Evaluation of an Intervention Designed to Enhance the Quality of Decision Support Provided to Patients Making Decisions About End-of-life Place of Care

Palliative Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614003
• Other study ID #: H-01-07-09
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2008
• Last updated: May 21, 2015
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Palliative Care

Intervention

Behavioral:
• Decision support skills building Intervention
Decision support skills

Locations

Country	Name	City	State
Canada	St. Elizabeths Health Care Agency	Kingston	Ontario
Canada	Ottawa Carefor Nursing Services	Ottawa	Ontario
Canada	SCOHS Regional Palliative Care Community Services	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Community Care Access Center's (CCAC)	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool		6 month	No
Secondary	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		6 months	No