Comprehensive-Care for Multimorbid Adults Effectiveness Study

Chronic Disease Clinical Trial

— CCMAP  

Official title:

The Clalit Comprehensive-Care for Multimorbid Adults Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01811173
• Other study ID #: CCMAP
• Status: Active, not recruiting
• Phase: N/A
• First received: March 12, 2013
• Last updated: April 28, 2015
• Start date: March 2013
• Est. completion date: March 2017

Study information

• Verified date: February 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• Nurse-physician comprehensive care
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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Israel National Institute for Health Policy and Health Services Research

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in SF-12 Physical and Menal component scores	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	No
Primary	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)	At enrollment and within 12 months and 24 months after enrollment	No
Secondary	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.	30 days post an index admission	No