Discharge Follow-up Phone CallsFUTR-30NCT03050918
Discharge Follow-up Phone Call Program
A study testing Follow-up Phone Call in people with Discharge Follow-up Phone Calls, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this project is to quantify the impact of post-hospital discharge follow-up phone calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general medicine inpatient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discharge Follow-up Phone Calls
- What is being tested?
- Follow-up Phone Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,054 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 15 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- VUMC patients discharged after an inpatient status hospital stay on a general medicine service.
Who cannot join
- patients who experience in-hospital death
- patient discharged to any post-acute care facility or inpatient hospice
- left the hospital against medical advice
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: A Pragmatic, Randomized, Controlled Trial Examining the Effectiveness of a Hospital Discharge Follow-up Phone Call Program
The goal of this project is to quantify the impact of post-hospital discharge follow-up phone calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general medicine inpatient population. We will obtain exploratory information on patient sub-groups at high risk for hospital readmission and on those experiencing high benefit from the follow-up phone call intervention. In addition, we will obtain data on discharge plan implementation assistance needed to support a successful transition from inpatient to outpatient care among those reached by the intervention phone call.
Read the detailed description
RATIONALE
In the current medical literature, it is unclear how follow-up calls influence these outcomes in a general medical population. Some studies have attempted to address this question, but are limited in that they target very specific patient populations, are of insufficient quality, or evaluated follow-up calls as part of a larger care bundle. We will conduct a high quality, real-time clinical care study to determine the efficacy of a follow-up phone call program.
STUDY DESIGN
This is a single center, pragmatic, randomized, controlled clinical trial to investigate whether a structured post-hospital discharge follow-up phone call can improve patients' transition from in-hospital to outpatient care and improve satisfaction with their care. We will also identify the discharge implementation assistance given to those in the intervention (Phone Call) group.
Outcome Measures Primary outcome for this study is readmission event rate within 30 days. Secondary outcomes include patient satisfaction which will be measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores, all cause VUMC emergency department (ED) visits, the need for assistance with discharge plan implementation, and 30 day mortality.
- Conditions
- Discharge Follow-up Phone Calls
- Being tested
- Follow-up Phone Call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up Phone CallBehavioural
Patients will receive a first call attempt within 72 hours discharge.
| Study group | Role | What they receive |
|---|---|---|
| Phone Call Group (Intervention Arm) | Active comparator | Follow-up phone call intervention: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care. Receives: Behavioral: Follow-up Phone Call |
| Usual Care Group (Control Arm) | No intervention | Patients assigned to the control group receive standard discharge planning and follow-up per the usual care of their medical providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With In-patient Re-admissions
Number of participants with in-patient re-admissions
Measured: 30 days
Secondary outcomes (7)
Patient Satisfaction: Experience
Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Higher scores indicate more patient satisfaction. Range is 0-9 with 9 being the most satisfied.
Measured: Within 60 days of Discharge
Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)
Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that reported a score of 3. Range is 0-3 with 3 being highest satisfaction.
Measured: Within 60 days of Discharge
Patient Satisfaction: Hospital Experience (Top Box Rating)
Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that rated the Hospital Experience as 9. Scale range is 0-9. Higher scores indicate more patient satisfaction.
Measured: Within 60 days of Discharge
Patient Satisfaction: Likelihood to Recommend the Facility
Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Scale range is 0-3. Higher scores indicate more patient satisfaction.
Measured: Within 60 days of Discharge
VUMC Emergency Department (ED) Visits
All cause ED visits following discharge
Measured: 30 days
Number of Patient Received Discharge Plan Implementation Assistance
Need for assistance in implementing discharge plan
Measured: 30 days
Mortality
All cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start20 Feb 2017
- Primary completion28 Sep 2017
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Discharge Follow-up Phone CallsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, pragmatic, randomized, controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 3,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maame Yaa A. B. Yiadom, Vanderbilt University Medical Center
- Investigators
- Maame Yaa Yiadom, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050918
- Sponsor's protocol ID
- 170019
- Acronym
- FUTR-30
- Status last verified
- Jul 2019
- First submitted
- 9 Feb 2017
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, semi-structured intervention script, randomization code, data flow design have been published to share with other investigators. Individual study data will be available to other investigators upon request per details below.
Publications
Yiadom MYAB, Domenico HJ, Byrne DW, Hasselblad M, Kripalani S, Choma N, Tucker-Marlow S, Gatto CL, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert TV, Lindsell CJ, Bernard GR. Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial. Med Care. 2020 Sep;58(9):785-792. doi: 10.1097/MLR.0000000000001353.
PubMed 32732787Yiadom MYAB, Domenico H, Byrne D, Hasselblad MM, Gatto CL, Kripalani S, Choma N, Tucker S, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert T, Bernard G. Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations. BMJ Open. 2018 Feb 14;8(2):e019600. doi: 10.1136/bmjopen-2017-019600.
PubMed 29444787
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Randomized, Controlled Trial Examining the Effectiveness of a Hospital Discharge Follow-up Phone Call Program
- ClinicalTrials.gov ID
- NCT03050918
- Acronym / sponsor ID
- FUTR-30 / 170019
- Conditions
- Discharge Follow-up Phone Calls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,054 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to quantify the impact of post-hospital discharge follow-up phone calls on hospital readmission, ED visits, patient satisfaction, and mortality in a general medicine inpatient population. We will obtain exploratory information on patient sub-groups at high risk for hospital readmission and on those experiencing high benefit from the follow-up phone call intervention. In addition, we will obtain data on discharge plan implementation assistance needed to support a successful transition from inpatient to outpatient care among those reached by the intervention phone call.
Detailed description
RATIONALE
In the current medical literature, it is unclear how follow-up calls influence these outcomes in a general medical population. Some studies have attempted to address this question, but are limited in that they target very specific patient populations, are of insufficient quality, or evaluated follow-up calls as part of a larger care bundle. We will conduct a high quality, real-time clinical care study to determine the efficacy of a follow-up phone call program.
STUDY DESIGN
This is a single center, pragmatic, randomized, controlled clinical trial to investigate whether a structured post-hospital discharge follow-up phone call can improve patients' transition from in-hospital to outpatient care and improve satisfaction with their care. We will also identify the discharge implementation assistance given to those in the intervention (Phone Call) group.
Outcome Measures Primary outcome for this study is readmission event rate within 30 days. Secondary outcomes include patient satisfaction which will be measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores, all cause VUMC emergency department (ED) visits, the need for assistance with discharge plan implementation, and 30 day mortality.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center, pragmatic, randomized, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Phone Call Group (Intervention Arm) | Active comparator | Behavioral: Follow-up Phone CallFollow-up phone call intervention: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care. |
| Usual Care Group (Control Arm) | No intervention | –Patients assigned to the control group receive standard discharge planning and follow-up per the usual care of their medical providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- VUMC patients discharged after an inpatient status hospital stay on a general medicine service.
Key exclusion criteria (3 listed)
- patients who experience in-hospital death
- patient discharged to any post-acute care facility or inpatient hospice
- left the hospital against medical advice
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 |
|---|---|---|
| Follow-up Phone CallPatients will receive a first call attempt within 72 hours discharge. | Behavioural | Phone Call Group (Intervention Arm) |
Primary outcome
Number of Participants With In-patient Re-admissions
Time frame: 30 days
Number of participants with in-patient re-admissions
7 secondary outcomes
Patient Satisfaction: Experience
Time frame: Within 60 days of Discharge
Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)
Time frame: Within 60 days of Discharge
Patient Satisfaction: Hospital Experience (Top Box Rating)
Time frame: Within 60 days of Discharge
Patient Satisfaction: Likelihood to Recommend the Facility
Time frame: Within 60 days of Discharge
VUMC Emergency Department (ED) Visits
Time frame: 30 days
Number of Patient Received Discharge Plan Implementation Assistance
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32732787Yiadom MYAB, Domenico HJ, Byrne DW, Hasselblad M, Kripalani S, Choma N, Tucker-Marlow S, Gatto CL, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert TV, Lindsell CJ, Bernard GR. Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial. Med Care. 2020 Sep;58(9):785-792. doi: 10.1097/MLR.0000000000001353.
- Derived from this study: PubMed 29444787Yiadom MYAB, Domenico H, Byrne D, Hasselblad MM, Gatto CL, Kripalani S, Choma N, Tucker S, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert T, Bernard G. Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations. BMJ Open. 2018 Feb 14;8(2):e019600. doi: 10.1136/bmjopen-2017-019600.
- Individual participant dataSharing planned: Yes. The study protocol, semi-structured intervention script, randomization code, data flow design have been published to share with other investigators. Individual study data will be available to other investigators upon request per details below.
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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.
Maame Yaa Yiadom, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up Phone Call in people with Discharge Follow-up Phone Calls, run by Vanderbilt University 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 1 inclusion and 3 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 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With In-patient Re-admissions (time frame: 30 days). 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 NCT03050918, which also lists 2 linked publications.
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 Jul 2019.