IMPACT Plus: The Integrated Complex Care Clinic

March 6, 2012 updated by: Sunnybrook Health Sciences Centre
The "IMPACT Plus" Integrated Complex Care Clinic will create a team model of simultaneous interprofessional consultation and planning that brings together patients with complex or multiple chronic diseases, significant others/caregivers, the primary care team, community care providers and, uniquely, secondary consultation in real time at the primary care site. The purpose of this study is to evaluate whether the IMPACT clinic will reduce admission to hospital and visits to the emergency department (ED) in comparison to a control (usual care) group during a one year period of observation. Chart audits will be conducted on a monthly basis to calculate patients' complexity scores and data on all health services provided during the intervention phase, and compared between the intervention and control group. Additionally, surveys and semi-structured interviews aimed to measure patient, caregiver, and healthcare professional satisfaction of the IMPACT+ prior to and after initial assessment will be collected.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators propose a pragmatic clinical trial to evaluate whether the IMPACT model will reduce hospital admissions and emergency room visits. All patients who meet the eligibility criteria will be randomized to be invited for assessment in IMPACT or be followed in usual care. Each FHT will generate a list of eligible participants drawn from their EMR. Participants will be randomly selected from this list and patients will be invited for an IMPACT assessment. Using data collected at each FHT by a trained chart abstractor on a monthly basis, all hospital admissions and emergency room visits will be counted. As well, all health service utilization for both intervention and control group will be collected. The investigators will compare the proportion of patients admitted to hospital or seen in the emergency room between the intervention and control group for the one year time period. For the secondary objectives of the study, patient and care givers in the intervention group will be asked to complete the Caregiver Strain Index (a standardized and validated instrument) both before the IMPACT intervention and up to 6 months later. The investigators will adapt an existing survey to measure health care professionals' experiences in providing care in an inter-professional team for seniors with complex chronic illness. The Dimensions of Teamwork Survey, will be administered at each FHT at the beginning of the study and at the end of the intervention period in order to assess team function and stability of team function. Lastly, interviews with patients, caregivers, and healthcare professionals will be conducted to explore satisfaction with the IMPACT experience and subsequent care as well as self-efficacy in managing their care. The interviews will be audio-recorded and professionally transcribed. Key themes emerging from the qualitative data will be identified. Preliminary findings will be subjected to a process of member checking/respondent validation to ensure accuracy of interpretation.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The inclusion criteria are as follows:

    • 65 years of age or older;
    • three or more chronic diseases requiring monitoring and treatment (or two chronic diseases when one is frequently unstable);
    • five or more long-term medications;
    • a minimum of one ADL limitation; and
    • approval by family physician as suitable for IMPACT assessment.

Exclusion Criteria:

  • The exclusion criteria are as follows:

    • previous IMPACT assessment; or
    • deemed not suitable by family physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interprofessional assessment
patients receive an interprofessional assessment in a team environment
assessment by interprofessional team
Active Comparator: usual care
Usual care in family practice
usual care in primary care clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Admissions
Time Frame: 6 months
We will compare the hospitalization rates between those who have received and those who have not received the intervention
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency room visits
Time Frame: 6 months
we will compare the rate of emergency room visits between those who received and those who did not receive the intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 123 (Giresun University Scientific Research Project)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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