IMPACT Plus: The Integrated Complex Care Clinic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01546441
First received: March 1, 2012
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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 Intervention
Aging
Behavioral: interprofessional assessment
Behavioral: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: IMPACT Plus: The Integrated Complex Care Clinic

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Hospital Admissions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will compare the hospitalization rates between those who have received and those who have not received the intervention


Secondary Outcome Measures:
  • Emergency room visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    we will compare the rate of emergency room visits between those who received and those who did not receive the intervention


Estimated Enrollment: 350
Study Start Date: April 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546441

Contacts
Contact: Jason Xin Nie, Bsc 416-735-5048 jason.nie@sunnybrook.ca
Contact: C Shawn Tracy, BA 416-480-5048 shawn.tracy@sunnybrook.ca

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01546441     History of Changes
Other Study ID Numbers: 123
Study First Received: March 1, 2012
Last Updated: March 6, 2012
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

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

ClinicalTrials.gov processed this record on April 23, 2014