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

May 21, 2015 updated by: Ottawa Hospital Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
decision support
Behavioral: Decision support skills building Intervention
Decision support skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Annette O'Connor, MD, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (ESTIMATE)

February 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-01-07-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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