NCT01811173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 29, 2015

Status Verified

February 1, 2013

Enrollment Period

4 years

First QC Date

March 12, 2013

Last Update Submit

April 28, 2015

Conditions

Keywords

multimorbidityprimary carephysician - nurse teamproactive monitoringsupport for self-careprimary caregiver

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Emergency 30-day readmissions

    30 days post an index admission

Other Outcomes (1)

  • Change in SF-12 Physical and Menal component scores

    At enrollment and 6, 12, and 24 months after enrollment

Study Arms (3)

Nurse-physician comprehensive care

EXPERIMENTAL

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

Other: Nurse-physician comprehensive care

Usual care survey control group

NO INTERVENTION

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

Usual care blinded control group

NO INTERVENTION

Patients will receive usual primary care.

Interventions

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.

Nurse-physician comprehensive care

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACG system high risk probabilty score - 4% Highest Risk Score
  • Age 18 and older
  • or more chronic conditions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Ashdod A

Ashdod, Israel

Location

Ashdod D

Ashdod, Israel

Location

Azur

Azor, Israel

Location

Arlozorov

Bat Yam, Israel

Location

Hashikma

Bat Yam, Israel

Location

Ramat Yosef

Bat Yam, Israel

Location

Sokolov

Bat Yam, Israel

Location

Halutz

Hulon, Israel

Location

Shikun Ammi

Hulon, Israel

Location

Lod Center

Lod, Israel

Location

Ramla Ztafon

Ramla, Israel

Location

Balfur

Rishon LeZiyyon, Israel

Location

Migdal HaIr

Rishon LeZiyyon, Israel

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ran D Balicer, PhD

    Clalit Research Institute, Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 29, 2015

Record last verified: 2013-02

Locations