- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01797497
Intervention to Increase Parent-provider Communication During Referrals (P3RC)
Parent-Provider Partnerships for Referral Communication
The overall goal of this three-year study is to adapt and test a brief, feasible intervention using a communication tool and brief parent coaching to increase the capability of parents of children and youth with special health care needs to exchange and use medical information in partnership with their child's physicians when their children require sub-specialty referral. We hypothesize that the use of tools to coordinate referrals between physicians and parents will facilitate increased communication between primary care physicians(PCPs) and specialists, and that parents trained in information exchange and care planning will experience increased self-efficacy in interacting with their child's physicians.
There are two primary aims of the study. The first aim is to adapt a joint parent-provider referral communication and care planning intervention (i.e., the 'referral care plan') for use with ethnically diverse populations in an electronic communication environment, and optimize its usability in the practice setting. The second aim is to test the referral care plan in nine pediatric primary care and subspecialty practices in two states, using a stepped wedge cluster randomized trial, to evaluate its effect on communication, parent self-efficacy, and patient outcomes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
One highly-promoted, evidence-based model for chronic illness service delivery for children is the Care Model for Child Health in the Medical Home. The Medical Home (MH) model has been promoted as way to improve quality while making care more efficient. Communication among members of the health care team is an essential part of the model, with sharing of care between providers preferred by families, PCPs and specialists. However, communication between referring and consulting physicians is frequently missing. Failure of communication can produce uncoordinated care, which may contribute to unmet family needs, duplication or omission of needed medical services, and medical errors.
Data on effectiveness of specific MH interventions, especially in children, are scarce. A large intervention in the MH setting was tested using written care plans and use of forms as tools to promote communication with specialists. Results indicated decreases of 40 to 70% in parent reports of lost work/school time, ER visits, and hospital admissions. Additional studies produced decreased hospitalizations and emergency room use in children.
Family-centered care (FCC), a Medical Home core component, has been conceptualized for measurement purposes as having four components: communication with health care providers, shared decision making, providing families with needed information, and self-care management and support. Interventions to improve FCC through parent-to-parent support groups and community-based support have produced increased parent confidence and problem-solving ability. Studies of asthma have shown that teaching primary care providers to take a family-centered approach to medication prescribing as part of an overall education protocol improves symptoms and decreases follow-up visits, and using a family coordinator to help physicians and parents interact more effectively is integral to improving asthma outcomes.
Shared decision-making (SDM), an element of FCC and an approach favored by family advocacy groups to help parents achieve the greatest benefits for their children with special needs, is addressed by our proposed intervention. Merely providing information to patients and families is not sufficient; families must be able to express preferences, participate in dialogue, and make informed decisions as partners with physicians.
The proposed project addresses the health care quality gaps outlined above by improving primary care-specialty-parent communication, family-centered care, and shared decision-making within the MH model. It also addresses knowledge gaps by examining the effectiveness of an important recommended component of the MH and investigating the relationship between the intervention and both process and outcome measures, in a "real-world" practice setting. If the aims of the project are achieved, we will have discovered a practical way to improve care that can be promoted to payers and policymakers.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Colorado
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Denver, Colorado, États-Unis, 80045
- University of Colorado Denver
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Sciences Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Parents of children aged 0-17, AND
- Parents of children with a chronic health condition, AND
- Parents whose children are receiving a NEW referral to a pediatric neurologist, gastroenterologist, cardiologist, or pulmonologist
Exclusion Criteria:
- Parents of children 18 and older
- Parents of children without a chronic health condition
- Parents of children who are not receiving a referral, or who are receiving a referral to a different sub-specialty
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Care plan and coaching group
In the intervention group, parents complete a referral care plan with their children's physicians and receive a brief coaching session about how to exchange information with specialists.
Outcome data are collected from parents before and after the specialist visit.
|
In the intervention group, primary care providers and parents complete their sections of the referral care plan.
Parents and referred specialists receive a copy of the form.
Parents receive a 5-10 minute brief intervention by phone consisting of education and coaching.
The care plan is reviewed with parents to help them practice exchanging information with the specialist and encourage parents to contact their child's primary care provider with any further questions.
At the specialist visit, specialists review and complete the care plan with the parent and return the plan to the referring primary care provider.
Outcome data are collected from parents before and after the specialist visit.
|
|
Aucune intervention: Preintervention group
In the preintervention group, no care plan is used and no coaching takes place.
Outcome data are collected from parents before and after the specialist visit.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient Outcomes
Délai: 3 Months
|
The main outcome measures of the intervention will be the number of days of lost parent work time or child school time, the number of child ER visits, and the number of unplanned hospital admissions in the 3 months after the specialty visit.
|
3 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parent Self-Efficacy
Délai: 3 Months
|
Self-efficacy in joint treatment planning will be assessed by administering the Perceived Efficacy in Physician-Patient Interactions (PEPPI) scale, a scale originally designed for use to evaluate older persons' self-efficacy in interacting with their physicians that has been successfully used in pediatrics.
|
3 Months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Information Transfer
Délai: 3 Months
|
Other outcome measures will be accurate information exchange, measured by asking parents and PCPs separately the reason for the child's referral on questionnaires, and asking parents and specialists separately the basic elements of the treatment plan (diagnosis, lab tests planned, and medications if any).
A trained specialty nurse clinician reviewer will determine whether parents and physicians agree completely, if they agree partially, or if they disagree.
Additionally, for patients in the intervention, parents will be asked whether they have a copy of the care plan (from the PCP) at enrollment and after the specialty visit (completed by the specialist), specialty physicians will be asked whether the care plan was available to them at the time of the consultation, and PCPs will be asked whether the completed care plan was available to them one month after the specialty visit.
|
3 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christopher Stille, MD, MPH, University of Colorado, Denver
- Chercheur principal: Paul Darden, MD, University of Oklahoma
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 12-0578
- 1 R40MC23632-01-00 (Autre subvention/numéro de financement: HRSA)
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