Palliative CarePhase 2NCT00614003
Evaluation of an Intervention Designed to Enhance the Quality of Decision Support Provided to Patients Making Decisions About End-of-life Place of Care
A Phase 2 study testing Decision support skills building Intervention in people with Palliative Care, run by Ottawa Hospital Research Institute at 5 sites in Canada.
Trial summary
Most dying cancer patients would prefer a home death yet die in an institution. Patients can experience uncertainty when weighing practical considerations, concern for others, and their personal ratings about the desirability and undesirability of various outcomes related to different locations of care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Decision support skills building Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesCanada
- Study dates
- Apr 2007to Jun 2008
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurses and case coordinators who:
- are members of a regulated health profession
- care for palliative cancer patients, and/or
- cancer patients with advanced disease, and
- work at least 4 shifts per month,
- in a clinical area where end of life care discussions are likely to be undertaken, and
- are proficient in written and spoken English.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
St. Elizabeths Health Care Agency
Kingston, Ontario
Ottawa Carefor Nursing Services
Ottawa, Ontario
SCOHS Regional Palliative Care Community Services
Ottawa, Ontario
The Ottawa Hospital
Ottawa, Ontario
Community Care Access Center's (CCAC)
Toronto, Ontario
About this study
Official title: Efficacy of a Training Intervention on the Quality of Case Coordinators and Nurses' Decision Support for Patients Deciding About the Place of Care at the End Of-Life: A Randomized Control Trial
Most dying cancer patients would prefer a home death yet die in an institution. Patients can experience uncertainty when weighing practical considerations, concern for others, and their personal ratings about the desirability and undesirability of various outcomes related to different locations of care. Health professionals, trained in decision support, can help patients to make decisions that are informed by both relevant information and what outcomes are most valued by patients. Therefore, I will study if an educational intervention can help nurses and case managers to strengthen their skills and confidence in providing patient decision support around place of end of life care.
Project Description:
Using a two step approach I will study if the quality of providers decision support can be improved with an education. In step one nurses and care coordinators will be interviewed to identify factors that make it easier or more difficult to provide patient decision support. This information will be used to develop an education program. In step two, nurses and care coordinator volunteers will be assigned by a flip of a coin to either receive the decision support education or not. Before and after the education program the quality of the decision support participants provide will be measured and compared. As well, participants receiving the education program will be asked about their satisfaction with the education program.
Read the detailed description
Most terminal cancer patients prefer home palliation yet die in an institution. Some experience decisional conflict when weighing options regarding place of care. Community Case Managers and Nurses are well positioned to identify decisional needs and provide decision support; however, they generally lack skills and confidence in doing so. This study aims to determine whether the quality of case managers' and nurses' decision support can be improved with a theory-based skills-building intervention.
In phase one a needs assessment will be conducted with about 20 key informants. In phase two, nurses will be randomly allocated to an intervention or control group. The intervention, informed by the needs assessment, is comprised of: an auto-tutorial; an interactive skills building workshop; a decision support protocol; performance feedback, and educational outreach.
Participants will be assessed: a) at baseline (quality of decision support); b) after the auto-tutorial (knowledge); and six to eight weeks after the other interventions (quality of decision support; confidence and intention to integrate decision support into practice). Between group differences in the primary outcome (quality of decision support scores) will be analyzed using a repeated measures ANOVA.
- Conditions
- Palliative Care
- Being tested
- Decision support skills building Intervention
- Keywords
- decisional conflict;, decision quality;, place of end of life care;, provider education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision support skills building InterventionBehavioural
Decision support skills
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | decision support Receives: Behavioral: Decision support skills building Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool
Measured: 6 month
Secondary outcomes (1)
Knowledge of place of care determinants and decision support concepts; self perceived quality of decision support provision in clinical practice and behavior intention survey; acceptability and utility of intervention components
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annette O'Connor, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614003
- Sponsor's protocol ID
- H-01-07-09
- Status last verified
- May 2015
- First submitted
- 18 Jan 2008
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Murray MA, O'Connor A, Stacey D, Wilson KG. Efficacy of a training intervention on the quality of practitioners' decision support for patients deciding about place of care at the end of life: A randomized control trial: Study protocol. BMC Palliat Care. 2008 Apr 30;7:4. doi: 10.1186/1472-684X-7-4.
PubMed 18447916
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Training Intervention on the Quality of Case Coordinators and Nurses' Decision Support for Patients Deciding About the Place of Care at the End Of-Life: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00614003
- Acronym / sponsor ID
- H-01-07-09
- Conditions
- Palliative Care
- Keywords
- decisional conflict;, decision quality;, place of end of life care;, provider education
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Feb 2008 (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.
Most dying cancer patients would prefer a home death yet die in an institution. Patients can experience uncertainty when weighing practical considerations, concern for others, and their personal ratings about the desirability and undesirability of various outcomes related to different locations of care. Health professionals, trained in decision support, can help patients to make decisions that are informed by both relevant information and what outcomes are most valued by patients. Therefore, I will study if an educational intervention can help nurses and case managers to strengthen their skills and confidence in providing patient decision support around place of end of life care.
Project Description:
Using a two step approach I will study if the quality of providers decision support can be improved with an education. In step one nurses and care coordinators will be interviewed to identify factors that make it easier or more difficult to provide patient decision support. This information will be used to develop an education program. In step two, nurses and care coordinator volunteers will be assigned by a flip of a coin to either receive the decision support education or not. Before and after the education program the quality of the decision support participants provide will be measured and compared. As well, participants receiving the education program will be asked about their satisfaction with the education program.
Detailed description
Most terminal cancer patients prefer home palliation yet die in an institution. Some experience decisional conflict when weighing options regarding place of care. Community Case Managers and Nurses are well positioned to identify decisional needs and provide decision support; however, they generally lack skills and confidence in doing so. This study aims to determine whether the quality of case managers' and nurses' decision support can be improved with a theory-based skills-building intervention.
In phase one a needs assessment will be conducted with about 20 key informants. In phase two, nurses will be randomly allocated to an intervention or control group. The intervention, informed by the needs assessment, is comprised of: an auto-tutorial; an interactive skills building workshop; a decision support protocol; performance feedback, and educational outreach.
Participants will be assessed: a) at baseline (quality of decision support); b) after the auto-tutorial (knowledge); and six to eight weeks after the other interventions (quality of decision support; confidence and intention to integrate decision support into practice). Between group differences in the primary outcome (quality of decision support scores) will be analyzed using a repeated measures ANOVA.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Decision support skills building Interventiondecision support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- are members of a regulated health profession
- care for palliative cancer patients, and/or
- cancer patients with advanced disease, and
- work at least 4 shifts per month,
- in a clinical area where end of life care discussions are likely to be undertaken, and
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Decision support skills building InterventionDecision support skills | Behavioural | 1 |
Primary outcome
Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool
Time frame: 6 month
1 secondary outcome
Knowledge of place of care determinants and decision support concepts; self perceived quality of decision support provision in clinical practice and behavior intention survey; acceptability and utility of intervention components
Time frame: 6 months
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 May 2015.
- Derived from this study: PubMed 18447916Murray MA, O'Connor A, Stacey D, Wilson KG. Efficacy of a training intervention on the quality of practitioners' decision support for patients deciding about place of care at the end of life: A randomized control trial: Study protocol. BMC Palliat Care. 2008 Apr 30;7:4. doi: 10.1186/1472-684X-7-4.
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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.
Annette O'Connor, MD principal investigator
Ottawa Hospital Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decision support skills building Intervention in people with Palliative Care, run by Ottawa Hospital Research Institute at 5 sites 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 7 inclusion and 0 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (time frame: 6 month). 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 NCT00614003, which also lists 1 linked publication.
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 May 2015.