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出境医 / 临床实验 / The Goals of Care Initiative (GOCI)
The Goals of Care Initiative (GOCI)
Study Description
Brief Summary:
A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI & sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Decision-Making Oncology Chemotherapy Effect | Behavioral: Goals of Care Initiative | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 960 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Stepped Wedge Cluster Randomised Controlled Trial |
| Masking: | Single (Participant) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative |
| Actual Study Start Date : | June 11, 2019 |
| Estimated Primary Completion Date : | March 31, 2021 |
| Estimated Study Completion Date : | March 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control arm
Participants will not receive GOCI materials
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Experimental: Intervention
Participants will receive GOCI materials and clinicians will receive training.
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Behavioral: Goals of Care Initiative
Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process. Furthermore, there will be instructional videos on how to complete the Goal conversations sheet. Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams. The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams. The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet. The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care.
Other Name: Can-GUIDE
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Outcome Measures
Primary Outcome Measures :
- SDM-Q-9 [ Time Frame: Immediately following intervention ]Patient involvement in decision making will be measured using the SDM-Q-9 questionnaire. The questionnaire contains nine items with respondents scoring on a six point scale (0 represents completely disagree to 5 which represents completely disagree) how much they agree with the presented statement. The highest score attainable, 45, represents the highest level of perceived Shared Decision Making and 0 represents no perceived involvement in Shared Decision Making.
- Decision Conflict Scale [ Time Frame: Immediately following intervention ]
Patient satisfaction with decision and overall decision conflict will be measured using the Ottawa Decisional Conflict Scale. The scale consists of 16 items with patients scoring themselves on a five point scale (0, Strongly Agree - 4, Strongly Disagree). The scale includes five subscales: uncertainty, support, values, informed, effective decision.
The total score and subscale scores are calculated by dividing the sum of the items by the number of items within that subscale and multiplying by twenty five (scored range from 0 to 100; 0 score indicates no decisional conflict, 100 indicates extremely high decisional conflict). This scale evaluates the quality of decision as outlined within internationally recognised guidelines to establish the effectiveness of decision aids. Furthermore, some of the subscales address evaluating the quality of the decision process (feeling informed about the options, clarity of values).
Secondary Outcome Measures :
- Decision Self Efficacy Scale [ Time Frame: Immediately following intervention, then at 6 weeks and 12 weeks. ]A patient's ability to make a decision about treatment (or decision self-efficacy) will be measured using the Ottawa Decision Self-Efficacy scale. The scale consists of 11 items where patients score themselves on a five point scale (0, not at all confident - 4, Very confident); high score indicates greater decision self-efficacy. The total score provides a global rating of self confidence in the patient's ability to engage with decision making regarding their treatment. The total score is calculated by summing the 11 items, dividing by 11 and then multiply by 25.
- EQ-5D-5L [ Time Frame: Immediately following intervention, then at 6 weeks and 12 weeks. ]
EQ-5D is a standardised instrument for use as a measure of health outcome and it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. The EuroQoL 5-level version (EQ-5D-5L) will be assessed to provide a preference based measure of health-related quality-of-life which will enable us to calculate a quality adjusted life-year (QALY) for use in the cost-effectiveness analysis. The preference weights to estimate utility values and QALYs will be those recommended by NICE at the time of data analysis.
Participants are asked to choose a statement which best relates to their current experience relating to the following health domains: mobility, self-care, ability to carry out usual activities, pain/discomfort, anxiety/depression.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Undergoing, or being considered for, systemic treatment from one of the cluster teams.
- 18+ years.
- Able to give written consent.
- Able to understand verbal and written English.
Exclusion Criteria:
• Patient is not being considered for Systemic Anti-Cancer Treatment.
Contacts and Locations
Contacts
| Contact: Grant Punnett, MSc | 01619182090 ext 2090 | grant.punnett@christie.nhs.uk | |
| Contact: Catherine Perry, PhD | 01619182090 ext 2090 | catherine.perry@christie.nhs.uk |
Locations
| United Kingdom | |
| The Christie NHS Foundation Trust | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Contact: Grant Punnett, MSc 01619182090 ext 2090 grant.punnett@christie.nhs.uk | |
| Principal Investigator: Janelle Yorke, PhD | |
Sponsors and Collaborators
The Christie NHS Foundation Trust
University of Manchester
Investigators
| Principal Investigator: | Janelle Yorke, PhD | University of Manchester |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 10, 2019 | ||||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||||
| Last Update Posted Date | July 16, 2019 | ||||||||
| Actual Study Start Date ICMJE | June 11, 2019 | ||||||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Goals of Care Initiative | ||||||||
| Official Title ICMJE | A Hybrid Implementation-effectiveness Stepped Wedge Cluster Randomised Controlled Trial to Determine the Effectiveness of the Goals of Care Initiative | ||||||||
| Brief Summary | A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI & sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Stepped Wedge Cluster Randomised Controlled Trial Masking: Single (Participant)Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Goals of Care Initiative
Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process. Furthermore, there will be instructional videos on how to complete the Goal conversations sheet. Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams. The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams. The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet. The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care.
Other Name: Can-GUIDE
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
960 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 31, 2021 | ||||||||
| Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: • Patient is not being considered for Systemic Anti-Cancer Treatment. |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04020679 | ||||||||
| Other Study ID Numbers ICMJE | 18_CPCR_17 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | The Christie NHS Foundation Trust | ||||||||
| Study Sponsor ICMJE | The Christie NHS Foundation Trust | ||||||||
| Collaborators ICMJE | University of Manchester | ||||||||
| Investigators ICMJE |
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| PRS Account | The Christie NHS Foundation Trust | ||||||||
| Verification Date | July 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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