NCT02621840

Brief Summary

The investigators aim to investigate the impact of mandating on-site pre-admission testing on cataract cancellation rates in a randomized, prospective, intervention study. Cataract extraction is the most commonly performed ocular surgery making surgical training an integral component of ophthalmology residency. Patient cancellation of surgery results in a financial burden to the institution and a loss of essential educational experiences for the residents. An earlier study explored variables impacting cancellation rates and identified incomplete pre-admission testing as a major contributing factor to surgery cancellation. Patients will be randomized to either 1) the intervention group where on-site pre-admission testing will be mandated or 2) the control group, where on-site pre-admission testing will be offered but not mandated. Cancellation rates will be collected prospectively and statistical analysis utilized to evaluate the significance of intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
442

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
Last Updated

May 9, 2017

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

November 30, 2015

Last Update Submit

May 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cataract Surgery Adherence Rate

    The adherence rate to cataract surgery will be assessed in the usual care and intervention groups and compared.

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Correlation between Cataract Surgery Adherence and Demographic/Clinical Characteristics

    Through study completion, an average of 1 year

  • Cost Analysis

    Through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in the intervention group will be mandated to complete the PAT with Dr. Koka. After scheduling the surgery with the surgical coordinator, intervention patients will be required to go directly to Dr. Koka's office, to complete all necessary pre-operative steps.

Behavioral: Mandatory On-Site Pre-Admission Testing

Usual Care

NO INTERVENTION

Patients in the usual care group will be treated with the standard protocol that is currently utilized in the Wills Eye Hospital Cataract and Primary Eye Care (CPEC) Service. After scheduling the surgery with the surgical coordinator, the patient will be given pre-admission testing (PAT) paperwork to be completed. The patient schedules the PAT on his or her own with the primary care physician.The patient will be given the information for Dr. Koka's cardiology office if he or she has any problem getting the PAT done.

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient scheduled for cataract surgery in the resident CPEC clinic at Wills Eye Hospital from the time period of 1/5/15 to 11/30/15.

You may not qualify if:

  • All prisoners, nursing home, dialysis patients, and patients under 18 years of age will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Robert Bailey, MD

    Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 4, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 9, 2017

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share

A manuscript is under development.

Locations