ElderlyMacyCoVENCT01080235
Improving Quality of Care for Elderly Patients in the Educational Setting
A study testing ABIM Care of Vulnerable Elderly Practice Improvement Module and Geriatric and Quality Improvement toolkit in people with Elderly, run by American Board of Internal Medicine.
Trial summary
This is a multi-center exploratory study (each site got local IRB approval) of the impact of an educational toolkit combined with a practice-performance self-evaluation instrument (ABIM Care of the Vulnerable Elderly Practice Improvement Module) on trainee knowledge, skills, and attitudes about practice-based learning… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- ABIM Care of Vulnerable Elderly Practice Improvement Module and Geriatric and Quality Improvement toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under age 65
- Patients who have a terminal illness
- Patients with a life expectancy of less than one-year
About this study
Official title: Improving Quality of Care for Elderly Patients in the Educational Setting: A Multicenter Exploratory Study of Quality Improvement
This is a multi-center exploratory study (each site got local IRB approval) of the impact of an educational toolkit combined with a practice-performance self-evaluation instrument (ABIM Care of the Vulnerable Elderly Practice Improvement Module) on trainee knowledge, skills, and attitudes about practice-based learning and improvement and systems-based practice in the care of elderly patients.
Read the 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.
- Conditions
- Elderly
- Being tested
- ABIM Care of Vulnerable Elderly Practice Improvement Module, Geriatric and Quality Improvement toolkit
- Keywords
- quality improvement, geriatric care, residency training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABIM Care of Vulnerable Elderly Practice Improvement ModuleOther
Also called Quality improvement module, Practice improvemnet module, Self-assesment in pratice based learning and improvement, PIM in residency
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.
Geriatric and Quality Improvement toolkitOther
Also called The Improvement Guide by Langley and Nolan, Geriatrics at Your Fingertips, ACOVE Physician Education Program DVD, Online resources
A resource toolkit about geriatrics and quality improvement was given to both study arms.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Other: Geriatric and Quality Improvement toolkit |
| 2 | Other | 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. Receives: Other: ABIM Care of Vulnerable Elderly Practice Improvement Module; Other: Geriatric and Quality Improvement toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practice Improvement Module (PIM) quality impact
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.
Measured: 2 years
Secondary outcomes (7)
Assess satisfaction
Assess resident and faculty satisfaction with the Care of the Vulnerable Elderly Practice Improvement Module.
Measured: 2 years
Assess feasibility
Assess the feasibility of conducting surveys of elderly patients in the residency training setting.
Measured: 2 years
Assess use of geriatric and quality improvement toolkit
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.
Measured: 2 years
Assess effects of disparities on elder care
Assess the effects of health disparities on the care of elderly patients in a training setting.
Measured: 2 years
Assess barriers in training setting
Assess structural barriers to providing quality care for vulnerable elderly in diverse training settings
Measured: 2 years
Practice Improvement Module impact for knowledge, skills, and attitudes
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.
Measured: 2 years
Practice Improvement Module impact vs traditional
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Board of Internal Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Josiah Macy, Jr. Foundation
- Investigators
- Eric S Holmboe, MD, Principal investigator, American Board of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080235
- Sponsor's protocol ID
- CPS 485
- Acronym
- MacyCoVE
- Status last verified
- Mar 2010
- First submitted
- 1 Mar 2010
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care for Elderly Patients in the Educational Setting: A Multicenter Exploratory Study of Quality Improvement
- ClinicalTrials.gov ID
- NCT01080235
- Acronym / sponsor ID
- MacyCoVE / CPS 485
- Conditions
- Elderly
- Keywords
- quality improvement, geriatric care, residency training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- American Board of Internal MedicineUniversity, hospital or other
- Collaborators
- The Josiah Macy, Jr. Foundation
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center exploratory study (each site got local IRB approval) of the impact of an educational toolkit combined with a practice-performance self-evaluation instrument (ABIM Care of the Vulnerable Elderly Practice Improvement Module) on trainee knowledge, skills, and attitudes about practice-based learning and improvement and systems-based practice in the care of elderly patients.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Geriatric and Quality Improvement toolkitControl. 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. |
| 2 | Other | Other: ABIM Care of Vulnerable Elderly Practice Improvement Module, Other: Geriatric and Quality Improvement toolkitThere 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under age 65
- Patients who have a terminal illness
- Patients with a life expectancy of less than one-year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABIM Care of Vulnerable Elderly Practice Improvement ModuleAlso: Quality improvement module, Practice improvemnet module, Self-assesment in pratice based learning and improvement, PIM in residencyThe 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 | 2 |
| Geriatric and Quality Improvement toolkitAlso: The Improvement Guide by Langley and Nolan, Geriatrics at Your Fingertips, ACOVE Physician Education Program DVD, Online resourcesA resource toolkit about geriatrics and quality improvement was given to both study arms. | Other | 1, 2 |
Primary outcome
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.
7 secondary outcomes
Assess satisfaction
Time frame: 2 years
Assess feasibility
Time frame: 2 years
Assess use of geriatric and quality improvement toolkit
Time frame: 2 years
Assess effects of disparities on elder care
Time frame: 2 years
Assess barriers in training setting
Time frame: 2 years
Practice Improvement Module impact for knowledge, skills, and attitudes
Time frame: 2 years
Practice Improvement Module impact vs traditional
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2010.
- ABIM website. Please go to "Helpful Resources" under "Residency Training" to see more information about the CoVE PIM.Link provided by the sponsor.
Related trials for Elderly
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric S Holmboe, MD principal investigator
American Board of Internal Medicine
Questions about this trial
What is this clinical trial studying?
A study testing ABIM Care of Vulnerable Elderly Practice Improvement Module and Geriatric and Quality Improvement toolkit in people with Elderly, run by American Board of Internal Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practice Improvement Module (PIM) quality impact (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2010.