Clinical trial NCT01811173: Comprehensive-Care for Multimorbid Adults Effectiveness Study
Official title: The Clalit Comprehensive-Care for Multimorbid Adults Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Keywords: multimorbidity
primary care
physician - nurse team
proactive monitoring
support for self-care
primary caregiver
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Israel National Institute for Health Policy and Health Services Research
First posted: 2013-03-14
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Percent change in admissions for ambulatory care sensetive conditions
timeFrame: At enrollment and within 12 months and 24 months after enrollment
Secondary outcomes:
measure: Emergency 30-day readmissions
timeFrame: 30 days post an index admission
Other outcomes:
measure: Change in SF-12 Physical and Menal component scores
timeFrame: At enrollment and 6, 12, and 24 months after enrollment
Locations:
city: Ashdod
country: Israel
facility: Ashdod A
city: Ashdod
country: Israel
facility: Ashdod D
city: Azur
country: Israel
facility: Azur
city: Bat YAm
country: Israel
facility: Arlozorov
city: Bat Yam
country: Israel
facility: Hashikma
city: Bat Yam
country: Israel
facility: Ramat Yosef
city: Bat Yam
country: Israel
facility: Sokolov
city: Hulon
country: Israel
facility: Halutz
city: Hulon
country: Israel
facility: Shikun Ammi
city: Lod
country: Israel
facility: Lod Center
city: Ramla
country: Israel
facility: Ramla Ztafon
city: Rishon Lezion
country: Israel
facility: Balfur
city: Rishon Lezion
country: Israel
facility: Migdal HaIr
Study officials:
affiliation: Clalit Research Institute, Clalit Health Services
name: Ran D Balicer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.