Chronic DiseaseNCT00121940
Guided Care: Integrating High Tech and High Touch
A study testing Guided Care in people with Chronic Disease, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Guided Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 904 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2009
- 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
- Over 65
- Insured by KPMAG, USFHP/TRICARE, or Medicare FFS
- High likelihood of use of services in the coming year based on predictive modeling using current year's health care expenses
Who cannot join
- Moving out of area
- Currently assigned to case manager/in case management program
- Cognitive impairment and no legal representative
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Guided Care
- Keywords
- Chronic Disease, Nurses, Caregivers, Support Groups
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided CareBehavioural
Specially trained registered nurse (Guided Care Nurse) 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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Care | Experimental | Not described Receives: Behavioral: Guided Care |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Physical Health Summary Scale
Measured: Baseline, 6, 18, and 32 months
SF-36 Mental Health Summary Scale
Measured: Baseline, 6, 18, and 32 months
Health Services Utilization
Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data
Measured: Baseline, 8, 20, and 32 months
Secondary outcomes (5)
Perceived Quality of Care
Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS)
Measured: Baseline, 6, 18, and 32 months
Patient Satisfaction with Care
Measured: Baseline, 6, 18, and 32 months
Physician Satisfaction with Care
Measured: Baseline, 12, 24, and 36 months
Caregiver Burden
Using Modified Caregiver Strain Index
Measured: Baseline, 6, and 18 months
Self-rated Health
Measured: Baseline, 6, 18, and 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startFeb 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), National Institute on Aging (NIA), The John A. Hartford Foundation, The Jacob and Valeria Langeloth Foundation
- Responsible party
- Principal investigator, Charles Boult, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Charles Boult, MD, MPH, MBA, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121940
- Sponsor's protocol ID
- R01HS014580-01A1
- Other IDs
- HS014580, 5R03HS018256
- Status last verified
- Apr 2012
- First submitted
- 18 Jul 2005
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Boult C, Reider L, Leff B, Frick KD, Boyd CM, Wolff JL, Frey K, Karm L, Wegener ST, Mroz T, Scharfstein DO. The effect of guided care teams on the use of health services: results from a cluster-randomized controlled trial. Arch Intern Med. 2011 Mar 14;171(5):460-6. doi: 10.1001/archinternmed.2010.540.
PubMed 21403043
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Care: Integrating High Tech and High Touch
- ClinicalTrials.gov ID
- NCT00121940
- Acronym / sponsor ID
- R01HS014580-01A1
- Conditions
- Chronic Disease
- Keywords
- Chronic Disease, Nurses, Caregivers, Support Groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 904 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), National Institute on Aging (NIA), The John A. Hartford Foundation, The Jacob and Valeria Langeloth Foundation
- Study start
- Feb 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Jul 2005 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Care | Experimental | Behavioral: Guided Care |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Over 65
- Insured by KPMAG, USFHP/TRICARE, or Medicare FFS
- High likelihood of use of services in the coming year based on predictive modeling using current year's health care expenses
Key exclusion criteria (3 listed)
- Moving out of area
- Currently assigned to case manager/in case management program
- Cognitive impairment and no legal representative
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 |
|---|---|---|
| Guided CareSpecially trained registered nurse (Guided Care Nurse) 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. | Behavioural | Guided Care |
Primary outcome
SF-36 Physical Health Summary Scale
Time frame: Baseline, 6, 18, and 32 months
SF-36 Mental Health Summary Scale
Time frame: Baseline, 6, 18, and 32 months
Health Services Utilization
Time frame: Baseline, 8, 20, and 32 months
Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data
5 secondary outcomes
Perceived Quality of Care
Time frame: Baseline, 6, 18, and 32 months
Patient Satisfaction with Care
Time frame: Baseline, 6, 18, and 32 months
Physician Satisfaction with Care
Time frame: Baseline, 12, 24, and 36 months
Caregiver Burden
Time frame: Baseline, 6, and 18 months
Self-rated Health
Time frame: Baseline, 6, 18, and 32 months
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 20 Apr 2012.
- Derived from this study: PubMed 21403043Boult C, Reider L, Leff B, Frick KD, Boyd CM, Wolff JL, Frey K, Karm L, Wegener ST, Mroz T, Scharfstein DO. The effect of guided care teams on the use of health services: results from a cluster-randomized controlled trial. Arch Intern Med. 2011 Mar 14;171(5):460-6. doi: 10.1001/archinternmed.2010.540.
- Related InfoLink provided by the sponsor.
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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.
Charles Boult, MD, MPH, MBA principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Care in people with Chronic Disease, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 3 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 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
SF-36 Physical Health Summary Scale (time frame: Baseline, 6, 18, and 32 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00121940, which also lists 1 linked publication.
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 20 Apr 2012; AzTrials last refreshed its copy on 2 Nov 2026.