AzTrials
AzTrials

Congestive Heart Failure (CHF)NCT01855022

A Trial to Reduce Readmissions Using Motivational Interviewing and Interactive Voice Response

A study testing MI + IVR in people with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD), run by Asante Health System at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MI + IVR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
2 sitesUnited States
Study dates
Jun 2010to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Asante Three Rivers Medical Center

    Grants Pass, Oregon, 97527

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504

Other trials in United States

About this study

Official title: A Hospital-based Intervention Using Motivational Interviewing and Interactive Voice Response to Reduce Readmissions in Congestive Heart Failure and Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial

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.

Read the detailed description

Recruitment and Enrollment of Participants:

Consented participants who met the criteria for either CHF or COPD, as identified via the daily hospital census report and using codes from the International Classification of Diseases, 9th Revision were randomized to either the treatment or control group. Participants who had mental or physical impairments that would prevent them from using the interactive voice response (IVR) system or communicating with the health coach were excluded. A study health coach visited the participant in their hospital room and, after explaining the study protocol, asked if they would like to participate and then consented them into the study if appropriate. After the participant signed the written consent, the health coach provided all participants with the 13-question set from the PAM and recorded the data. Lastly, the health coach assigned the study participant into either the treatment or control group using a pre-determined randomization system.

Description of the Intervention:

Control Group Activities:

Study staff did not interact with control group participants beyond the consenting and collection of PAM data, with the health coaches only interacting at baseline. Usual care occurred in the form of typical discharge planning by hospital staff, which consisted of providing brief traditional patient education before the participant was discharged.

Treatment Group Activities:

The intervention for the treatment group consisted of three components - Interactive Voice response (IVR), MI-based health coaching, and notification to the PCP.

First, participants used an interactive, voice telephony and web-based database system to monitor and improve their self-care behaviors and clinical status in the 30 days post discharge. Program participants were given the call-in number and followed through their first interaction with the system while they were still in the hospital, thereby ensuring their proficiency in the IVR functionality after discharge. Daily thereafter, participants were instructed to call in to the Tel-Assurance system using their cell phone, land-line, or via the internet. Participants entered into the Tel-Assurance system using a touch-tone phone or web browser and answered a set of daily survey questions that are customized to assess worsening of symptoms of their chronic disease. Information from the IVR system was automatically downloaded to a secure Internet site for review by the health coaches. The data was checked frequently and was displayed in such a way that participants' with "variances" were displayed at the top of the screen, flagging the coach's attention. Participants who triggered an alert for symptoms or out-of-range biometric values (such as increased body weight for congestive heart failure [CHF], or low forced expiratory volume for chronic obstructive pulmonary disease [COPD]), received a "same-day" follow-up call from the program health coach (who is also a registered nurse). If participants missed a daily call, they received an automated reminder call from the IVR service to encourage adherence. The health coaches also monitored adherence to the system and would call a participant if s/he had missed more than one day. Participants in the study were instructed that the IVR system was not to be used for urgent/emergent matters. They were also encouraged to call their health coach to discuss their symptoms or condition.

Second, participants received motivational interviewing (MI)-based health coaching, commencing while they are still in the hospital prior to discharge and for 90-days post-discharge. Motivational interviewing is a collaborative goal-oriented style of communication with particular attention to the language of change. It is designed to strengthen personal motivation of and commitment to a specific goal by eliciting and exploring the person's own reason for change within an atmosphere of acceptance and compassion. MI is an evidence-based patient-centered approach with four main principles: partnership, acceptance, compassion and evocation. There is a health coaching framework that provides structure for a provider to assist in being time-efficient in the coaching session: engaging, focusing, evoking, planning. In a review of literature of health coaching approaches, MI was found to be the only health coaching technique to be fully described and consistently demonstrated as causally and independently associated with positive behavioral outcomes. Health coaches received rigorous training in the MI approach and regular monitoring. Another optimal feature of MI is that there are validated standardized tools that have been developed to assess the fidelity of the provider/patient session to the approach. The Motivational Interviewing Treatment Integrity (MITI) tool was used during the training and active phases of the study to ensure that the coaches had achieved/maintained the level of proficiency that has been linked to clinical outcomes. Starting the health coaching process while the participant was still in the hospital was an attempt to ease the transition to the home by helping the participant understand the treatment plan and empower him/her to communicate in case there was a shift in health status that could result in a readmission. Continued health coaching sessions with the participant throughout the 90-day study period were provided to address the participant's activation level and, thus, the ability to self-manage his/her condition better. This approach was individually tailored to each participant based on their initial PAM score. In addition, the health coach discussed typical challenges with participants that they may face when recuperating from the hospital stay, such as understanding and following their treatment plan. Lastly, participants were empowered to take an active role in managing their condition and health, including appropriate and timely interaction with their PCP when a problem arose that could lead to a deterioration of their health status. If the participant was readmitted to the hospital during the study period, the health coach provided follow up with the participant and the PCP to determine the best course of action. In addition, study staff determined the cause of the readmission and recorded it for analysis, which was performed and discussed by study staff on an on-going basis throughout the study period.

Third, the investigators attempted to engage the participant's primary care provider (PCP) in the care plan by directly providing them with the discharge summary upon the participant's release from the hospital. Informing the PCP of the participant's hospitalization should have increased the likelihood the PCP's office would be proactive in reaching out to the participant to schedule a follow-up office visit. The provider was encouraged to: (a) schedule an office visit with the participant; and (b) to communicate directly with the health coach to suggest areas of focus for the care plan. The investigators were not successful in getting any of the PCP's to contact the health coaches to discuss their patient's progress or health plans.

Outcome Measures:

All outcomes were analyzed separately for each of the two conditions, congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD). The investigators' primary outcomes for this study were readmissions, hospital days, and emergency department visits occurring within 90 days of discharge from the index admission. The investigators' secondary outcomes were 90 day mortality and patient activation measure scores at 30 and 90 days. The investigators further review statistics relating to the IVR technology used to track treatment patients' disease specific symptoms. All analyses were conducted using the intention to treat approach.

Being tested
MI + IVR
Keywords
Motivational interviewing, Interactive voice response, Hospital readmission
Medical subject headings
Heart Failure, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MI + IVRBehavioural

    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.

Study groups in NCT01855022
Study groupRoleWhat they receive
MI + IVRExperimental90 days of motivational interviewing and 30 days of interactive voice response monitoring
Receives: Behavioral: MI + IVR
Usual CareNo interventionUsual care that a patient would receive absent the intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital readmission rate (all cause)

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

    Measured: 90 days

Secondary outcomes (4)
  1. Emergency department visit rate (all cause)

    Visits to the emergency department within 90 days from discharge of the index admission, for any diagnosis

    Measured: 90 days

  2. Hospital days (all cause)

    The total number of hospitals days for those readmissions occurring in the 90 day period after discharge of the index admission

    Measured: 90 days

  3. Mortality

    Deaths occurring within 90 days of discharge of the index admission

    Measured: 90 days

  4. Patient Activation Measure (PAM) score

    Patient Activation Measure (PAM) score at 30 and 90 days post discharge of the index admission

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study startJun 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855022
Sponsor's protocol ID
H2AIT16621-B
Status last verified
May 2013
First submitted
10 May 2013
Last updated
16 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25365681

Questions about this trial

What is this clinical trial studying?

A study testing MI + IVR in people with Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD), run by Asante Health System at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital readmission rate (all cause) (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855022, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in