Reducing Structural Inequities in Heart Failure Management: An Approach to Improve the Quality of Heart Failure Care on the General Medicine Service: Longitudinal Equity Action Plan (LEAP)

NCT03942978 | Completed

• 1 other identifier: 2019P000951
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Recent institutional research has demonstrated that black and Latinx patients are significantly less likely to be admitted to cardiology and more likely to be admitted to general medicine for their inpatient heart failure (HF) care. Subsequent HF care on general medicine has been demonstrated to have worse outcomes including lower rates of follow-up with cardiology and higher readmission rates. Given this, this project is a institutional quality improvement initiative, with a stepped wedge design, with the aim to improve the quality of care for heart failure patients admitted to general medicine for their care, and improve discharge planning. General medicine services by hospital pods will be enrolled in a stepped wedge fashion to a Longitudinal Equity Action Plan (LEAP) which includes a standardized clinical management plan to ensure patients are on guideline-appropriate therapy, receive cardiology consultation if appropriate, are discharged when clinically appropriate, discharge planning and systematic follow up with cardiology, transportation support as needed for follow-up visits, post-discharge follow up to identify any post-discharge issues.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Cardiology post-discharge follow-up within 14 days

  Rates of patients that complete post-discharge follow up appropriate with a cardiologist within 14 days of discharge

  14 days

Secondary Outcomes (3)

• Seven-day Heart Failure Readmission

  7 days

• 30-day Heart Failure Readmission

  30 days

• Cardiology post-discharge follow-up within 30 days

  30 days

Other Outcomes (2)

• Cardiology Consultation

  Within admission

• Transportation Support

  Within 14 days of discharge

Study Arms (2)

Longitudinal Equity Action Plan (LEAP)

ACTIVE COMPARATOR

Heart failure patients admitted with a principal diagnosis of heart failure to general medicine service and admitted to a general medicine pod that is randomized to the intervention arm.

Other: Longitudinal Equity Action Plan

Standard Care

NO INTERVENTION

Heart Failure patients admitted to a general medicine pod at our institution, which is not randomized to intervention arm. Patients will be treated for their heart failure as per standard of care while admitted to the hospital.

Interventions

Longitudinal Equity Action Plan OTHER

Patients admitted to general medicine pod randomized to intervention will receive a Longitudinal Equity Action Plan (LEAP), which will include a program manager to ensure they are on appropriate medical therapy, that cardiology is consulted when appropriate, that patient is set up with appropriate follow-up appointment with cardiology, that transportation is set up for follow-up visits, and a post-discharge follow up call to remind patients of the appointment and identify any post-discharge issues. This is in addition to standard of care, and there will not be any drug or device interventions.

Longitudinal Equity Action Plan (LEAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the general medicine service at our hospital with a principal diagnosis of heart failure

You may not qualify if:

• Patients less than 18 years of age

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (11)

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  PMID: 23741057 BACKGROUND

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  PMID: 28409010 BACKGROUND

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  PMID: 12821540 BACKGROUND

• Foody JM, Rathore SS, Wang Y, Herrin J, Masoudi FA, Havranek EP, Krumholz HM. Physician specialty and mortality among elderly patients hospitalized with heart failure. Am J Med. 2005 Oct;118(10):1120-5. doi: 10.1016/j.amjmed.2005.01.075.

  PMID: 16194643 BACKGROUND

• Salata BM, Sterling MR, Beecy AN, Ullal AV, Jones EC, Horn EM, Goyal P. Discharge Processes and 30-Day Readmission Rates of Patients Hospitalized for Heart Failure on General Medicine and Cardiology Services. Am J Cardiol. 2018 May 1;121(9):1076-1080. doi: 10.1016/j.amjcard.2018.01.027. Epub 2018 Feb 7.

  PMID: 29548676 BACKGROUND

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  PMID: 25637324 BACKGROUND

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  PMID: 25694226 BACKGROUND

• Farias M, Jenkins K, Lock J, Rathod R, Newburger J, Bates DW, Safran DG, Friedman K, Greenberg J. Standardized Clinical Assessment And Management Plans (SCAMPs) provide a better alternative to clinical practice guidelines. Health Aff (Millwood). 2013 May;32(5):911-20. doi: 10.1377/hlthaff.2012.0667.

  PMID: 23650325 BACKGROUND

• Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

  PMID: 16829207 BACKGROUND

• Cook NL, Ayanian JZ, Orav EJ, Hicks LS. Differences in specialist consultations for cardiovascular disease by race, ethnicity, gender, insurance status, and site of primary care. Circulation. 2009 May 12;119(18):2463-70. doi: 10.1161/CIRCULATIONAHA.108.825133. Epub 2009 Apr 27.

  PMID: 19398667 BACKGROUND

• Caitlin S. Drescher, Kathryn A. Britton, Lynne W. Stevenson, Akshay S. Desai. Clinical Outcomes during Generalist Vs. Subspecialty Care of Inpatients with Heart Failure and Preserved Ejection Fraction. Journal of Cardiac Failure. 2017; 23(8):S23.

  RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped Wedge Randomized Control Trial

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 8, 2019
• Study Start: May 31, 2019
• Primary Completion: May 31, 2020
• Study Completion: August 31, 2020
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)