- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080235
Improving Quality of Care for Elderly Patients in the Educational Setting (MacyCoVE)
Improving Quality of Care for Elderly Patients in the Educational Setting: A Multicenter Exploratory Study of Quality Improvement
Study Overview
Status
Conditions
Detailed Description
This is a longitudinal quasi-experimental study. Programs will be randomly assigned to either the comparison or intervention group, stratified based on program size, affiliation, geographic location, and presence of a geriatrics fellowship program.
Faculty will be trained in use of the CoVE PIM and in the development and implementation of a quality improvement plan. Residents in the intervention group will perform the medical record audit portion of the CoVE PIM. Patient surveys will be distributed by the residency clinics. The goal will be to audit the medical records of patients who complete the patient survey. Residents in intervention groups will participate in completing the practice system survey as a group. Finally, the residents in the intervention group will use the data from the medical record audit, patient survey, and practice system survey, working with faculty, to develop a quality improvement project to improve care for their geriatric patients.
Local medical record abstractors will be trained to perform a separate medical record audit of a random sample of the same patients identified by the residents for both the intervention and comparison groups. The abstractors will perform both a baseline and follow-up audit and will target the same patients who are still living from the baseline period. The follow-up audit will occur 12 months after completion of the initial PIM data collection phase, or approximately 18 months after the initiation of the study.
Evaluation of study outcomes will occur on the program, resident, and patient level.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All residents at a resident clinic site
- Preceptors that are selected by the Champion for a particular resident clinic site
- Patients age 65 years or older for whom any of the following measures would be appropriate: falls prevention, identifying urinary incontinence, screening for depression and cognitive impairment, and providing other preventive care.
- Patients who have been in the practice for at least one year
- Patients who are ambulatory
- Patients who have been seen at least once by the practice within the past 12 months.
Exclusion Criteria:
- Patients under age 65
- Patients who have a terminal illness
- Patients with a life expectancy of less than one-year
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
Control.
Forty-two residency programs randomly assigned and stratified according to size, affiliation, geographic location, and presence of geriatrics fellowship.
Twenty-one in the control arm.
This group will use PIM as a data collection tool during baseline and follow-up time (i.e.
audit of 50-75 charts, survey from 50-75 patients, and one system survey).
They will not see the summary results of the data collected; they will not be required to complete a quality improvement plan based on the summary data.
Local researchers will collect the data.
Individual trainees will not do data collection or audits.
At both baseline and follow-up, trainees will complete pre and post test surveys of 1) geriatric and 2) quality improvement knowledge, skills, and attitudes.
|
A resource toolkit about geriatrics and quality improvement was given to both study arms.
Other Names:
|
|
OTHER: 2
There are 21 residency programs in intervention arm who will 1) use PIM as a data collection tool (local researchers will audit 50-75 charts, survey 50-75 patients, and complete one system survey); 2) Each trainee will audit of up to five patient charts; collect 5 patient surveys; and complete the system survey as a group; 3) Summary data from these data streams will be reviewed by group; then they will design and implement a quality improvement plan; 4) At follow-up, local researchers will re-audit same 50-75 charts, collect surveys from same 50-75 patients, and complete one system survey.
At baseline and follow-up, trainees and faculty will complete surveys of geriatric and quality improvement knowledge, skills, and attitudes.
|
A resource toolkit about geriatrics and quality improvement was given to both study arms.
Other Names:
The ABIM CoVE PIM is a practice-performance self-evaluation instrument.
It is a web-based tool based on nationally recognized guidelines that uses chart abstraction, patient surveys, and a practice system survey in order to generate a performance report focused on a key aspects of care for vulnerable elderly.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Practice Improvement Module (PIM) quality impact
Time Frame: 2 years
|
Assess the impact of the Care of the Vulnerable Elderly (CoVE) Practice Improvement Module to improve the quality of care received by elderly patients in the residency ambulatory setting.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess satisfaction
Time Frame: 2 years
|
Assess resident and faculty satisfaction with the Care of the Vulnerable Elderly Practice Improvement Module.
|
2 years
|
|
Assess feasibility
Time Frame: 2 years
|
Assess the feasibility of conducting surveys of elderly patients in the residency training setting.
|
2 years
|
|
Assess use of geriatric and quality improvement toolkit
Time Frame: 2 years
|
Assess the use and impact of an educational toolkit for teaching geriatric quality of care.
The analysis will specifically focus on what components of the toolkit are used by programs.
|
2 years
|
|
Assess effects of disparities on elder care
Time Frame: 2 years
|
Assess the effects of health disparities on the care of elderly patients in a training setting.
|
2 years
|
|
Assess barriers in training setting
Time Frame: 2 years
|
Assess structural barriers to providing quality care for vulnerable elderly in diverse training settings
|
2 years
|
|
Practice Improvement Module impact for knowledge, skills, and attitudes
Time Frame: 2 years
|
Assess the impact of the Care of the Vulnerable Elderly Practice Improvement Module to improve the knowledge, skills, and attitudes of residents in the care of specific geriatric conditions.
|
2 years
|
|
Practice Improvement Module impact vs traditional
Time Frame: 2 years
|
Assess the impact of the Care of the Vulnerable Elderly Practice Improvement Module compared to a traditional educational intervention on residents' knowledge of and attitudes about practice-based learning and improvement, systems based practice, and geriatric care guidelines.
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eric S Holmboe, MD, American Board of Internal Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CPS 485
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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