Comprehensive-Care for Multimorbid Adults Effectiveness Study (CCMAP)
Primary Purpose
Chronic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nurse-physician comprehensive care
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Disease focused on measuring multimorbidity, primary care, physician - nurse team, proactive monitoring, support for self-care, primary caregiver
Eligibility 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
Sites / Locations
- Ashdod A
- Ashdod D
- Azur
- Arlozorov
- Hashikma
- Ramat Yosef
- Sokolov
- Halutz
- Shikun Ammi
- Lod Center
- Ramla Ztafon
- Balfur
- Migdal HaIr
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Nurse-physician comprehensive care
Usual care survey control group
Usual care blinded control group
Arm Description
Comprehensive self management support and care coordination by a nurse-primary care physician team
Patients will receive usual primary care and asked to complete questionnaires on four time points throughout the study
Patients will receive usual primary care.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01811173
First Posted
March 12, 2013
Last Updated
April 28, 2015
Sponsor
Meir Medical Center
Collaborators
Israel National Institute for Health Policy and Health Services Research
1. Study Identification
Unique Protocol Identification Number
NCT01811173
Brief Title
Comprehensive-Care for Multimorbid Adults Effectiveness Study
Acronym
CCMAP
Official Title
The Clalit Comprehensive-Care for Multimorbid Adults Project
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
Israel National Institute for Health Policy and Health Services Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
multimorbidity, primary care, physician - nurse team, proactive monitoring, support for self-care, primary caregiver
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nurse-physician comprehensive care
Arm Type
Experimental
Arm Description
Comprehensive self management support and care coordination by a nurse-primary care physician team
Arm Title
Usual care survey control group
Arm Type
No Intervention
Arm Description
Patients will receive usual primary care and asked to complete questionnaires on four time points throughout the study
Arm Title
Usual care blinded control group
Arm Type
No Intervention
Arm Description
Patients will receive usual primary care.
Intervention Type
Other
Intervention Name(s)
Nurse-physician comprehensive care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent change in admissions for ambulatory care sensetive conditions
Description
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)
Time Frame
At enrollment and within 12 months and 24 months after enrollment
Secondary Outcome Measure Information:
Title
Emergency 30-day readmissions
Description
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.
Time Frame
30 days post an index admission
Other Pre-specified Outcome Measures:
Title
Change in SF-12 Physical and Menal component scores
Description
Change in Physical and Menal Component scores of the SF-12 measure, as completed by patients through patient interviews
Time Frame
At enrollment and 6, 12, and 24 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran D Balicer, PhD
Organizational Affiliation
Clalit Research Institute, Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashdod A
City
Ashdod
Country
Israel
Facility Name
Ashdod D
City
Ashdod
Country
Israel
Facility Name
Azur
City
Azur
Country
Israel
Facility Name
Arlozorov
City
Bat YAm
Country
Israel
Facility Name
Hashikma
City
Bat Yam
Country
Israel
Facility Name
Ramat Yosef
City
Bat Yam
Country
Israel
Facility Name
Sokolov
City
Bat Yam
Country
Israel
Facility Name
Halutz
City
Hulon
Country
Israel
Facility Name
Shikun Ammi
City
Hulon
Country
Israel
Facility Name
Lod Center
City
Lod
Country
Israel
Facility Name
Ramla Ztafon
City
Ramla
Country
Israel
Facility Name
Balfur
City
Rishon Lezion
Country
Israel
Facility Name
Migdal HaIr
City
Rishon Lezion
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
33431488
Citation
Cohen-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.
Results Reference
derived
PubMed Identifier
30189846
Citation
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.
Results Reference
derived
Learn more about this trial
Comprehensive-Care for Multimorbid Adults Effectiveness Study
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