Comprehensive-Care for Multimorbid Adults Effectiveness Study (CCMAP)

April 28, 2015 updated by: Meir Medical Center

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  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.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ran D Balicer, PhD, Clalit Research Institute, Clalit Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2017

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (ESTIMATE)

March 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

February 1, 2013

More Information

Terms related to this study

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.

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