Abstract
Background and Aims
Heart failure (HF) management guidelines offer evidence-based recommendations but can be difficult to implement in primary care. This randomized controlled trial evaluated a multifaceted intervention to improve adherence to pharmacological and nonpharmacological HF management guidelines in primary care.
Methods and results
Patients hospitalized with HF were randomized 1:1 to an intervention or control group. The intervention group received guideline-based inpatient education, a postdischarge plan including referral to cardiac rehabilitation (CR) and scheduled general practitioner follow-ups at 1 and 4 weeks, and 3 months, supported by a cardiologist-approved medication titration plan. The control group received usual care. The primary outcome, measured at 6 months, was adherence to five recommended treatments: (i) ACEI/ARB/ARNI ≥50% target dose, (ii) beta blocker ≥50% target dose, (iii) MRA at any dose, (iv) anticoagulation for atrial fibrillation, and (v) CR referral. Adherence was compared using chi-squared tests and logistic regression.
Of 225 participants (25% female), a greater proportion in the intervention group achieved the primary outcome (61.8% vs. 28.7%; P < .01). The unadjusted odds ratio showed that the intervention group was 6.27 times more likely to achieve the outcome compared to the control group (95% confidence interval [CI], 3.35–11.76, P < .01). This difference was driven by higher prescription rates of ACEI/ARB/ARNI and beta blocker, and higher referral rates to CR.
Conclusion
Hospital-based support for HF-management in primary care improved adherence to pharmacological and non-pharmacological components of guideline-recommended care. Greater implementation of transitional care processes of this nature has the potential to improve clinical outcomes for patients with HF.
Keywords: Heart failure, Guideline adherence, Clinical trial
Introduction
Heart failure (HF) is a chronic condition which places a significant and increasing burden on healthcare systems worldwide.1 HF is characterized by acute episodes of decompensation requiring hospitalization, interspersed with periods of relative quiescence when the treatment objective is to optimize pharmacological and non-pharmacological management to help maintain clinical stability.2 During these periods, many patients are managed by a primary care physician, such as a general practitioner (GP); on average, patients with HF in Australia attend 14.4 GP appointments annually3 for HF-specific and -nonspecific reasons. Evidence-based guidelines2 provide recommendations for optimizing HF management, however due to the challenges of managing HF in primary care, guideline adherence is often suboptimal.4,5 For example, while core HF medications are often initiated at low dose, many patients do not have their medication titrated to the target dose,6–8 which may contribute to the high incidence of re-hospitalization.9
Transitional care strategies, aimed at enhancing the coordination and continuity of care from hospital to primary care, provide an opportunity to improve the quality of HF management and reduce adverse clinical outcomes. For example, collaborative care between hospital-based clinicians and GPs has been found to prevent rehospitalization,10,11 and can reduce mortality in patients recently discharged from hospital emergency departments.12 Moreover, transitional care strategies provide an opportunity to consolidate management initiated in hospital, such as the titration of guideline-directed pharmacological therapy. An observational study of a structured medication titration plan provided by the discharging hospital, with point-of-care reminders combined with specific medication titration guidance, led to greater responsibility for medication titration being assumed by GPs and improved medication prescription in accordance with guidelines.13 However, this study was limited in its trial design, hence the need for a randomized controlled trial to evaluate this strategy.
In Australia, collaboration between GPs and specialists is often limited to referral and occasional shared care, with minimal structured coordination in HF management. Moreover, discharge summaries to GPs, after patients are hospitalized, are often delayed or lack specific detail to guide care.14 The PATHFINDER intervention delivers a more integrated, protocol-driven model that enhances continuity between primary and specialist care—an approach that is relatively novel in routine HF management. The aim of the current study was to evaluate primary care adherence to HF guidelines in post-discharge, evaluation and routine management (PATHFINDER) in a randomized controlled trial of a multifaceted transitional care intervention, with the provision of medication optimization guidance for GPs at its core.
Methods
Study design
This was a prospective, parallel-group, randomized controlled trial. Study recruitment is described in accordance with the reporting guidelines outlined in the Consolidated Standards of Reporting Trials (CONSORT) statement15 (Figure 1). The trial was registered as ACTRN Identifier:12620001069943 and the protocol has been published in full.16 The study was approved by the South Metropolitan Health Service Ethics Committee (RGS3531) with reciprocal approval from the Curtin University Human Research Ethics Committee (HRE-2020-0322). Participants provided written informed consent.
Figure 1.
Participant recruitment, randomization and follow-up
Participants
Adults ≥18 years hospitalized with HF with reduced ejection fraction (HFrEF), as characterized by left ventricular ejection fraction (LVEF) <40% or a LVEF 41–49% and fulfilling the diagnostic criteria for HFrEF according to the Australian Clinical Guidelines for the Management of Heart Failure2 (e.g. displaying signs of HF, B-type natriuretic peptides (BNP) >100 ng/L or NT-proBNP >300 ng/L, or objective evidence of high filling pressures in echocardiography measures). Eligible participants were required to nominate a personal GP. Exclusion criteria included patients currently under the management of a specialist HF service, receiving palliative care or with a life expectancy less than 6 months for conditions other than HF, in nursing home/assisted living residents, with impaired cognitive function, non-English speaking or end-stage renal failure (eGFR <15 ml/min per 1.73 m2).
Randomization and blinding
Randomization involved a block randomization sequence with a 1:1 allocation ratio generated by an independent researcher not involved in the study. The study statistician was blinded to group allocation, but it was not possible to blind either participants or the HF nurse practitioner (HFNP) supporting the trial.
Intervention group
In addition to usual care, the intervention group received the following: (1) inpatient HF education provided by an HFNP covering self-management and medication adherence; (2) a post-discharge plan involving the provision of the PATHFINDER Envelope with a cover letter and a PATHFINDER study follow-up form which included a medication optimization plan for participants to take to GP appointments at 1 week, 4 weeks, and 3 months after discharge; (3) referral to cardiac rehabilitation (CR). The PATHFINDER Envelope was updated prior to each GP appointment with current information about the participant’s clinical status such as blood pressure, weight and symptoms from the previous study visit, class and doses of prescribed medication, and target doses completed by the HFNP and approved by a hospital-based cardiologist specializing in HF management. The follow-up form included a medication titration problem-solving guide and a helpline for guidance, if GPs required further assistance with titration. GPs were asked to complete the form at the appointments, documenting vital signs, symptoms, and medication adjustments as recommended and fax or email the form back to the research team.
Control group
The control group received usual care, defined as the standard care from their treating cardiologist or general physician while in the hospital and from their GP after discharge. Prior to hospital discharge, all control participants were given the ‘Living Well with Heart Failure’ guide (third edition 2020, National Heart Foundation of Australia).
Outcomes
Primary outcome
The primary outcome was adherence to HF guidelines as defined by the proportion of participants prescribed five out of five guideline-recommended treatments at 6 months post-discharge;16 (i) angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB)/angiotensin receptor neprilysin inhibitors (ARNI) ≥ 50% of target dose, (ii) beta blocker ≥50% of target dose, (iii) mineralocorticoid receptors antagonist (MRA) at any dose, (iv) anticoagulation in patients with atrial fibrillation, and (v) referral to CR.
Secondary outcomes
Secondary outcomes were the proportion of participants receiving: (1) ACEI/ARB/ARNI, beta blocker, and MRA at the target dose, or maximum tolerated dose at 6 months; (2) ACEI/ARB/ARNI, beta blockers, and MRA at any dose at 6 months; (3) at least 50% of the target dose or maximum tolerated dose for each of ACEI/ARB/ARNI, beta blockers and MRA at 6 months; (4) anticoagulation at 6 months, if diagnosed with atrial fibrillation; (5) any dose of each of ACEI/ARB/ARNI, beta blockers, MRA at 1 week, 4 weeks, 3 months and 6 months; (6) at least 50% of the target dose for each of ACEI/ARB/ARNI, beta blockers and MRA at 1 week, 4 weeks, 3 months and 6 months; (7) referral to an exercise training programme or CR programme by 6 months; (8) attendance at 16 sessions of an exercise training programme or CR programme at 6 months. The target dose or maximum-tolerated dose is defined as optimal dose.
Additional outcomes
The following outcomes were assessed at baseline and 6 months follow-up: (1) depression assessed by the Patient Health Questionnaire-2 (PHQ-2);17 (2) patient medication adherence using the Morisky Medication Adherence Scale-8 (MMAS-8);18 (3) quality of life using the Kansas City Cardiomyopathy Questionnaire-Short Version (KCCQ-12);19 (4) six-minute walk test (6MWT) distance.20 The short versions of these questionnaires were used to reduce the assessment burden on participants.
The following outcomes were only assessed at 6 months follow-up: (1) Patient-Reported Outcome Measurement Information System (PROMIS®) physical function short form 4a;21 (2) the Self Care of Heart Failure Index (SCHFI V.7.2);22 (3) GP feedback.
Statistical analyses
Randomized participants’ data were included in the analysis of primary and secondary outcomes, according to the intention-to-treat principle. Descriptive summaries of baseline participant characteristics and outcome data included means and standard deviations, or medians and interquartile ranges, for continuous variables, depending on normality of distribution, and frequency distributions (counts, percentages) for categorical variables. Univariate group comparisons between the intervention and control groups were conducted using t-tests or Mann–Whitney U tests for continuous data and Chi squared tests for categorical data.
Proportional differences between groups in the primary outcome (overall guideline adherence) and secondary outcomes (participant medication adherence, CR and the SCHFI V.7.2) were compared univariately and using logistic regression models to further examine univariately significant outcomes, adjusting for baseline creatinine. Results have been summarized as odds ratios (OR) and 95% confidence intervals (CI).
Longitudinal secondary continuous outcomes (e.g. 6MWT, participant medication adherence) were examined using linear mixed models, mixed effects tobit regression models and mixed effects negative binominal models. Mixed effects binary and ordinal logistic regression models were used to examine longitudinal categorical outcomes. Results have been summarized as estimated means and 95% CI, or OR and 95% CI, respectively with between and within group differences and interaction effects. Models included random participant effects and were adjusted for covariates of sex, age and baseline creatinine. Model results were summarized as OR and 95% CI. Stata Version 17.0 (StataCorp, College Station, TX) was used for data analyses.
Results
Baseline characteristics
Between January 2020 and March 2022, 544 patients were screened, and 225 patients consented to participate in the trial. Primary endpoint follow-up at 6 months was obtained from 194 participants (Figure 1). Baseline characteristics were not significantly different between groups except for serum creatinine, which was included as a covariate in logistic regression analyses. Similarly, there was no difference in medication precription at baseline between the groups. Overall, the mean (±SD) age of participants was 66 ± 12 years, and 25% were women. Baseline participant characteristics indicated a diverse population with a high burden of comorbid illnesses (Table 1).
Table 1.
Baseline characteristics of participants
| Intervention group (n = 110) |
Control group (n = 115) |
P-value | |
|---|---|---|---|
| Age, y, mean (SD) | 65.8 (12.0) | 65.74 (11.3) | .97 |
| Female sex, n (%) | 26 (24) | 31 (27) | .57 |
| Ethnicity, Caucasian, n (%) | 99 (90) | 108 (94) | .28 |
| Insurance status | |||
| Medicare | 95 (87) | 98 (86) | .81 |
| Private | 15 (14) | 17 (15) | .64 |
| NYHA functional class, n (%) | |||
| I | 8 (7) | 13 (11) | .57 |
| II | 87 (79) | 88 (77) | |
| III | 15 (14) | 14 (12) | |
| Heart rate, beats/min, mean (SD) | 79.6 (15.5) | 79.5 (15.9) | .94 |
| Systolic BP, mmHg, mean (SD) | 118.4 (16.3) | 116.4 (17.0) | .37 |
| Diastolic BP, mmHg, mean (SD) | 67.9 (12.6) | 68.0 (11.1) | .91 |
| Body mass index, mean (SD) | 29.3 (6.8) | 29.5 (6.9) | .85 |
| LVEF %, mean (SD) | 30.7 (8.5) | 31.2 (9.0) | .21 |
| LVEF ≤40%, n (%) | 99 (90.0) | 96 (83.5) | .15 |
| BNP, pg/ml, median (IQR) | 1280 (520–2550) | 684 (319–2000) | .25 |
| NT-proBNP, pg/ml, median (IQR) | 2140 (1670–5840) | 2630 (1500–5940) | .37 |
| Creatinine, mmol/L, mean (SD) | 105.2 (43.4) | 94.1 (40.0) | .047 |
| eGFR, ml/min/1.73m2, n (%) | |||
| 30 | 5 (5) | 5 (5) | .62 |
| 30–44 | 19 (17) | 13 (11) | |
| 45–60 | 14 (13) | 14 (12) | |
| >60 | 72 (66) | 83 (72) | |
| Sodium, mmol/L, mean (SD) | 138.4 (3) | 138.2 (3) | .63 |
| Haemoglobin, mean (SD) | 134.5 (23) | 136.2 (21) | .56 |
| Ischaemic aetiology of HF, n (%) | 74 (67) | 74 (64) | .64 |
| Medical history, n (%) | |||
| Hypertension | 54 (49) | 65 (56) | .26 |
| Atrial fibrillation | 32 (29) | 33 (29) | .90 |
| Diabetes mellitus | 40 (36) | 35 (30) | .35 |
| Chronic renal insufficiency | 14 (13) | 10 (9) | .33 |
| Chronic lung disease | 26 (24) | 23 (20) | .51 |
| Depression | 17 (16) | 23 (20) | .37 |
| Device therapy n (%) | |||
| Implantable cardioverter-defibrillator | 8 (7) | 3 (3) | .17 |
| Cardiac resynchronization therapy | 3 (3) | 3 (3) | |
| HF medications at any dose, n (%) | |||
| ACEI/ARB/ARNI | 98 (89) | 100 (87) | .45 |
| Beta blocker | 106 (96) | 106 (92) | .07 |
| MRA | 73 (66) | 68 (59) | .26 |
Bold values indicate significant P-values. ACEI, angiotensin converting enzyme inhibitors; ARB, angiotensin receptor blockers; ARNI, angiotensin receptor neprilysin inhibitors; BP, blood pressure; BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; HF, heart failure; MRA, mineralocorticoid receptors antagonist; IQR, interquartile range; LVEF, Left ventricular ejection fraction; NT-proBNP, N-terminal pro-B-type natriuretic peptide; NYHA, New York Heart Association; SD, standard deviation.
Primary outcome
The intervention group had a higher proportion of participants prescribed all five pre-specified guideline-advocated treatments (68 [61.8%]) at 6 months follow-up compared with the control group (33 [28.7%]; P < .01), with an OR of 6.27, [95% CI 3.35–11.76], P < .01). After adjusting for age, sex, history of myocardial infarction, history of hypertension, history of atrial fibrillation and baseline serum creatinine, the OR remained significant (OR: 6.77, [95% CI 3.50–13.08], P < .01). This was driven by a higher proportion of patients prescribed ACEI/ARB/ARNI ≥50% of target dose, beta blocker ≥50% of target dose and being referred to CR (Table 2).
Table 2.
Prescription of each guideline-recommended treatment at 6 months in the intervention and control groups
| Secondary outcome | Intervention group n (%) |
Control group n (%) |
P-valuea | Unadjusted OR (95% CI) |
P-value | Adjustedb OR (95% CI) |
P-value |
|---|---|---|---|---|---|---|---|
| ACEI/ARB/ARNI | |||||||
| Any dose | 84 (76.4) | 92 (80.0) | .63 | ||||
| ≥50% of the target dose or maximum-tolerated dose | 75 (68.2) | 55 (47.8) | <.01 | 5.14 (2.39, 11.08)* | <.01 | 4.94 (2.28, 10.71)a | <.01 |
| Target dose or maximum-tolerated dose | 63 (57.3) | 35 (30.4) | <.01 | 4.38 (2.36, 8.13) | <.01 | 4.22 (2.26, 7.88) | <.01 |
| Beta blockers | |||||||
| Any dose | 88 (80.0) | 92 (80.0) | 1.00 | ||||
| ≥50% of the target dose or maximum-tolerated dose | 77 (70.0) | 60 (52.2) | <.01 | 3.74 (1.77, 7.93) | .01 | 3.85 (1.80, 8.25) | .01 |
| Target dose or maximum-tolerated dose | 62 (56.4) | 37 (32.2) | <.01 | 3.22 (1.77, 5.86) | <.01 | 3.35 (1.82, 6.17) | <.01 |
| MRA | |||||||
| Any dose | 64 (58.2) | 62 (53.9) | .21 | ||||
| ≥50% of the target dose or maximum-tolerated dose | 56 (50.9) | 41 (35.7) | <.01 | 2.74 (1.40, 5.37) | <.01 | 2.59 (1.31, 5.11) | <.01 |
| Target dose or maximum-tolerated dose | 18 (16.4) | 9 (7.8) | .09 | ||||
| Anticoagulationc | 23 (82.1) | 24 (82.8) | .71 | ||||
| Referral for CR/exercise training | 91 (82.7) | 65 (56.5) | <.01 | ||||
| ≥16 sessions of CR/exercise training | 14 (12.7) | 8 (7.0) | .10 | ||||
Bold values indicate significant P-values. ACEI, angiotensin converting enzyme inhibitors; ARB, angiotensin receptor blockers; ARNI, angiotensin receptor neprilysin inhibitors; CR, cardiac rehabilitation; CI, confidence interval; MRA, mineralocorticoid receptor antagonists; OR, odds ratio.
a P-value for cross-sectional difference.
bAdjusted for baseline creatinine.
cPatients diagnosed with atrial fibrillation; the target dose or maximum-tolerated dose is defined as optimal dose.
Secondary outcomes at six-month follow-up
The intervention group had a higher proportion of participants prescribed each class of medication (i.e. ACEI/ARB/ARNI, beta blockers, MRA) at ≥50% of the target dose or maximum-tolerated dose compared to the control group (Table 2).
Similarly, the proportion of participants prescribed ACEI/ARB/ARNI and the proportion of participants prescribed beta blockers at the target dose or maximum-tolerated dose was higher in the intervention group compared to the control group. However, there was no difference in the proportion of participants prescribed MRA at the target or maximum-tolerated dose between the two groups. Similarly, there was no difference between the intervention and control groups in the proportion of participants prescribed ACEI/ARB/ARNI, beta blockers and MRA at any dose, nor anticoagulants in participants diagnosed with atrial fibrillation. When medication prescription was adjusted for participant eligibility (in the absence of a contraindication to the medication), there was no significant difference between groups in the prescription of beta blockers at any dose or ≥50% target dose, at any of the time points (Table 2).
For non-pharmacological management, the proportion of participants referred to CR was higher in the intervention compared to the control group. However, there was no difference between groups in the proportion of participants receiving at least 16 sessions of CR (Table 2).
Longitudinal change in medication prescription at any dose or 50% of target dose at 1 week, 4 weeks, 3 months, and 6 months
There was no difference in the prescription of ACEI/ARB/ARNI at any dose at 1 week, 4 weeks, 3 months, and 6 months post-discharge between the two groups. However, the intervention group were more likely to be prescribed ACEI/ARB/ARNI at ≥50% target dose at 4 weeks, 3 months, and 6 months post-discharge (Figure 2A). While a numerically higher proportion of patients in the intervention group were prescribed ≥50% target dose of beta blockers at all time points, this was not statistically significant. (Figure 2B).
Figure 2.
Longitudinal change in medication prescription at ≥50% of target dose at 1 week, 4 weeks, 3 months and 6 months. OR adjusted for sex, age, baseline creatinine. Abbreviations: ACEI/ARB/ARNI, angiotensin converting enzyme inhibitors; ARB, angiotensin receptor blockers; ARNI, angiotensin receptor neprilysin inhibitors; CI, confidence interval; MRA, mineralocorticoid receptor antagonists; OR, odds ratio; n., number
The intervention group had a higher proportion of participants being prescribed MRA at any dose compared to the control group at 3 months post-discharge, but there was no difference in the proportion of participants prescribed MRA at any dose at 1 week, 4 weeks or 6 months post-discharge. However, a higher proportion of participants in the intervention group were prescribed MRA at ≥50% target dose at 1 week, 4 weeks, 3 months and 6 months compared with the control group (Figure 2C).
Psychosocial outcomes
In both the intervention and control groups, the mean KCCQ-12 overall summary score (OSS) improved at 6 months but the change from baseline was not different between groups (P = .94). Similarly, the change in physical limitation, symptom frequency, quality of life, and social limitation scores were not different between groups (Supplementary Table S1).
There was no difference in the change in PHQ-2 score from baseline to 6 months between the two groups (Supplementary Table S2).
Functional capacity
There was no difference in the PROMIS® physical function short form T-scores between groups at 6 months (median T scores for intervention and control group: 42 and 42, respectively, P = .76), nor the change in 6MWT distance from baseline to 6 months (P = .39) between the intervention and control groups (Supplementary Tables S3 and S4).
Self-care
There were no significant differences between the intervention and control groups in self-care maintenance (P = .42), symptoms perception (P = .56), and self-care management (P = .16) (Supplementary Table S5).
Patient medication adherence
The MMAS-8 score improved from baseline in the intervention and usual care groups, however, but there was no difference in the change in MMAS-8 score from baseline to six months between groups (P = .14) (Supplementary Table S6).
There were no adverse events related to the intervention.
GP feedback
In the intervention group, 12 GPs provided feedback on the PATHFINER intervention. Of these, 92% agreed or strongly agreed that the medication titration instructions were useful in helping to up-titrate HF medications to target dose (or maximum-tolerated dose). (Supplementary Table S7) Two GPs provided additional comments in the survey. One GP noted the potential for confusion when patients are also under the care of a private cardiologist, raising uncertainty about which management plan to follow. Another GP mentioned the study follow-up form was helpful to increase the medication dose.
Discussion
In participants recently hospitalized with HF, a multifaceted transitional care intervention which included the provision of a medication titration plan to participants’ GPs at 1 week, 4 weeks and 3 months post discharge, resulted in significantly higher guideline adherence at 6 months post discharge, compared with a control group who received usual care. This finding highlights the value of transitional care strategies, provided by discharging hospitals, to support primary care providers in the best practice management of patients with HF.
Evidence-based management guidelines are important for directing clinicians in the delivery of best practice care. A key clinical objective of HF management is the prescription of evidence-based medication, with medication titrated to the target dose deemed to provide the peak benefit from clinical trials, or alternatively to the maximum tolerated dose, collectively known as the ‘optimal dose’. To support this objective, the intervention provided in the current study included a GP follow-up form which guided the prescription and titration of ACEI/ARB/ARNI, beta blockers, MRA and anticoagulation in participants experiencing atrial fibrillation, consistent with guidelines current at the time of the study. At 6-month follow-up, there were no differences in the proportion of participants prescribed ACEI/ARB/ARNI, beta blockers or MRA at any dose, or anticoagulation medication for atrial fibrillation. However, the proportion of participants prescribed ACEI/ARB/ARNI and beta blockers at ≥50% target dose and optimal dose, and MRA at ≥50% target dose were all higher in the intervention group. These observations highlight two important points; that with usual care, many patients remained on low doses of core HF medication for at least 6 months post discharge, and that a medication titration plan provided by the hospital to the patient’s GP can significantly increase the prescription of medication towards the target dose, in accordance with guideline recommendations during this period. Suboptimal adherence to HF guidelines in primary care, has been reported by several previous studies across different countries,6–8 highlighting that this phenomenon is not unique to the healthcare system in which the current study was conducted, and suggesting that a similar intervention to that trialled in the current study may help improve guideline adherence in other healthcare settings.
The study also presents a variety of secondary outcomes, which describe specific pharmacological and non-pharmacological components of guideline advocated management and at different timepoints (1 week, 4 weeks, 3 months, and 6 months) to provide additional insight into the management of HF in primary care and the time-course of related actions, including medication titration. After adjusting for eligibility (without contraindications), beta-blocker prescription (at any dose or ≥50% target dose) was not significantly different between groups at any time point. While a numerically higher proportion of patients in the intervention group achieved ≥50% target dose of beta blocker, this was not statistically significant. However, for ACEI/ARB/ARNI and MRA, prescription at 4 weeks, 3 and 6 months were all significantly higher in the intervention group. There are several factors that may explain these findings. The greater impact of the intervention on prescribing ACEI/ARB/ARNI and MRA, compared with beta blockers, may reflect the recommendation in guidelines to titrate beta-blockers initially.2 If up-titration is conservatively applied, this may extend the titration of ACEI/ARB/ARNI and MRA beyond 6 months. These findings may also reflect concerns about the impact of ACEI/ARB/ARNI and MRA on already low blood pressure, renal dysfunction and hyperkalaemia present in some patients. This is especially germane in the setting of primary care where the capacity for clinical evaluation is restricted compared with a specialist HF service (participants enrolled in an HF service were excluded from the trial). Such clinical inertia is well described in the management of patients with HF and can be exacerbated by patient-, provider-, and system-level factors.23 For example, older age, female sex,24 atrial fibrillation4 and hyperkalaemia25 have all been associated with the suboptimal prescription of HF medication, highlighting the complexity of managing patients with HF by non-specialists. Furthermore, GPs may lack ready access to monitoring cardiac function (echocardiography, NT-proBNP assessment) to inform decision making, or alternatively, competing priorities may limit their uptake of HF management specific education, which may limit their confidence in performing up-titration.26 At a system level, hospital discharge summaries often lack detail about medication titration13 and coordination between the discharging hospital and patients’ GPs may be poor.27 The PATHFINDER intervention was specifically designed to address these issues, by providing structured support for GPs in managing patients in the critical first 3 months following an HF hospitalization and highlights that this approach can significantly improve the adherence to guideline-recommended medical therapy.
The findings in the current study contrast with those of the CONNECT-HF study, which found that a quality improvement intervention focusing on clinician education and feedback of HF quality of care post discharge did not improve a composite quality score (beta blockers and ACEI/ARB/ARNI ≥50% target dose, MRA, anticoagulation for atrial fibrillation, cardiac device implantation and HF disease management), compared with usual care.28 The difference in outcome between this and the current study may reflect the timing, content and frequency of the respective interventions. For example, interventions delivered before discharge may not result in benefits over the long-term, post discharge. The effectiveness of the PATHFINDER intervention may reflect that it provided a prompt to reinforce medication titration at multiple timepoints over the 3 months following discharge, that it linked GPs with guidance from an HF specialist, improving the GP’s confidence to enact titration, or that it had accompanying written information to further inform the titration decision making process. These factors combine to support GPs in adopting a more holistic approach to managing patients with HF and their adoption may to strengthen collaborative management between cardiology and general practice. Moreover, the multifaceted intervention provides GPs with a structured and standardized management plan for patients with HF, embedding guideline-advocated care in routine clinical practice.
In the current study, there was no effect of the intervention on psychosocial outcomes, functional capacity or reported self-care. The majority of patients followed-up were in NYHA II, with a small number in NYHA III and none in NYHA IV, which may explain the apparent lack of effect on quality of life and symptoms burden. With respect to psychosocial outcomes, a recent meta-analysis reported that the effects of HF medication on quality of life is highly variable.29 This may reflect the increased symptoms experienced by some patients on higher medication doses, the economic burden of buying medication or the feeling of dependence on medication, which reinforces the awareness of having a serious chronic condition. Although CR is well-known to improve functional capacity and quality of life,30 there was no significant difference in the proportion of participants in each group who attended a full programme of CR (≥16 sessions), so this may explain the lack of an improvement in quality of life or functional capacity. The low completion rate of CR amongst the study cohort (approximately ∼10%) may reflect that beyond referral at the time of discharge, there was not any dedicated action taken to encourage participants to complete CR. A more proactive approach to CR provision in primary care may increase the utilization of this important non-pharmacological component of HF management. Alternate delivery models for CR are required to improve greater access to CR services to accommodate diverse patient needs and preferences. Finally, the lack of difference in reported self-care at 6-months follow-up suggests that a one-off education session, and the provision of educational material prior to hospital discharge, has a limited impact on self-care behaviour over the longer term, an observation consistent with previous findings.31
There were several limitations to the trial that we wish to highlight. Firstly, blinding participants to their allocated treatment was not possible, however research personnel undertaking data collection and analysis were blinded to participants’ group allocation. Because patients rather than GPs were the subject of randomization, a potential confounder in the trial was the possibility of a GP managing patients who were allocated to the intervention and control groups. However, this only occurred for one GP (two participants), so the impact on the trial outcomes should have been minimal. A further limitation of the study was that nutritional advice was not included as one of the 5 guideline recommended treatments contributing to the primary outcome (although this is incorporated into CR). For example, there was no specific assessment of sodium restriction, which remains a recommendation in guidelines,2 but is controversial; a recent systematic review reported that sodium restriction may be associated with a higher risk of the composite endpoint of mortality and hospitalizations, without significantly impacting either all-cause mortality or HF-related hospitalizations.32 This underscores the importance evidence-based, patient-centred dietary advice for patients with HF.
Because the study was conducted before sodium-glucose co-transporter 2 inhibitors (SGLT2i) were recommended in Australian HF management guidelines, SGLT2i were not included in the GP follow-up forms. However, in the future, the GP follow-up forms could easily be adapted to include support for the prescription of SGLT2i. The study was conducted during the coronavirus disease-2019 (COVID-19) pandemic which resulted in a small sample size for the 6MWT because many patients elected not to attend the hospital for follow-up testing, which may have compromised the power to detect a significant difference in the change in 6MWT distance between groups. The study was localized to a single metropolitan area in Western Australia, which may limit generalisability to other regions or rural and remote settings. However, given that suboptimal adherence to HF-guidelines is widely reported,6–8 a similar intervention has potential to be transferrable to other healthcare settings. Additionally, the study was not powered to test clinical outcomes, so it was not possible to evaluate the impact of improved guideline-adherence on morbidity and mortality. This remains an important focus of future research. Finally, the study was restricted to English-speaking participants, which may reduce the applicability of findings to patients with limited English proficiency or those from culturally and linguistically diverse backgrounds. Wider implementation of this type of structured intervention may require additional resources such as clinician time, education, and care coordination support; however, these costs may be offset by potential reductions in hospitalizations and improved chronic disease management efficiency.33
Conclusions
In the current study, a transitional care intervention provided by the patient’s admitting hospital improved guideline-recommended care, including the titration of core HF medications in primary care towards target dose. This highlights that greater support of primary healthcare physicians by the patients’ admitting hospital can strengthen the delivery of evidence-based therapy for patients with HF in the months following an HF hospitalization. Strategies of this kind, focussed on care coordination between healthcare sectors in the management of HF, have great potential to improve patient outcomes.
Supplementary Material
Acknowledgements
We would like to acknowledge the participants who volunteered to undertake this research study.
Contributor Information
Andrew Maiorana, Curtin School of Allied Health, Curtin University, Bentley, Western Australia 6102, Australia; Allied Health Department, Fiona Stanley Hospital, Murdoch, Western Australia 6150, Australia.
Liying Dai, Curtin School of Allied Health, Curtin University, Bentley, Western Australia 6102, Australia.
Tashi Dorje, Cardiology Department, Joondalup Health Campus, Joondalup, Western Australia 6027, Australia; Department of Cardiovascular Medicine, Sir Charles Gairdner Hospital, Nedlands, Western Australia 6009, Australia.
Jan Gootjes, WA Cardiology, Murdoch, Western Australia 6150, Australia.
Amit Shah, Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Western Australia 6150, Australia.
Lawrence Dembo, Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Western Australia 6150, Australia.
Graham S Hillis, Department of Cardiology, Royal Perth Hospital, Perth, Western Australia 6000, Australia; Medical School, University of Western Australia, Nedlands, Western Australia 6009, Australia.
Angela Jacques, Institute for Health Research, The University of Notre Dame, Fremantle, Western Australia 6160, Australia.
HuiJun Chih, Curtin School of Population Health, Curtin University, Bentley, Western Australia 6102, Australia.
James Rankin, Department of Cardiology, Fiona Stanley Hospital, Murdoch, Western Australia 6150, Australia.
John J Atherton, Department of Cardiology, Royal Brisbane and Women's Hospital, Herston, Queensland 4006, Australia; Faculty of Medicine, University of Queensland, St Lucia, Queensland 4067, Australia.
Suzanne Robinson, Deakin Health Economics, Deakin University, Burwood, Victoria 3125, Australia.
Christopher M Reid, Curtin School of Population Health, Curtin University, Bentley, Western Australia 6102, Australia; School of Public Health and Preventive Medicine, Monash University, Clayton, Victoria 3800, Australia.
Supplementary data
Supplementary data are available at ESC Heart Failure online.
Declarations
Disclosure of Interest
None declared.
Data Availability
Data is available from the corresponding author on request.
Funding
This work was supported by the Medical Research Future Fund Rapid Applied Research Translation (RART) Grants from the Western Australia Health Translation Network (WAHTN, grant number N/A). LD is funded by a postgraduate research scholarship funded by Curtin University. CMR is funded through a NHMRC Principal Research Fellowship (GNT 1136372).
References
- 1. Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res 2023;118:3272–87. 10.1093/cvr/cvac013 [DOI] [PubMed] [Google Scholar]
- 2. Atherton JJ, Sindone A, Pasquale D, De Pasquale CG, Driscoll A, MacDonald PS, , et al. National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Australian clinical guidelines for the management of heart failure 2018. Med J Aust 2018;209:363–9. 10.5694/mja18.00647 [DOI] [PubMed] [Google Scholar]
- 3. Audehm RG, Neville AM, Piazza P, Haikerwal D, Sindone AP, Parsons RW, et al. Healthcare services use by patients with heart failure in Australia: findings from the SHAPE study. Aust J Gen Pract 2022;51:713–20. 10.31128/ajgp-10-21-6197 [DOI] [PubMed] [Google Scholar]
- 4. Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, et al. Medical therapy for heart failure with reduced ejection fraction: the CHAMP-HF registry. J Am Coll Cardiol 2018;72:351–66. 10.1016/j.jacc.2018.04.070 [DOI] [PubMed] [Google Scholar]
- 5. Teng TK, Tromp J, Tay WT, Anand I, Ouwerkerk W, Chopra V, et al. Prescribing patterns of evidence-based heart failure pharmacotherapy and outcomes in the ASIAN-HF registry: a cohort study. Lancet Glob Health 2018;6:e1008–18. 10.1016/s2214-109x(18)30306-1 [DOI] [PubMed] [Google Scholar]
- 6. Sindone AP, Haikerwal D, Audehm RG, Neville AM, Lim K, Parsons RW, et al. Clinical characteristics of people with heart failure in Australian general practice: results from a retrospective cohort study. ESC Heart Fail 2021;8:4497–505. 10.1002/ehf2.13661 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7. Giezeman M, Arne M, Theander K. Adherence to guidelines in patients with chronic heart failure in primary health care. Scand J Prim Health Care 2017;35:336–43. doi: 10.1080/02813432.2017.1397253 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8. Rachamin Y, Meier R, Rosemann T, Flammer AJ, Chmiel C. Heart failure epidemiology and treatment in primary care: a retrospective cross-sectional study. ESC Heart Fail 2021;8:489–97. 10.1002/ehf2.13105 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9. Johnston J, Longman J, Ewald D, King J, Das S, Passey M. Study of potentially preventable hospitalisations (PPH) for chronic conditions: what proportion are preventable and what factors are associated with preventable PPH? BMJ Open 2020;10:e038415. 10.1136/bmjopen-2020-038415 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10. Phelan D, Smyth L, Ryder M, Murphy N, O’Loughlin C, Conlon C, et al. Can we reduce preventable heart failure readmissions in patients enrolled in a disease management programme? Ir J Med Sci 2009;178:167–71. 10.1007/s11845-009-0332-6 [DOI] [PubMed] [Google Scholar]
- 11. Hernandez AF, Greiner MA, Fonarow GC, Hammill BG, Heidenreich PA, Yancy CW, et al. Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA 2010;303:1716–22. 10.1001/jama.2010.533 [DOI] [PubMed] [Google Scholar]
- 12. Lee DS, Stukel TA, Austin PC, Schull MJ, You JJ, Chong A, et al. Improved outcomes with early collaborative care of ambulatory heart failure patients discharged from the emergency department. Circulation 2010;122:1806–14. 10.1161/circulationaha.110.940262 [DOI] [PubMed] [Google Scholar]
- 13. Hickey A, Suna J, Marquart L, Denaro C, Javorsky G, Munns A, et al. Improving medication titration in heart failure by embedding a structured medication titration plan. Int J Cardiol 2016;224:99–106. 10.1016/j.ijcard.2016.09.001 [DOI] [PubMed] [Google Scholar]
- 14. Scarfo NL, Dehghanian S, Duong M, Woodman RJ, Shetty P, Lu H, et al. General practitioners’ perspectives on discharge summaries from a health network of three hospitals in South Australia. Aust Health Rev 2023;47:433–40. 10.1071/ah23072 [DOI] [PubMed] [Google Scholar]
- 15. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. BMJ 2010;340:c332. 10.1136/bmj.c332 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16. Dai L, Dorje T, Gootjes J, Shah A, Dembo L, Rankin J, et al. Primary care adherence to heart failure guidelines IN diagnosis, evaluation and routine management (PATHFINDER): a randomized controlled trial protocol. BMJ Open 2023;13:e063656. 10.1136/bmjopen-2022-063656 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17. Kroenke K, Spitzer RL, Williams JB. The patient health questionnaire-2: validity of a two-item depression screener. Med Care 2003;41:1284–92. 10.1097/01.Mlr.0000093487.78664.3c [DOI] [PubMed] [Google Scholar]
- 18. Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich) 2008;10:348–54. 10.1111/j.1751-7176.2008.07572.x [DOI] [PMC free article] [PubMed] [Google Scholar] [Retracted]
- 19. Spertus JA, Jones PG. Development and validation of a short version of the Kansas city cardiomyopathy questionnaire. Circ Cardiovasc Qual Outcomes 2015;8:469–76. 10.1161/circoutcomes.115.001958 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20. Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW. et al. et al. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J 1985;132:919–23. doi [PMC free article] [PubMed] [Google Scholar]
- 21. Schalet BD, Hays RD, Jensen SE, Beaumont JL, Fries JF, Cella D. Validity of PROMIS physical function measured in diverse clinical samples. J Clin Epidemiol 2016;73:112–8. 10.1016/j.jclinepi.2015.08.039 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22. Barbaranelli C, Lee CS, Vellone E, Riegel B. Dimensionality and reliability of the self-care of heart failure Index scales: further evidence from confirmatory factor analysis. Res Nurs Health 2014;37:524–37. 10.1002/nur.21623 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23. Verhestraeten C, Heggermont WA, Maris M. Clinical inertia in the treatment of heart failure: a major issue to tackle. Heart Fail Rev 2021;26:1359–70. 10.1007/s10741-020-09979-z [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24. Jarjour M, Henri C, de Denus S, Fortier A, Bouabdallaoui N, Nigam A, et al. Care gaps in adherence to heart failure guidelines: clinical inertia or physiological limitations? JACC Heart Fail 2020;8:725–38. 10.1016/j.jchf.2020.04.019 [DOI] [PubMed] [Google Scholar]
- 25. Chioncel O, Mebazaa A, Harjola VP, Coats AJ, Piepoli MF, Crespo-Leiro MG, et al. Clinical phenotypes and outcome of patients hospitalized for acute heart failure: the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2017;19:1242–54. 10.1002/ejhf.890 [DOI] [PubMed] [Google Scholar]
- 26. Hsieh V, Paull G, Hawkshaw B. Heart Failure Integrated Care Project: overcoming barriers encountered by primary health care providers in heart failure management. Aust Health Rev 2020;44:451–8. 10.1071/ah18251 [DOI] [PubMed] [Google Scholar]
- 27. Sall F, Adoubi A, Boka C, Koffi N, Ouattara P, Dakoi A, et al. Post discharge management of heart failure patients: clinical findings at the first medical visit in a single-center study. BMC Cardiovasc Disord 2023;23:94. 10.1186/s12872-023-03113-1 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28. DeVore AD, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Lewis EF, et al. Care optimization through patient and hospital engagement clinical trial for heart failure: rationale and design of CONNECT-HF. Am Heart J 2020;220:41–50. 10.1016/j.ahj.2019.09.012 [DOI] [PubMed] [Google Scholar]
- 29. Taylor RS, Dalal HM, Zwisler AD. Cardiac rehabilitation for heart failure: ‘Cinderella’ or evidence-based pillar of care? Eur Heart J 2023;44:1511–8. 10.1093/eurheartj/ehad118 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30. Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, et al. Impact of exercise rehabilitation on exercise capacity and quality-of-life in heart failure: individual participant meta-analysis. J Am Coll Cardiol 2019;73:1430–43. 10.1016/j.jacc.2018.12.072 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31. Meng K, Musekamp G, Schuler M, Seekatz B, Glatz J, Karger G, et al. The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation. Patient Educ Couns 2016;99:1190–7. 10.1016/j.pec.2016.02.010 [DOI] [PubMed] [Google Scholar]
- 32. Urban S, Fułek M, Błaziak M, Fułek K, Iwanek G, Jura M, et al. Role of dietary sodium restriction in chronic heart failure: systematic review and meta-analysis. Clin Res Cardiol 2024;113:1331–42. 10.1007/s00392-023-02256-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33. Takeda A, Martin N, Taylor RS, Taylor SJ. Disease management interventions for heart failure. Cochrane Database Syst Rev 2019;1:Cd002752. 10.1002/14651858.CD002752.pub4 [DOI] [PMC free article] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
Data is available from the corresponding author on request.


