Mixed Methods Study Web-based Life Support Decision Aid (eLSDA)
26 de octubre de 2018 actualizado por: Anh Pham, University of Saskatchewan
Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient
Patients and families want to be involved in healthcare decisions.
When the decision-making process does not engage older patients and their families, the care provided does not match patient preferences or meet their needs.
Healthcare teams can collaborate to support patients and families facing difficult healthcare decisions, such as decisions about the use of technology used to keep a person alive when they are critically ill.
Tools called patient decision aids are used in many health care settings to help patients and families understand their options and figure out the benefits and harms of a treatment to decide what is right for them.
The healthcare team can make sure that patients understand the information provided, give them opportunities to ask questions, and help them talk more about the decision with others.
This research study is trialing a web based patient decision aid class of intervention.
It is anticipated that 120 hospitalized, seriously ill, older adult patients/ families and their healthcare professionals will be recruited.
The study will determine if the intervention can improve dialogue about whether life sustaining technology for seriously ill older patients.
The findings will contribute to what is already known about overcoming challenges to involving patients and families with a goal of keeping patients and families at the centre of decisions about their health.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A concurrent mixed method study of a life support decision aid (eLSDA) intends to prepare hospitalized, seriously ill older adult patients and their families to participate in shared decision-making. The study includes 1) randomized controlled trial and 2) a qualitative (naturalistic observation) study. The experimental study compares a convenience cohort of participants who receive usual care (n=60 patients or patient/surrogate pairs) to a cohort of participants who receive the intervention (n=60 patients or patient/surrogate pairs). The investigators intend to measure a) knowledge of life-sustaining technologies, b) clarity of values, c) congruence between documented physician's orders and patient choice, d) decisional conflict, and e) quality of communication. For the intervention group only, investigators will measure comprehensibility and acceptability of the eLSDA. The observational qualitative study derived from naturalistic observation will involve participant observation to examine dialogue about life support between hospitalized, seriously ill older adult patients, families and their healthcare professionals. Quantitative and qualitative data will be collected to better understand the comprehensibility, acceptability, usability, feasibility and impact of the eLSDA used in routine clinical practice.
Questionnaires, patient/family/physician discussions and web based tool viewing will be completed in a hospital setting. The investigator will administer pre-intervention questionnaires to the participants, which will take approximately 15 minutes. Participants will then be randomized to groups, and be invited to use the web based eLSDA or usual care materials on a laptop computer or tablet (30 minutes). This will be followed by post-intervention questionnaires in a second interview (15 minutes). Physicians and nurses/social workers will be asked to complete a survey to examine the barriers to discussions about goals of care (15 minutes). The investigator will also fill out the chart abstraction tool after the participants give consent.
Tipo de estudio
Intervencionista
Inscripción (Actual)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canadá, S7N 0W8
- Royal University Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
55 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Potential users of eLSDA, which are those who are hospitalized, seriously ill, older patients, their families, and their health care providers.
Age 55 + with one or more of the following diseases:
- Chronic obstructive lung disease
- Congestive heart failure
- Cirrhosis
- Cancer
- End-stage dementia
- Renal failure
- Any patient 70 + admitted to the hospital from the community because of an acute medical or surgical condition.
- Any patient 55 - 69 years of age admitted to the hospital, who has high likelihood of death in the next 6 months, in the opinion of the treating physician.
Exclusion Criteria:
- People who are not hospitalized or do not have family members that are hospitalized and are not a potential user of the eLSDA.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Patient/family are randomized to either the active intervention (web based life support patient decision aid - eLSDA and decision coaching) or usual care comparison.
|
The web-based life support decision aid (eLSDA) was adapted from a print-based decision aid.
The eLSDA includes information on the pros and cons of both life support and comfort care.
The eLSDA lays out the decision about life support for an individual patient/family in a logical stepwise fashion to permit discussion, ask questions, and permit reflection on each step.
At the end of the eLSDA, unmet decision-making needs are identified to seek support from the healthcare team.
Otros nombres:
During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.
Otros nombres:
|
|
Sin intervención: Usual Care Comparison
Patients may also randomized to review current web based resources provided by the health region for seriously ill patients.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Acceptability & Usability of the eLSDA
Periodo de tiempo: up to 15 minutes
|
The acceptability and usability is assessed by conducting an Acceptability Survey which asks participants 8 validated questions about the use, amount of information, length, clarity, balance in presentation, willingness to recommend to others and overall suitability for decision making.
The intervention will be considered acceptable if score of the acceptability survey exceeds 80%.
|
up to 15 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Knowledge about life-sustaining technologies
Periodo de tiempo: up to 15 minutes
|
This knowledge of life-sustaining technologies will be measured after using the eLSDA using the self-report questionnaire.
The knowledge questionnaire was developed for this study based on the eLSDA to test users' knowledge of life-sustaining technologies.
|
up to 15 minutes
|
|
Clarity of values regarding life-sustaining technologies
Periodo de tiempo: up to 30 minutes
|
The patient's values will be collected in the eLSDA.
|
up to 30 minutes
|
|
Congruence between the documented physician's orders and patient choice
Periodo de tiempo: up to 5 minutes
|
Congruence between documented physician orders and patient choice when participants use the eLSDA and/or based on patient communication during the discussion with their physician will be reported as simple agreement: (Yes/No)
|
up to 5 minutes
|
|
Feasibility of Evaluation Process
Periodo de tiempo: up to 30 minutes
|
The measures of feasibility are established by the rate of completion of the eLSDA, debriefing and study procedures.
The study will be considered feasible if 60% of those approached agreed to participate in the study; >75% of participants discuss the decision about life support during the encounter, <5% of the participants are distressed by the eLSDA, and 80% of participants complete data collection.
|
up to 30 minutes
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer Kryworuchko, PhD RN CNCC, University of British Columbia
- Director de estudio: Wanda Martin, PhD RN, University of Saskatchewan
- Silla de estudio: Donna Goodridge, University of Saskatchewan
- Silla de estudio: Petrina McGrath, Saskatoon Health Region
- Silla de estudio: Karen Levesque, Saskatoon Health Region
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
- The Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.
- Heyland DK, Groll D, Rocker G, Dodek P, Gafni A, Tranmer J, Pichora D, Lazar N, Kutsogiannis J, Shortt S, Lam M; Canadian Researchers at the End of Life Network (CARENET). End-of-life care in acute care hospitals in Canada: a quality finish? J Palliat Care. 2005 Autumn;21(3):142-50.
- O'Connor AM, Graham ID, Visser A. Implementing shared decision making in diverse health care systems: the role of patient decision aids. Patient Educ Couns. 2005 Jun;57(3):247-9. doi: 10.1016/j.pec.2005.04.010. No abstract available.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2014
Finalización primaria (Actual)
29 de enero de 2017
Finalización del estudio (Actual)
29 de enero de 2017
Fechas de registro del estudio
Enviado por primera vez
29 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
29 de agosto de 2017
Publicado por primera vez (Actual)
5 de septiembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- BEH12334
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
There is not a plan to make IPD available.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Web based life support patient decision aid
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Activo, no reclutandoCáncer de mama anatómico en estadio I AJCC v8 | Cáncer de mama anatómico en estadio IA AJCC v8 | Cáncer de mama en estadio anatómico IB AJCC v8 | Cáncer de mama anatómico en estadio II AJCC v8 | Cáncer de mama anatómico en estadio IIA AJCC v8 | Cáncer de mama en estadio anatómico IIB AJCC v8 | Cáncer... y otras condicionesEstados Unidos
-
Emory UniversityTerminadoAnemia drepanocíticaEstados Unidos