Patient ComplianceNCT03101969
Human Outreach to Improve Adherence With Scheduled Pain Clinic Appointments
An observational study of Patient Compliance, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Patients tend to miss their scheduled appointments in chronic pain clinics for unknown reasons. This study will test the hypothesis in a prospective pragmatic trial that a human telephone call in the primary language of the patient, promising a clinical encounter in this language improves attendance at scheduled… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Call
- How many people
- 1,022 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2016
- Phase
- Observational
- 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
Study population: Individuals who are 18 years of age and older that has a scheduled appointment at Montefiore Medical Center.
Who may be able to join
- 18 years of age or older
- have scheduled appointment at Montefiore Medical Center
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Targeted Intervention (a Telephone Call in the Dominant Language) to Increase Attendance at Scheduled Appointment in an Inner City Academic Pain Clinic
Patients tend to miss their scheduled appointments in chronic pain clinics for unknown reasons. This study will test the hypothesis in a prospective pragmatic trial that a human telephone call in the primary language of the patient, promising a clinical encounter in this language improves attendance at scheduled appointments in an academic inner city pain clinic.
Read the detailed description
Language barriers may lead to poor attendance at pain clinic appointments, especially in underserved patients. Targeted interventions can help overcome barriers and significantly improve adherence, but have rarely been rigorously investigated in randomized clinical trials. Our objective is to investigate if (1) making a telephone call in the patient's preferred language increases adherance with scheduled appointment in an inner city academic pain clinic or at least reduces failure to attend without a prior cancellation call and (2) if this intervention is more effective in Spanish speakers.
After institutional review board approval and waiver of informed consent, we enroll all adult patients (18 years and up) with a scheduled first appointment at our outpatient Pain Center at Montefiore Medical Center located in the Bronx, New York from October 2014 through October 2015. Participants are randomized to receive a phone call in their preferred language before their appointment, or not. We recorded if participants attended as scheduled and/or called to cancel. We fit stratified and multivariate multinomial logistic regression models.
In a methodologically rigorous randomized design, we seek to demonstrate that a human phone call in the patient's primary language increases adherence with scheduled appointments in an ethnically diverse, poor population, typical for an inner city pain clinic. Our targeted intervention may provide considerable cost savings to the institution while bolstering the patient-doctor relationship and overcoming barriers to access much needed care.
- Conditions
- Patient Compliance
- Being tested
- Call
- Keywords
- language, scheduled, appointment
- Medical subject headings
- Patient Compliance, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CallOther
not called, not reached, and spoken to
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient attendance at scheduled pain clinic appointment
patient attends a scheduled appointment at a chronic pain clinic the day after the call or not, as ascertained from the clinic attendance sheet
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Andreae, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101969
- Sponsor's protocol ID
- 2014-3683
- Status last verified
- Mar 2017
- First submitted
- 29 Jun 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Intervention (a Telephone Call in the Dominant Language) to Increase Attendance at Scheduled Appointment in an Inner City Academic Pain Clinic
- ClinicalTrials.gov ID
- NCT03101969
- Acronym / sponsor ID
- 2014-3683
- Conditions
- Patient Compliance
- Keywords
- language, scheduled, appointment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,022 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
Patients tend to miss their scheduled appointments in chronic pain clinics for unknown reasons. This study will test the hypothesis in a prospective pragmatic trial that a human telephone call in the primary language of the patient, promising a clinical encounter in this language improves attendance at scheduled appointments in an academic inner city pain clinic.
Detailed description
Language barriers may lead to poor attendance at pain clinic appointments, especially in underserved patients. Targeted interventions can help overcome barriers and significantly improve adherence, but have rarely been rigorously investigated in randomized clinical trials. Our objective is to investigate if (1) making a telephone call in the patient's preferred language increases adherance with scheduled appointment in an inner city academic pain clinic or at least reduces failure to attend without a prior cancellation call and (2) if this intervention is more effective in Spanish speakers.
After institutional review board approval and waiver of informed consent, we enroll all adult patients (18 years and up) with a scheduled first appointment at our outpatient Pain Center at Montefiore Medical Center located in the Bronx, New York from October 2014 through October 2015. Participants are randomized to receive a phone call in their preferred language before their appointment, or not. We recorded if participants attended as scheduled and/or called to cancel. We fit stratified and multivariate multinomial logistic regression models.
In a methodologically rigorous randomized design, we seek to demonstrate that a human phone call in the patient's primary language increases adherence with scheduled appointments in an ethnically diverse, poor population, typical for an inner city pain clinic. Our targeted intervention may provide considerable cost savings to the institution while bolstering the patient-doctor relationship and overcoming barriers to access much needed care.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are 18 years of age and older that has a scheduled appointment at Montefiore Medical Center.
Key inclusion criteria (2 listed)
- 18 years of age or older
- have scheduled appointment at Montefiore Medical Center
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Callnot called, not reached, and spoken to | Other | – |
Primary outcome
Patient attendance at scheduled pain clinic appointment
Time frame: 1day
patient attends a scheduled appointment at a chronic pain clinic the day after the call or not, as ascertained from the clinic attendance sheet
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 5 Apr 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Compliance, run by Montefiore Medical Center 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 2 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 5 Apr 2017. 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?
Patient attendance at scheduled pain clinic appointment (time frame: 1day). 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 5 Apr 2017.