Unrecognized ConditionNCT03130283
Study Design of the Empirical Evaluation of the AISBE Program in Catalonia
A study testing Home Hospitalization and Conventional Hospitalization in people with Unrecognized Condition, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care services; and, (iii) Population-based study on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Home Hospitalization and Conventional Hospitalization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 1 Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in his/her house within the healthcare sector
- Having caregiver during 24h per day
- Having phone at home
- Signing written acceptance to participate in the study
Who cannot join
- High risk of severe clinical deterioration not treatable at home, as assessed by best medical judgment
- Admission in a short stay unit; and, iii) severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
The project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care services; and, (iii) Population-based study on cost-effectiveness of integrated care services in the urban healthcare sector of Barcelona-Esquerra (540.000 inhabitants). The central hypothesis is that the approach will show safety and effectiveness with high level of user's acceptance and health value generation leading to sustainability of the service.The preliminary data indicate that HH/ED shows potential to strengthen care coordination between highly specialized hospital-based care and home-based services involving different levels of complexity. The need for appropriately designed transitional care services has been identified as the best option, not only for an efficient transference of patients from hospital to the community after hospital discharge, but as a way to overcome well identified limitations for generalization of community-based integrated care services.
AISBE is a population-based health initiative aiming at deployment of integrated care in one urban healthcare sector (Barcelona-Esquerra, 540.000 inhabitants) in the city of Barcelona. Within this initiative, the HH/ED program carried out by Hospital Clinic provides home-based hospitalization. Moreover, the program aims to implement transitional care strategies for optimal discharge.
Read more
The current document describes three studies: (Study 1) Analysis of the period 2006-2015; (Study 2) Program-based analysis of Home Hospitalization/Early Discharge (HH/ED) , and, (Study 3) Population-based analysis of cost-effectiveness of AISBE-based services. Study 2 is a program-based analysis of Home Hospitalization/Early Discharge (HH/ED). A quasi-experimental design. That is, a non-randomized intervention group (integrated care) will be compared with a control group (usual care) using propensity score matching wherein age, gender and health risk scoring will be main matching variables. The population-based evaluation will be done using registry data obtained from the Catalan Health Surveillance System (CHSS).
The protocol evaluation follows a Triple Aim approach considering pre-defined outcome variables for: a) health and well-being, b) experience with care, and c) costs.
Read the detailed description
AIMS: 1) To evaluate the HH/ED as mainstream service during the last decade (2006-2015); 2) To assess healthcare value generation of during the process of large scale deployment of the HH/ED program including generation of information useful for further refinement of transitional care in AISBE; and, 3) To assess the cost-effectiveness of AISBE's integrated care services using a population-based approach. These studies will contribute to refine three core aspects of the ongoing services; that is, a) Service evaluation; b) Health risk assessment and service selection; and, c) Service workflow definition and execution.
Study 1 - It evaluates both characteristics and outcomes of the process of HH/ED deployment from 2006 to 2015 without a control group.
Study 2 - Since late 2016, HH/ED is offered as a first choice for hospitalization to patients admitted in the Emergency room of Hospital Clinic. The current program has potential for 36 home-based admissions on a 24x7 day basis. The study will cover all patients admitted in the program (estimated 1,500 candidates) using both registry data and electronic medical records. Moreover, a subset of 200 consecutive HH candidates admitted through the Emergency room at Hospital Clinic will be selected using a 1:4 ratio. They will perform a complete study adding administration of standardized questionnaires carried out during HH/ED admission, one-month and three month after HH/ED discharge.
The intervention group will receive the standard HH/ED service and it will be compared with a control group that will include the same number of patients (n=200) under conventional hospitalization. The control group will be selected from those patients admitted in the Emergency room of the Hospital Clinic, but transferred to Hospital Sagrat Cor (within AISBE) for conventional hospitalization. Inclusion of the control group will also follow 1:4 ratio. Matching between intervention and control groups will be periodically assessed by groups of 10 patients.
The study design, as described, does not include Early Discharge patients included from highly specialized programs carried out at Hospital Clinic. Consequently, an additional HH/ED group of 100 patients from those programs will be also characterized (without control group) in order to properly identify the needs of this subset of patients for transitional care.
Finally, the population-based study (Study 3) will assess the Barcelona-Esquerra as intervention group will be compared with data from the other three healthcare sectors from the city of Barcelona, taken as control groups, because they do no have well identified integrated care programs.
- Conditions
- Unrecognized Condition
- Being tested
- Home Hospitalization, Conventional Hospitalization
- Keywords
- Acute patients, Exacerbated chronic patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home HospitalizationOther
Visit every 24 hours
Conventional HospitalizationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Home Hospitalization | Active comparator | Visit every day at home Receives: Other: Home Hospitalization |
| Conventional Hospitalization | Placebo comparator | Review Clinical History Receives: Other: Conventional Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs
Health Care Cost
Measured: 30 days
Secondary outcomes (2)
Health and well-being
Hospital admissions
Measured: 30 days
Experience with care
Satisfaction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Dec 2017
- Primary completion30 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unrecognized ConditionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- quasi experimental study design with propensity score matching
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carme Hernandez, Hospital Clinic of Barcelona
- Investigators
- Carme Hernandez, PhD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130283
- Sponsor's protocol ID
- SELFIE-HH/ED
- Status last verified
- Sep 2019
- First submitted
- 10 Apr 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez C, Herranz C, Baltaxe E, Seijas N, Gonzalez-Colom R, Asenjo M, Coloma E, Fernandez J, Vela E, Carot-Sans G, Cano I, Roca J, Nicolas D. The value of admission avoidance: cost-consequence analysis of one-year activity in a consolidated service. Cost Eff Resour Alloc. 2024 Apr 15;22(1):30. doi: 10.1186/s12962-024-00536-1.
PubMed 38622593Herranz C, Gonzalez-Colom R, Baltaxe E, Seijas N, Asenjo M, Hoedemakers M, Nicolas D, Coloma E, Fernandez J, Vela E, Cano I, Molken MR, Roca J, Hernandez C. Prospective cohort study for assessment of integrated care with a triple aim approach: hospital at home as use case. BMC Health Serv Res. 2022 Sep 7;22(1):1133. doi: 10.1186/s12913-022-08496-z.
PubMed 36071439
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Design of the Empirical Evaluation of the AISBE Program in Catalonia
- ClinicalTrials.gov ID
- NCT03130283
- Acronym / sponsor ID
- SELFIE-HH/ED
- Conditions
- Unrecognized Condition
- Keywords
- Acute patients, Exacerbated chronic patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 26 Apr 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 project has a threefold aim: (i) Assessment of Home Hospitalization and Early Discharge (HH/ED) deployment at Hospital Clinic over a period of 10 years (2006-2015) as a preliminary analysis fo the second aim (ii) Large scale deployment of HH/ED and Transitional Care services; and, (iii) Population-based study on cost-effectiveness of integrated care services in the urban healthcare sector of Barcelona-Esquerra (540.000 inhabitants). The central hypothesis is that the approach will show safety and effectiveness with high level of user's acceptance and health value generation leading to sustainability of the service.The preliminary data indicate that HH/ED shows potential to strengthen care coordination between highly specialized hospital-based care and home-based services involving different levels of complexity. The need for appropriately designed transitional care services has been identified as the best option, not only for an efficient transference of patients from hospital to the community after hospital discharge, but as a way to overcome well identified limitations for generalization of community-based integrated care services.
AISBE is a population-based health initiative aiming at deployment of integrated care in one urban healthcare sector (Barcelona-Esquerra, 540.000 inhabitants) in the city of Barcelona. Within this initiative, the HH/ED program carried out by Hospital Clinic provides home-based hospitalization. Moreover, the program aims to implement transitional care strategies for optimal discharge.
The current document describes three studies: (Study 1) Analysis of the period 2006-2015; (Study 2) Program-based analysis of Home Hospitalization/Early Discharge (HH/ED) , and, (Study 3) Population-based analysis of cost-effectiveness of AISBE-based services. Study 2 is a program-based analysis of Home Hospitalization/Early Discharge (HH/ED). A quasi-experimental design. That is, a non-randomized intervention group (integrated care) will be compared with a control group (usual care) using propensity score matching wherein age, gender and health risk scoring will be main matching variables. The population-based evaluation will be done using registry data obtained from the Catalan Health Surveillance System (CHSS).
The protocol evaluation follows a Triple Aim approach considering pre-defined outcome variables for: a) health and well-being, b) experience with care, and c) costs.
Detailed description
AIMS: 1) To evaluate the HH/ED as mainstream service during the last decade (2006-2015); 2) To assess healthcare value generation of during the process of large scale deployment of the HH/ED program including generation of information useful for further refinement of transitional care in AISBE; and, 3) To assess the cost-effectiveness of AISBE's integrated care services using a population-based approach. These studies will contribute to refine three core aspects of the ongoing services; that is, a) Service evaluation; b) Health risk assessment and service selection; and, c) Service workflow definition and execution.
Study 1 - It evaluates both characteristics and outcomes of the process of HH/ED deployment from 2006 to 2015 without a control group.
Study 2 - Since late 2016, HH/ED is offered as a first choice for hospitalization to patients admitted in the Emergency room of Hospital Clinic. The current program has potential for 36 home-based admissions on a 24x7 day basis. The study will cover all patients admitted in the program (estimated 1,500 candidates) using both registry data and electronic medical records. Moreover, a subset of 200 consecutive HH candidates admitted through the Emergency room at Hospital Clinic will be selected using a 1:4 ratio. They will perform a complete study adding administration of standardized questionnaires carried out during HH/ED admission, one-month and three month after HH/ED discharge.
The intervention group will receive the standard HH/ED service and it will be compared with a control group that will include the same number of patients (n=200) under conventional hospitalization. The control group will be selected from those patients admitted in the Emergency room of the Hospital Clinic, but transferred to Hospital Sagrat Cor (within AISBE) for conventional hospitalization. Inclusion of the control group will also follow 1:4 ratio. Matching between intervention and control groups will be periodically assessed by groups of 10 patients.
The study design, as described, does not include Early Discharge patients included from highly specialized programs carried out at Hospital Clinic. Consequently, an additional HH/ED group of 100 patients from those programs will be also characterized (without control group) in order to properly identify the needs of this subset of patients for transitional care.
Finally, the population-based study (Study 3) will assess the Barcelona-Esquerra as intervention group will be compared with data from the other three healthcare sectors from the city of Barcelona, taken as control groups, because they do no have well identified integrated care programs.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quasi experimental study design with propensity score matching
| Arm | Type | Receives |
|---|---|---|
| Home Hospitalization | Active comparator | Other: Home HospitalizationVisit every day at home |
| Conventional Hospitalization | Placebo comparator | Other: Conventional HospitalizationReview Clinical History |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Living in his/her house within the healthcare sector
- Having caregiver during 24h per day
- Having phone at home
- Signing written acceptance to participate in the study
Key exclusion criteria (2 listed)
- High risk of severe clinical deterioration not treatable at home, as assessed by best medical judgment
- Admission in a short stay unit; and, iii) severe psychiatric disorder
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 |
|---|---|---|
| Home HospitalizationVisit every 24 hours | Other | Home Hospitalization |
| Conventional HospitalizationNo intervention | Other | Conventional Hospitalization |
Primary outcome
Costs
Time frame: 30 days
Health Care Cost
2 secondary outcomes
Health and well-being
Time frame: 30 days
Experience with care
Time frame: 30 days
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 6 Sep 2019.
- Derived from this study: PubMed 38622593Hernandez C, Herranz C, Baltaxe E, Seijas N, Gonzalez-Colom R, Asenjo M, Coloma E, Fernandez J, Vela E, Carot-Sans G, Cano I, Roca J, Nicolas D. The value of admission avoidance: cost-consequence analysis of one-year activity in a consolidated service. Cost Eff Resour Alloc. 2024 Apr 15;22(1):30. doi: 10.1186/s12962-024-00536-1.
- Derived from this study: PubMed 36071439Herranz C, Gonzalez-Colom R, Baltaxe E, Seijas N, Asenjo M, Hoedemakers M, Nicolas D, Coloma E, Fernandez J, Vela E, Cano I, Molken MR, Roca J, Hernandez C. Prospective cohort study for assessment of integrated care with a triple aim approach: hospital at home as use case. BMC Health Serv Res. 2022 Sep 7;22(1):1133. doi: 10.1186/s12913-022-08496-z.
- NEXTCARE is an innovation project belonging to the Healthcare Ris3Cat community lead by Biocat which officially starts on October 2016Link provided by the sponsor.
- SELFIE (Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performancE) is a Horizon2020 EU projectLink provided by the sponsor.
- 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.
Carme Hernandez, PhD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Hospitalization and Conventional Hospitalization in people with Unrecognized Condition, run by Hospital Clinic of Barcelona 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 4 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 6 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Costs (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130283, which also lists 2 linked publications.
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 6 Sep 2019.