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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up Phone Call | Behavioral | Patients will receive a first call attempt within 72 hours discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With In-patient Re-admissions | Number of participants with in-patient re-admissions | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 60 days of Discharge |
| Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maame Yaa Yiadom, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32732787 | Derived | 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. | |
| 29444787 |
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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.
The study protocol was published in BMJ Open in 2017 (Yiadom MYAB, Domenico H, Byrne D, et al 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;8:e019600. doi: 10.1136/bmjopen-2017-019600)
A full de-identified version of the database including participate data for this study will be available to other investigators upon request after consideration of their proposed use for the data. We are happy to begin accepting requests starting 12 months following the publication of the manuscript including study results.
All requests should be directed to the corresponding author (maya.yiadom@vumc.org).
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| ID | Title | Description |
|---|---|---|
| FG000 | Phone Call Group (Intervention Arm) | Follow-up phone call program: 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. |
| FG001 | Usual Care Group (Control Arm) | Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phone Call Group (Intervention Arm) | Follow-up Phone Call Program: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With In-patient Re-admissions | Number of participants with in-patient re-admissions | Posted | Count of Participants | Participants | 30 days |
|
30 days
Adverse Events were evaluated in 3 ways: 1) all-cause mortality, 2) reviewing a 10% sample of the Phone Call Nurse's daily reports, and 3) reviewing the Phone Call Program office's internal quality assessment for evidence the intervention may introduce harm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phone Call Group (Intervention Arm) | Follow-up phone call program: 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. |
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A data lag due to limited national electronic health record informatics connectivity prevents us from tracking adverse events documented outside of our facility. Unmeasured outcomes should be equally distributed between the randomized groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maame Yaa Yiadom | Vanderbilt University Medical Center | 615-936-0087 | maya.yiadom@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2017 | Oct 23, 2018 | Prot_SAP_000.pdf |
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This is a single center, pragmatic, randomized, controlled clinical trial.
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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. |
| 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. | 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. | Within 60 days of Discharge |
| VUMC Emergency Department (ED) Visits | All cause ED visits following discharge | 30 days |
| Number of Patient Received Discharge Plan Implementation Assistance | Need for assistance in implementing discharge plan | 30 days |
| Mortality | All cause mortality | 30 days |
| Derived |
| Yiadom 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. |
| BG001 | Usual Care Group (Control Arm) | Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest Education/grade completed | Mean | Standard Deviation | grade level in years |
|
| Brief Health Literacy Score | Measures health literacy and patients ability to act as an independent agent for their own medical care. A score of <10 is considered to be inadequate to act alone as an independent agent for their own medical care and can identify patients that need assistance. Total score can range from 3 (low health literacy) to 15 (high health literacy). | Mean | Standard Deviation | scores on a scale |
|
| Established Primary Care Provider | Count of Participants | Participants |
|
| Hospital Length of Stay | Mean | Standard Deviation | days |
|
| Any time on Intensive Care Unit during stay | Count of Participants | Participants |
|
| Predicted Re-admission risk before discharge | The Predicted Readmission Risk Before Discharge is the result of a real-time predictive model embedded and displayed in the Vanderbilt Adult Hospital's electronic health record (EHR). It was developed through a collaboration between the Medical Center's Office of Quality Safety and Risk Prevention and the Vanderbilt Institute for Clinical and Translational Research and embedded into the EHR. The range for the predicted readmission risk is 0-100 (percent). Higher numbers indicate higher risk of re-admission. | Mean | Standard Deviation | percent risk |
|
| In-patient Admission in prior 6 months | Count of Participants | Participants |
|
| Mean number of In-Patient admissions in the prior 6 months | Mean | Standard Deviation | in-patient admissions |
|
| CMS Re-admission Penalty Group: COPD Exacerbation | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: Pneumonia | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: Heart Failure | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: Acute Myocardial Infarction | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: Stroke | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: Total hip/knee | Re-admission for Elective Primary Total Hip Arthroplasty and/or Total Knee Arthroplasty (THA/TKA) | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: Coronary Artery Bypass Graph | Count of Participants | Participants |
|
| CMS Re-admission Penalty Group: None | Count of Participants | Participants |
|
Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers. |
|
|
|
| Secondary | 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. | Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned | Posted | Mean | Standard Deviation | score on a scale | Within 60 days of Discharge |
|
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| Secondary | 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. | Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned. | Posted | Count of Participants | Participants | Within 60 days of Discharge |
|
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| Secondary | 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. | Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned | Posted | Count of Participants | Participants | Within 60 days of Discharge |
|
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|
| Secondary | 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. | Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned | Posted | Mean | Standard Deviation | score on a scale | Within 60 days of Discharge |
|
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| Secondary | VUMC Emergency Department (ED) Visits | All cause ED visits following discharge | Posted | Number | ED visits | 30 days |
|
|
|
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| Secondary | Number of Patient Received Discharge Plan Implementation Assistance | Need for assistance in implementing discharge plan | Discharge plan implementation assistance was offered as part of the intervention and not to the control group. | Posted | Count of Participants | Participants | 30 days |
|
|
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| Secondary | Mortality | All cause mortality | Thirty-day mortality data was retrieved from the EHR data repository after a 120-day lag to capture delayed reporting. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| 68 |
| 1,534 |
| 0 |
| 1,534 |
| 0 |
| 1,534 |
| EG001 | Usual Care Group (Control Arm) | Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers. | 75 | 1,520 | 0 | 1,520 | 0 | 1,520 |
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| .05 |
We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively. |
| Superiority |
| .05 |
We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively. |
| Superiority |