Eye DiseasesNCT02001129
Improving Follow-Up Adherence in a Primary Eye Care Setting
A study testing Automated Telephone System and Personalized Telephone Call in people with Eye Diseases, run by Wills Eye at 1 site in United States.
Trial summary
This study aims to examine the effectiveness of three different ways of helping patients attend their recommended eye care appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Automated Telephone System and Personalized Telephone Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Over 18 years
- Primary Eye Care Patients who were recommended for a 6-month, 12-month, or 24-month follow-up appointment during September 2013 through November 2013.
- Access to a telephone
Who cannot join
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Improving Follow-Up Adherence in a Primary Eye Care Setting: A Prospective, Randomized Controlled Trial
This study aims to examine the effectiveness of three different ways of helping patients attend their recommended eye care appointments.
Read the detailed description
The three ways are 1) usual care, which involves a standard reminder letter; 2) automated telephone calls, which utilizes a machine to automatically call patients one month prior to their recommended follow-up date; 3)personalized telephone calls, which utilizes a staff member to personally call patients and offer them the opportunity to schedule at the time of the telephone call.
- Conditions
- Eye Diseases
- Being tested
- Automated Telephone System, Personalized Telephone Call, Usual Care
- Keywords
- Eye care adherence, health care utilization
- Medical subject headings
- Eye Diseases, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Telephone SystemBehavioural
Also called Patient appointment message 2000
Participants receive automated reminder phone calls.
Personalized Telephone CallBehavioural
Also called Study staff phone call
Participants receive reminder phone calls by study staff.
Usual CareBehavioural
Also called Reminder letter sent in the mail.
Participants receive a standard reminder letter in the mail.
| Study group | Role | What they receive |
|---|---|---|
| Automated Telephone System | Experimental | In addition to a standardized reminder letter, participants also received a telephone call from an automated system to remind them of a recommended follow-up appointment. Receives: Behavioral: Personalized Telephone Call; Behavioral: Usual Care |
| Personalized Telephone Call | Experimental | In addition to the usual care letter, a staff member called participants one month prior of recommended follow-up appointment. During this call, participants were given the option to schedule an appointment. Receives: Behavioral: Automated Telephone System; Behavioral: Usual Care |
| Usual Care | Active comparator | Participants randomized to this arm receive a "usual care" letter which is a standard reminder letter from the primary eye care office. This is usual practice in many primary eye care facilities. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appointment Adherence
A research assistant examines the Electronic Medical Records (EMR) system to assess recommended appointment adherence.
Measured: 3 months
Secondary outcomes (1)
Scheduling Appointment
Tracking whether the patient made an appointment within 1 month of the reminder letter (usual care), automated phone call, or personalized phone call.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Haller, Wills Eye
- Investigators
- Lisa Hark, PhD, Study director, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001129
- Sponsor's protocol ID
- WEF 14-040
- Status last verified
- Nov 2016
- First submitted
- 26 Nov 2013
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Callinan CE, Kenney B, Hark LA, Murchison AP, Dai Y, Leiby BE, Mayro EL, Bilson J, Haller JA. Improving Follow-Up Adherence in a Primary Eye Care Setting. Am J Med Qual. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.
PubMed 26656245
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Follow-Up Adherence in a Primary Eye Care Setting: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02001129
- Acronym / sponsor ID
- WEF 14-040
- Conditions
- Eye Diseases
- Keywords
- Eye care adherence, health care utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the effectiveness of three different ways of helping patients attend their recommended eye care appointments.
Detailed description
The three ways are 1) usual care, which involves a standard reminder letter; 2) automated telephone calls, which utilizes a machine to automatically call patients one month prior to their recommended follow-up date; 3)personalized telephone calls, which utilizes a staff member to personally call patients and offer them the opportunity to schedule at the time of the telephone call.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Automated Telephone System | Experimental | Behavioral: Personalized Telephone Call, Behavioral: Usual CareIn addition to a standardized reminder letter, participants also received a telephone call from an automated system to remind them of a recommended follow-up appointment. |
| Personalized Telephone Call | Experimental | Behavioral: Automated Telephone System, Behavioral: Usual CareIn addition to the usual care letter, a staff member called participants one month prior of recommended follow-up appointment. During this call, participants were given the option to schedule an appointment. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants randomized to this arm receive a "usual care" letter which is a standard reminder letter from the primary eye care office. This is usual practice in many primary eye care facilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: Over 18 years
- Primary Eye Care Patients who were recommended for a 6-month, 12-month, or 24-month follow-up appointment during September 2013 through November 2013.
- Access to a telephone
Key exclusion criteria (1 listed)
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Telephone SystemAlso: Patient appointment message 2000Participants receive automated reminder phone calls. | Behavioural | Personalized Telephone Call |
| Personalized Telephone CallAlso: Study staff phone callParticipants receive reminder phone calls by study staff. | Behavioural | Automated Telephone System |
| Usual CareAlso: Reminder letter sent in the mail.Participants receive a standard reminder letter in the mail. | Behavioural | Automated Telephone System, Personalized Telephone Call, Usual Care |
Primary outcome
Appointment Adherence
Time frame: 3 months
A research assistant examines the Electronic Medical Records (EMR) system to assess recommended appointment adherence.
1 secondary outcome
Scheduling Appointment
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Background: PubMed 26656245Callinan CE, Kenney B, Hark LA, Murchison AP, Dai Y, Leiby BE, Mayro EL, Bilson J, Haller JA. Improving Follow-Up Adherence in a Primary Eye Care Setting. Am J Med Qual. 2017 Jan/Feb;32(1):73-79. doi: 10.1177/1062860615616860. Epub 2016 Jul 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hark, PhD study director
Wills Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Telephone System and Personalized Telephone Call in people with Eye Diseases, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appointment Adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.