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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • New York
      • New York, New York, United States, 10002
        • Gouverneur TDC

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Provider workload
Time Frame: 6 months
The number of minutes spent in conversation during the telephone visit
6 months
Provider workload
Time Frame: 6 months
The total number of scheduled and unscheduled clinic sessions
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New York City Health and Hospitals Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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