Effect of Collaborative Requesting on DCD Refusal Rates: Randomized Controlled Trial

NCT05660252 | Recruiting

• 1 other identifier: RC21_0368
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief Summary

The most common reason for not obtaining donation after brain death (DBD) or donation after controlled circulatory death (DCD) in France is refusal of consent by the relatives. Many observational studies suggest that consent rates may increase when the request is made by specially trained and highly experienced professionals. One technique that may maximize the consent rate is collaborative requesting made jointly by the physician in charge of the patient and an organ procurement coordinator (OPC). Although the general principles are the same for DCD as for DBD, several differences and specificities exist. First, withdrawal of life-sustaining treatments (WLST) decisions should be entirely independent from organ-donation considerations, in order to eliminate potential conflicts of interest. However, separating conversations about WLST and donation may not always be possible. Potential DCD situations often occur after an extended ICU stay with the development of close ties between families and staff. The ICU physician may therefore feel that suggesting donation during the WLST conversation serves the family-ICU staff relationship. An unblinded multicenter randomized controlled trial tested the null hypothesis of no difference in organ-donation consent rates between collaborative requesting (clinical team and OPC together) vs. the clinical team only (routine requesting). The potential donors met criteria for brain-stem death or had impending brain-stem death; none were candidates for DCD. Collaborative requesting did not increase the consent rate. The PRODON study will test whether collaborative requesting by the ICU team and OPC decreases the rate of DCD refusal by families compared to routine requesting by the ICU team only.

Conditions

Organ Donation; Required Organ Donation Request; Professional Family Relations; Intensive Care Units

Keywords

Donation request; Organ donation; Consent for organ donation; Health care professionals; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Rate of DCD refusal by the family

  Our primary outcome measure (refusal of organ donation) will be determined very shortly after the organ-donation request.

  One day

Secondary Outcomes (6)

• The Hospital Anxiety and Depression Scale (HADS) completed by the participating relative

  3 and 12 months after the death of the patient

• The Revised Impact of Event Scale (IES-R) completed by the participating

  3 and 12 months after the death of the patient

• The Inventory of Complicated Grief (ICG) completed by the participating relative

  12 months after the death of the patient

• A qualitative psychosociological evaluation of the experience of the family

  3 months after the death of the patient

• Healthcare staff member questionnaire

  24 hours

Study Arms (2)

Collaborative request

EXPERIMENTAL

The patient's relative is approached by the ICU team and an organ procurement coordinator together.

Other: Collaborative request

Routine request

NO INTERVENTION

The patient's relative is approached by the clinical team only.

Interventions

Collaborative request OTHER

The relative is approached by the clinical team and an organ procurement coordinator together.

Collaborative request

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years or more Patients in the ICU for whom a decision to withdraw life-sustaining treatments (WLST) has been made and for whom the cessation of circulatory and respiratory functions is anticipated to occur within a time frame that will enable organ recovery

You may not qualify if:

• None

Sponsors & Collaborators

• Nantes University Hospital: lead
• University of Burgundy: collaborator
• Famirea Study Group: collaborator

Study Sites (1)

CHU Nantes

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Study Officials

• Laurent MARTIN-LEFEVRE, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent MARTIN-LEFEVRE, MD

CONTACT

44768435; laurent.martinlefevre@chu-nantes.fr

Jean REIGNIER, MD - Pr

CONTACT

jean.reigner@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All participants are necessarily unblinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label multicenter randomized controlled trial

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 21, 2022
• Study Start: June 16, 2022
• Primary Completion: June 16, 2025
• Study Completion (Estimated): June 16, 2026
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)