- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01784575
Increasing Use of Publicly Reported Pediatric Quality Data (IDEAS)
IDEAS for a Healthy Baby: Reducing Disparities in Consumer Use of Publicly Reported Quality Data
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Efforts to increase transparency regarding health care quality and safety are partially guided by the belief that making performance information publicly available will enable patients to make more informed choices. Although the amount of information reported on websites and through other channels has increased dramatically, use by consumers remains limited and largely restricted to white, college educated and middle aged consumers. There are many barriers that prevent patients from making effective use of current public reporting websites, including failure to recognize that quality may vary between providers, lack of awareness of publicly reported data, limited internet access, and low health literacy and numeracy. Innovative approaches are therefore needed to overcome barriers to using these data, particularly in vulnerable populations, to ensure a health care system in which every consumer can benefit from public reporting. Patient navigators have helped patients take greater advantage of the complex health care delivery environment, and use of patient navigators may be an effective approach to engage consumers and to help them to interpret the information presented in public reports.
The scientific aims of the study are: 1) to test the efficacy of an office-based patient navigator to assist low income pregnant women in using publicly reported data to select a pediatric care provider; 2) to assess the efficacy of the intervention in subgroups defined by parity, race/ethnicity, and health literacy; 3) to evaluate the importance of publicly reported information about quality compared to other factors when selecting a pediatric provider; and 4) to assess the intervention's impact on self-management of health care. English speaking women ages 16-45 attending the prenatal clinic at a large urban medical center will be recruited, enrolled, consented and randomized to the navigator intervention or an informational pamphlet control between 24-34 weeks of gestation. Women randomized to the intervention arm will receive two 20 minute sessions with a trained patient navigator who will guide women in navigating and interpreting information about the quality of care provided at local pediatric practices on the Massachusetts Health Quality Partners web site. A survey designed for the purpose of this study will be administered at baseline and post-intervention. Health literacy, numeracy and level of activation for self-management of health care will also be assessed as potential mediators of intervention effectiveness. The primary study outcome will be the average performance on quality measures for the practices selected in the intervention and control groups. Secondary outcomes will include analyses of efficacy among groups of women defined by parity and an assessment of the relative importance of factors considered when choosing a pediatric care provider. Successful completion of the study aims will yield important new knowledge about the value of guided web-site navigation as a strategy to reduce disparities in the use of publicly reported information.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 20-34 weeks of pregnancy
- comfortable speaking English
- ages 16-50
Exclusion Criteria:
- age 15 or younger
- age 51 or greater
- not comfortable speaking or understanding English
- less than 20 or greater than 34 weeks of pregnancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Patient Navigator Intervention
The Patient Navigator Intervention arm will have two 20 minute interactive sessions with a patient navigator in which they will learn about quality measures and view scores on the Massachusetts Health Quality Partner's website.
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The Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site.
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Comparatore attivo: Control
The control arm will receive an information pamphlet about health care quality.
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The Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality score of pediatric practices chosen by participants
Lasso di tempo: 6-20 weeks
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Each pediatric practice will be given a composite clinical quality and patient experience score based upon scores reported on the Massachusetts Health Quality Partners "Quality Insights" reports.
The mean scores of practices chosen by women in the intervention compared to the control arm will assessed.
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6-20 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Factors important to pregnant women when choosing a pediatric practice
Lasso di tempo: 6-20 weeks
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The study survey will assess relative importance of a range of factors that might be important to women when selecting a pediatric practice.
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6-20 weeks
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient activation
Lasso di tempo: 6-20 weeks
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We will be assessing changes in patients engagement in self-management of their and their child's health care using Patient Activation Measures.
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6-20 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sarah L Goff, MD, Baystate Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
- Goff SL, Mazor KM, Guhn-Knight H, Budway YY, Murphy L, White KO, Lagu T, Pekow PS, Priya A, Lindenauer PK. Factors That Matter to Low-Income and Racial/Ethnic Minority Mothers When Choosing a Pediatric Practice: a Mixed Methods Analysis. J Racial Ethn Health Disparities. 2017 Dec;4(6):1051-1060. doi: 10.1007/s40615-016-0309-x. Epub 2017 Mar 8.
- Goff SL, Mazor KM, Pekow PS, White KO, Priya A, Lagu T, Guhn-Knight H, Murphy L, Youssef Budway Y, Lindenauer PK. Patient Navigators and Parent Use of Quality Data: A Randomized Trial. Pediatrics. 2016 Oct;138(4):e20161140. doi: 10.1542/peds.2016-1140. Epub 2016 Sep 6.
- Goff SL, Youssef Y, Pekow PS, White KO, Guhn-Knight H, Lagu T, Mazor KM, Lindenauer PK. Successful Strategies for Practice-Based Recruitment of Racial and Ethnic Minority Pregnant Women in a Randomized Controlled Trial: the IDEAS for a Healthy Baby Study. J Racial Ethn Health Disparities. 2016 Dec;3(4):731-737. doi: 10.1007/s40615-015-0192-x. Epub 2016 Apr 11.
- Goff SL, Pekow PS, White KO, Lagu T, Mazor KM, Lindenauer PK. IDEAS for a healthy baby--reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial. Trials. 2013 Aug 7;14:244. doi: 10.1186/1745-6215-14-244.
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 1R21HS021864-01 (Sovvenzione/contratto AHRQ degli Stati Uniti)
- R21HS021864-01 (Sovvenzione/contratto AHRQ degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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