- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393534
Feasibility of Telephone Follow-up Visits in Primary Care
April 5, 2016 updated by: NYU Langone Health
The Feasibility of Replacing Follow-up Visits With Telephone Calls in Primary Care: A Randomized Clinical Trial
Doctors frequently speak with their patients over the telephone.
Having a visit with a doctor over the telephone rather than face-to-face can be convenient for patients and allow them to save time and money on transportation and missed time from work.
However, some patients may prefer seeing the doctor in person.
In this study, we will study two groups of patients - some who have their visits with their doctor over the telephone and some who have them face-to-face.
Using surveys and interviews, we will study if the groups differ in their satisfaction with their visit with their doctor after participating in the study for 6 months.
We will also look at doctor satisfaction with telephone visits, use of clinic resources and if patients received recommended care such as laboratory tests and vaccines during the study period.
Study Overview
Detailed Description
This two arm randomized controlled trial will evaluate the effect of telephone follow-up versus standard in-person follow-up (usual care) on patient satisfaction among a sample of 360 primary care patients followed at the Gouverneur Ambulatory Care Practice.
All primary care patients will be considered eligible at the outset.
Providers will determine patient's study eligibility at the baseline visit based on the ability to safely follow-up the patient's health issue over the telephone in subsequent visits.
Eligible patients that are randomized to the telephone follow-up arm will have their next medical visit with their primary care provider via a telephone call.
Eligible patients that are randomized to the usual care arm will have a standard in-person clinic visit with their primary care provider.
In both study arms, the timing and frequency of follow-up appointments will be determined by the patient's primary care provider.
Regardless of group assignment, outcomes will be assessed at the baseline and 6-month study visit.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10002
- Gouverneur TDC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a follow-up issue that can be addressed over the phone (as determined by their provider);
- 18 years of age or older;
- Have a working telephone number; and
- Are English, Spanish, Cantonese or Mandarin-speaking.
Exclusion Criteria:
- Patient refusal or are unable to provide informed consent;
- Currently participate in another clinical trial;
- Have significant psychiatric comorbidity or cognitive impairment that would compromise their ability to participate (as determined by their provider); or
- Plan to discontinue care at the Gouverneur Ambulatory Care Practice within the next 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Usual Care
Eligible patients that are randomized to the usual care arm will have a standard in-person clinic visit with their primary care provider.
|
|
EXPERIMENTAL: Telephone visit
Eligible patients that are randomized to the telephone follow-up arm will have their next medical visit with their primary care provider via a telephone call.
|
Eligible patients that are randomized to the telephone follow-up arm will have their next medical visit with their primary care provider via a telephone call.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility assessment
Time Frame: 6 months
|
Proportion of patients recruited out of the total population and proportion of patients retained at 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider workload
Time Frame: 6 months
|
The number of minutes spent in conversation during the telephone visit
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6 months
|
Provider workload
Time Frame: 6 months
|
The total number of scheduled and unscheduled clinic sessions
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6 months
|
Patient Satisfaction
Time Frame: 6 months
|
Patient satisfaction assessed with the CG-CAHPS questionnaire.
For the purposes of this study we will only use measures related to provider ratings and communication .
Semi-structured in-depth interviews will also be conducted with a subsample of patients in the telephone visit arm to elicit their beliefs on the usefulness and appropriateness of telephone visits for their health care needs as well as suggestions for instituting a telephone visit program, and willingness to participate in future telephone visits.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider Satisfaction
Time Frame: 6 months
|
Provider satisfaction will be assessed with a Likert-type scale that assesses satisfaction with the telephone medicine program after 6 months of participation.
A focus group will also be conducted to elicit providers' opinions beliefs regarding the logistical, organizational, and administrative barriers to conducting telephone follow-up visits, usefulness/suitability of telephone visit to address patient concerns, disadvantages and advantages of using telephone visits, opinions on which patients benefit the most from the service, suggestions for improving the process.
|
6 months
|
Patient receipt of medical recommendations
Time Frame: 6 months
|
Electronic medical records (EMR) will be reviewed to collect data on patient's comorbid conditions, receipt of chronic disease management measures (i.e., blood pressure checks, HbA1c levels), and clinic appointment attendance (i.e., number of visits scheduled with the provider but not attended during the 6-month study period divided by the total number of visits scheduled).
Documentation of the receipt of chronic disease management measures (e.g.
whether or not patient had recommended blood tests performed) will be used as a proxy for patient adherence.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Antoinette Schoenthaler, NYU School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (ACTUAL)
April 1, 2016
Study Completion (ACTUAL)
April 1, 2016
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 13, 2015
First Posted (ESTIMATE)
March 19, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 5, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 14-01863
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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