Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

This study has been completed.
Sponsor:
Collaborators:
Cambridge Health Alliance
Harvard School of Public Health
Information provided by (Responsible Party):
Alison Galbraith, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT01619098
First received: June 11, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Hospital Readmission
Post-discharge Care Transitions
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease
Other: Patient Navigator
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

Resource links provided by NLM:


Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Hospital readmission [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Inpatient readmission for any reason within 30 days of the index discharge;


Secondary Outcome Measures:
  • Primary and specialty care visit [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Number of days to first PCP visit post-discharge; 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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Any ED visit within 30 days post-discharge; Number of ED visits within 30 days post-discharge

  • Adherence to medication instructions in Home Care Plan [ Time Frame: Up to 30 days post-discharge ] [ Designated as safety issue: No ]
    A binary indicator of patient adherence to prescription medication instruction in the discharge plan

  • Patient preparedness for discharge; problems with post-discharge care [ Time Frame: Up to 30 days post-discharge ] [ Designated as safety issue: No ]
    Satisfaction with inpatient preparation for discharge; receipt of specific written care plan instructions and contact information; satisfaction with understanding of condition, medications, and follow-up appointments; confidence in self-management of post-discharge care; problems with post-discharge care

  • Costs [ Time Frame: within 180 days of discharge ] [ Designated as safety issue: No ]
    We will compare the cost per patient of the PN intervention vs usual care from the perspective of Cambridge Health Alliance. Costs will be measured for each patient's 180 days post-discharge and will include Patient Navigator labor, interpreter services, primary care RN labor, and estimated patient care revenues/costs paid for each billable service utilized for study patients using the Medicare fee schedule.

  • hospital readmission [ Time Frame: 15 and 180 days ] [ Designated as safety issue: No ]
    Readmission within 15 and 180 days of the index discharge; number of days until first readmission; total number of hospital days in the 180 days post-discharge; readmission before first scheduled PCP or specialist follow-up visit


Enrollment: 1510
Study Start Date: October 2011
Study Completion Date: November 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient Navigator
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
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.
Other: Usual care
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
No Intervention: Usual Care
Home care plan at discharge, outreach phone call from RN at patient's primary care clinic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619098

Locations
United States, Massachusetts
Cambridge Hospital
Cambridge, Massachusetts, United States, 02139
Whidden Hospital
Everett, Massachusetts, United States, 02149
Sponsors and Collaborators
Alison Galbraith
Cambridge Health Alliance
Harvard School of Public Health
Investigators
Principal Investigator: Dennis Ross-Degnan, ScD Harvard Medical School and Harvard Pilgrim Health Care Institute
Study Director: Alison Galbraith, MD, MPH Harvard Medical School and Harvard Pilgrim Health Care Institute
  More Information

No publications provided

Responsible Party: Alison Galbraith, Assistant Professor, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT01619098     History of Changes
Other Study ID Numbers: 1R01HS020628
Study First Received: June 11, 2012
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Harvard Pilgrim Health Care:
Hospital readmission
Care transition
Discharge-transfer intervention
Community health worker
Patient Navigatgor

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014