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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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    Strengths and limitations of this study

    • This pragmatic randomised trial investigating clinical pharmacologist-led intervention for oral anticoagulant management for older patients in transitions of care used recommended coordination of care interventions.

    • Multiple feasibility and clinical outcomes were assessed to determine whether a full-sized randomised trial was warranted.

    • Two main methodological innovations in this trial include the use of a Capacity to Consent questionnaire to be sure that participants provide consent that was truly informed and the use of cost per research subject recruited as a key feasibility outcome given the limits of public research funding.

    Introduction

    Background and rationale

    Anticoagulants are highly effective medications with widespread use among older adults.1–4 However, they are also the most common cause of medication-related serious harm, in terms of emergency department visits, hospitalisations and fatalities.5 6 Transitions in care have been identified as a particularly high-risk period for adverse events.7 Each adverse drug event requiring a hospital visit approximately doubles the cost of care in the subsequent 6 months.8 Our previous study of thromboembolic and haemorrhagic events after hospital discharge for patients taking oral anticoagulants (OACs) found rates to be approximately 2–3 times higher in the first month compared with later.9 Root cause analyses and patient safety inquiries cite problems with the recognition of individual risk factors for benefit versus harm, drug interactions and contraindications, dosing adjustments over time and around procedures, drug monitoring and reversal strategies, and communications and poor adherence by patients.10–12 Furthermore, the direct OACs (DOACs), each with different dosage regimens based on indication and no widely available test to measure the anticoagulant effect, have increased opportunities for medication errors while greatly increasing drug costs.13–15 Despite high-quality guidelines, it is difficult for physicians and other healthcare providers to keep up with ever-evolving evidence for the many patient benefit–harm situations that occur.1–3 As well, patient education and patient decision aids have failed to make a significant impact on clinical outcomes.16

    Optimal medication safety requires not only best practices based on clinical evidence but also impeccable application and uptake. The latter requires coordination, communication with and education of all key providers, caregivers and patients, as well as frequent monitoring, handovers and constant quality improvement.4 17 18 All of these may be most efficiently provided on a large scale across large regions by telehealth or virtual visits.16 19 20 However, the effectiveness and cost-effectiveness of telehealth or online interventions for medication management remain uncertain.21 22 In addition, methods of coordination and communication of care, including in anticoagulant management programmes or clinics, vary, although toolkits exist for content guidance.23–25 Significantly, coordination interventions have rarely involved clinical pharmacologists—medical specialists with expertise in medication management and the ability to diagnose, prescribe and change prescriptions.

    We hypothesised that expert coordination and management of OAC therapy with frequent virtual visits and regular communication with the patient’s circle of care in the early posthospital discharge period, led by a clinical pharmacologist with pharmacist assistance, would be feasible and have the potential to decrease adverse anticoagulant-related events, medication-related problems and healthcare resource utilisation while improving patient’s health-related quality of life, satisfaction and coordination and continuity of care (CCC) compared with usual care. A pilot randomised controlled trial (RCT) was required to inform a potential publicly funded grant application for a definitive large RCT, to confirm the feasibility of the intervention, the research instruments and that a large trial budget would be within the scope of available public research funding agencies.

    Objectives

    The aim of this pilot RCT was to test whether high-quality, easily scalable, expert multidisciplinary medication management and care coordination at hospital discharge and during short-term postdischarge virtual visits is feasible (primary) to move to a definitive trial and can improve OAC-related adverse event (thrombotic events, bleeds and deaths) rates, medication problems, quality of life, cost-effectiveness and satisfaction with care (secondary).

    Methods and analysis

    Trial design and setting

    The protocol was developed according to the Standard Protocol Items: Recommendations for Interventional Trials and Template for Intervention Description and Replication guidelines and is published.26 , 27 28 This pragmatic pilot RCT was designed as a two-arm, parallel, blinded assessment trial with individual-level variable-block randomisation stratified by site and outcomes of feasibility and clinical outcomes, during 3 months of follow-up.

    Participating sites include six hospitals in southwest Ontario—three academic teaching hospitals and three community hospitals. The trial was severely delayed initially by staff shortages and then by COVID-19restrictions on hospital-based research.29

    Eligibility criteria

    Inclusion criteria included (1) adult patients within a day of their hospital discharge from internal medicine services with a discharge prescription for an OAC intended to be taken for at least 4 weeks (including both incident and prevalent users); (2) discharge to home or to a congregant setting such as a retirement home where the patient manages their own medications; (3) English-speaking and (4) capable of providing informed consent. To ensure that we could ethically recruit vulnerable participants, including those cognitively impaired, we developed the Coordination of Oral Anticoagulant Care at Hospital Discharge (COACHeD) Capacity to Consent test, with a passing score of 14 or more.28 30 If the patient did not pass, a close caregiver (defined as a family member in daily contact with the patient and involved in their medication supervision) was invited to provide consent on the patient’s behalf by signing a caregiver consent form.

    Patients were excluded if they were less than 18 years of age, had an expected lifespan of less than 3 months, were to be discharged to long-term care or other institutions where medications are controlled by staff or declined informed consent.

    Intervention

    The intervention arm was an interdisciplinary intervention led by a clinical pharmacologist who regularly leads hospital internal medicine teams and is a leader in evidence-based prescribing, including:

    • A detailed discharge medication reconciliation and management plan focused on OACs at hospital discharge; a circle of care handover and coordination with patients, hospital team and community providers; and three scheduled early postdischarge virtual medication check-up visits at 24 hours, 1 week and 1 month with triage of any problems. The focus was on OAC choice, dosage, indication, duration, potential drug interactions, patient risk factors for thromboembolism versus bleeding, drug insurance, adherence challenges and health literacy, but all medications were reviewed.

    • Handovers to the community care team, including the main patient caregiver (if applicable), family physician, medical specialist(s) and community pharmacist, using a templated consult summary note that included the patient profile, details of recent hospitalisation, discharge medications, an OAC monitoring checklist, a circle of care with upcoming appointments and recommendations. Online supplemental appendix 1 shows a sample consult note. All consult notes were written by or reviewed in detail with the clinical pharmacologist.

    • ‘Virtual visits’ (secure video calls from within our electronic medical record or phone visits where video was not possible) by the study pharmacist or clinical pharmacologist at three follow-up time points: 24 hours, 1 week and 1 month postdischarge to ensure medication adherence, review the OAC monitoring checklist and other medications, and solicit concerns. After each follow-up visit, a summary consult note was sent to the circle of care providers and any clinical events or serious concerns were addressed by the clinical pharmacologist.

    Supplemental material

    Control arm: patients allocated to the control group received the usual care, plus the URL to the Thrombosis Canada website (https://thrombosiscanada.ca/patients_and_caregivers). Usual care in our region means care coordination by family doctors with the variable involvement of specialists for new thromboembolic events, complicated atrial fibrillation or anticoagulant clinics for some patients taking warfarin.

    For both arms, there were no restrictions placed on concomitant medical intervention or treatments, as this was a pragmatic randomised trial.

    Outcomes

    Study outcomes, their measurement methods, timing and analysis are presented in detail in online supplemental appendix 2. Primary outcomes were study feasibility outcomes aiming for recruitment of at least 30% of those eligible, retention of 90% of those recruited and a cost of no more than $1500 per patient for the trial recruitment period.

    Supplemental material

    Secondary outcomes included the adjudicated adverse anticoagulant safety events composite—any thromboembolic events or clinically relevant bleeding or death. Thromboembolic events include objectively verified ischaemic stroke, systemic embolism, pulmonary embolism or deep vein thrombosis. Clinically relevant bleeds in this study were defined as bleeding that causes death, hospitalisation or emergency department visits. We also measured (1) the quality of transitional care using CCC Questionnaire7 31; (2) patient’s quality of life using EuroQoL five-dimension five-level (EQ-5D-5L), which provides utility measurements and has been well validated for the Canadian population with a minimal clinically important difference of 0.0632–34; (3) patient knowledge of OAC management35; (4) patient satisfaction with anticoagulant treatment as measured by the Anti-Clot Treatment Scale (ACTS)36 and patient and provider satisfaction with care; (5) patient problems with medication, which measures adherence and the concept of ‘bother’ which includes adverse effects, inconvenience and cost37; and (6) health resource utilisation.31 33 38 39

    Sample size estimation

    Pilot RCT guidance is to base the potential sample size on the ability to detect a significant feasibility problem that might interfere with a subsequent full-size RCT. This calculation suggested that a sample size of 59 participants would be sufficient to identify, with a 95% CI, problems with a 5% probability of occurring.40

    Recruitment methods

    We planned to use a rolling recruitment method, spending 2 weeks at a time at each of our six participating hospitals on a cyclical basis. However, the COVID-19 pandemic resulted in intermittent bans on recruitment that had a severe impact.

    Allocation

    Participants who passed screening and informed consent completed baseline assessments and then were randomised via a computer-generated randomisation sequence stratified by site to intervention or control. The randomisation schedule was produced by a programme written in SAS V.9.4 software (SAS Institute, Cary, North Carolina, USA) and implemented in research electronic data capture (REDCap) such that each patient’s treatment assignment was available online at the time of randomisation.

    Blinding

    Since this was a pragmatic RCT of care coordination, it was not possible to completely blind patients or their providers; however, outcome data collectors, adjudicators and statisticians were blinded to group allocation until analysis was completed at the end of the study. Also, patients and providers in the circle of care were not aware of the actual study hypothesis beyond general management of OACs perihospital discharge.

    Data collection and analysis

    Trained research staff conducted the interviews with the patients or caregivers and reviewed medical charts to abstract data on baseline characteristics, medical history and medication information. Data were kept in REDCap, a secure, web-based research form platform. Serious adverse events were reviewed by the trial steering committee. Analysis used intention-to-treat methods with censoring for patient death or withdrawal with refusal of further assessments. We used descriptive statistics, χ2 and t-test analyses.

    We report the results following the Consolidated Standards of Reporting Trials extension for pilot trials.41

    Patient and public involvement

    Patients were involved in the trial, including as co-investigator (KA), in planning the intervention and outcomes and in critiquing the actual operation of the trial.42

    Results

    The study flow diagram for both groups is shown in figure 1.43 The patient characteristics are shown in table 1.

    Figure 1
    Figure 1

    Coordination of Oral Anticoagulant Care at Hospital Discharge flow diagram.

    View this table:
    Table 1

    Coordination of Oral Anticoagulant Care at Hospital Discharge baseline characteristics

    845 patients were screened during 64 active study weeks over a 78-week period, to find 137 approachables who met eligibility requirements, and of these, 56 (40.9%) were randomised. Reasons for declining participation were most commonly a lack of interest in or enthusiasm for research due to the pandemic. Of the 56 randomised, 31 were to the intervention arm, 25 to the control arm and two were lost to follow-up.

    Patient’s mean age was 71.2 years (SD 12.5), with 24 (42.9%) females, 7 (12.5%) from rural areas and only one person requiring a caregiver to consent. The mean length of hospital stay was 8.9 (SD 7.8) days, with a mean of 9.1 (SD 4.1) prescription medications per patient at discharge. The most common OAC indication was atrial fibrillation at 62.5%; the mean CHADS2 score (CHADS2 and CHADSVasc predict risk of thromboembolic outcomes) was 2.2 (SD 1.6); the mean HAS-BLED score (clinical prediction rule for bleeding) was 2.4 (SD 1.4), and the most common OAC used was apixaban (32, 57.1%). 18 (32.1%) patients were new OAC users. 22 (39.3%) patients took a medication known to interact with their OAC. All patients had a primary care provider, which was a family physician in 55 (98.2%) cases and most (73.2%) also saw at least one medical specialist, most commonly cardiologists.

    Study feasibility in terms of process and management assessments, including cost per patient recruited, was problematic. There were extraordinary delays in trial recruitment primarily related to the COVID-19 pandemic, with periods of bans on research requiring in-hospital research staff presence, a lack of qualified intervention assistance and the difficulties of accessing sufficient time with patients on the day of discharge. This led to estimates of >$3900 per patient spent on the trial for recruitment periods only.

    There were five adverse anticoagulant safety events during the 3 months of follow-up, including one death, four clinically significant bleeding events and no thromboembolic events, with no significant difference between groups (table 2).

    View this table:
    Table 2

    Main results

    CCC showed gaps in recommended transitional care at the time of hospital discharge in both groups, with only 37 of 55 respondents (67.3%) provided education to manage their health at home, including guidance on medications. In addition, five patients (9.1%) declared trouble paying for their out-of-pocket medication costs but received no help from the hospital team. However, the rating of the end-study CCC was significantly better for intervention (18 of 27, 66.7%) versus the control group (7 of 22, 31.8%; p=0.015) in terms of further education and training on self-management of OAC and other medications.

    Patient’s quality of life using the EQ-5D-5L improved from baseline in the intervention group by a mean of 0.096 (SD 0.27) (minimal clinically important difference 0.057), while the control group declined by 0.05 (SD 0.25); however, this difference was not significant (p=0.06).44 OAC knowledge was tested with 10 practical questions on OAC use, with scores ranging from 0 to 10. Scores at baseline (mean 5.4 (SD 1.8)) and at end-study did not significantly differ between groups at any time point. Ratings of appropriateness of prescribing using the Appropriateness of Prescribing Questionnaire at end-study showed a significantly higher number of inappropriate medications in the control group (15 (60.0%) vs 7 (22.5%) OR 0.19 (95% CI 0.06 to 0.62)) patients with at least one inappropriate medication; the most common group being ineffective supplements. The Patient Problems with Medication Questionnaire showed that the intervention group, compared with the control group, reported significantly less bother from their medications.

    Patient satisfaction with OAC therapy was measured using the ACTS, which has subscales for burdens and benefits, with higher scores meaning greater satisfaction.36 Both scores suggested good treatment satisfaction at 55.6 (SD 4.5) of the maximum 60 for burden and 12.4 (SD 2.5) of the maximum 15 for benefit, with no significant difference between groups. Patient satisfaction with care was high in the intervention arm, with improvements in perceived self-efficacy (20/23, 87.0%) and continuity of care (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Most patients preferred virtual as opposed to in-person services (21/23, 91.3%). The intervention group was significantly more likely to rate their ability to manage their anticoagulant medication as improved compared with the control group (17/27 (63.0%) vs 7/22 (31.8%) OR 3.6 (95% 1.1 to 12.0)).

    In terms of provider satisfaction, pharmacists (n=52) reported frequently lacking required information on hospital discharge prescriptions and 36/51 (70.6%) thought a Clinical Pharmacology consult would be helpful. Despite multiple attempts, it was not possible to obtain feedback from a quorum of patients’ family physicians.

    The health resource utilisation review found that the level of detail requested led to concerns about unduly lengthy patient interviews. We did examine medical visits defined as physician or emergency department visits, hospitalisations or visits for laboratory testing, diagnostic imaging or cardiac testing. This showed a similar mean number of medical visits per person during 3-month follow-up: 8.1 (SD 5.8) for the intervention group versus 7.5 (SD 5.3) for the control group, including a similar rate for the subset of emergency department visits or hospitalisation: 0.77 (1.26) vs 0.64 (1.04).

    Discussion

    Principal findings

    This pragmatic pilot trial of expert clinical pharmacology coordination of OAC management for older adults in a high-risk transition of care period was well received, made an impact on patient satisfaction with their care and ability to self-manage and reduced medication bother and inappropriate medication utilisation. Since this was a pilot trial, it was not powered to show a statistically significant impact on adverse anticoagulant events. The participant’s mean age of 71 years, with a mean of >9 medications prescribed at hospital discharge, is typical of the underlying population. Our ability to recruit only one patient sufficiently cognitively impaired to require caregiver consent illustrates the difficulties of research in this population, in that caregivers were often difficult to track down in a timely manner and many cognitively impaired patients were no longer living in their own homes.

    Ironically, although OAC utilisation was the gateway into the trial, for patients taking DOACs, their anticoagulant was usually well managed and not the source of the inappropriate utilisation or other medication-related problems. We noted issues with the management of warfarin, now used rarely in Ontario, and thus physicians, particularly younger physicians, are unfamiliar with its very exacting standards of dosing, monitoring and patient communication. Unfortunately, the feasibility difficulties and unexpectedly large expense per patient recruited (>$3900), even with improvements related to the easement of COVID-19 pandemic restrictions, made it unlikely we would be able to attract peer-reviewed funding for a large trial of more than 1000 patients. We therefore are not proceeding with a full-size randomised trial.

    Strengths and weaknesses

    In preparation for this trial, we extensively investigated barriers and facilitators to optimal OAC management using systematic and scoping reviews of the literature, followed by a qualitative focus group study of the opinions of 26 patients and caregivers and 16 providers.16 42 45 46 These results were used to guide the intervention content and timing, particularly to support the use of virtual or online visits, influence the content of OAC education resources and prioritise communications. Our benchmark ‘burden of illness’ large database study of 123 000 older adults continuing or newly starting OAC therapy after hospital discharge had already established that event rates were very high in the first month after discharge: 25.8 and 19.3 per 100 patient-years for clinically significant bleeding and thromboembolic events, respectively. These rates fell by >64% and 180%, respectively, over the remaining year, making it clear that the first month after hospital discharge needed to be the time period focus of an intervention designed to improve medication safety. In addition, our choice of outcomes was guided by our recently published systematic survey of the literature regarding patient-important outcomes in OAC trials, as advised by patient groups.47 One of our knowledge user and dissemination lead groups is ISMP Canada, which is the national lead on medication safety with well-developed two-way communications with patients. However, our study does have some limitations: mainly as a pilot, the small sample size prevents any meaningful interpretation of clinical outcomes. Second, the scarcity of expertise required for this type of intervention requires innovation in generalisability, especially in smaller communities.

    Other studies

    Because anticoagulants are consistently at the top of medication safety concerns leading to hospitalisation, they have long been the target of specific initiatives to improve the benefit:harm ratio of these medications.2 3 48 In all settings, there is a lack of high-quality evidence that particular models of OAC care are better or worse than usual care. For example, a small observational study at high risk of bias showed that attempts at coordination of OAC (mainly DOAC) management in primary care had no impact on patient clinical outcomes.49 Even in the former era of vitamin K antagonists-dominated OAC use, our international guidelines on anticoagulant management and others noted that while improvements were suggested by lower quality observational studies, none of the randomised trials were able to show that a care management system generally led by pharmacists improved clinical outcomes.1 2 50

    The transitional care literature focusing on the impact of anticoagulant management on important patient outcomes is dominated by recommendations based on expert opinion, consensus commentaries and low-quality studies.51 52 However, we were unable to find any other randomised trials addressing a management intervention to improve OAC outcomes in the high-risk period shortly after hospital discharge. In general, while pharmacist-led medication reconciliation improves some process measures, there is a lack of evidence of its impact on important clinical outcomes. We believe that this lack of success lies in two main themes: lack of focus on randomised trials of high-risk medications that are the main causes of patient harm, including higher healthcare utilisation, and the lack of necessary expertise and direct involvement of such expertise in the intervention for these usually complex patients. Our clinical experience and evidence-based management training as clinical pharmacologists who specialise in complex multimorbidity, accurate diagnosis and addressing polypharmacy allow us to appropriately identify, prioritise and make the changes most impactful on patient outcomes and cost-effectiveness.

    Implications for practice, policy and research

    Our pilot trial demonstrates the promise of the impact of an intervention that will lessen the burden of comorbidity, polypharmacy and recurrent high-cost healthcare utilisation that is typical of older adults discharged from hospitals taking high-risk medications such as OACs. Healthcare systems worldwide are looking for interventions that can address the high-cost healthcare user to maintain or improve their health and clinical outcomes while reducing their costs. Many studies suggest that medication discrepancies or potentially inappropriate prescriptions predict poor outcomes, but addressing predictors of poor outcomes with an intervention in a randomised trial does not necessarily lead to better outcomes. This is an area of very active research but where observational studies cannot be relied on, given the multiple confounders involved in patient access to community and routine care services.53–56 However, the results are pilot only and therefore not suitable for direct clinical or policy application.

    Based on this pilot RCT, we strongly support large randomised trials in the area of specialist-led medication management of high-risk medications in the early posthospital discharge period. We found that OACs, primarily DOACs, were not themselves a frequent clinical problem and may not warrant this level of intervention. However, we identified a group of patients taking other high-risk medications that often included inappropriate medications and unregulated supplements along with their OAC. These patients, given their high level of complexity and polypharmacy, are more likely to require a clinical pharmacology-internal medicine specialist-led intervention. We are currently starting a second pilot RCT similar to COACHeD but expanding to multiple high-risk medications and expanding the recruitment period to any time during hospitalisation to improve feasibility.

    Supplemental material

    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.

    Ethics statements

    Patient consent for publication

    Ethics approval

    This study involves human participants and was approved by Hamilton Integrated Research Ethics Board (HiREB) study #1639, Brant Community Healthcare System Research Ethics Committee and by the Tri-Hospital Research Ethics Board of Waterloo. There were no major protocol modifications throughout the trial. Participants gave informed consent to participate in the study before taking part.

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    Supplementary materials

    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.