Decision Process About the Location of Care Among Frail ElderlyDOLCENCT02244359
Improving Decision Making On Location of Care With the Frail Elderly and Their Caregivers
A study testing Training in people with Decision Process About the Location of Care Among Frail Elderly, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Decision Process About the Location of Care Among Frail Elderly
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Decision Making Process About Location of Care With the Frail Elderly and Their Caregivers
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.
- Being tested
- Training, Usual care
- Keywords
- Shared Decision making, Patient Centred care, Interprofessionalism, Home care, Frail elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Online tutorial, decision aid and interactive workshop Receives: Behavioral: Training |
| Usual care | Other | Usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assumed role in the decision making process, and the preferred and chosen options.
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.
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Decision Process About the Location of Care Among Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- TVN 2013 Core Research Grant Program, Ministere de la Sante et des Services Sociaux, Health and Social Services Agency, Montreal
- Responsible party
- Principal investigator, France Legare, CHU de Quebec-Universite Laval
- Investigators
- France Légaré, MD, PhD, Principal investigator, CHUQ Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244359
- Sponsor's protocol ID
- CORE 2013-56
- Acronym
- DOLCE
- Status last verified
- Aug 2016
- First submitted
- 17 Sep 2014
- Last updated
- 25 Aug 2016
- Results posted
- No
Publications
Adekpedjou R, Haesebaert J, Stacey D, Briere N, Freitas A, Rivest LP, Legare F. Variations in factors associated with healthcare providers' intention to engage in interprofessional shared decision making in home care: results of two cross-sectional surveys. BMC Health Serv Res. 2020 Mar 12;20(1):203. doi: 10.1186/s12913-020-5064-3.
PubMed 32164669Boucher A, Haesebaert J, Freitas A, Adekpedjou R, Landry M, Bourassa H, Stacey D, Croteau J, Genevieve PG, Legare F. Time to move? Factors associated with burden of care among informal caregivers of cognitively impaired older people facing housing decisions: secondary analysis of a cluster randomized trial. BMC Geriatr. 2019 Sep 9;19(1):249. doi: 10.1186/s12877-019-1249-1.
PubMed 31500590Garvelink MM, Emond J, Menear M, Briere N, Freitas A, Boland L, Perez MMB, Blair L, Stacey D, Legare F. Development of a decision guide to support the elderly in decision making about location of care: an iterative, user-centered design. Res Involv Engagem. 2016 Jul 19;2:26. doi: 10.1186/s40900-016-0040-0. eCollection 2016.
PubMed 29062524Garvelink MM, Freitas A, Menear M, Briere N, Stacey D, Legare F. In for a penny, in for a pound: the effect of pre-engaging healthcare organizations on their subsequent participation in trials. BMC Res Notes. 2015 Dec 8;8:751. doi: 10.1186/s13104-015-1743-2.
PubMed 26645477Legare F, Briere N, Stacey D, Bourassa H, Desroches S, Dumont S, Fraser K, Freitas A, Rivest LP, Roy L. Improving Decision making On Location of Care with the frail Elderly and their caregivers (the DOLCE study): study protocol for a cluster randomized controlled trial. Trials. 2015 Feb 12;16:50. doi: 10.1186/s13063-015-0567-7.
PubMed 25881122
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Decision Making Process About Location of Care With the Frail Elderly and Their Caregivers
- ClinicalTrials.gov ID
- NCT02244359
- Acronym / sponsor ID
- DOLCE / CORE 2013-56
- Keywords
- Shared Decision making, Patient Centred care, Interprofessionalism, Home care, Frail elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- TVN 2013 Core Research Grant Program, Ministere de la Sante et des Services Sociaux, Health and Social Services Agency, Montreal
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: TrainingOnline tutorial, decision aid and interactive workshop |
| Usual care | Other | Behavioral: Usual careUsual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training | Behavioural | Training |
| Usual care | Behavioural | Usual care |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Derived from this study: PubMed 32164669Adekpedjou R, Haesebaert J, Stacey D, Briere N, Freitas A, Rivest LP, Legare F. Variations in factors associated with healthcare providers' intention to engage in interprofessional shared decision making in home care: results of two cross-sectional surveys. BMC Health Serv Res. 2020 Mar 12;20(1):203. doi: 10.1186/s12913-020-5064-3.
- Derived from this study: PubMed 31500590Boucher A, Haesebaert J, Freitas A, Adekpedjou R, Landry M, Bourassa H, Stacey D, Croteau J, Genevieve PG, Legare F. Time to move? Factors associated with burden of care among informal caregivers of cognitively impaired older people facing housing decisions: secondary analysis of a cluster randomized trial. BMC Geriatr. 2019 Sep 9;19(1):249. doi: 10.1186/s12877-019-1249-1.
- Derived from this study: PubMed 29062524Garvelink MM, Emond J, Menear M, Briere N, Freitas A, Boland L, Perez MMB, Blair L, Stacey D, Legare F. Development of a decision guide to support the elderly in decision making about location of care: an iterative, user-centered design. Res Involv Engagem. 2016 Jul 19;2:26. doi: 10.1186/s40900-016-0040-0. eCollection 2016.
- Derived from this study: PubMed 26645477Garvelink MM, Freitas A, Menear M, Briere N, Stacey D, Legare F. In for a penny, in for a pound: the effect of pre-engaging healthcare organizations on their subsequent participation in trials. BMC Res Notes. 2015 Dec 8;8:751. doi: 10.1186/s13104-015-1743-2.
- Derived from this study: PubMed 25881122Legare F, Briere N, Stacey D, Bourassa H, Desroches S, Dumont S, Fraser K, Freitas A, Rivest LP, Roy L. Improving Decision making On Location of Care with the frail Elderly and their caregivers (the DOLCE study): study protocol for a cluster randomized controlled trial. Trials. 2015 Feb 12;16:50. doi: 10.1186/s13063-015-0567-7.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France Légaré, MD, PhD principal investigator
CHUQ Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Decision Process About the Location of Care Among Frail Elderly, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assumed role in the decision making process, and the preferred and chosen options. (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244359, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.