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- Klinische proef NCT01871948
Effective Communication for Preventing and Responding to Oncology Adverse Events (CanComm)
12 december 2013 bijgewerkt door: Kathleen Mazor, University of Massachusetts, Worcester
Cancer patients often experience problems in their care, many of which are caused by communication breakdowns.
Some communication breakdowns lead to adverse events and even harmful errors.
Deficiencies in provider-patient communication can compound patients' distress, lower the quality of care, and disrupt patient-provider relationships.
There is little research on patients' and providers' experiences of the communication breakdowns that precipitate adverse events and errors, or on effective responses to these events.
Because of this, cancer providers are unsure how to communicate with patients in these difficult situations.
The goal of the proposed study is to improve patient-centered communication around adverse events and errors in cancer care.
Our specific aims are: 1) To describe patients' experiences with communication around adverse events and errors in cancer care, 2) To describe providers' experiences and practices with communication around adverse events and errors in cancer care, 3) To develop practical recommendations, provider training materials and patient educational materials for improving communication around adverse events and errors in cancer care, 4) To disseminate the recommendations and materials through three health plans, and 5) To conduct a preliminary evaluation of the perceived usefulness and impact of the materials.
The investigators will first conduct interviews with breast and colorectal cancer patients who have experienced adverse events or errors at 3 Cancer Research Network (CRN) health plans (Atlanta, Georgia; Seattle, Washington and Worcester, Massachusetts).
The interviews will focus on instances where patients believe that better communication might have prevented an adverse event or error, or mitigated the event's impact.
Next the investigators will conduct focus groups to understand providers' attitudes and experiences with these communication dilemmas, and use simulations to describe providers' communication practices.
Finally, the investigators will interview health plan leaders to identify the systems factors that influence communication with patients around adverse events and errors.
These perspectives will be synthesized to create patient and provider educational material for improving communication.
Three advisory panels: a Patient Advisory Panel, a Health Plan Advisory Panel and a Dissemination Advisory Panel (including all 14 CRN health plans) will help create and disseminate these educational interventions.
Dissemination will occur at the three core clinical sites.
The investigators use patient and provider surveys to evaluate the educational materials' impact.
This evaluation will provide the evidence-base to refine the study products before widespread dissemination throughout the CRN and beyond.
The project will have the advantage of the CRN infrastructure, the CRN Clinical Communication Research Center, and is led by nationally recognized communication researchers.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
500
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30305
- Kaiser Permanente Georgia
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Washington
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Seattle, Washington, Verenigde Staten, 98124
- Group Health
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Cancer survivors
- 21 to 80 years of age
- Able to communicate in English
- have adequate hearing
- no cognitive impairments
Exclusion Criteria:
-Any non-melanoma skin cancer, Breast cancer in situ, Cervical intraepithelial neoplasia (CIN): types I, II, III, Stage I colon cancer, Stage IV cancer, Recurrent cancer or second primary
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Patient survey at 2 points in time
Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.
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Experimenteel: "WeWant to Know" campaign, patient survey at 2 time points
Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.
Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.
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Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later.
Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Calculate differences in satisfaction with cancer care communication, using a summary score from patient surveys, between intervention and control groups.
Tijdsspanne: 8 months
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8 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Kathleen M Mazor, EdD, University of Massachusetts, Worcester
- Hoofdonderzoeker: Thomas H Gallagher, MD, University of Washington
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2008
Primaire voltooiing (Werkelijk)
1 augustus 2013
Studie voltooiing (Werkelijk)
1 augustus 2013
Studieregistratiedata
Eerst ingediend
22 mei 2013
Eerst ingediend dat voldeed aan de QC-criteria
4 juni 2013
Eerst geplaatst (Schatting)
7 juni 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
16 december 2013
Laatste update ingediend die voldeed aan QC-criteria
12 december 2013
Laatst geverifieerd
1 december 2013
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 1184
- P20CA137219 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .