Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

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

Intervention / Treatment
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* Other: Patient Navigator
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Navigator<br>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<br>* 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.<br>Other: Usual care<br>* 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<br>|
| No Intervention: Usual Care<br>Home care plan at discharge, outreach phone call from RN at patient's primary care clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission | Inpatient readmission for any reason within 30 days of the index discharge; | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary and specialty care visit | 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 | 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 | Any ED visit within 30 days post-discharge; Number of ED visits within 30 days post-discharge | 30 days | 
| Adherence to medication instructions in Home Care Plan | A binary indicator of patient adherence to prescription medication instruction in the discharge plan | Up to 30 days post-discharge | 
| Patient preparedness for discharge; problems with post-discharge care | 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 | Up to 30 days post-discharge | 
| Costs | 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. | within 180 days of discharge | 
| hospital readmission | 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 | 15 and 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital readmission, Care transition, Discharge-transfer intervention, Community health worker, Patient Navigatgor