- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811173
Comprehensive-Care for Multimorbid Adults Effectiveness Study (CCMAP)
The Clalit Comprehensive-Care for Multimorbid Adults Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with multi-morbidities pose a significant challenge for healthcare organizations because they require continuity of care among a wide range of long-term therapeutic paradigms for many different types of diseases. The current study is based on a treatment model entailing a nurse-primary care physician team to provide care for patients with multiple morbidities.
Patients in the intervention group who agreed and signed the consent form to participate in the study will receive treatment by the physician - nurse team in accordance with the components of the Clalit's Comprehensive Care for Mutlimorbid Adults Project model. Components of the intervention include:
- Comprehensive assessment of the patient's and family's needs
- Coordinated care plan based on integrated care guides
- "Multimorbid Action Plan" for patients
- All-inclussive patient centered care and caregiver support
- Proactive monitoring according to the plan.
Patients in the control groups will receive usual care in their primary care clinics. The Usual Care Survey control group will complete study questionnaires at 6, 12 and 24 months after enrollement.
The Usual Care Blinded group will be assessed only retrospectively based on deidentified information from Clalit's admistrative databases.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ashdod, Israel
- Ashdod A
-
Ashdod, Israel
- Ashdod D
-
Azur, Israel
- Azur
-
Bat YAm, Israel
- Arlozorov
-
Bat Yam, Israel
- Hashikma
-
Bat Yam, Israel
- Ramat Yosef
-
Bat Yam, Israel
- Sokolov
-
Hulon, Israel
- Halutz
-
Hulon, Israel
- Shikun Ammi
-
Lod, Israel
- Lod Center
-
Ramla, Israel
- Ramla Ztafon
-
Rishon Lezion, Israel
- Balfur
-
Rishon Lezion, Israel
- Migdal HaIr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ACG system high risk probabilty score - 4% Highest Risk Score
- Age 18 and older
- 2 or more chronic conditions
Exclusion Criteria:
- Patients already included in a controlled disease management program (e.g., COPD disease management and telehealth).
- Participation in any medical research.
- Confined to bed.
- Inpatient nursing care, nursing homes.
- Kidney, liver or heart transplant patients.
- Active (receipt of oncology chemotherapy , radiotherapy or other oncology treatment during the past 3 years).
- Dialysis patients.
- Clalit Healthcare Services employees.
- Patients with major active mental illness, such as schizophrenia.
- Cognitive failure.
- Non Hebrew speaking patients without Hebrew speaking primary informal caregiver.
- Bedridden patients
- Housebound patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Nurse-physician comprehensive care
Comprehensive self management support and care coordination by a nurse-primary care physician team
|
Components of the intervention include:
|
NO_INTERVENTION: Usual care survey control group
Patients will receive usual primary care and asked to complete questionnaires on four time points throughout the study
|
|
NO_INTERVENTION: Usual care blinded control group
Patients will receive usual primary care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent change in admissions for ambulatory care sensetive conditions
Time Frame: At enrollment and within 12 months and 24 months after enrollment
|
Ambulatory Care Sensitive Conditions will be defined by ICD-9 codes, based on the classification published by: Ansari, Barbetti, Carson, Auckland, & Cicuttini, 2003 (adapted from Weissman JS, Gatsonis C, Epstein AM ,1992; Millman M, ed.
1993)
|
At enrollment and within 12 months and 24 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency 30-day readmissions
Time Frame: 30 days post an index admission
|
Emergency readmissions are defined as an urgent (via the Emergency Room) admission of one night or longer, following an index admission that lasted 2 nights or longer, in the prior 30 days.
|
30 days post an index admission
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SF-12 Physical and Menal component scores
Time Frame: At enrollment and 6, 12, and 24 months after enrollment
|
Change in Physical and Menal Component scores of the SF-12 measure, as completed by patients through patient interviews
|
At enrollment and 6, 12, and 24 months after enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ran D Balicer, PhD, Clalit Research Institute, Clalit Health Services
Publications and helpful links
General Publications
- Cohen-Stavi CJ, Giveon S, Key C, Molcho T, Balicer R, Shadmi E. Guideline deviation and its association with specific chronic diseases among patients with multimorbidity: a cross-sectional cohort study in a care management setting. BMJ Open. 2021 Jan 11;11(1):e040961. doi: 10.1136/bmjopen-2020-040961.
- Steinman MA, Low M, Balicer RD, Shadmi E. Impact of a nurse-based intervention on medication outcomes in vulnerable older adults. BMC Geriatr. 2018 Sep 6;18(1):207. doi: 10.1186/s12877-018-0905-1.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCMAP
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.
Clinical Trials on Chronic Disease
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Parker Research InstituteOak Foundation; Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre... and other collaboratorsRecruitingChronic Disease | Chronic Conditions, Multiple | Chronic ConditionDenmark
-
Parker Research InstituteOak Foundation; Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre... and other collaboratorsActive, not recruitingChronic Conditions, Multiple | Chronic ConditionDenmark
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
Radboud University Medical CenterRecruitingChronic Conditions, Multiple | Chronic ConditionNetherlands
-
University of Alabama at BirminghamRecruitingDisability Physical | Chronic Conditions, Multiple | Chronic ConditionUnited States
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
Radboud University Medical CenterRecruiting
-
Virta HealthActive, not recruitingDisease Progression | Chronic Disease | Telemedicine | Multiple Chronic Conditions | Long-Term CareUnited States
Clinical Trials on Nurse-physician comprehensive care
-
University of ChicagoPatient-Centered Outcomes Research InstituteRecruitingComprehensive Care | Quality of Care | Medicare | Cost of CareUnited States
-
University Hospital, LinkoepingSkane University Hospital; Kalmar County Hospital; Ryhov County HospitalCompletedAdults With Congenitally Malformed Hearts
-
University Hospital, GenevaCompleted
-
The University of Texas Health Science Center,...National Institutes of Health (NIH); Centers for Medicare and Medicaid ServicesCompleted
-
Centre Hospitalier Régional d'OrléansCompleted
-
Arizona State UniversityNational Institute of Nursing Research (NINR); University of Wisconsin, MilwaukeeCompletedCognitive Impairment | Chronic IllnessUnited States
-
Chulalongkorn UniversityCompleted
-
Miami VA Healthcare SystemEnrolling by invitationGeriatric Assessment | Veterans | Care-Coordination | Outpatient CareUnited States
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Chang Gung Memorial HospitalNational Health Research Institutes, TaiwanCompleted