Clinical trial NCT01619098: Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population
Official title: Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Cambridge Health Alliance
name: Harvard School of Public Health (HSPH)
First posted: 2012-06-14
Enrollment: 1510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Hospital readmission
timeFrame: 30 days
Secondary outcomes:
measure: Primary and specialty care visit
timeFrame: 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
measure: Emergency department visit
timeFrame: 30 days
measure: Adherence to medication instructions in Home Care Plan
timeFrame: Up to 30 days post-discharge
measure: Patient preparedness for discharge; problems with post-discharge care
timeFrame: Up to 30 days post-discharge
measure: Costs
timeFrame: within 180 days of discharge
measure: hospital readmission
timeFrame: 15 and 180 days
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Cambridge Hospital
state: Massachusetts
city: Everett
country: United States
facility: Whidden Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School and Harvard Pilgrim Health Care Institute
name: Dennis Ross-Degnan, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School and Harvard Pilgrim Health Care Institute
name: Alison Galbraith, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.