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interruption of study enrollment and procedures due to COVID-19 health crisis
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Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.
In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 diabetes and poor glycemic control (HbA1c >8.5%) will receive standard of care insulin therapy including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 222 patients (type 2 diabetes) will be recruited. Hospitalized patients with type 2 diabetes (HbA1c >8.5%) who are receiving basal insulin at least 10 unit per day and are able to provide informed consent and complete study procedures will be approached. All patients will be discharged on glargine U300 with initial doses determined by the discharging team. Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Patients will have follow-up phone calls at week 2, 6, and in-person visits at week 12 and 24. Phone calls will assess adherence with instructions for self-titration in the DOS group but are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. The study and all study-related documents will be approved by the OSU IRB. All data analyses will be completed as intention to treat analyses. Longitudinal outcomes (e.g., HbA1c) will be analyzed using mixed models utilizing all available measurements from individuals randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Discharge Order Set (DOS) | Experimental | Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. |
|
| Enhanced Standard Care (ESC) | Other | Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discharge Order Set (DOS) | Other | In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to 24 Weeks | We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to 12 Weeks | We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 12 weeks change in Hb1Ac. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Dungan, M.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19364697 | Background | Cook CB, Seifert KM, Hull BP, Hovan MJ, Charles JC, Miller-Cage V, Boyle ME, Harris JK, Magallanez JM, Littman SD. Inpatient to outpatient transfer of diabetes care: planing for an effective hospital discharge. Endocr Pract. 2009 Apr;15(3):263-9. doi: 10.4158/EP.15.3.263. | |
| 25100371 | Background | Dungan K, Lyons S, Manu K, Kulkarni M, Ebrahim K, Grantier C, Harris C, Black D, Schuster D. An individualized inpatient diabetes education and hospital transition program for poorly controlled hospitalized patients with diabetes. Endocr Pract. 2014 Dec;20(12):1265-73. doi: 10.4158/EP14061.OR. |
| Label | URL |
|---|---|
| Toujeo prescribing instructions | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Discharge Order Set (DOS) | Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 2, 2017 |
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| Enhanced Standard Care (ESC) | Other | Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. |
|
| Proportion Using Insulin Glargine U300 at 24 Weeks | proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions. | 24 weeks |
| Fasting Glucose | We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model. reported measure differs from original plan due to lack of fasting glucose in hospitalized patients. | 24 weeks |
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| 35958875 | Derived | White A, Buschur E, Harris C, Pennell ML, Soliman A, Wyne K, Dungan KM. Influence of Literacy, Self-Efficacy, and Social Support on Diabetes-Related Outcomes Following Hospital Discharge. Diabetes Metab Syndr Obes. 2022 Aug 4;15:2323-2334. doi: 10.2147/DMSO.S327158. eCollection 2022. |
| 35881437 | Derived | White A, Bradley D, Buschur E, Harris C, LaFleur J, Pennell M, Soliman A, Wyne K, Dungan K. Effectiveness of a Diabetes-Focused Electronic Discharge Order Set and Postdischarge Nursing Support Among Poorly Controlled Hospitalized Patients: Randomized Controlled Trial. JMIR Diabetes. 2022 Jul 26;7(3):e33401. doi: 10.2196/33401. |
| FG001 | Enhanced Standard Care (ESC) | Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis population is the same as the participant flow.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Discharge Order Set (DOS) | Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration. |
| BG001 | Enhanced Standard Care (ESC) | Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in HbA1c From Baseline to 24 Weeks | We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac. | Data were collected at study visits and extracted from the electronic medical records. | Posted | Mean | Standard Error | percentage of glycosylated hemoglobin | 24 weeks |
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| Secondary | Change in HbA1c From Baseline to 12 Weeks | We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 12 weeks change in Hb1Ac. | HbA1c was obtained from study visits as well as from the electronic medical record. | Posted | Mean | Standard Error | percentage of glycosylated hemoglobin | 12 weeks |
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| Secondary | Proportion Using Insulin Glargine U300 at 24 Weeks | proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions. | The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions. | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | Fasting Glucose | We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model. reported measure differs from original plan due to lack of fasting glucose in hospitalized patients. | Data were collected from study visits from participants who were fasting. | Posted | Median | Inter-Quartile Range | mg/dl | 24 weeks |
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24 weeks
Adverse events will include severe hypoglycemia rates, pregnancy, overdose, and breach of confidentiality. In addition the following definitions apply:
DEFINITIONS
Serious adverse event (SAE): any untoward medical occurrence including:
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Discharge Order Set (DOS) | Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration. | 1 | 82 | 30 | 82 | 0 | 82 |
| EG001 | Enhanced Standard Care (ESC) | Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. | 0 | 76 | 34 | 76 | 0 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemia | Endocrine disorders | Non-systematic Assessment | hypoglycemia associated with seizure or hemodynamic compromise or in need of outside assistance |
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| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Diabetic ketoacidosis | Endocrine disorders | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| hyperkalemia | Renal and urinary disorders | Non-systematic Assessment |
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| Transient Ischemic Attack | Nervous system disorders | Non-systematic Assessment |
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| Lumbar degenerative disc disease | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| sarcoidosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| chest pain | Cardiac disorders | Non-systematic Assessment |
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| wound infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| foot ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| lower extremity edema | Vascular disorders | Non-systematic Assessment |
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| arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| clostridium dificile collitis | Gastrointestinal disorders | Non-systematic Assessment |
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| hypertensive urgency | Cardiac disorders | Non-systematic Assessment |
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| neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| cervical stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
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| heart failure | Cardiac disorders | Non-systematic Assessment |
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| dental abscess | Infections and infestations | Non-systematic Assessment |
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| dacroadenitis | Eye disorders | Non-systematic Assessment |
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| fall | General disorders | Non-systematic Assessment |
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| angina | Cardiac disorders | Non-systematic Assessment |
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| cystitis | Renal and urinary disorders | Non-systematic Assessment |
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| hernia | Surgical and medical procedures | Non-systematic Assessment |
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| cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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Not provided
The study was stopped early due to loss to follow-up.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Dungan | The Ohio State University | 6146853333 | kathleen.dungan@osumc.edu |
| Feb 26, 2018 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2017 | Feb 26, 2018 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
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Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
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