NCT01855022

Brief Summary

The primary purpose of this study is to determine the effectiveness of a hospital-based intervention, using motivational interviewing and interactive voice response (IVR), to reduce hospital readmissions within 90 days of enrollment compared to usual care, for patients with heart failure and chronic obstructive pulmonary disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

Enrollment Period

2.6 years

First QC Date

May 10, 2013

Last Update Submit

May 13, 2013

Conditions

Keywords

Motivational interviewingInteractive voice responseHospital readmission

Outcome Measures

Primary Outcomes (1)

  • Hospital readmission rate (all cause)

    Readmissions within 90 days from discharge of the index admission, for any diagnosis

    90 days

Secondary Outcomes (4)

  • Emergency department visit rate (all cause)

    90 days

  • Hospital days (all cause)

    90 days

  • Mortality

    90 days

  • Patient Activation Measure (PAM) score

    90 days

Other Outcomes (1)

  • Days compliant with interactive voice response system (treatment group only)

    30 days

Study Arms (2)

MI + IVR

EXPERIMENTAL

90 days of motivational interviewing and 30 days of interactive voice response monitoring

Behavioral: MI + IVR

Usual Care

NO INTERVENTION

Usual care that a patient would receive absent the intervention

Interventions

MI + IVRBEHAVIORAL

Participants in the intervention group received motivational interviewing from a registered nurse who is trained and proficient in this behavioral change modality. In addition, participants were instructed to make a daily toll-free call to an automated interactive voice response (IVR) system provided by Pharos Innovations® (Chicago, IL) for 30 days after discharge from the index admission. On each call patients heard a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the IVR system was automatically downloaded to a secure Internet site for review by the nurse at each hospital location.

MI + IVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Index hospitalization for congestive heart failure or chronic obstructive pulmonary disease
  • Access to telephone

You may not qualify if:

  • Cognitive impairment
  • Resident of a nursing home
  • Does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asante Three Rivers Medical Center

Grants Pass, Oregon, 97527, United States

Location

Asante Rogue Regional Medical Center

Medford, Oregon, 97504, United States

Location

Related Publications (1)

  • Linden A, Butterworth S. A comprehensive hospital-based intervention to reduce readmissions for chronically ill patients: a randomized controlled trial. Am J Manag Care. 2014 Oct;20(10):783-92.

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ariel Linden, DrPH

    Linden Consulting Group, LLC

    PRINCIPAL INVESTIGATOR
  • Debra Flickinger, BS

    Asante Health System

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President, Linden Consulting Group, LLC

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 16, 2013

Study Start

June 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations