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Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

Primary Purpose

Hospital Readmission, Post-discharge Care Transitions, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigator
Usual care
Sponsored by
Alison Galbraith
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospital Readmission focused on measuring Hospital readmission, Care transition, Discharge-transfer intervention, Community health worker, Patient Navigatgor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cambridge Hospital
  • Whidden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Navigator

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Emergency department visit
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
A binary indicator of patient adherence to prescription medication instruction in the discharge plan
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
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.
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

Full Information

First Posted
June 11, 2012
Last Updated
January 21, 2014
Sponsor
Alison Galbraith
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Cambridge Health Alliance, Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT01619098
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alison Galbraith
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Cambridge Health Alliance, Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1510 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Navigator
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Home care plan at discharge, outreach phone call from RN at patient's primary care clinic
Intervention Type
Other
Intervention Name(s)
Patient Navigator
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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
Primary Outcome Measure Information:
Title
Hospital readmission
Description
Inpatient readmission for any reason within 30 days of the index discharge;
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Primary and specialty care visit
Description
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
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
Title
Emergency department visit
Description
Any ED visit within 30 days post-discharge; Number of ED visits within 30 days post-discharge
Time Frame
30 days
Title
Adherence to medication instructions in Home Care Plan
Description
A binary indicator of patient adherence to prescription medication instruction in the discharge plan
Time Frame
Up to 30 days post-discharge
Title
Patient preparedness for discharge; problems with post-discharge care
Description
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
Time Frame
Up to 30 days post-discharge
Title
Costs
Description
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.
Time Frame
within 180 days of discharge
Title
hospital readmission
Description
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
Time Frame
15 and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Ross-Degnan, ScD
Organizational Affiliation
Harvard Medical School and Harvard Pilgrim Health Care Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alison Galbraith, MD, MPH
Organizational Affiliation
Harvard Medical School and Harvard Pilgrim Health Care Institute
Official's Role
Study Director
Facility Information:
Facility Name
Cambridge Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Facility Name
Whidden Hospital
City
Everett
State/Province
Massachusetts
ZIP/Postal Code
02149
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25617166
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.
Results Reference
derived

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Evaluating Sequential Strategies to Reduce Readmission in a Diverse Population

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