Comprehensive-Care for Multimorbid Adults Effectiveness Study

Not Applicable

• Conditions: Chronic Disease
• Interventions: Other: Nurse-physician comprehensive care

• Registration Number: NCT01811173
• Lead Sponsor: Meir Medical Center

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 Timeline

• Status Verified: 2013-02
• Study Start: 2013-03
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1800

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse-physician comprehensive care	Nurse-physician comprehensive care	Comprehensive self management support and care coordination by a nurse-primary care physician team

Primary Outcome Measures

Name	Time	Method
Percent change in admissions for ambulatory care sensetive conditions	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)

Secondary Outcome Measures

Name	Time	Method
Emergency 30-day readmissions	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.

Trial Locations

Locations (13)

Ashdod A; 🇮🇱 Ashdod, Israel

Ashdod D; 🇮🇱 Ashdod, Israel

Balfur; 🇮🇱 Rishon Lezion, Israel

Lod Center; 🇮🇱 Lod, Israel

Halutz; 🇮🇱 Hulon, Israel

Arlozorov; 🇮🇱 Bat YAm, Israel

Sokolov; 🇮🇱 Bat Yam, Israel

Azur; 🇮🇱 Azur, Israel

Ramla Ztafon; 🇮🇱 Ramla, Israel

Hashikma; 🇮🇱 Bat Yam, Israel

Shikun Ammi; 🇮🇱 Hulon, Israel

Migdal HaIr; 🇮🇱 Rishon Lezion, Israel

Ramat Yosef; 🇮🇱 Bat Yam, Israel