Comprehensive-Care for Multimorbid Adults Effectiveness Study

NCT ID: NCT01811173

Last Updated: 2015-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Chronic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nurse-physician comprehensive care

Comprehensive self management support and care coordination by a nurse-primary care physician team

Group Type EXPERIMENTAL

Nurse-physician comprehensive care

Intervention Type OTHER

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.

Usual care survey control group

Patients will receive usual primary care and asked to complete questionnaires on four time points throughout the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Usual care blinded control group

Patients will receive usual primary care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Israel National Institute for Health Policy and Health Services Research

OTHER_GOV

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ran D Balicer, PhD

Role: PRINCIPAL_INVESTIGATOR

Clalit Research Institute, Clalit Health Services

Locations

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Ashdod A

Ashdod, , Israel

Site Status

Ashdod D

Ashdod, , Israel

Site Status

Azur

Azor, , Israel

Site Status

Arlozorov

Bat Yam, , Israel

Site Status

Hashikma

Bat Yam, , Israel

Site Status

Ramat Yosef

Bat Yam, , Israel

Site Status

Sokolov

Bat Yam, , Israel

Site Status

Halutz

Hulon, , Israel

Site Status

Shikun Ammi

Hulon, , Israel

Site Status

Lod Center

Lod, , Israel

Site Status

Ramla Ztafon

Ramla, , Israel

Site Status

Balfur

Rishon LeZiyyon, , Israel

Site Status

Migdal HaIr

Rishon LeZiyyon, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 33431488 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30189846 (View on PubMed)

Other Identifiers

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CCMAP

Identifier Type: -

Identifier Source: org_study_id

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