Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

NCT01619098 | Completed

• 1 other identifier: 1R01HS020628
• Study Type: interventional
• Target: 1,510
• Locations: 1 country
• Sites: 2

Brief Summary

Hospital readmissions are common, costly, and potentially preventable. They are also potentially responsive to health system interventions. However, it is uncertain which components of care transition interventions are efficacious, for which populations, and at what cost. This randomized controlled study is part of a larger project that will evaluate a three-tiered quality improvement (QI) intervention intended to reduce hospital readmissions within 30 days post-discharge from an urban safety net hospital that serves a racially and linguistically diverse population (the randomized controlled study evaluates Tier 3). Few studies have evaluated care transition interventions to reduce readmissions among low-income, diverse patient populations, and the accumulated evidence on the effects of these multi-faceted interventions on readmission rates has been inconclusive. This project will take advantage of a unique sequence of three QI innovations to reduce hospital readmissions implemented beginning in 2007 in an integrated safety net health care system. The "discharge-transfer" tiers are as follows: 1) Tier 1 includes a comprehensive, individualized home care plan (HCP) reviewed by the medical service floor nurse with the patient prior to discharge; 2) Tier 2 adds the electronic transmission of the HCP to the patient's primary care medical home where, on the business day following discharge, a Registered Nurse makes an outreach telephone call to the discharged patient to confirm comprehension of the HCP and to address medical questions or needs; 3) Tier 3 further adds a community health worker, the Patient Navigator, to participate in bedside discussions to develop rapport and learn about patients' home situations, weekly outreach calls to assess patients' needs and to facilitate communication between the patient and the primary care team, and reminder calls to patients prior to all medical appointments to eliminate barriers to outpatient follow-up. The Aim of the study being registered is to evaluate the effects of an ongoing randomized natural experiment on readmissions, health care use, adherence to medication instructions, and preparedness for discharge. This natural experiment features random assignment to one of two QI interventions, Tier 2 or Tier 3, and exclusively targets patients at high risk for readmission, those with one or more of the following risk factors for readmission: discharge diagnosis of congestive heart failure or COPD; length of stay \> 3 days; age \> 60; or previous hospitalization within the past six months. The investigators hypothesize that the Patient Navigator intervention (Tier 3) compared to usual care (Tier 2) will increase the rates of 30-day post-discharge PCP visits; reduce 30-day hospital readmission rates; and reduce the total number of days in hospital in the 180 days following the index admission for high risk patients. The investigators further expect that the PN intervention will improve patient adherence to medication instructions in the HCP and reduce the probability of reported problems with post-discharge care.

Conditions

Hospital Readmission; Post-discharge Care Transitions; Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Keywords

Hospital readmission; Care transition; Discharge-transfer intervention; Community health worker; Patient Navigatgor

Outcome Measures

Primary Outcomes (1)

• Hospital readmission

  Inpatient readmission for any reason within 30 days of the index discharge;

  30 days

Secondary Outcomes (6)

• Primary and specialty care visit

  Number of days to first PCP or specialist visit post-discharge; number of PCP or specialist visits within 7, 15, and 30 days post-discharge

• Emergency department visit

  30 days

• Adherence to medication instructions in Home Care Plan

  Up to 30 days post-discharge

• Patient preparedness for discharge; problems with post-discharge care

  Up to 30 days post-discharge

• Costs

  within 180 days of discharge

Study Arms (2)

Patient Navigator

EXPERIMENTAL

Hospital-based Patient Navigator (a bilingual community health worker) engaged in discharge planning and made outreach phone calls to patients for 30 days after discharge and assisted patints with follow-up appointments, obtaining and taking medications, transportation, financial barriers, and linkages to community resources

Other: Patient Navigator; Other: Usual care

Usual Care

NO INTERVENTION

Home care plan at discharge, outreach phone call from RN at patient's primary care clinic

Interventions

Patient Navigator OTHER

In addition to usual care, the intervention adds the services of a community health worker, the Patient Navigator (PN), for study patients. The PN participates in bedside meetings, facilitates communication between the patient and the primary care team, conducts weekly outreach phone calls to further address patient needs, and makes reminder calls prior to all medical appointments to facilitate timely outpatient follow-up.

Patient Navigator

Usual care OTHER

Usual care includes provision of a Home Care Plan (HCP) to patients at discharge, and electronic transmission of HCP to PCP with telephone follow-up by primary care RN

Patient Navigator

Eligibility Criteria

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

You may qualify if:

• medical patients discharged to home or skilled nursing facility between October 1, 2011 and June 30, 2013
• Cambridge Health Alliance PCP at time of discharge
• at least one of four risk factors for readmission: discharge diagnosis of CHF or COPD; length of stay \>3 days; age \>60; or previous hospitalization within the past 6 months

Sponsors & Collaborators

• Alison Galbraith: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Cambridge Health Alliance: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (2)

Cambridge Hospital

Cambridge, Massachusetts, 02139, United States

Location

Whidden Hospital

Everett, Massachusetts, 02149, United States

Location

Related Publications (1)

• Balaban RB, Galbraith AA, Burns ME, Vialle-Valentin CE, Larochelle MR, Ross-Degnan D. A Patient Navigator Intervention to Reduce Hospital Readmissions among High-Risk Safety-Net Patients: A Randomized Controlled Trial. J Gen Intern Med. 2015 Jul;30(7):907-15. doi: 10.1007/s11606-015-3185-x. Epub 2015 Jan 24.

  PMID: 25617166 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Dennis Ross-Degnan, ScD

  Harvard Medical School and Harvard Pilgrim Health Care Institute

  PRINCIPAL INVESTIGATOR

• Alison Galbraith, MD, MPH

  Harvard Medical School and Harvard Pilgrim Health Care Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 14, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

US (2)