Chronic DiseaseNCT04456725
Intensive Management of At-risk Patients
A study testing Intensive management in people with Chronic Disease, run by CareMore Health, San Bernardino.
Trial summary
The purpose of this study is to assess if intensive management of at-risk participants, utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring, will lead to better patient outcomes than usual care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Intensive management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- enrolled in hospice
- enrolled in Institutional Special Needs Plan
- primary patient of study investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intensive Management of At-risk Patients: a Randomized Controlled Trial
The purpose of this study is to assess if intensive management of at-risk participants, utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring, will lead to better patient outcomes than usual care.
Read the detailed description
At-risk participants will be randomized 1:1 to either usual care or intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring for 6 months. Participants in the intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them with the support of the study team. Staff will focus on contacting all patients within one week of any emergency department visit or hospital discharge, contacting all highest-risk participants weekly and all participants monthly, and completing high-priority tasks for participant care within one week. The primary outcomes of this quality improvement study are inpatient bed days and number of inpatient admissions.
- Conditions
- Chronic Disease
- Being tested
- Intensive management, Control
- Keywords
- high need high cost, population health, care management, quality improvement, ambulatory care, primary care, readmission prevention
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive managementBehavioural
The intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team.
ControlBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Usual care group Receives: Behavioral: Control |
| Intervention | Experimental | Intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring. Receives: Behavioral: Intensive management |
What is being measured
The primary outcome is the main question the study is designed to answer.
inpatient bed days
number of total participants' days of care in an inpatient setting
Measured: 6 months
inpatient admissions
total number of participants' inpatient admissions
Measured: 6 months
Secondary outcomes (14)
ED visits
participants' total emergency department visits
Measured: 6 months
30-day readmissions
participants' total inpatient readmissions within 30 days
Measured: 30 days
180-day readmissions
participants' total inpatient readmissions within 180 days
Measured: 180 days
ACSC admits
participants' inpatient admissions for ambulatory care sensitive conditions
Measured: 6 months
inpatient plus SNF bed days
number of total days of participants' care in an inpatient or skilled nursing facility setting
Measured: 6 months
cost
participants' total medical expenditures
Measured: 6 months
delta MLR
average change in each participant's medical loss ratio
Measured: 6 months
average percent post-acute contact within 1 week
average percent of participants contacted within 1 week of emergency department visit, hospital or skilled-nursing facility discharge
Measured: 1 week
average percent of high-priority tasks completed within 1 week
average percent of participant care tasks designated as high-priority that are completed within 1 week of being assigned
Measured: 1 week
average percent of Gold patients contacted weekly
average percent of participants in Gold tier contacted every week
Measured: 1 week
average percent of participants contacted monthly
average percent of participants contacted every 4 weeks
Measured: 1 month
average change in percent of high-priority HEDIS gaps
average change in percent of open Healthcare Effectiveness Data and Information Set (HEDIS) measures that are high-priority, meaning statin use in diabetics and cardiovascular disease; medication adherence for oral diabetes, hypertension and statin; diabetes A1c control; and blood pressure control
Measured: 6 months
average change in staff satisfaction score
average difference in sum of Likert scale responses to staff satisfaction survey
Measured: 6 months
average change in participant satisfaction score
average difference in sum of Likert scale responses to participant satisfaction survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareMore Health, San Bernardino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Bixenstine, CareMore Health, San Bernardino
- Investigators
- Paul Bixenstine, MD, Principal investigator, CareMore Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456725
- Sponsor's protocol ID
- 001
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Management of At-risk Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04456725
- Acronym / sponsor ID
- 001
- Conditions
- Chronic Disease
- Keywords
- high need high cost, population health, care management, quality improvement, ambulatory care, primary care, readmission prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- CareMore Health, San BernardinoUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Jul 2020 (actual)
- 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 this study is to assess if intensive management of at-risk participants, utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring, will lead to better patient outcomes than usual care.
Detailed description
At-risk participants will be randomized 1:1 to either usual care or intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring for 6 months. Participants in the intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them with the support of the study team. Staff will focus on contacting all patients within one week of any emergency department visit or hospital discharge, contacting all highest-risk participants weekly and all participants monthly, and completing high-priority tasks for participant care within one week. The primary outcomes of this quality improvement study are inpatient bed days and number of inpatient admissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlUsual care group |
| Intervention | Experimental | Behavioral: Intensive managementIntensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- enrolled in hospice
- enrolled in Institutional Special Needs Plan
- primary patient of study investigator
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 |
|---|---|---|
| Intensive managementThe intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team. | Behavioural | Intervention |
| ControlUsual care | Behavioural | Control |
Primary outcome
inpatient bed days
Time frame: 6 months
number of total participants' days of care in an inpatient setting
inpatient admissions
Time frame: 6 months
total number of participants' inpatient admissions
14 secondary outcomes
ED visits
Time frame: 6 months
30-day readmissions
Time frame: 30 days
180-day readmissions
Time frame: 180 days
ACSC admits
Time frame: 6 months
inpatient plus SNF bed days
Time frame: 6 months
cost
Time frame: 6 months
delta MLR
Time frame: 6 months
average percent post-acute contact within 1 week
Time frame: 1 week
average percent of high-priority tasks completed within 1 week
Time frame: 1 week
average percent of Gold patients contacted weekly
Time frame: 1 week
average percent of participants contacted monthly
Time frame: 1 month
average change in percent of high-priority HEDIS gaps
Time frame: 6 months
average change in staff satisfaction score
Time frame: 6 months
average change in participant satisfaction score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Paul Bixenstine, MD principal investigator
CareMore Health
Questions about this trial
What is this clinical trial studying?
A study testing Intensive management in people with Chronic Disease, run by CareMore Health, San Bernardino.
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 0 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: status not confirmed, as of the sponsor's last update on 2 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul J Bixenstine, MD (909-296-8800, paul.bixenstine@caremore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inpatient bed days (time frame: 6 months). The study lists 2 primary outcomes in all. 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 2 Jul 2020.