PB1528 - Understanding patients’ perspectives and barriers to postpartum clinical trial participation: A qualitative substudy of the pilot PARTUM trial

Tuesday, June 27, 2023

18:30 – 19:30 ET

Room: Exhibition

Presenting Author(s)

Lauren Andrew, MD FRCSC (she/her/hers)

Minimally Invasive Gynecology Fellow
Department of Obstetrics and Gynecology, University of Calgary, Calgary, AB, Canada
Calgary, Alberta, Canada

Co-Author(s)

AG

Alexandra Garven

Research Coordinator
Department of Medicine, University of Calgary, Calgary, AB, Canada
Calgary, Alberta, Canada
TT

Taryn Taylor

Assistant Professor
Department of Obstetrics and Gynecology, Western University, London, ON, Canada
London, Ontario, Canada
AR

Anne Roggensack

Assistant Professor
Department of Obstetrics and Gynecology, University of Calgary, Calgary, AB, Canada
Calgary, Alberta, Canada
CM

Claire McCarthy

Consultant Obstetrician and Gynaecologist
Rotunda Hospital and Royal College of Surgeons in Ireland
Dublin, Dublin, Ireland
SD

Suzanne Dubois

Patient Partner
CanVECTOR
Brantford, Ontario, Canada
Lisa Duffett, MD, MSc

Assistant Professor
Department of Medicine, University of Ottawa, Ottawa, ON, Canada
Ottawa, Ontario, Canada
A. Kinga Malinowski, MD, MSc

Associate Professor
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Lunenfeld-Tanenbaum Research Institute, Sinai Health, University of Toronto, Toronto, ON, Canada
Toronto, Ontario, Canada
DE

Darine El-Chaar

Associate Professor
Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, ON, Canada
Ottawa, Ontario, Canada
JD

Jennifer Donnelly

Consultant Obstetrician and Gynaecologist
Department of Obstetrics and Gynaecology, Rotunda Hospital and Mater Misericordiae University Hospital, Dublin, Ireland
Dublin, Dublin, Ireland
FN

Fionnuala Ní Áinle

Consultant Haematologist
Department for Haematology, Mater Misericordiae University Hospital, Dublin, Ireland
Dublin, Dublin, Ireland
Wee-Shian Chan, MD FRCPC

Professor
Department of Medicine, University of British Columbia, Vancouver, BC, Canada
Vancouver, British Columbia, Canada
CC

Celine Chauleur

Professor
Department of Obstetrics and Gynecology, Université Jean Monnet Saint-Étienne, University Hospital, INSERM, SAINBIOSE U1059, F-42023 SAINT-ÉTIENNE, FRANCE
Saint-Etienne, Rhone-Alpes, France
AB

Andrea Buchmuller

Researcher
Centre d’Investigation Clinique 1408, INSERM, Centre Hospitalier Universitaire, Saint Etienne, France
Saint-Etienne, Rhone-Alpes, France
WG

Wessel Ganzevoort

Associate Professor
Department of Obstetrics and Gynaecology, University Medical Centers Amsterdam, University of Amsterdam, Amsterdam, Netherlands
Amsterdam, Noord-Holland, Netherlands
Hanke M. Wiegers, MD

PhD Researcher
Department of Obstetrics and Gynaecology, University Medical Centers Amsterdam, University of Amsterdam, Amsterdam, Netherlands
Amsterdam, Noord-Holland, Netherlands
Saskia Middeldorp, MD PhD

Professor
Department of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands
Nijmegen, Gelderland, Netherlands
Shannon M. Bates, MDCM, MSc

Professor
Division of Hematology & Thromboembolism, Department of Medicine, McMaster University, Hamilton, ON, Canada
Hamilton, Ontario, Canada
Marc A. Rodger, MD (he/him/his)

Professor
Department of Medicine, McGill University, McGill University Health Center, Montreal, Quebec, Canada
Montreal, Quebec, Canada
Leslie Skeith, MD

Associate Professor
Division of Hematology and Hematological Malignancies, Department of Medicine, University of Calgary, Calgary, AB, Canada
Calgary, Alberta, Canada

Background: Previous research cannot be reliably generalized to the pregnant or postpartum population. As clinical trials increasingly attempt to include pregnant participants, we must better understand the factors that influence trial participation in this underrepresented group. The pilot PARTUM trial assesses the feasibility of six weeks of low-dose aspirin versus placebo to prevent venous thromboembolism (VTE) in postpartum patients with moderate VTE risk factors. This represents a unique situation to explore facilitators and barriers to trial participation, so we can improve the design and uptake of postpartum clinical trials.

Aims: To explore patients’ perspectives and experiences about the recruitment and participation in a randomized placebo-controlled trial in the postpartum period.

Methods: Patients eligible for the pilot PARTUM trial were invited to participate in a qualitative substudy, which also included patients who declined trial participation. A separate informed consent was obtained (REB19-1237). Purposive and convenience sampling strategies were used. Thirty-minute semi-structured telephone interviews were conducted by two researchers. Data were analyzed iteratively using reflexive thematic analysis. The substudy funded by the Foundation for Women and Girls with Blood Disorders and the CanVECTOR VTE Research Network.

Results: Nineteen patient interviews were conducted at a single Canadian centre. Nine pilot PARTUM participants and 10 non-participants were included. The major themes were identified: Helping Other Parents by Providing Knowledge, Participating is an “Easy Ask”, Evaluating Personal Risk, Birth Experience Informs Perspective, and Engaging Trusted Care Providers. Most patients invoked altruism, however, their final decision to participate in the trial was influenced by their perception of VTE risk, their birth experience, and opinion of their obstetrical care provider.

Conclusion(s): Trial participation is uniquely affected by experiences during pregnancy, delivery and new parenthood. Improved understanding of the factors most important to patients will inform the design and conduct of future patient-focused clinical trials.