Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121940
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2005-07-18
Brief Title:
Guided Care Integrating High Tech and High Touch
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Guided Care Integrating High Tech and High Touch
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of the health and well-being of the frail elderly A specially trained registered nurse will work closely with 1-3 primary care physicians to provide the most complex older patients and their unpaid caregivers with health care that is comprehensive coordinated patient-centered and proactive The study will evaluate the effects of Guided Care on
older persons physical and mental health health services utilization quality of care self-efficacy and satisfaction with care
older persons unpaid caregivers burden and
primary care physicians satisfaction with their care of chronically ill patients
older persons physical and mental health health services utilization quality of care self-efficacy and satisfaction with care
older persons unpaid caregivers burden and
primary care physicians satisfaction with their care of chronically ill patients
Detailed Description:
Health care for older Americans with chronic conditions is often fragmented and provider-centric In response a team of investigators at Johns Hopkins University has translated the scientific principles of seven successful innovations into one patient-centered system of care Supported by evidence-based guidelines and state-of-the-art information technology Guided Care is undergoing a 12-month pilot test in older primary care patients with complex needs A specially trained Guided Care nurse GCN based in a primary care practice collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients comprehensive assessment and care planning best practices for chronic conditions self-management healthy lifestyles coordinating care educating and supporting unpaid caregivers and accessing community resources
The proposed multi-site study will measure the effects of Guided Care on the quality and outcomes of care for high-risk older persons their unpaid caregivers and their primary care physicians The panels of 53 physicians in 7 practices will be screened to identify 1350 high-risk older patients After about 850 have given informed consent and baseline interviews clusters of 2-5 physicians at each practice site will be randomized to provide either Guided Care or usual care to their consenting patients Each physician cluster in the Guided Care group will incorporate a GCN into its practice the physician clusters in the control group will not
Interviews and queries of administrative databases will provide evaluative data at baseline and at 12- 24- and 32-month follow-up intervals The primary outcome variables are the participants physical health and mental health SF-36 Summary Scales and health services utilization Secondary outcome variables include the quality of care unpaid caregivers burden self-rated health patient satisfaction and primary care physicians satisfaction Intention-to-treat analyses will have 85 power range of 70-97 to detect clinically meaningful differences between the two groups
The study is designed to facilitate the prompt dissemination of Guided Care if the results of the trial are favorable A stakeholders advisory board representing consumers providers delivery systems insurers regulators and policy-makers will inform the operation and evaluation of the study - and it will facilitate the subsequent dissemination of its tools and technology throughout American health care
The proposed multi-site study will measure the effects of Guided Care on the quality and outcomes of care for high-risk older persons their unpaid caregivers and their primary care physicians The panels of 53 physicians in 7 practices will be screened to identify 1350 high-risk older patients After about 850 have given informed consent and baseline interviews clusters of 2-5 physicians at each practice site will be randomized to provide either Guided Care or usual care to their consenting patients Each physician cluster in the Guided Care group will incorporate a GCN into its practice the physician clusters in the control group will not
Interviews and queries of administrative databases will provide evaluative data at baseline and at 12- 24- and 32-month follow-up intervals The primary outcome variables are the participants physical health and mental health SF-36 Summary Scales and health services utilization Secondary outcome variables include the quality of care unpaid caregivers burden self-rated health patient satisfaction and primary care physicians satisfaction Intention-to-treat analyses will have 85 power range of 70-97 to detect clinically meaningful differences between the two groups
The study is designed to facilitate the prompt dissemination of Guided Care if the results of the trial are favorable A stakeholders advisory board representing consumers providers delivery systems insurers regulators and policy-makers will inform the operation and evaluation of the study - and it will facilitate the subsequent dissemination of its tools and technology throughout American health care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R03HS018256 | AHRQ | NIA- Administrative Supplement | httpsreporternihgovquickSearch5R03HS018256 |
| HS014580 | OTHER | None | None |