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Comprehensive-Care for Multimorbid Adults Effectiveness Study (CCMAP)

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ClinicalTrials.gov Identifier: NCT01811173
Recruitment Status : Unknown
Verified February 2013 by Meir Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : March 14, 2013
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Meir Medical Center

Study Description
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Brief 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 for patients with multiple chronic conditions.

Condition or disease Intervention/treatment Phase
Chronic Disease Other: Nurse-physician comprehensive care Not Applicable

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:

  1. Comprehensive assessment of the patient's and family's needs
  2. Coordinated care plan based on integrated care guides
  3. "Multimorbid Action Plan" for patients
  4. All-inclussive patient centered care and caregiver support
  5. 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Clalit Comprehensive-Care for Multimorbid Adults Project
Study Start Date : March 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nurse-physician comprehensive care
Comprehensive self management support and care coordination by a nurse-primary care physician team
 Other: Nurse-physician comprehensive care

Components 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811173


Locations
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Israel
Ashdod A
Ashdod, Israel
Ashdod D
Ashdod, Israel
Azur
Azur, Israel
Arlozorov
Bat YAm, Israel
Hashikma
Bat Yam, Israel
Ramat Yosef
Bat Yam, Israel
Sokolov
Bat Yam, Israel
Halutz
Hulon, Israel
Shikun Ammi
Hulon, Israel
Lod Center
Lod, Israel
Ramla Ztafon
Ramla, Israel
Balfur
Rishon Lezion, Israel
Migdal HaIr
Rishon Lezion, Israel
Sponsors and Collaborators
Meir Medical Center
Israel National Institute for Health Policy and Health Services Research
Investigators
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Principal Investigator: Ran D Balicer, PhD Clalit Research Institute, Clalit Health Services
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01811173    
Other Study ID Numbers: CCMAP
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: February 2013
Keywords provided by Meir Medical Center:
multimorbidity
primary care
physician - nurse team
 proactive monitoring
support for self-care
primary caregiver
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes