The Approach Study - Full Text View

Purpose

In the Approach Study, the investigators will study the 'process' by which Substitute Decision Makers (SDMs) are approached for consent for their loved one's participation in critical care research. The investigators will randomize SDMs of critically ill patients who are eligible to participate in any research study in operation to either 'physician introduction' of the research team or 'non-physician approach (non-physician)' in which research coordinators are introduced by allied health care team members or introduce themselves directly to SDMs. This study seeks to identify important features of the 'consent to research' process that can be modified to enhance both SDM satisfaction with the consent process and recruitment into critical care research studies.

Condition	Intervention	Phase
Critical Care Trial Participation Consent by SDM	Other: Physician Introduction of research personnel	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	A Randomized Pilot Study of Different Methods of Approaching Substitute Decision Makers Regarding Research Participation in the Intensive Care Unit: The Approach Study

Resource links provided by NLM:

MedlinePlus related topics: Critical Care

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Feasibility Outcome [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Feasibility of the pilot study will be assessed by the following:
1. We expect that (i) ≤ 15% of physician introductions will be missed due to lack of physician availability (physician introduction arm) and (ii) cross-overs (from either arm to the other) will occur in ≤ 15% on introductions.
2. Following randomization, we expect that ≤ 20% of introductions will be missed due to inability of the RC to contact existing SDMs once identified (either intervention or control arm).
3. We will obtain at least 70% of initial SDM questionnaires Part A and at least 50% of questionnaires Part B.

Secondary Outcome Measures:

Consent Obtained Vs Consent Declined [ Time Frame: 7 days ] [ Designated as safety issue: No ]
1. describe the proportion of SDMs providing and declining consent when approached by a RC or accompanied by the most responsible physician and when an update accompanies an introduction.
2. determine the time interval between critically ill patients' meeting eligibility criteria and sentinel events.
3. elucidate reasons why SDMs provide or decline consent
4. assess agreement between SDMs, RCs and attending physicians acceptance of and comfort and satisfaction with the alternative approaches

Enrollment:	138
Study Start Date:	July 2011
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Physician introduction Physicians will introduce Research Coordinators (RCs) by name to SDMs and acknowledge patient eligibility to participate in a study using a standardized script.	Other: Physician Introduction of research personnel Physicians will introduce Research Coordinators (RCs) by name and acknowledge patient eligibility to participate in a research study using a standardized script. Other Names: Approach to Consent Consent Substitute Decision Maker
Active Comparator: Non-physician introduction (usual approach) RCs will either introduce themselves or be introduced by a non-physician member of the health care team.	Other: Physician Introduction of research personnel Physicians will introduce Research Coordinators (RCs) by name and acknowledge patient eligibility to participate in a research study using a standardized script. Other Names: Approach to Consent Consent Substitute Decision Maker

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

SDMs of critically ill adults who are eligible (meet all inclusion criteria and have no exclusion criteria) to participate in a critical care research study in progress in the ICU

Exclusion Criteria:

Eligible critically ill adults who die or are transferred out of a participating ICU prior to being screened by a RC
Critically ill adults capable of providing primary consent for research participation.
We will limit participation to initial encounters (the same patient will not be included more than once)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232621

Locations

Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators

Principal Investigator:

Karen EA Burns, MD, FRCPC, MSc (Epid)

St. Michael's Hospital, Toronto and the Keenan Research Centre/Li Ka Shing Knowledge Institute (Toronto)

More Information

Publications:

Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. Erratum in: N Engl J Med 1999 Apr 1;340(13):1056.

Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14.

Cook D, Guyatt G, Marshall J, Leasa D, Fuller H, Hall R, Peters S, Rutledge F, Griffith L, McLellan A, Wood G, Kirby A. A comparison of sucralfate and ranitidine for the prevention of upper gastrointestinal bleeding in patients requiring mechanical ventilation. Canadian Critical Care Trials Group. N Engl J Med. 1998 Mar 19;338(12):791-7.

SHIMKIN MB. The problem of experimentation on human beings. I. The research worker's point of view. Science. 1953 Feb 27;117(3035):205-7. No abstract available.

Coppolino M, Ackerson L. Do surrogate decision makers provide accurate consent for intensive care research? Chest. 2001 Feb;119(2):603-12.

Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9.

Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7.

Bolmsjö I, Hermerén G. Interviews with patients, family, and caregivers in amyotrophic lateral sclerosis: comparing needs. J Palliat Care. 2001 Winter;17(4):236-40.

Upadya A, Muralidharan V, Thorevska N, Amoateng-Adjepong Y, Manthous CA. Patient, physician, and family member understanding of living wills. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1430-5. Epub 2002 Sep 11.

Shalowitz DI, Garrett-Mayer E, Wendler D. The accuracy of surrogate decision makers: a systematic review. Arch Intern Med. 2006 Mar 13;166(5):493-7. Review.

Ciroldi M, Cariou A, Adrie C, Annane D, Castelain V, Cohen Y, Delahaye A, Joly LM, Galliot R, Garrouste-Orgeas M, Papazian L, Michel F, Barnes NK, Schlemmer B, Pochard F, Azoulay E; Famirea study group. Ability of family members to predict patient's consent to critical care research. Intensive Care Med. 2007 May;33(5):807-13. Epub 2007 Mar 15.

Morley CJ, Lau R, Davis PG, Morse C. What do parents think about enrolling their premature babies in several research studies? Arch Dis Child Fetal Neonatal Ed. 2005 May;90(3):F225-8.

Scales DC, Smith OM, Pinto R, Barrett KA, Friedrich JO, Lazar NM, Cook DJ, Ferguson ND. Patients' preferences for enrolment into critical-care trials. Intensive Care Med. 2009 Oct;35(10):1703-12. Epub 2009 Jun 24.

Chenaud C, Merlani P, Verdon M, Ricou B. Who should consent for research in adult intensive care? Preferences of patients and their relatives: a pilot study. J Med Ethics. 2009 Nov;35(11):709-12.

Heyland DK, Rocker GM, Dodek PM, Kutsogiannis DJ, Konopad E, Cook DJ, Peters S, Tranmer JE, O'Callaghan CJ. Family satisfaction with care in the intensive care unit: results of a multiple center study. Crit Care Med. 2002 Jul;30(7):1413-8.

Responsible Party:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01232621 History of Changes
Other Study ID Numbers:	10-278
Study First Received:	October 28, 2010
Last Updated:	January 4, 2013
Health Authority:	Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 16, 2013