- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02684188
Rural Options At Discharge Model of Active Planning (ROADMAP)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Residents of rural counties experience significant disparities in health care access and outcomes when compared to their urban counterparts. These disparities are structural; based in our market-based medical care delivery system. For rural residents with multiple chronic conditions, transitioning along the continuum of care, between systems of treatment and support, and between dispersed locations both expose and produce disparities. The transition home from hospitalization for treatment exposes the current urban bias. Indeed, discharge planning is fragmented and uncoordinated, and contributes to poor the disparities. The specific aims of this research is to ascertain rural patients' actual experience of discharge; then to involve patients and rural providers in using those data to design a contextually appropriate rural options at discharge model of active planning (ROADMAP) that improves patient outcomes and reduces disparities. Objectives include:
- Ascertain actual patient experience in the rural discharge process.
- Design the ROADMAP model to fit the emerging health services context.
- Test the ROADMAP's efficacy in enhancing patient defined outcomes.
- Design the components for rapid diffusion.
Researchers will work in four counties of the Missoula Hospital Referral Region with a total population of 53,116 living on 12,342 square miles (4.3 persons per square mile). Researchers will recruit patients seeking treatment from St. Patrick Hospital. Patients and patient advocates will serve on an Innovations Design Team (IDT) to create the ROADMAP. Researchers will first interview patients (n = 40) who have been discharged to one of the rural counties. Researchers will compare their experiences to guidelines. Next, they will conduct a Design Survey (n=600) to verify goals important to patients. The IDT will use these findings to develop design requirements for ROADMAP. Finally, we will use a quasi-experimental research design to compare the patient designed rural ROADMAP to standard practice. The primary outcome measures are measures that reflect the patient's values for health-related quality of life and functional status, as well as hospital re-admissions. An independent statistician will use Hierarchical Linear Modeling to examine the complex relationships. This approach accounts for patients nested in four counties and the correlated errors inherent in within subject analysis. Health care reform sets the occasion for rapid diffusion of ROADMAP. This can provide an incremental reduction in rural disparities. Incorporating patient and provider input increases the likelihood it will fit within the emerging reimbursement model. Researchers expect that ROADMAP will reduce re-hospitalizations by as much as 30%, and improve patient recovery and return to participation in daily life.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Between 18 and 75 years of age
- Admitted to St. Patrick regional referral hospital for treatment
- Discharged home to one of four rural counties in Montana
Exclusion Criteria:
- Primary diagnosis involves psychiatric condition or substance abuse
- Inmates of state prison
- Admitted under ongoing criminal investigation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Standard hospital discharge services
Patients received standard discharge planning; the baseline and return to baseline groups were combined to form a single standard discharge group
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Expérimental: Enhanced rural discharge and transition
Enhanced rural discharge and transition involved conducting a functional needs assessment before discharge.
Identified needs were shared with a Local Community Transition Coordinator (LCTC).
Needs include such patient centered issues as housing, transportation, emotional support, support for completing daily chores, and assistance in securing local follow-up appointments.
Once a patient returned home, the LCTC conduct a review of discharge orders to insure a patient can meet those recommendations.
Then the LCTC worked with the patient to develop and implement a transition plan that linked the patient to local resources he or she can use to address needs.
The LCTC also provided direct supports.
This plan was implemented over the course of the first 30 days after discharge.
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While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hospital Re-admissions Analyzed by Poisson Regression
Délai: 3, 7 ,14, 21, 30, 60, and 90 days after discharge
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Number of admissions to any hospital reported by the patients after discharge from a regional hospital to one of four rural counties.
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3, 7 ,14, 21, 30, 60, and 90 days after discharge
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Hospital Re-admissions Analyzed by Logistic Regression
Délai: 3, 7 ,14, 21, 30, 60, and 90 days after discharge
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Proportion of patients who self-report at least one hospital readmission to any hospital after discharge from a regional hospital to one of four rural counties.
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3, 7 ,14, 21, 30, 60, and 90 days after discharge
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Emergency Department (ED) Visits Analyzed by Poisson Regression
Délai: 3, 7, 14, 21,30, 60, and 90 days after discharge
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Number of self-reported visits to the emergency department of any hospital reported by patients after discharge from a regional hospital to one of four rural counties.
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3, 7, 14, 21,30, 60, and 90 days after discharge
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Emergency Department (D) Visits Analyzed by Logistic Regression
Délai: 3, 7, 14, 21,30, 60, and 90 days after discharge
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Proportion of patients who report at least one emergency department visit after discharge from a regional hospital to one of four rural counties.
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3, 7, 14, 21,30, 60, and 90 days after discharge
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Primary Care Provider (PCP) Visits Analyzed by Poisson Regression
Délai: 3, 7, 14, 21, 30, 60, and 90 days after discharge
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This reflects the number of visits to a patient's local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.
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3, 7, 14, 21, 30, 60, and 90 days after discharge
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Primary Care Provider (PCP) Visits Analyzed by Logistic Regression
Délai: 3, 7, 14, 21, 30, 60, and 90 days after discharge
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This reflects the proportion of patients who reported at least one visit to a their local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.
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3, 7, 14, 21, 30, 60, and 90 days after discharge
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Short Form (SF12) Physical Health Score
Délai: 3, 7, 14, 21, 30, 60, and 90 days after discharge
|
The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health.
Patients rate each item on an ordinal scale.
Data are analyzed using a proprietary algorithm.
Scores range from 0 to 100.
Higher scores reflect a better health status.
The analysis creates an overall health score and sub scores that reflect physical health and mental health.
Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.
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3, 7, 14, 21, 30, 60, and 90 days after discharge
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Short Form (SF12) Mental Health Score
Délai: 3, 7, 14, 21, 30, 60, and 90 days after discharge
|
The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health.
Patients rate each item on an ordinal scale.
Data are analyzed using a proprietary algorithm.
Scores range from 0 to 100.
Higher scores reflect a better health status.
The analysis creates an overall health score and sub scores that reflect physical health and mental health.
Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.
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3, 7, 14, 21, 30, 60, and 90 days after discharge
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Care Transition Measure (CTM3)
Délai: 3 days after discharge
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The CTM3 is a three-item standardized questionnaire to measures patients' perspectives on coordination of hospital discharge care.
Patients rate whether they strongly agree, agree, disagree, or strongly disagree with three items (hospital staff too my preferences into account, I had a good idea what I was responsible for once I left the hospital, and I clearly understood the purpose for taking each of my medications).
They may also rate an items as not applicable to their situation.
Ratings are converted to a scale that ranges from 0 to 100.
Higher scores reflect better discharge care.
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3 days after discharge
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Rural Transition Measure (RTM14)
Délai: 7, 14, 21, 30, 60, and 90 days after discharge
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The RTM14 is a fourteen-item questionnaire to measures patients' perspectives on the delivery of transition services and supports after discharge from a regional hospital to a small town or rural community.
Patients respond by indicating whether they strongly disagree, disagree, agree, or strongly agree with each of the 14 items.
Patients may also indicate whether an item is not applicable to their situation.
Ratings are converted to a scale that ranges from 0 to 100.
Higher scores reflect better transition service performance.
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7, 14, 21, 30, 60, and 90 days after discharge
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Tom W Seekins, Ph.D., University of Montana
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 (Estimation)
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
- 177-15
Plan pour les données individuelles des participants (IPD)
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