Comprehensive-Care for Multimorbid Adults Effectiveness Study (CCMAP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Meir Medical Center
Sponsor:
Collaborator:
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01811173
First received: March 12, 2013
Last updated: March 13, 2013
Last verified: February 2013
  Purpose

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 Intervention
Chronic Disease
Other: Nurse-physician comprehensive care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Clalit Comprehensive-Care for Multimorbid Adults Project

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Percent change in admissions for ambulatory care sensetive conditions [ Time Frame: At enrollment and within 12 months and 24 months after enrollment ] [ Designated as safety issue: No ]
    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:
  • Emergency 30-day readmissions [ Time Frame: 30 days post an index admission ] [ Designated as safety issue: No ]
    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:
  • Change in SF-12 Physical and Menal component scores [ Time Frame: At enrollment and 6, 12, and 24 months after enrollment ] [ Designated as safety issue: No ]
    Change in Physical and Menal Component scores of the SF-12 measure, as completed by patients through patient interviews


Estimated Enrollment: 1800
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACG system high risk probabilty score - 4% Highest Risk Score
  • Age 18 and older
  • 3 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811173

Contacts
Contact: Tali Lang, MA (972) 52-8187640 tali1981@gmail.com
Contact: Efrat Shadmi, PhD (972) 526212182 eshadmi@gmail.com

Locations
Israel
Ashdod D Not yet recruiting
Ashdod, Israel
Contact: Alon Zahava, PhD    927(08)9306222    zahavaa@clalit.org.il   
Ashdod A Not yet recruiting
Ashdod, Israel
Contact: Yifat Abuhazera, MA    927(08)8637200    yifatabu@clalit.org.il   
Sub-Investigator: Yifat Abuhazera, MA         
Azur Not yet recruiting
Azur, Israel
Contact: Irena Fuxman, MA    927(03)5020900    IrenaFu@clalit.org.il   
Sub-Investigator: Irena Fuxman, MA         
Arlozorov Not yet recruiting
Bat YAm, Israel
Contact: Henri Gigihashvili    927(03)5001700    Henriye@clalit.org.il   
Hashikma Not yet recruiting
Bat Yam, Israel
Contact: Henri Gigihashvili, PhD    927(03)5001700    Henriye@clalit.org.il   
Ramat Yosef Not yet recruiting
Bat Yam, Israel
Contact: Taliya Shahnis, BA    927(03)9376308    TalyaSh2@clalit.org.il   
Sub-Investigator: Taliya Shahnis, BA         
Sokolov Not yet recruiting
Bat Yam, Israel
Contact: Henri Gigihashvili, PhD    927(03)5001700    Henriye@clalit.org.il   
Shikun Ammi Not yet recruiting
Hulon, Israel
Contact: Rama Zilber, MA       taramazi@clalit.org.il   
Contact    927(03)9253808      
Sub-Investigator: Rama Zilber, BA         
Halutz Not yet recruiting
Hulon, Israel
Contact: Inna Fidelman, BA    927(09)7634000    ShInaFi@clalit.org.il   
Sub-Investigator: Inna Fidelman, BA         
Lod Center Not yet recruiting
Lod, Israel
Contact: Zahava Alon    927(08)9306222    Zahavav@clalit.org.il   
Ramla Ztafon Not yet recruiting
Ramla, Israel
Contact: Olga Matatov, BA    927(08)9770056    olgam2@clalit.org.il   
Sub-Investigator: Olga Matatov, BA         
Balfur Not yet recruiting
Rishon Lezion, Israel
Contact: Zahava Alon, PhD    927(08)9036222    zahavaa@clalit.org.il   
Migdal HaIr Not yet recruiting
Rishon Lezion, Israel
Contact: Dorit Grinberg, MA    927(03)9595915    doritgr@clalit.org.il   
Sub-Investigator: Dorit Grenberg, MA         
Sponsors and Collaborators
Meir Medical Center
Israel National Institute for Health Policy and Health Services Research
Investigators
Principal Investigator: Ran D Balicer, PhD Clalit Research Institute, Clalit Health Services
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01811173     History of Changes
Other Study ID Numbers: CCMAP
Study First Received: March 12, 2013
Last Updated: March 13, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
multimorbidity
primary care
physician - nurse team
proactive monitoring
support for self-care
primary caregiver

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014