A Research Proposal: Reducing 30-Day Hospital Readmissions in Patients with Heart Failure Through Nurse-Led Follow-Up

> This is a sample research proposal written by an Assignment Help Center subject expert in Nursing to illustrate the structure, depth and referencing expected at Master’s level. It is a conceptual planning document intended as a model of academic writing. It is not clinical guidance, and the figures used to describe the sample, timeline and Gantt chart are illustrative placeholders only.

Title and Abstract

Working title: Reducing 30-day hospital readmissions in patients with heart failure through a nurse-led follow-up intervention: a protocol for a randomised controlled trial.

Abstract. Heart failure is a common and burdensome long-term condition, and unplanned readmission within 30 days of discharge is widely used as an indicator of care quality and care-transition failure. Existing evidence suggests that structured, nurse-led follow-up after discharge can support self-care and reduce healthcare utilisation, yet the size of effect reported across studies is heterogeneous and the components of effective interventions remain contested. This proposal sets out a plan for a two-arm, parallel-group randomised controlled trial (RCT) comparing a nurse-led follow-up intervention with usual care among adults discharged after an admission for decompensated heart failure. The primary outcome is all-cause readmission within 30 days of discharge; secondary outcomes include heart-failure-specific readmission, self-care behaviour and health-related quality of life. The proposal describes the background and rationale, the aim and objectives framed using the PICO structure, a review of the relevant literature, the proposed methodology, ethical considerations, an illustrative timeline, and the anticipated significance of the work. The intention is to demonstrate how a feasible, ethically sound and theoretically informed nursing study can be designed to address a persistent clinical and organisational problem.

Background and Rationale

Heart failure affects a substantial and growing number of people. A large UK population-based study of four million individuals reported that, although the age-standardised incidence of heart failure has declined modestly, the absolute number of people living with the condition has risen because of population growth and ageing (Conrad et al., 2018). This distinction between incidence and prevalence matters for service planning: even where the risk to any single individual is stable or falling, the total population requiring ongoing management continues to expand, and with it the demand placed on acute and community services. Heart failure is characterised by recurrent episodes of decompensation, in which fluid overload and worsening symptoms compel a return to hospital, and each admission carries risks to the patient and significant costs to the health system. National guidance identifies the period immediately following discharge as particularly high-risk and recommends that people with heart failure are supported by a specialist multidisciplinary team that includes a specialist heart-failure nurse (National Institute for Health and Care Excellence [NICE], 2018).

The transition from hospital to home is a recognised point of vulnerability. In the days and weeks after discharge, patients must absorb new information about their condition, reconcile changes to often complex medicines regimens, arrange and attend follow-up, and interpret bodily signals that may indicate recovery or deterioration. Any weakness in this handover, whether an incomplete discharge conversation, a misunderstanding about diuretic use, a delayed community review, or an inability to recognise early warning signs, can precipitate a return to hospital that timely support might have averted. Unplanned readmission within 30 days of discharge has therefore become a key quality indicator internationally, partly because early readmissions are considered potentially preventable and are frequently linked to problems in the transition of care rather than to the unavoidable progression of disease itself.

The 30-day metric is not without its critics, and a mature proposal should acknowledge this. Readmission rates are influenced by factors beyond the control of any single intervention, including local admission thresholds, the availability of community alternatives, comorbidity burden and social circumstances, and a proportion of readmissions are clinically appropriate rather than a marker of failure. Nonetheless, the indicator retains value precisely because it captures the interface between hospital and community care that nursing follow-up is designed to strengthen. Nurses are well placed to address the gaps that drive avoidable readmission because follow-up interventions can combine education, monitoring, medicines support and rapid access to advice within a single, continuous professional relationship. The rationale for this study is therefore both clinical and organisational: reducing early readmission has the potential to improve patient experience and outcomes while relieving pressure on acute services. However, because the evidence base includes interventions of differing intensity and content, there is a clear need for well-designed studies that specify the intervention precisely and evaluate it rigorously in a defined local context.

Aim, Objectives and Research Question (PICO)

Aim. To evaluate whether a structured nurse-led follow-up intervention, compared with usual care, reduces 30-day all-cause hospital readmission among adults discharged after an admission for decompensated heart failure.

Objectives.

1. To measure the difference in 30-day all-cause readmission between the intervention and usual-care groups. 2. To compare heart-failure-specific readmission, self-care behaviour and health-related quality of life between the two groups. 3. To explore the feasibility and acceptability of the intervention from the perspective of patients and staff.

Research question, structured using PICO.

• Population (P): adults aged 18 and over discharged from hospital following an admission for decompensated heart failure.
• Intervention (I): a structured nurse-led follow-up programme, including an early post-discharge telephone contact, at least one home or clinic review, self-care education and a defined route for rapid nursing advice.
• Comparison (C): usual post-discharge care as currently provided at the study site.
• Outcome (O): all-cause hospital readmission within 30 days of discharge (primary), with heart-failure-specific readmission, self-care behaviour and quality of life as secondary outcomes.

The resulting question is: In adults discharged after an admission for heart failure, does a structured nurse-led follow-up intervention, compared with usual care, reduce all-cause hospital readmission within 30 days?

Brief Literature Context

The theoretical foundation for this proposal draws on the situation-specific theory of heart-failure self-care, which conceptualises self-care as a naturalistic decision-making process encompassing maintenance behaviours, symptom perception and symptom management (Riegel, Dickson and Faulkner, 2016). This theory is useful because it locates the mechanism of any follow-up intervention: nurse-led support is expected to work not by acting on the disease directly but by strengthening patients’ ability to monitor themselves and to respond appropriately to early signs of deterioration, thereby averting the crises that lead to readmission. Framing the intervention in this way has practical consequences for the design, because it directs attention to whether the intervention actually changes self-care behaviour, and not only to whether readmission rates differ. The logic connecting the intervention to its intended outcome is summarised in Figure 1.

Empirically, transitional and nurse-led care models have been studied for some time, and the accumulated evidence forms the immediate context for this proposal. An early and influential RCT of a transitional care model directed by advanced practice nurses reported reductions in readmission and improvements in outcomes among older adults hospitalised with heart failure (Naylor et al., 2004). This trial is often cited as a foundational demonstration that intensive, nurse-led continuity across the hospital-to-home boundary can alter the trajectory of care, and its design, in which a single accountable professional followed the patient across settings, informs the conceptual shape of the intervention proposed here.

More recent synthesis supports the broad direction of these findings. A meta-analysis of nurse-led transitional care interventions, drawing on twenty-five randomised trials, found reductions in both all-cause and heart-failure-specific readmission alongside shorter hospital stays (Li et al., 2021). The value of a synthesis of this kind is that it aggregates evidence across diverse settings and thereby offers a more stable estimate of effect than any single trial; its limitation, acknowledged by the authors of most such reviews, is that the pooled interventions are not identical, so the summary effect describes a category of interventions rather than a specific one. Complementary evidence comes from an individual patient data meta-analysis of self-management interventions, which reported benefits for time to readmission and mortality but also highlighted that effects can vary between patient subgroups (Jonkman et al., 2016). This heterogeneity of response is analytically important, because it suggests that the question is not simply whether self-management support works, but for whom and under what conditions. The Care Transitions Intervention, a nurse- and coach-led model built around a personal health record and post-discharge coaching, similarly demonstrated lower readmission rates in a randomised trial (Coleman et al., 2006), reinforcing the theme that the mechanism of benefit runs through patient activation and capability rather than through the intensity of contact alone.

Despite this generally supportive picture, three issues justify further study. First, interventions differ markedly in intensity and content, some consisting of a single telephone call and others of sustained home visiting over months, which makes it difficult to identify the active ingredients and to specify what a service should actually commission. Second, the magnitude of benefit is heterogeneous across settings and healthcare systems, so findings do not transfer automatically to a given local context; an intervention that adds value where usual care is minimal may add little where usual care is already comprehensive. Third, contemporary guideline-directed medical therapy has evolved considerably (McDonagh et al., 2021), meaning that older trials were conducted against a materially different standard of usual care, and the incremental benefit of nurse-led follow-up must be re-examined in the context of current pharmacological management. A well-specified, locally relevant trial is therefore warranted, and this proposal is designed to address each of these three concerns through precise intervention definition, single-site contextualisation and a contemporary comparator.

Methodology

Design. A two-arm, parallel-group, individually randomised controlled trial is proposed, as this design offers the strongest basis for causal inference about the effect of the intervention on readmission. Randomisation, when successful, distributes both known and unknown confounders evenly between the groups, so that any difference in outcome can be attributed to the intervention with greater confidence than an observational design would permit. A pragmatic orientation is intended, so that the intervention is evaluated under conditions resembling routine practice rather than an idealised research environment, thereby improving the applicability of the findings to the services that would ultimately deliver the intervention. A cluster design was considered but rejected for a single-site study, since individual randomisation is more efficient and the risk of contamination between arms can be managed through clear operational separation of the follow-up pathway. Table 1 summarises the principal design parameters.

Table 1. Summary of the proposed trial design.

Setting. The study would be conducted within the cardiology and acute medical services of a single NHS acute trust, with the follow-up component delivered across hospital and community settings. A single-site design is proposed for feasibility at Master’s level, while acknowledging that multi-site replication would strengthen external validity. Conducting the trial in one organisation allows the intervention to be embedded within an existing pathway and the usual-care comparator to be characterised accurately, which is essential given the earlier observation that the value of follow-up depends heavily on the baseline standard of care against which it is measured.

Sample and recruitment. Eligible participants would be adults admitted with, and discharged following, an episode of decompensated heart failure, who are able to give informed consent and to participate in follow-up. Patients receiving end-of-life care or unable to engage with the intervention would be excluded, since including them would neither serve their interests nor allow the intervention to be tested fairly. Participants would be identified by clinical staff during the admission and approached by the research team before discharge, at a point when the person is stable enough to consider participation without being rushed. A formal sample-size calculation would be undertaken during protocol development, based on a clinically meaningful difference in 30-day readmission, an agreed significance level and power, and an allowance for attrition; the specific numbers are deliberately not fixed here because they depend on local baseline readmission rates, which would be established from the trust’s own administrative data before the trial opens. (Illustrative note: for planning purposes a target of approximately 200 participants, allocated equally between arms, is used later in the timeline; this figure is illustrative and would be replaced by the calculated sample size.)

Randomisation and blinding. Following consent and collection of baseline data, participants would be randomised on a 1:1 basis to the intervention or usual-care arm using a computer-generated sequence with allocation concealment, so that neither the recruiting nurse nor the participant can anticipate or influence the assignment. Because the intervention is a behavioural and organisational one, blinding of participants and delivering nurses is not feasible; a person cannot be unaware that they are receiving additional telephone contacts and reviews. This is a recognised limitation of complex-intervention trials rather than a flaw peculiar to this design. To mitigate the resulting risk of bias, outcome assessment for the primary endpoint would rely on routinely recorded administrative data, which are captured independently of the trial, and, where feasible, outcome assessors handling secondary and self-reported measures would be blinded to allocation to reduce ascertainment bias.

The intervention. The intervention is a structured nurse-led follow-up programme delivered by registered nurses with heart-failure experience. Conceptually, and as depicted in Figure 1, it comprises an early post-discharge contact, at least one subsequent review, structured self-care education informed by the self-care theory described above, medicines support in liaison with prescribers, and a clearly signposted route for patients to obtain timely nursing advice. Each component is intended to act on a specific mechanism: the early contact addresses the immediate post-discharge period of greatest vulnerability, the review provides an opportunity for assessment and reinforcement, the education strengthens symptom perception and management, and the advice route shortens the interval between a patient noticing deterioration and receiving a professional response. The comparison arm receives usual post-discharge care as currently configured at the site. The precise content, frequency and duration of contacts would be documented in an intervention manual to support fidelity and future replication; no clinical dosing or treatment instructions are specified in this proposal, which remains a design document rather than a clinical protocol.

Data collection. Baseline data would include demographic and clinical characteristics, self-care behaviour and health-related quality of life measured with validated instruments, so that the two arms can be compared for balance and so that change over time can be assessed. The primary outcome, 30-day all-cause readmission, would be obtained from hospital administrative records, which offer a complete and objective account of readmission independent of participant recall. Secondary outcomes would be collected at a defined follow-up point and would include heart-failure-specific readmission, repeat measurement of self-care and quality of life, and short interviews or questionnaires exploring acceptability, the last of these providing insight into whether the intervention is experienced as helpful and sustainable by those who receive and deliver it.

Analysis. Analysis would follow the intention-to-treat principle, whereby participants are analysed in the group to which they were randomised regardless of the follow-up they actually received, since this preserves the benefit of randomisation and gives a realistic estimate of effectiveness under ordinary conditions. The primary outcome, being binary, would be compared between arms using an appropriate measure of effect such as a risk ratio or risk difference with a 95% confidence interval; adjusted analysis using regression could account for pre-specified baseline covariates such as age and comorbidity. Continuous secondary outcomes would be compared using suitable regression models, and any qualitative acceptability data would be analysed thematically to complement the quantitative findings. A pre-specified analysis plan would be agreed before data collection to reduce the risk of selective reporting and data-driven analysis choices, consistent with established guidance on rigorous nursing research (Polit and Beck, 2021).

Ethical Considerations

The study would proceed only after favourable opinion from an NHS Research Ethics Committee and the relevant institutional and site approvals. Informed consent is central: potential participants would receive accessible written and verbal information, adequate time to decide, and assurance that declining would not affect their care in any way. Because participants are recovering from an acute admission, care would be taken to avoid approaching people who are too unwell to consider participation, and consent would be treated as an ongoing process with the right to withdraw at any time and without penalty. The power imbalance inherent in approaching patients within a clinical environment is recognised, and information-giving would be separated as far as possible from the immediate clinical team to protect voluntariness.

Confidentiality and data protection would be maintained through pseudonymisation, secure storage and access controls, in line with data-protection law and institutional information-governance policy. A particular ethical consideration in a readmission trial is that the usual-care arm continues to receive the current standard of care, so no participant is deprived of established treatment; the intervention adds structured support rather than removing anything, which addresses the principle of equipoise on which a randomised comparison depends. Any signs of clinical deterioration identified during research contact would be managed through normal clinical routes, and safeguarding and escalation procedures would be defined in advance so that the research relationship never delays necessary care. The principles of beneficence, non-maleficence, autonomy and justice would guide the conduct of the study throughout, and the potential burden of additional data collection would be weighed carefully against the value of the knowledge to be gained.

Timeline (Illustrative Gantt Description)

The following timeline is illustrative and assumes a twelve-month study period; actual durations would depend on approvals and recruitment rates. The phases are summarised in Figure 2, which shows how preparation, recruitment and analysis overlap rather than proceeding in strict sequence.

• Months 1–2: finalise protocol, complete sample-size calculation, prepare the intervention manual and data-collection tools, and submit ethics and governance applications.
• Months 2–4: obtain approvals, train the delivering nurses and outcome assessors, and pilot the recruitment and data-collection procedures.
• Months 4–9: recruit and randomise participants, deliver the intervention, and collect baseline and 30-day outcome data on a rolling basis.
• Months 9–10: complete follow-up data collection and clean the dataset.
• Months 10–11: conduct the pre-specified analysis.
• Months 11–12: write up findings and prepare dissemination.

Described as a Gantt chart, each activity appears as a horizontal bar spanning its months, with overlapping bars during months 2–4 (approvals and preparation) and months 4–9 (recruitment, intervention and data collection) to show that these phases run partly in parallel rather than in strict sequence. This overlap is deliberate: preparation activities can begin before every approval is finalised, and outcome data for early participants can be collected while later participants are still being recruited, which shortens the overall study duration without compressing any single phase unrealistically.

Expected Outcomes and Significance

It is anticipated that the nurse-led follow-up intervention will be associated with a lower rate of 30-day all-cause readmission than usual care, together with improvements in self-care behaviour and quality of life, consistent with the direction of existing evidence (Naylor et al., 2004; Li et al., 2021). A null or inconclusive result would nonetheless be informative, particularly if usual care at the site is already of high quality, since it would help to define the conditions under which additional nurse-led follow-up does or does not add value. Framing both a positive and a negative result as useful reflects a mature understanding of research: the purpose is to reduce uncertainty about whether and how the intervention works, not merely to confirm an expectation.

The significance of the work is threefold. Clinically, it addresses a common and costly problem with an intervention that lies within the nursing scope of practice and could therefore be implemented without new professional roles or major structural change. Theoretically, it tests a plausible mechanism grounded in the self-care theory of heart failure, contributing to understanding of how, and not only whether, follow-up works (Riegel, Dickson and Faulkner, 2016); by measuring self-care behaviour as a secondary outcome, the study can examine whether any reduction in readmission is accompanied by the change in behaviour that the theory predicts. Organisationally, a clearly manualised intervention evaluated in a defined setting would provide a transferable model that other services could adapt and replicate, and the accompanying record of fidelity would allow them to judge how faithfully they have reproduced it. In this way, the proposed study aims to strengthen the evidence base for nurse-led care transitions and to support safer, more sustainable discharge for people living with heart failure.

References

Coleman, E.A., Parry, C., Chalmers, S. and Min, S.-J. (2006) ‘The Care Transitions Intervention: results of a randomized controlled trial’, Archives of Internal Medicine, 166(17), pp. 1822–1828.

Conrad, N., Judge, A., Tran, J., Mohseni, H., Hedgecott, D., Crespillo, A.P., Allison, M., Hemingway, H., Cleland, J.G., McMurray, J.J.V. and Rahimi, K. (2018) ‘Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals’, The Lancet, 391(10120), pp. 572–580.

Jonkman, N.H., Westland, H., Groenwold, R.H.H., Ågren, S., Atienza, F., Blue, L., Bruggink-André de la Porte, P.W.F., DeWalt, D.A., Hebert, P.L., Heisler, M., Jaarsma, T., Kempen, G.I.J.M., Leventhal, M.E., Lok, D.J.A., Mårtensson, J., Muñiz, J., Otsu, H., Peters-Klimm, F., Rich, M.W., Riegel, B., Strömberg, A., Tsuyuki, R.T., van Veldhuisen, D.J., Trappenburg, J.C.A., Schuurmans, M.J. and Hoes, A.W. (2016) ‘Do self-management interventions work in patients with heart failure? An individual patient data meta-analysis’, Circulation, 133(12), pp. 1189–1198.

Li, M., Li, Y., Meng, Q., Li, Y., Tian, X., Liu, R. and Fang, J. (2021) ‘Effects of nurse-led transitional care interventions for patients with heart failure on healthcare utilization: a meta-analysis of randomized controlled trials’, PLOS ONE, 16(12), e0261300.

McDonagh, T.A., Metra, M., Adamo, M., Gardner, R.S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., Cleland, J.G.F., Coats, A.J.S., Crespo-Leiro, M.G., Farmakis, D., Gilard, M., Heymans, S., Hoes, A.W., Jaarsma, T., Jankowska, E.A. and Lainscak, M. (2021) ‘2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure’, European Heart Journal, 42(36), pp. 3599–3726.

National Institute for Health and Care Excellence (2018) Chronic heart failure in adults: diagnosis and management (NG106). London: National Institute for Health and Care Excellence.

Naylor, M.D., Brooten, D.A., Campbell, R.L., Maislin, G., McCauley, K.M. and Schwartz, J.S. (2004) ‘Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial’, Journal of the American Geriatrics Society, 52(5), pp. 675–684.

Polit, D.F. and Beck, C.T. (2021) Nursing research: generating and assessing evidence for nursing practice. 11th edn. Philadelphia: Wolters Kluwer.

Riegel, B., Dickson, V.V. and Faulkner, K.M. (2016) ‘The situation-specific theory of heart failure self-care: revised and updated’, Journal of Cardiovascular Nursing, 31(3), pp. 226–235.