Chronic DiseaseCCMAPNCT01811173
Comprehensive-Care for Multimorbid Adults Effectiveness Study
A study testing Nurse-physician comprehensive care in people with Chronic Disease, run by Meir Medical Center at 13 sites in Israel.
Trial summary
This study is intended to examine whether directed care of a nurse working jointly with the patient's primary care physician, including a comprehensive assessment, creation of a tailored care plan, proactive follow-up, self management support and caregiver support and care coordination, can reduce hospital admissions… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Nurse-physician comprehensive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 13 sitesIsrael
- Study dates
- Mar 2013to Mar 2017
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACG system high risk probabilty score - 4% Highest Risk Score
- Age 18 and older
- 2 or more chronic conditions
Who cannot join
- 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).
Show all 13Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Israel13 sites
Ashdod A
Ashdod
Ashdod D
Ashdod
Azur
Azor
Arlozorov
Bat Yam
Hashikma
Bat Yam
Ramat Yosef
Bat Yam
Sokolov
Bat Yam
Halutz
Hulon
Shikun Ammi
Hulon
Lod Center
Lod
Ramla Ztafon
Ramla
Balfur
Rishon LeZiyyon
Migdal HaIr
Rishon LeZiyyon
About this study
Official title: The Clalit Comprehensive-Care for Multimorbid Adults Project
This study is intended to examine whether directed care of a nurse working jointly with the patient's primary care physician, including a comprehensive assessment, creation of a tailored care plan, proactive follow-up, self management support and caregiver support and care coordination, can reduce hospital admissions for patients with multiple chronic conditions.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Nurse-physician comprehensive care
- Keywords
- multimorbidity, primary care, physician - nurse team, proactive monitoring, support for self-care, primary caregiver
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-physician comprehensive careOther
Components of the intervention include:
- Complete assessment of the patient's and family's needs conducted by the nurse.
- Comprehensive treatment program developed by the nurse and in consultation with the primary care physician.
- "Multimorbid care plan" integrating all care aspects.
- "Action Plan" for patients, supporting self management
- Proactive monitoring according to the plan.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-physician comprehensive care | Experimental | Comprehensive self management support and care coordination by a nurse-primary care physician team Receives: Other: Nurse-physician comprehensive care |
| Usual care survey control group | No intervention | Patients will receive usual primary care and asked to complete questionnaires on four time points throughout the study |
| Usual care blinded control group | No intervention | Patients will receive usual primary care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in admissions for ambulatory care sensetive conditions
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)
Measured: At enrollment and within 12 months and 24 months after enrollment
Secondary outcomes (1)
Emergency 30-day readmissions
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.
Measured: 30 days post an index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Israel National Institute for Health Policy and Health Services Research
- Responsible party
- Sponsor
- Investigators
- Ran D Balicer, PhD, Principal investigator, Clalit Research Institute, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811173
- Sponsor's protocol ID
- CCMAP
- Acronym
- CCMAP
- Status last verified
- Feb 2013
- First submitted
- 12 Mar 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shadmi E, Tonkikh O, Low M, Key C, Netzer D, Molcho T, Giveon S, Boult C, Balicer RD. The effect of nurse care management on multimorbid patients' hospital utilization: a comparative-controlled trial and an exploratory cohort study. Nat Commun. 2026 May 15;17(1):6474. doi: 10.1038/s41467-026-73104-1.
PubMed 42140977Cohen-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.
PubMed 33431488Steinman 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.
PubMed 30189846
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clalit Comprehensive-Care for Multimorbid Adults Project
- ClinicalTrials.gov ID
- NCT01811173
- Acronym / sponsor ID
- CCMAP / CCMAP
- Conditions
- Chronic Disease
- Keywords
- multimorbidity, primary care, physician - nurse team, proactive monitoring, support for self-care, primary caregiver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Israel National Institute for Health Policy and Health Services Research
- Study start
- Mar 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 14 Mar 2013 (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 study is intended to examine whether directed care of a nurse working jointly with the patient's primary care physician, including a comprehensive assessment, creation of a tailored care plan, proactive follow-up, self management support and caregiver support and care coordination, can reduce hospital admissions for patients with multiple chronic conditions.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurse-physician comprehensive care | Experimental | Other: Nurse-physician comprehensive careComprehensive self management support and care coordination by a nurse-primary care physician team |
| Usual care survey control group | No intervention | –Patients will receive usual primary care and asked to complete questionnaires on four time points throughout the study |
| Usual care blinded control group | No intervention | –Patients will receive usual primary care. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ACG system high risk probabilty score - 4% Highest Risk Score
- Age 18 and older
- 2 or more chronic conditions
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Nurse-physician comprehensive careComponents of the intervention include: 1. Complete assessment of the patient's and family's needs conducted by the nurse. 2. Comprehensive treatment program developed by the nurse and in consultation with the primary care physician. 3. "Multimorbid care plan" integrating all care aspects. 4. "Action Plan" for patients, supporting self management 5. Proactive monitoring according to the plan. | Other | Nurse-physician comprehensive care |
Primary outcome
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)
1 secondary outcome
Emergency 30-day readmissions
Time frame: 30 days post an index admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Derived from this study: PubMed 42140977Shadmi E, Tonkikh O, Low M, Key C, Netzer D, Molcho T, Giveon S, Boult C, Balicer RD. The effect of nurse care management on multimorbid patients' hospital utilization: a comparative-controlled trial and an exploratory cohort study. Nat Commun. 2026 May 15;17(1):6474. doi: 10.1038/s41467-026-73104-1.
- Derived from this study: PubMed 33431488Cohen-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.
- Derived from this study: PubMed 30189846Steinman 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.
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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.
Ran D Balicer, PhD principal investigator
Clalit Research Institute, Clalit Health Services
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-physician comprehensive care in people with Chronic Disease, run by Meir Medical Center at 13 sites in Israel.
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 13 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Israel. 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?
Results are not available in the source record.
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?
Percent change in admissions for ambulatory care sensetive conditions (time frame: At enrollment and within 12 months and 24 months after enrollment). 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 NCT01811173, which also lists 3 linked publications.
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 29 Apr 2015.