Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619098
• Other study ID #: 1R01HS020628
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: January 21, 2014
• Start date: October 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1510
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Heart Failure
• Hospital Readmission
• Lung Diseases, Obstructive
• Post-discharge Care Transitions
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Cambridge Hospital	Cambridge	Massachusetts
United States	Whidden Hospital	Everett	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Alison Galbraith	Agency for Healthcare Research and Quality (AHRQ), Cambridge Health Alliance, Harvard School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmission	Inpatient readmission for any reason within 30 days of the index discharge;	30 days	No
Secondary	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	No
Secondary	Emergency department visit	Any ED visit within 30 days post-discharge; Number of ED visits within 30 days post-discharge	30 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No