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| Name | Class |
|---|---|
| Consorci Sanitari de Terrassa | OTHER |
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The goal of this randomized clinical trial is to determine whether an interdisciplinary, community-based intervention can reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions following hospital discharge.
The main questions it aims to answer are:
Can the Reforça't program reduce 30-day hospital readmission rates to 25% compared to standard care? Does participation in Reforça't improve functional outcomes, medication adherence, quality of life, and mortality rates in this patient population?
Researchers will compare patients enrolled in Reforça't (intervention group) with those receiving standard care (control group) to determine whether the program leads to lower readmission rates, improved health outcomes, and higher cost-effectiveness.
Participants will:
Undergo a pre- and post-intervention assessment (30 days post-discharge). Receive comprehensive, interdisciplinary care integrating medical, social, and rehabilitation services.
Be monitored for 12 months to assess readmissions, survival, nursing home admissions, and overall well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Standard Follow-up under hospital at home regime in our institution | |
| Intervention Group | Experimental | Presential Follow-up by a multidisciplinary team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary Program for Post-Hospitalization / Hospital at home Management and Long-Term Outcomes in Older Adults with Chronic Cardiorespiratory Condition | Other | Intervention Phase 1: Feasibility Assessment Duration: January 7, 2025 - January 11, 2025 Participants: 10-15 patients Description: All involved services will be available to address and resolve potential issues. The objective is to assess the feasibility of the program, ensuring that the intervention can be implemented as planned and identifying any practical or logistical challenges. Phases 2 & 3: Comprehensive Intervention Duration: January 12, 2025 - June 30, 2025 Participants: 200 patients Description: Full-scale implementation of the intervention. Includes interdisciplinary care, home follow-ups, therapeutic optimization, functional rehabilitation, health education, and psychosocial support. Phase 4: Long-Term Follow-Up Duration: April 7, 2025 - June 30, 2026 Participants: 200 patients Description: Follow-up assessments at 3, 6, 9, and 12 months post-intervention. Evaluates hospital readmissi |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the Readmission Rate in the Intervention Group | The investigators aim for the intervention to result in a 20% reduction of the readmission rate among users included in the experimental group | 30 days after hospital discharge |
| Reduction of mortality, readmission and nursing home admission | 3, 6, 9, and 12 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Frailty Index Score | 30 days after hospital discharge | |
| Reduction of the mortality rate | 30 days after hospital discharge | |
| Reduction in the number of inappropriate prescriptions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Griselda Manzano Monfort | Contact | +34620215477 | gmanzano@salutms.cat | |
| Noelia Quirant Arellano | Contact | +34695803416 | nquirant@salutms.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Comarcal de Calella - Corporació de Salut del Maresme i la Selva | Recruiting | Calella | Barcelona | 08370 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26068277 | Background | Aranda-Gallardo M, Morales-Asencio JM, Canca-Sanchez JC, Morales-Fernandez A, Enriquez de Luna-Rodriguez M, Moya-Suarez AB, Mora-Banderas AM, Perez-Jimenez C, Barrero-Sojo S. [Consequences of errors in the translation of questionnaires: Spanish version of Downton index]. Rev Calid Asist. 2015 Jul-Aug;30(4):195-202. doi: 10.1016/j.cali.2015.04.003. Epub 2015 Jun 9. Spanish. | |
| 24005886 |
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Randomized Intervention Study, control vs intervention group
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|
| 30 days after hospital discharge |
| Increase in pharmacotherapeutic adherence | The investigators will conduct the spanish version of the Adherence to Refills and Medications Scale (ARMS-e). Per this scale, high scores indicate low therapeutic adherence. Subjects are classified into high adherence (scores from 0 to 16), intermediate adherence (scores from 17 to 32), and low adherence (scores from 33 to 48). - Expected experimental range values: 12 - 48 | 30 days after hospital discharge |
| Reduction in functional deterioration | The investigators will measure Barthel and Lawton scores to determine functional activity. Barthel index indicates the ability to perform daily tasks autonomously. Higher Barthel index equals higher degree of autonomy. Values range from 0 to 100. Scores lower than 20 indicate total dependence, between 20 and 35 equal severe dependence, between 50 and 55 indicate moderate dependence, between 60 and 90 indicate light dependent, and higher than 95 indicate autonomy. Lawton and Brody scores measure the degree of autonomy in the performance of instrumental activities of daily living. Values range from 0 to 8, with higher score indicating higher autonomy. | 30 days after hospital discharge |
| Reduction in the risk of falls | The investigators will assess the Downton score. This measure is expected to decrease in the intervention group. Values range from 0 to 11, where higher score equals higher risk. Starting at 3, the values are considered to indicate relevant risk of fall. | 30 days after hospital discharge |
| Increase in physical function | The investigators will conduct Short Physical Performance Battery (SPPB) and assess Daniels score, to determine subjects' physical function.
| 30 days after hospital discharge |
| Increase in the number of beneficiaries of social prescribing or community referrals | 30 days after hospital discharge |
| Obtain positive patient satisfaction | The investigators will administer ad hoc patient satisfaction surveys. Results will be numerical, from 0 (min) to 10 (max). Average above 7 will be considered a success, although results greater than 5 will be deemed satisfactory. | 30 days after hospital discharge |
| Reduction or delay in institutionalization in nursing homes among users | 30 days after hospital discharge |
| Reduction in Zarit Score for caregiver burden | The investigators will conduct Zarit Burden Interviews (ZBI) on caregivers for patients included in the study. Specifically, the short ZBI-7 will be assessed. It consists of 7 items, each item scoring from 1 to 5. Per this score, the higher the score equals a higher caregiver burden. Thus, a reduction in the Zarit Score for caregivers included in the study is expected. The obtained values per caregiver range from 7 to 35, and a total score of 17 or higher is considered excessive burden. | 30 days after hospital discharge |
| Reduction in the risk of social isolation | The investigators will determine OSSS-3 score for patients included in the study. Higher scores determine higher perception of social support. Scores between 3 and 8 equal low social support, between 9 and 11 intermediate social support, and higher scores equal high social support. The patients included in the study are expected to range between 3 and 14. | 30 days after hospital discharge |
| Increase in emotional well-being | The investigators will conduct the short Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) to measure subject emotional well-being. Higher scores indicate better emotional wellbeing. A score lower than 26 is considered to relate to emotional discomfort. The patients included are expected to range between 7 and 35 in score (35 is the maximum score for this short version). | 30 days after hospital discharge |
| Increase in the smoking cessation rate | 30 days after hospital discharge |
| Background |
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| 30016997 | Background | Kocalevent RD, Berg L, Beutel ME, Hinz A, Zenger M, Harter M, Nater U, Brahler E. Social support in the general population: standardization of the Oslo social support scale (OSSS-3). BMC Psychol. 2018 Jul 17;6(1):31. doi: 10.1186/s40359-018-0249-9. |
| 35307198 | Background | Zamora-Sanchez JJ, Zabaleta-Del-Olmo E, Gea-Caballero V, Julian-Rochina I, Perez-Tortajada G, Amblas-Novellas J. [Convergent and discriminative validity of the Frail-VIG index with the Braden scale in people cared for in home care]. Rev Esp Geriatr Gerontol. 2022 Mar-Apr;57(2):71-78. doi: 10.1016/j.regg.2021.12.003. Epub 2022 Mar 17. Spanish. |
| 18619805 | Background | Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi.2008.01.006. Epub 2008 Jul 10. |
| 26363992 | Background | Pinzon-Pulido S, Garrido Pena F, Reyes Alcazar V, Lima-Rodriguez JS, Raposo Triano MF, Martinez Domene M, Alonso Trujillo F. [Predictors of institutionalization of elderly persons in dependency situation in Andalusia]. Enferm Clin. 2016 Jan-Feb;26(1):23-30. doi: 10.1016/j.enfcli.2015.08.003. Epub 2015 Sep 9. Spanish. |
| 35700618 | Background | Acosta-Benito MA, Martin-Lesende I. [Frailty in primary care: Diagnosis and multidisciplinary management]. Aten Primaria. 2022 Sep;54(9):102395. doi: 10.1016/j.aprim.2022.102395. Epub 2022 Jun 11. Spanish. |
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| 31893574 | Background | Miranda J, Underwood D, Kuepfer-Thomas M, Coulson D, Park AC, Butler SJ, Goldstein R, Brooks D, Everall AC, Guilcher SJT. Exploring transitions in care from pulmonary rehabilitation to home for persons with chronic obstructive pulmonary disease: A descriptive qualitative study. Health Expect. 2020 Apr;23(2):414-422. doi: 10.1111/hex.13012. Epub 2020 Jan 1. |
| 27157795 | Background | Saavedra-Quiros V, Montero-Hernandez E, Menchen-Viso B, Santiago-Prieto E, Bermejo-Boixareu C, Hernan-Sanz J, Sanchez-Guerrero A, Campo Loarte J. [Medication reconciliation at admission and discharge. A consolidated experience]. Rev Calid Asist. 2016 Jun;31 Suppl 1:45-54. doi: 10.1016/j.cali.2016.02.002. Epub 2016 May 4. Spanish. |
| 34448906 | Background | Gonzalez-Bueno J, Sevilla-Sanchez D, Puigoriol-Juvanteny E, Molist-Brunet N, Codina-Jane C, Espaulella-Panicot J. Improving medication adherence and effective prescribing through a patient-centered prescription model in patients with multimorbidity. Eur J Clin Pharmacol. 2022 Jan;78(1):127-137. doi: 10.1007/s00228-021-03207-9. Epub 2021 Aug 27. |
| 24831061 | Background | Doos L, Bradley E, Rushton CA, Satchithananda D, Davies SJ, Kadam UT. Heart failure and chronic obstructive pulmonary disease multimorbidity at hospital discharge transition: a study of patient and carer experience. Health Expect. 2015 Dec;18(6):2401-12. doi: 10.1111/hex.12208. Epub 2014 May 16. |
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| 28029467 | Background | Amblas-Novellas J, Martori JC, Molist Brunet N, Oller R, Gomez-Batiste X, Espaulella Panicot J. [Frail-VIG index: Design and evaluation of a new frailty index based on the Comprehensive Geriatric Assessment]. Rev Esp Geriatr Gerontol. 2017 May-Jun;52(3):119-127. doi: 10.1016/j.regg.2016.09.003. Epub 2016 Oct 28. Spanish. |
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| 39859079 | Background | Di Chiara C, Sartori G, Fantin A, Castaldo N, Crisafulli E. Reducing Hospital Readmissions in Chronic Obstructive Pulmonary Disease Patients: Current Treatments and Preventive Strategies. Medicina (Kaunas). 2025 Jan 9;61(1):97. doi: 10.3390/medicina61010097. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000375 | Aging |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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