NCT04834648

Brief Summary

An effective referral system helps to ensure a close relationship between all levels of the health system and ensures clients receive optimum care at the appropriate level and at affordable cost, and hospital facilities are used optimally and cost-effectively. A referral system requires consideration of all its important components that can be then adjusted to the local situation. Being a system, the important components of a referral system are Health system issues (Service providers, Referral protocols, Communication \& transportation provide), Referring facility\& Referral practicalities (Client \& their condition, Protocols of care, Care provider \& documents, Referral decision, Outward referral form, Communicate with referral facility, Client information, Referral register), Referral facility\& Referral practicalities (Client with referral form, Treat the client with the document, Rehabilitation plan, Back referral form, Feedback to referring facility, Referral register) and Supervision and capacity building (Referral monitoring, Ensure back referral, Feedback and training to facility staff and Feedback to central level) ((USAID), 2012). There are mainly two limitations on referring Diabetic Retinopathy patients. Patient-related reasons: lack of awareness, belief, cost, distance from screening/ treatment centers, discomfort from dilating drops, efforts to attend yet another center, fear of laser treatment, fear of its impact on quality of life and jobs, lack of family support and guilt surrounding the failure to control blood sugar. Provider-related reasons are poor counseling and advisory services about ocular complications for patients with diabetes, inefficient call and recall system, long waiting times for screening or treatment, and complicated referral mechanism. Lumbini eye institute is a comprehensive tertiary eye care center in western Nepal. In spite of 19 peripheral referral centers under it, there is a poor inflow of Diabetic retinopathy patients as against the estimated disease burden in the catchment area. The objective of our study is to improve timely referral flow from referring centers and compliance with referral cases after the intervention. In order to meet our objective, the investigators tend to implement patient counseling at referral centers, a referral tracking system, and a fast-track mechanism for patients at base hospitals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

April 4, 2021

Last Update Submit

March 9, 2022

Conditions

Keywords

referral ratediabetic retinopathycounselling

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    Percentage of referral compliance before and after intervention

    8 months

Study Arms (2)

Structured Counseling

EXPERIMENTAL

Structured Counseling, which includes A. Counseling is done by a trained counselor B. Telephonic Follow up: C. Development of Fast Track system at the Base Hospital. D. Provide Health Education Material to all Diabetic Patients. E. Referral communication and feedback between referring and referral facility.

Behavioral: Structured Counseling

Control Arm

NO INTERVENTION

General Counseling, which included saying you need to visit the hospital and you have involvement in the eyes due to diabetes, providing a health education leaflet.

Interventions

Structured Counseling, which includes A. Counseling is done by a trained counselor B. Telephonic Follow up: C. Development of Fast Track system at the Base Hospital. D. Provide Health Education Material to all Diabetic Patients. E. Referral communication and feedback between referring and referral facility.

Structured Counseling

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All Diabetic Retinopathy patients attending the peripheral eye centers linked with LEIRC.

You may not qualify if:

  • All referred Diabetic patients who not is willing to be part of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lumbini Eye Institute and Research Center

Butwāl, Nepal

Location

Related Publications (1)

  • Bhattarai B, Thapa HB, Bashyal S, Thapa SK, Chaudhuri S, Agiwal V, Pant H, Singh S, Mahajan H. Structured Counselling and Regular Telephonic follow up to improve Referral flow and compliance in Nepal for Diabetic Retinopathy(SCREEN-D Study): a randomised controlled trial. BMC Health Serv Res. 2024 Feb 10;24(1):188. doi: 10.1186/s12913-024-10647-3.

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
At LEI the staff will be blinded about the intervention/ control referring centers
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 8, 2021

Study Start

March 15, 2021

Primary Completion

August 30, 2021

Study Completion

December 30, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations