Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population

NCT02347670 | Completed

• 1 other identifier: IRB#14-380
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The project aims to determine the effectiveness of a patient-centered health care delivery system focused on improving follow-up adherence in patients diagnosed with glaucoma. Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educators, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits. The patient navigator will assist participants in community groups and a portion of the office-based participants with scheduling follow-up appointments

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Efficacy of Patient Navigator in a community setting or office based setting or usual care

  Using data from randomized patients only, we will fit population average Poisson regression models using generalized estimating equations to estimate the rates of timely attendance by randomization assignment and assess the efficacy of the interventions while accounting for within-site clustering. The primary analysis will be adjusted for baseline individual characteristics believed to be associated with adherence to follow-up including age, glaucoma diagnosis, geriatric depression score, and overall vision-related quality of life.

  Following 1 year

Secondary Outcomes (2)

• Differences between rates of follow-up adherence; Community Groups (1-Main v.s Group 1-Randomized).

  1 Year

• Effectiveness of the patient navigator intervention on long-term patterns of follow-up.

  1 Year

Other Outcomes (1)

• Differences of baseline patient characteristics of glaucoma severity, vision-related quality of life, and depression.

  1 year

Study Arms (4)

Group 1M- Community Site

ACTIVE COMPARATOR

Participants randomized to Group 1-Main will attend follow-up visits at one of the four main community sites. A glaucoma specialist will perform the comprehensive eye examination and a ophthalmic technician will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. Intervention: Efficacy-patient navigator to improve follow-up adherence

Behavioral: Efficacy-patient navigator to improve follow-up adherence

Group 2- Office-Based

ACTIVE COMPARATOR

Office-Based, Follow-Up Eye Care with Patient Navigation Protocol: Participants randomized to Group 2 will attend follow-up visits at the Wills Eye Hospital Glaucoma Research Center. A glaucoma specialist will perform the eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. Intervention: Efficacy-patient navigator to improve follow-up adherence

Behavioral: Efficacy-patient navigator to improve follow-up adherence

Group 3- Office-Based

ACTIVE COMPARATOR

Group 3- follow-up eye care at the Wills Eye Hospital. There will be no charge or co-pay for these visits. Those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. These participants will receive a phone number to call and schedule their appointment and will receive a reminder phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. Group 3 represents a realistic choice currently available for patients and thus will be used to compare with usual care and will have 2-3 visits over the one-year period depending on diagnosis. Intervention: Office-Based Usual Care

Behavioral: Office-Based Usual Care

Group 1R- Community Site

ACTIVE COMPARATOR

Participants randomized to Group 1-Randomized will attend follow-up visits at one of the four main community sites, these participants were randomized from the 40 community sites to the closest community location. A glaucoma specialist will perform the comprehensive eye examination. Ophthalmic technicians will conduct the testing. There will be no charge or co-pay for these visits. Group 1 participants will test the efficacy of the patient navigator to improve follow-up adherence. During the first and final follow-up visit, those enrolled will undergo the National Eye Institute-Visual Function Questionnaire-25 and the Geriatric Depression Scale-15 and Research Participation Questionnaire. Intervention: Efficacy-patient navigator to improve follow-up adherence

Behavioral: Efficacy-patient navigator to improve follow-up adherence

Interventions

Efficacy-patient navigator to improve follow-up adherence BEHAVIORAL

Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.

Group 1M- Community Site; Group 1R- Community Site; Group 2- Office-Based

Office-Based Usual Care BEHAVIORAL

Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital.

Group 3- Office-Based

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participated in the Wills Eye community-based comprehensive eye examination.
• Have a diagnosis of glaucoma-suspect or any type of glaucoma, including open angle glaucoma, chronic angle closure glaucoma, ocular hypertension, anatomically narrow-angle, pigmentary glaucoma, low tension glaucoma, or pseudoexfoliative glaucoma (identified using ICD-9 codes).
• Are recommended for follow-up care.
• Are willing and able to give informed consent and participate for 1 year.
• May have undergone laser therapy.

You may not qualify if:

• Are unwilling to go to any site for follow-up visits.
• Requested to follow-up only with their own ophthalmologist for their glaucoma eye-care.

Sponsors & Collaborators

• Wills Eye: lead
• Partridge Foundation: collaborator

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.

  PMID: 27660423 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• L. J. Katz, MD

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: January 27, 2015
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)