Pilot Study to Evaluate the Decentralization of Patient Care Among People With HIV in Out-of-hospital Settings (OOH)
The goal of this 24-week, open-label, randomized pilot study is to assess the feasibility and impact of decentralized HIV care in a community setting (BCN Checkpoint), focusing on patient satisfaction and experience and carbon footprint.
The main question it aims to answer is patients' satisfaction with the medical care at week 24, derived from decentralizing the patient care compared to continuing with the usual follow-up at the hospital.
Participants will attend a medical follow-up visit at week 24, an analytical test visit at week 24, and collect ARV every 8 weeks, at the center assigned during randomization (Hospital or BCN Checkpoint); as well as to fill a series of questionnaires at baseline and week 24.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The OOH (Out-Of-Hospital) study is a 24-week, open-label, randomized pilot study assessing the feasibility and impact of decentralized HIV care in a community setting (BCN Checkpoint), focusing on patient satisfaction and experience and carbon footprint.
Participants are randomized 2:1 to receive medical care and pick up ART at the BCN Checkpoint community centre (OOH Group) or at the Hospital (Hospital Group). Medical care encompass medical follow-up visits, collection of ART medication, vaccinations and analytical tests. Those who are randomized to the OOH Group are attended by the same physician they had at the hospital, and ART is collected every two months through self-automated lockers. Those who are randomized to the Hospital Group are attended as usual, at the hospital, and ART is collected every two months at the pharmacy service from the hospital.
For both Groups, study visits are scheduled at baseline, week 8, week 16, and week 24. The baseline visit includes medical evaluation and randomization; visits at weeks 8 and 16 consist exclusively of ART collection, while the week 24 visit includes ART collection, a medical consultation, and blood testing. After the 24-week study period, all participants have the option to switch their medical care to the other centre.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Barcelona
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Badalona, Barcelona, Espagne, 08916
- Hospital Universitario Germans Trias i Pujol
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
Stable ARV treatment for ≥6 months with oral medications including:
- Biktarvy (bictegravir/emtricitabina/tenofovir alafenamida)
- Dovato (dolutegravir/lamivudina)
- Juluca (dolutegravir/rilpivirina)
- dolutegravir + emtricitabina/tenofovir
- Symtuza (darunavir/cobicistat/emtricitabina/tenofovir alafenamida)
- Undetectable HIV viral load for ≥6 months.
- Good treatment adherence according to the HIV and pharmacy teams.
- Good adherence to medical appointments
- Using a mobile app and acceptance of the established process.
- Signed Informed Consent.
Exclusion Criteria:
- Acute disease or decompensated chronic diseases in the last 6 months.
- Any other condition that advises against out-of-hospital follow-up.
- Participants who are already using the locker system to pick up their medication.
- Pregnant Women
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Medical care at the Hospital
Includes medical follow-up visits, collection of ARV and analytical tests, as per usual rutinary practice, in Hospital.
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Expérimental: Medical care at Out-of-Hospital community center
Evaluates the benefits of implementing the decentralization of patient care into communitary facilities such as BCN Checkpoint/BCN Prep·Point.
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Decentralization of medical care includes: medical follow-up visits, collection of ARV and analytical tests.
As per usual rutinary practice, medication will be collected every two months at both facilities.
The study will have a duration of 24 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To evaluate and compare the benefits in terms of patients' satisfaction derived from decentralizing the patient care versus continuing with the usual follow-up.
Délai: week 24
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Compare between groups the percentage of patients who, in the item No. 8 of the patients' expectations and satisfaction questionnaire self-developed ad hoc for this study, have indicated ≥ 8 points of satisfaction at week 24.
This item consists of a 10-point scale were 10 is the maximum expression of satisfaction and 1 is the lowest rank.
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week 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To evaluate and compare patients' expectations regarding a positive impact of decentralizing the patient care in the following areas: treatment adherence, visits follow-up, disease perception, physical and emotional QoL, family and social relationships
Délai: week 24
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Compare between groups the median of the obtained scores from items 1 to 7 in a patients' expectations and satisfaction questionnaire self-developed ad hoc for this study at week 24.
Items 1 to 7 of the questionnaire consist of a 5-point likert scale were 1 corresponds to "completely disagree" and 5 corresponds to "completely agree".
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week 24
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To evaluate and compare patients' quality of life
Délai: week 24
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Compare between groups the percentage of participants who report a very good or good quality of life, obtaining a score between 1 or 2 on the Medical Outcomes study HIV Health Survey (MOS-HIV) scale at week 24.
MOS-HIV quality of life and transitory health items were quantified separately, and the score ranged from 1 (best) to 5 (worse).
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week 24
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To evaluate and compare patients' perception of illness severity.
Délai: week 24
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Compare between groups the percentage of patients with moderate illness severity perception (Score 42 to 49) and patients with severe illness severity perception (score ≥ 50) using the 8-item Brief Illness Perception Questionnaire, were each item consists of a 10-point scale ranging from 0 (no influence) to 10 (major influence).
Additionally, among illness perception criteria, Cognitive Representation is obtained from the sum of items 1-5; the Emotional Representation is obtained from the sum of items 6 and 8; and the item 7 corresponds to the Disease Understanding dimension.
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week 24
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To evaluate and compare expectations and satisfaction among health staff (a nurse and a physician) regarding the positive impact of decentralizing the patient care.
Délai: week 24
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Compare changes at week 24 in the median of the obtained scores from all items in the health staff's expectations and satisfaction questionnaire self-developed ad hoc for this study at week 24.
Items 1 to 7 of the questionnaire consist of a 5-point likert scale were 1 corresponds to "completely disagree" and 5 corresponds to "completely agree".
item No. 8 consists of a 10-point scale were 10 is the maximum expression of satisfaction and 1 is the lowest rank.
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week 24
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Distance to care facility (out-of-hospital facility or hospital)
Délai: 24 weeks
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To assess and compare the two-way total transportation distance (in km) to out-of-hospital facility and to the hospital at week 24 for a total of 3 study visits in the study period.
Distance data from a single transfer is requested at the baseline visit.
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24 weeks
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Time to care facility (out-of-hospital facility or hospital)
Délai: 24 weeks
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To assess and compare the two-way total transportation time (in minutes) to the out-of-hospital facility and to the hospital at week 24 for a total of 3 study visits in the study period.
Time data from a single transfer is requested at the baseline visit.
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24 weeks
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Carbon footprint associated with healthcare visits
Délai: week 24
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Comparison of the estimated carbon footprint (in gCO2) generated by healthcare visits up to Week 24 between participants attending the out-of-hospital facility and those attending the hospital at week 24 for a total of 3 study visits in the study period.
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week 24
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- OOH Study
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
The raw and individual personal data are protected and not available to anyone due to applicable data privacy legislation: The processing of the data are subjected to current legislation as regards data protection (LOPD, The Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights complementary to the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data).
The raw dataset that supports the findings of this study are available from Fundació FLS de Lluita contra la Sida, les Malalties Infeccioses i la Promoció de la Salut i La Ciència but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Raw datasets results are however available for other researchers from the authors upon reasonable request.
Informations sur les médicaments et les dispositifs, documents d'étude
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