IMPACT Plus: The Integrated Complex Care Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546441
Recruitment Status : Unknown
Verified March 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:
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.

Condition or disease Intervention/treatment
Aging Behavioral: interprofessional assessment Behavioral: usual care

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  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: IMPACT Plus: The Integrated Complex Care Clinic
Study Start Date : April 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546441

Contact: Jason Xin Nie, Bsc 416-735-5048
Contact: C Shawn Tracy, BA 416-480-5048

Sponsors and Collaborators
Sunnybrook Health Sciences Centre

Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT01546441     History of Changes
Other Study ID Numbers: 123
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Sunnybrook Health Sciences Centre:
primary care
interprofessional care