- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03181724
The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis
A Randomized Trial Measuring the Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice.
Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life.
Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- at least 18 years of age
- English-speaking
- Diagnosis of trapeziometacarpal (TMC) arthritis
Exclusion Criteria:
- Prior surgical intervention for trapeziometacarpal (TMC) arthritis
- Previously accessed or used the online TMC arthritis Decision Aid (DA)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Decision Aid
Cohort that will receive a decision aid.
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Kohorte I vil blive ledet med et beslutningshjælpemiddel (fremover "DA"), og årgang II vil blive ledet uden.
Patienterne i Kohorte I vil modtage DA, som de kan udfylde i et separat rum og tage med hjem.
Beslutningshjælpemidlerne omfatter information om sygdommen/tilstanden, behandlingsmuligheder, fordele, risici, videnskabelige usikkerheder og sandsynligheder for potentielle udfald skræddersyet til patientens sundhedsrisikofaktorer.
Derudover indeholder den værdiafklaringer, såsom at beskrive resultater i funktionelle termer, at bede patienter om at overveje, hvilke fordele og risici der betyder mest for dem, og vejledning i beslutningsprocessen og drøfte deres beslutning med familie/venner.
Det er interaktivt og dynamisk og hjælper patienter med at afklare deres præferencer og komme til en beslutning, der føles bedst for dem.
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Ingen indgriben: No Decision Aid (control)
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Decision Conflict Scale (DCS)
Tidsramme: Day 1
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This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision.
We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options.
Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
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Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
Tidsramme: Day 1
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The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability.
The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
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Day 1
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Patient Health Questionnaire-2 (PHQ-2)
Tidsramme: Day 1
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The PHQ-2 screens for depressive mood over the past 2 weeks.
The score ranges from 0-6, where 0 is not at all depressed and 6 is major depression.
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Day 1
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Consultation and Relational Empathy (CARE) Measure
Tidsramme: Day 1
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The CARE measure is a 10-item questionnaire capturing patient perception of the physician's empathetic understanding under the office visit.
Each item is rated on a 5-point Likert scale, yielding a total score from 0-50.
A higher score indicates greater empathy.
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Day 1
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11-point Ordinal Satisfaction Scale
Tidsramme: Day 1
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The patient satisfaction scale measures how satisfied a patient is with their treatment for their thumb arthritis.
Patients score satisfaction on a scale of 0 to 10, where 0 is not satisfied and 10 is extremely satisfied.
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Day 1
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Change in Decision Regret Scale After 6 Weeks and 6 Months
Tidsramme: 6 week and 6 month follow up
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Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
The scale consists of 5 questions, which range from strongly agree to strongly disagree, scoring 0-100 with higher scores indicating more regret.
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6 week and 6 month follow up
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
- Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG Jr. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care. 2000 Sep;38(9):959-69. doi: 10.1097/00005650-200009000-00009.
- Jayadev C, Khan T, Coulter A, Beard DJ, Price AJ. Patient decision aids in knee replacement surgery. Knee. 2012 Dec;19(6):746-50. doi: 10.1016/j.knee.2012.02.001. Epub 2012 Mar 2.
- Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. BMJ. 2001 Sep 1;323(7311):493-6. doi: 10.1136/bmj.323.7311.493.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015P002550
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med Trapeziometacarpal Arthritis
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Schulthess KlinikWinterthur Institute of Health Economics (WIG), SwitzerlandAfsluttetRivning af rotatormanchet | Rotator Cuff Tear Arthropathy | Trapeziometacarpal slidgigt | Degenerativ arthritis i venstre Glenohumeral led | Degenerativ arthritis i højre Glenohumerale ledSchweiz
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Federal University of São PauloAfsluttet
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Massachusetts General HospitalAfsluttetTrapeziometacarpal artroseForenede Stater
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Corporacion Parc TauliAfsluttet
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Herlev and Gentofte HospitalRekrutteringTrapeziometacarpal slidgigt | CMC-1 SlidgigtDanmark
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Massachusetts General HospitalAfsluttetTrapeziometacarpal (TMC) artroseForenede Stater
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IsalaUkendtTrapeziometacarpal slidgigt | Tommelfinger Carpometacarpal slidgigtHolland
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IsalaUkendtTrapeziometacarpal slidgigt | Tommelfinger Carpometacarpal slidgigtHolland
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University of AarhusAarhus University HospitalAfsluttetPolyartikulær juvenil reumatoid arthritis | Systemisk juvenil idiopatisk arthritis | Juvenil Idiopatisk Arthritis, OligoarthritisDanmark
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University of Sao Paulo General HospitalIkke rekrutterer endnuJuvenil idiopatisk arthritis | Juvenil reumatoid arthritis | Juvenil arthritisBrasilien
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