No Specific ConditionPhase 4NCT02393534
Feasibility of Telephone Follow-up Visits in Primary Care
A Phase 4 study testing Telephone Visit in people with No Specific Condition, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Specific Condition
- What is being tested?
- Telephone Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Apr 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- No Specific Condition
- Being tested
- Telephone Visit
- Keywords
- Primary Care, Health Services Research, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone VisitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Eligible patients that are randomized to the usual care arm will have a standard in-person clinic visit with their primary care provider. |
| Telephone visit | Experimental | 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. Receives: Other: Telephone Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessment
Proportion of patients recruited out of the total population and proportion of patients retained at 6 months.
Measured: 6 months
Secondary outcomes (3)
Provider workload
The number of minutes spent in conversation during the telephone visit
Measured: 6 months
Provider workload
The total number of scheduled and unscheduled clinic sessions
Measured: 6 months
Patient Satisfaction
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific ConditionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Health and Hospitals Corporation
- Responsible party
- Sponsor
- Investigators
- Antoinette Schoenthaler, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393534
- Sponsor's protocol ID
- 14-01863
- Status last verified
- Apr 2016
- First submitted
- 9 Mar 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Replacing Follow-up Visits With Telephone Calls in Primary Care: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02393534
- Acronym / sponsor ID
- 14-01863
- Conditions
- No Specific Condition
- Keywords
- Primary Care, Health Services Research, Telemedicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- New York City Health and Hospitals Corporation
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Mar 2015 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Eligible patients that are randomized to the usual care arm will have a standard in-person clinic visit with their primary care provider. |
| Telephone visit | Experimental | Other: Telephone VisitEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Telephone VisitEligible 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 |
Primary outcome
Feasibility assessment
Time frame: 6 months
Proportion of patients recruited out of the total population and proportion of patients retained at 6 months.
3 secondary outcomes
Provider workload
Time frame: 6 months
Provider workload
Time frame: 6 months
Patient Satisfaction
Time frame: 6 months
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 6 Apr 2016.
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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.
Antoinette Schoenthaler principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telephone Visit in people with No Specific Condition, run by NYU Langone Health 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 4 inclusion and 4 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 6 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2016.