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Comprehensive-Care for Multimorbid Adults Effectiveness Study (CCMAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 12, 2013
First Posted Date  ICMJE March 14, 2013
Last Update Posted Date April 29, 2015
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 13, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comprehensive-Care for Multimorbid Adults Effectiveness Study
Official Title  ICMJE The Clalit Comprehensive-Care for Multimorbid Adults Project
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Nurse-physician comprehensive care
    Comprehensive self management support and care coordination by a nurse-primary care physician team
    Intervention: Other: Nurse-physician comprehensive care
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 13, 2013)
1800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811173
Other Study ID Numbers  ICMJE CCMAP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Israel National Institute for Health Policy and Health Services Research
Investigators  ICMJE
Principal Investigator: Ran D Balicer, PhD Clalit Research Institute, Clalit Health Services
PRS Account Meir Medical Center
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP