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Pharmacology and therapeutics
Original research
Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial
  1. Anne Holbrook1,2,3,
  2. Sue Troyan2,
  3. Victoria Telford2,
  4. Yousery Koubaesh4,5,
  5. Kristina Vidug2,
  6. Lindsay Yoo2,
  7. Jiawen Deng2,
  8. Simran Lohit2,
  9. Stephen Giilck4,6,
  10. Amna Ahmed4,7,
  11. Marianne Talman4,7,
  12. Blair Leonard8,9,
  13. Mohammad Refaei9,
  14. Jean-Eric Tarride3,10,11,
  15. Sam Schulman7,8,
  16. James Douketis4,8,
  17. Lehana Thabane3,12,13,
  18. Sylvia Hyland14,
  19. Joanne Man-Wai Ho15,16,
  20. Deborah Siegal17,18
  1. 1 Division of Clinical Pharmacology and Toxicology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  2. 2 Clinical Pharmacology Research, Research Institute of St. Joes Hamilton, Hamilton, Ontario, Canada
  3. 3 Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, Ontario, Canada
  4. 4 Division of General Internal Medicine, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  5. 5 Department of Medicine, Brantford General Hospital, Brantford, Ontario, Canada
  6. 6 Department of Medicine, Grand River Hospital, Kitchener, Ontario, Canada
  7. 7 Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada
  8. 8 Division of Hematology and Thromboembolism, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  9. 9 Department of Medicine, Niagara Health System, St. Catharines, Ontario, Canada
  10. 10 Center for Health Economic and Policy Analysis (CHEPA), McMaster University, Hamilton, Ontario, Canada
  11. 11 Programs for Assessment of Technology in Health (PATH), Research Institute of St. Joes Hamilton, Hamilton, Ontario, Canada
  12. 12 Biotatistics Unit, Research Institute of St. Joes Hamilton, Hamilton, Ontario, Canada
  13. 13 Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa
  14. 14 Institute for Safe Medication Practices Canada, North York, Ontario, Canada
  15. 15 Research Institute for Aging, University of Waterloo, Waterloo, Ontario, Canada
  16. 16 Division of Geriatric Medicine, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  17. 17 Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
  18. 18 Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  1. Correspondence to Dr Anne Holbrook; holbrook{at}mcmaster.ca

Abstract

Objectives To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.

Design Randomised, parallel design.

Setting Medical wards at six hospital sites in southern Ontario, Canada.

Participants Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.

Interventions Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.

Outcomes measures Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.

Results Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).

Conclusion This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.

Trial registration number NCT02777047.

  • Anticoagulation
  • Hospitalization
  • CLINICAL PHARMACOLOGY

Data availability statement

Data are available upon reasonable request. Deidentified participant data are available upon reasonable request from the corresponding author, Dr AH at holbrook@mcmaster.ca. Reuse will be permitted for expansion into a larger randomised control trial as long as recognition is provided for this original work. The study protocol is published and can be accessed here https://doi.org/10.1186/s40814-022-01130-z. Study questionnaires (Coordination and Continuity of Care, Patient Knowledge of OAC Management, Patient/Caregiver Study Satisfaction) are available here http://hdl.handle.net/11375/27213, while the Capacity to Consent Questionnaire can be accessed here http://hdl.handle.net/11375/27712.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-079353

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    Data availability statement

    Data are available upon reasonable request. Deidentified participant data are available upon reasonable request from the corresponding author, Dr AH at holbrook@mcmaster.ca. Reuse will be permitted for expansion into a larger randomised control trial as long as recognition is provided for this original work. The study protocol is published and can be accessed here https://doi.org/10.1186/s40814-022-01130-z. Study questionnaires (Coordination and Continuity of Care, Patient Knowledge of OAC Management, Patient/Caregiver Study Satisfaction) are available here http://hdl.handle.net/11375/27213, while the Capacity to Consent Questionnaire can be accessed here http://hdl.handle.net/11375/27712.

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    Footnotes

    • Contributors AH is the principal investigator and conceived the study idea, wrote the protocol, wrote the grant for funding, led the project team, led the intervention and wrote the manuscript. SH, JMWH, JET, DS, SS, JaD and LT were involved in the design of the study and securing funding. AH, ST, KV, LY and VT drafted the protocol manuscript, applied for ethics approval and coordinated the study. SG, BL, AA, MT, YK and MR are local investigators. SL and JiD assisted with data analysis. All authors have read and approved the final manuscript. AH acts as guarantor.

    • Funding This work was supported by Canadian Institutes of Health Research grant number FRN 148803 and the Hamilton Academic Health Services Organization grant number HAH-16-06. The study funders had no role in the study design; collection, management, analysis, or interpretation of data; writing of the report or the decision to submit the report for publication.

    • Competing interests DMS has received honoraria paid indirectly to her research institute from AstraZeneca, BMS-Pfizer, Roche and Servier. DMS is supported by a Tier 2 Canada Research Chair in Anticoagulant Management of Cardiovascular Disease. The other authors declare no competing interests.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.