethical approval for the study will be obtained from the Review
      Committee of NNJS / Nepal Health Research Council. Written consent will be taken from the
      children in an assent form (if 9 years or older) and from their parents/guardians in a
      consent form before enrolling them in the study. Approval for conducting the study has also
      been taken from Bharatpur Eye Hospital.
    

Intervention name(s): Counseling group; SMS and phone call reminder group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Follow up; Counselling; SMS and phone calls; intervention study; Children; Peadiatric eye conditions