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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03297320
Other study ID # R-16-299
Secondary ID
Status Recruiting
Phase N/A
First received September 26, 2017
Last updated September 26, 2017
Start date January 1, 2017
Est. completion date March 31, 2019

Study information

Verified date September 2017
Source Lawson Health Research Institute
Contact Launa Elliott, BSc
Phone 519 685-8500
Email Ravi.Taneja@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that necessitate an Intensive Care Unit (ICU) admission.

Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but rarely is this the case.

The innovation will involve the use of trained nurse facilitators to have meaningful conversations with patients and their families in an effective way that bridges the gap between resuscitation status, GOC discussions and ACP across the continuum of care.


Description:

1. On admission, the usual LHSC process will be followed whereby the patient's wishes for resuscitation are documented on the resuscitation record in the patient's chart. This constitutes the "original" resuscitation status.

2. After referral or screening and written consent, the RA will conduct semi-structured, face-to-face interviews with the patient and or SDM as appropriate. If the RA has concern about a discordance, he/she will then provide verbal feedback to the health-care team (Attending Physician or the Senior Medical Resident (SMR)) immediately and request them to communicate with the patient/SDM again. A case of discordance shall be recorded ONLY if the health-care team (Attending Physician or Senior Medical Resident) confirms that a change in resuscitation status is needed. The output of this intervention will be the "revised" resuscitation status. This "standardized" process for determining this outcome has worked well in our pilot study. Any disagreements between RA and SMR on patient/SDM preferences will be reported to Team#1 Attending and recorded. It will be up to the team to reconcile the "revised" resuscitation preferences on official records (Resuscitation status can only be filled in only by an MD as per hospital policy).

4. Advanced Clinical Notes: These will be typed by the RA and a note be made of the "revised" resuscitation preferences along with GOC and ACP discussions.

5. A pilot study related to this work started in August 2016 and has allowed the research team to evaluate barriers and facilitators of conducting this intervention on Internal Medicine patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients admitted to internal medicine teams at or after hospitalization day 2 with:

1. Age =55 years with =1 diagnoses: Chronic lung disease, Coronary artery disease, Congestive heart failure, Cirrhosis, Renal failure, Diabetes, Peripheral vascular disease, Cancer, Dementia (inability with ADLs) or

2. If none of these criteria were met, any patient whose death within the next 1 year would not surprise health-care team members.

Exclusion Criteria:

1. Lack of written consent

2. Patients who do not speak English; hard of hearing

3. Expected to die or be discharged = 24 hours

4. Referral to or having an established palliative care plan

Study Design


Related Conditions & MeSH terms


Intervention

Other:
In-depth conversation about Goals of Care and ACP
In-depth conversation regarding Goals of Care and ACP by an experienced practitioner

Locations

Country Name City State
Canada London Health Sciences Centre London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Discordance Discordance between patients' prior expressed preferences and those documented in their healthcare record 2 years
Secondary Risk factors associated with discordance Evaluate predisposing factors for the discordance 2 years
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