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

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ClinicalTrials.gov Identifier: NCT02347670
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
Partridge Foundation
Information provided by (Responsible Party):
Wills Eye

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

Condition or disease Intervention/treatment Phase
Glaucoma Behavioral: Efficacy-patient navigator to improve follow-up adherence Behavioral: Office-Based Usual Care Not Applicable

Detailed Description:

The Partridge Foundation has funded the Wills Eye Hospital Glaucoma Research Center for the project: Comparison Study of Glaucoma Eye Care Follow-up Adherence in a High-Risk Population to continue follow-up eye care for those who received a glaucoma diagnosis during the 2010 Center for Disease Control and Prevention funded cooperative agreement: Improving Access to Eye Care among High-Risk Persons for Glaucoma in Philadelphia Project. 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.

There are approximately 700 potentially eligible persons from the 39 community sites, and of that the investigators hope to enroll 250 into 1 of four groups. Eligible participants have participated in the community-based comprehensive eye examination, have received 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 International Classification of Diseases (ICD)-9 codes), are recommended for follow-up care and have attended their Center for Disease Control and Prevention 6-month follow-up visit, are willing and able to give informed consent and participate for 1 year, any have undergone laser therapy. Excluded subjects are unwilling to attend randomized site for follow-up visits or prefers to continue follow-up eye care with their personal ophthalmologists.

Over the course of 1 year, a 6-person team comprised of one attending physician; project managers and community health educations, ophthalmic technician, and patient navigators will complete a baseline visit, baseline assessment and 2-3 follow-up visits in community and office-based locations. A leased Wills Eye van will transport the intervention team and all necessary equipment to the site. The equipment will occupy a designated location at each site for 1 to 2 days per month, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. The same team will see participants who are randomized to the Wills Eye Glaucoma Research Center location.

Participants randomized to receiving help in patient navigation protocol at the community and office-based locations will receive more individualized care than others such as assistance with scheduling; a confirmation letter, text or email; a personal phone call the day before the appointment; and assistance with rescheduling appointments as needed and will consistently arrange transportation to appointments as needed, provide materials, and accompany study participants to their follow-up appointments at Wills Eye. Patient navigators, ocular technicians, and physicians will also communicate with family members regarding recommended follow-up visits, medication refills, and laser-therapy recommendations, as needed.

Participants randomized to usual care protocol at the office-based location will receive a phone number to call and schedule an appointment. Prior to the follow-up visit, participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure commonly used at the Wills Eye Hospital. If participants do not show-up for their appointment that will be documented. Participants in the usual-care group will receive any necessary interpretation services, educational materials, and referrals to cataract surgery or other eye-care services, as needed. The intervention team will assure that participants with literacy issues can understand all information. This group is a realistic choice currently available for patients and thus will be used to compare with the patient navigator protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparison Study of Glaucoma Eye Care Follow-Up Adherence in a High Risk Population
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Group 1M- Community Site

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
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.

Active Comparator: Group 2- Office-Based

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
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.

Active Comparator: Group 3- Office-Based

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

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.


Active Comparator: Group 1R- Community Site

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
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.




Primary Outcome Measures :
  1. Efficacy of Patient Navigator in a community setting or office based setting or usual care [ Time Frame: Following 1 year ]
    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.


Secondary Outcome Measures :
  1. Differences between rates of follow-up adherence; Community Groups (1-Main v.s Group 1-Randomized). [ Time Frame: 1 Year ]
    This analysis will be primarily descriptive since although we expect follow-up to be higher in Group 1-Main (Main Community Group), we do not expect the difference to be large.

  2. Effectiveness of the patient navigator intervention on long-term patterns of follow-up. [ Time Frame: 1 Year ]
    Additional secondary analysis will consider the effect of intervention on long-term patterns of follow-up. Since the pattern of expected visits differs by severity, we will classify subjects as long-term adherent if they attend all of their recommended follow-up visits and non-adherent otherwise. Analysis will use the same model as the primary outcome analysis.


Other Outcome Measures:
  1. Differences of baseline patient characteristics of glaucoma severity, vision-related quality of life, and depression. [ Time Frame: 1 year ]
    We will consider whether the effect of the intervention differs by baseline patient characteristics of glaucoma severity, vision-related quality of life, and depression. The primary model will be extended to include the interaction between these variables and randomization assignment to allow for estimation of intervention effects by baseline categories.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347670


Locations
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United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Partridge Foundation
Investigators
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Principal Investigator: L. J. Katz, MD Wills Eye Hospital
Publications:
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Responsible Party: Wills Eye
ClinicalTrials.gov Identifier: NCT02347670    
Other Study ID Numbers: IRB#14-380
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A manuscript has been published.
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases