- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01546441
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
Intervention / Treatment
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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