- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03091036
Impact of a Health Intervention on Some Indicators in the Care of Chronic Complex Patient (CCP). (CCP)
April 7, 2017 updated by: María José del Olmo Rubio
Impact of a Proactive and Integrated Health Intervention Between Different Assistance Levels Over Some Indicators in the Care of Chronic Complex Patient (CCP)
The aim of this study is to assess the effectiveness of proactive and integrated healthcare program for chronic complex patients (CCP).
This program are based in coordination the primary level of attention with and speciality level.
The objective is reducing hospital readmissions and know the benefit in total cost of care in 4 month before and 4 after intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Quasi-experimental study with single-arm (pre-post study design without control group). The investigators checking pre and post intervention the effectiveness of a healthcare program for CCP. The interventions consist:
- - Help the nurse in the hospital to carry out the care plans and the continuity care report.
- - Refer patients to the social workers.
- - Collaborate with the social worker to refer to centers of media, long stay and reference hospital.
- - Ensure the follow-up appointments for the CCP.
- - Make proactive calls to the CCP and/or their caregiver after discharge
- - Plan the hospital discharge 48 hours in advance, so that the family and the patient can be organized.
The investigator analysed if with this program, the CCP reducing hospital readmission and reducing the Hospital expenditure.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre de Madrid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient ≥ 75 years.
- Having attended 5 or more emergency visits or having had more than 3 hospital admissions in the last 12 months.
- Identified with social risk alert.
Exclusion Criteria:
- Participate in other health programs (AHT, diabetes mellitus,...).
- Terminal patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Proactive healthcare intervention
Participants who were included before (single-arm pre-post study), now a proactive and integrated intervention program for the health is performed of the complex chronic patient, based in an improvement of the care process.
|
There is an intervention in the coordination of health resources, and monitoring readmissions and know the benefit in total cost of care in 4 month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-post change in days of Hospital stay from baseline to 16 weeks.
Time Frame: Baseline and 16 weeks.
|
The same group of patients are analyzed the days of hospital stay at the end of 16 weeks of follow-up pre intervention (baseline) and 16 week after the intervention.
|
Baseline and 16 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of hospital readmissions visits for CCP change from baseline to 16 weeks.
Time Frame: Baseline and 16 weeks.
|
The same group of patients are analyzed the number of hospital readmissions visit for CCP at the end of 16 weeks pre intervention (considered baseline) of follow-up and 16 weeks after the intervention.
|
Baseline and 16 weeks.
|
|
Number of urgency visits for CCP change from baseline to 16 weeks.
Time Frame: Baseline and 16 weeks.
|
The same group of patients are analyzed the number of urgency visits and primary care visit for CCP at the end of 16 weeks pre intervention (considered baseline) of follow-up and 16 weeks after the intervention.
|
Baseline and 16 weeks.
|
|
Number of primary care visits for CCP change from baseline to 16 weeks.
Time Frame: Baseline and 16 weeks.
|
The same group of patients are analyzed the number of primary care visits for CCP at the end of 16 weeks pre intervention (considered baseline) of follow-up and 16 weeks after the intervention.
|
Baseline and 16 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: María José del Olmo Rubio, Hospital 12 de Octubre de Madrid
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
March 16, 2017
First Submitted That Met QC Criteria
March 21, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 10, 2017
Last Update Submitted That Met QC Criteria
April 7, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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