Preventive CareCCPNCT03091036
Impact of a Health Intervention on Some Indicators in the Care of Chronic Complex Patient (CCP).
A study testing Proactive healthcare intervention in people with Preventive Care, run by María José del Olmo Rubio at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Preventive Care
- What is being tested?
- Proactive healthcare intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Participate in other health programs (AHT, diabetes mellitus,...).
- Terminal patient.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario 12 de Octubre de Madrid
Madrid, Madrid, 28041
About this study
Official title: 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.
Read the 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.
- Conditions
- Preventive Care
- Being tested
- Proactive healthcare intervention
- Keywords
- Chronic, Complex
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive healthcare interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Proactive healthcare intervention | Other | 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. Receives: Other: Proactive healthcare intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-post change in days of Hospital stay from baseline to 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.
Measured: Baseline and 16 weeks.
Secondary outcomes (3)
Number of hospital readmissions visits for CCP change from baseline to 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.
Measured: Baseline and 16 weeks.
Number of urgency visits for CCP change from baseline to 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.
Measured: Baseline and 16 weeks.
Number of primary care visits for CCP change from baseline to 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.
Measured: Baseline and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startJul 2015
- Primary completionJul 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- María José del Olmo Rubio
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor-investigator, María José del Olmo Rubio, Hospital Universitario 12 de Octubre
- Investigators
- María José del Olmo Rubio, Principal investigator, Hospital 12 de Octubre de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091036
- Sponsor's protocol ID
- InveCuidPCC16
- Acronym
- CCP
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Proactive and Integrated Health Intervention Between Different Assistance Levels Over Some Indicators in the Care of Chronic Complex Patient (CCP)
- ClinicalTrials.gov ID
- NCT03091036
- Acronym / sponsor ID
- CCP / InveCuidPCC16
- Conditions
- Preventive Care
- Keywords
- Chronic, Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- María José del Olmo RubioUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proactive healthcare intervention | Other | Other: Proactive healthcare interventionParticipants 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Participate in other health programs (AHT, diabetes mellitus,...).
- Terminal patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive healthcare interventionThere is an intervention in the coordination of health resources, and monitoring readmissions and know the benefit in total cost of care in 4 month. | Other | Proactive healthcare intervention |
Primary outcome
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.
3 secondary outcomes
Number of hospital readmissions visits for CCP change from baseline to 16 weeks.
Time frame: Baseline and 16 weeks.
Number of urgency visits for CCP change from baseline to 16 weeks.
Time frame: Baseline and 16 weeks.
Number of primary care visits for CCP change from baseline to 16 weeks.
Time frame: Baseline and 16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María José del Olmo Rubio principal investigator
Hospital 12 de Octubre de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive healthcare intervention in people with Preventive Care, run by María José del Olmo Rubio at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post change in days of Hospital stay from baseline to 16 weeks. (time frame: Baseline and 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.