Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Decision Making On Location of Care With the Frail Elderly and Their Caregivers (DOLCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02244359
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : August 25, 2016
Sponsor:
Collaborators:
TVN 2013 Core Research Grant Program
Ministere de la Sante et des Services Sociaux
Health and Social Services Agency, Montreal
Information provided by (Responsible Party):
France Legare, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE September 17, 2014
First Posted Date  ICMJE September 19, 2014
Last Update Posted Date August 25, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2014)
The assumed role in the decision making process, and the preferred and chosen options. [ Time Frame: 3 to 6 months ]
We will use the modified version of the Control Preferences Scale designed to assess the assumed role in the decision making process reported by the client.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02244359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Decision Making On Location of Care With the Frail Elderly and Their Caregivers
Official Title  ICMJE Improving the Decision Making Process About Location of Care With the Frail Elderly and Their Caregivers
Brief Summary

One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home or move to a care facility. It is certainly difficult to make this decision alone, but can be even harder if someone else makes it for you. Shared decision making is when, instead of making decisions for the patient, healthcare professionals share information about what the evidence says, and they talk about what's important with the patient, and then make the decision together. In the case of the frail elderly in home care services, there are many health care professionals involved, e.g. the doctor, nurse and social worker. In this case decisions should be shared by all the professionals involved with the elderly person along with his or her caregivers. Unfortunately, in this context, shared decision making rarely occurs.

We have designed a training program that teaches interprofessional teams how to share decisions with their frail elderly patients, and tested it in one Quebec City and one Edmonton home care team. This project tests the training program on a broader scale with 16 home care teams attached to community health centres across the province of Quebec, and will compare the results with what happens when no one has completed the training (usual care). Home care is a rapidly growing sector and this study will lay the foundations for a national strategy to ensure that no one has to make this difficult decision alone.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Decision Process About the Location of Care Among Frail Elderly
Intervention  ICMJE
  • Behavioral: Training
  • Behavioral: Usual care
Study Arms  ICMJE
  • Experimental: Training
    Online tutorial, decision aid and interactive workshop
    Intervention: Behavioral: Training
  • Usual care
    Usual care
    Intervention: Behavioral: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2016)
455
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
560
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Receiving care from the home care team
  • Faced the decision about whether to stay at home or move to a care facility in the previous 3 to 6 months
  • Able to read, understand and write french or english
  • Able to give informed consent
  • For the case of clients unable to provide informed consent, their caregivers who was involved into decision making process will be eligible

Exclusion Criteria:

  • Clients who cannot provide informed consent (e. g. clients with cognitive impairment) without a caregiver
  • Clients who require acute care hospitalization and whom the location of care decision is transferred to hospital-based social services
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02244359
Other Study ID Numbers  ICMJE CORE 2013-56
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party France Legare, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE
  • TVN 2013 Core Research Grant Program
  • Ministere de la Sante et des Services Sociaux
  • Health and Social Services Agency, Montreal
Investigators  ICMJE
Principal Investigator: France Légaré, MD, PhD CHUQ Research Center
PRS Account CHU de Quebec-Universite Laval
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP