1.4.1. Included studies

Two studies were included in the review;^{10, 29} these are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 3).

Both studies were RCTs comparing post-discharge key worker with usual care in adults on PD and in fact used near identical methods. No RCTs or NRS were identified for any other population or intervention that met the protocol.

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

1.4.2. Excluded studies

See the excluded studies list in appendix I.

1.4.3. Summary of clinical studies included in the evidence review

Table 2

Summary of studies included in the evidence review.

See appendix D for full evidence tables.

1.4.4. Quality assessment of clinical studies included in the evidence review

Table 3

Clinical evidence summary: Key worker vs usual care.

See appendix F for full GRADE tables.

1.5.1. Included studies

No relevant health economic studies were included.

1.5.2. Excluded studies

No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in appendix G.

1.5.3. Summary of studies included in the economic evidence review

None.

1.5.4. Unit costs

Relevant unit costs were provided to the committee to aid consideration of cost effectiveness. Cost calculations based on resource use from the clinical review have also been included.

The clinical evidence identified two studies both about the same enhanced post-discharge planning with comprehensive assessment and 6 weeks of nurse led telephone follow-up compared to routine discharge. This is described as involving:

• Discharge plan (nurse grade and time involved not reported – nurse costs in Table 4)

  • Discussion involving patient and family
  • A pre-discharge comprehensive assessment of the patient’s physical, social, cognitive and emotional needs
  • An individualised education programme conducted by the nurse case manager
• Weekly follow-up calls by nurse case manager for 6 weeks (first call 20–30 mins, others as required – see non-consultant led, non-face-to-face attendance costs in Table 5; estimated total cost £321)
• Patients were also able to call the case manager (or a 24 hour hotline service available to all patients) as they wished (information not provided about time involved with this)
• The case manager could refer the patient where further interventions were required e.g. for a home visit from community nurse or clinic follow-up (clinic visits was an outcome of the study)

Routine discharge care included:

• Standard information
• Telephone hotline service
• Printed material
• Reminder to attend their outpatient appointment

The clinical review reported resource utilisation data about readmission and clinic visits showing a possible reduction with the intervention. The weighted average cost of a non-elective CKD admission is £2409; a reduction of 65 admissions per 1000 (CI: −119 to 87) as reported in the clinical review would result in a cost saving of £156,616 (CI: −£286,727 to £209,624). The weighted average cost of an outpatient nephrology attendance is £151 (see Table 5 for details); based on this a reduction of 414 admissions per 1000 (CI: −158 to −581) as reported in the clinical review would result in a cost saving of £62,423 (CI: −£23,823 to £87,604). Based on a total cost saving of £219,039 per 1000 patients, the intervention would be cost saving if it cost less than £219 per patient. Given that the estimated cost of the weekly follow-up calls alone is greater than this it is judged likely that there would be an overall additional cost of providing the intervention over usual care, although it is not possible to exactly estimate what this would be due to missing information about the resource use involved in providing the intervention.

Table 4

UK hospital-based nurse costs per working hour.

Table 5

UK NHS reference costs 2015/16 for nephrology outpatient appointments.

1.7.1. Clinical evidence statements

1.7.2. Health economic evidence statements

• No relevant economic evaluations were identified.

1.8.1. Interpreting the evidence

1.8.2. Cost effectiveness and resource use

No published economic evaluations were included.

The clinical review found evidence relating to post-discharge case management for people on PD who had been hospitalised. Case management as described in these studies would have additional costs due to the additional nurse timing required. However, there was evidence for a reduction in clinic visits and this would offset these costs. Readmission rates were also lower but not judged to be clinically important. A cost calculation based on this evidence suggested that it was likely there would be a net cost of this type of case management. There was no evidence to suggest QALYs would be higher with this intervention – no mortality or quality of life benefit was seen – therefore the intervention may not be cost effective. As described above there was uncertainty relating to the generalisability of the resource use in the clinical studies based in China and Hong Kong. This uncertainty also effects these economic considerations which are based on this evidence.

The committee agreed that the use of a key worker to coordinate care for people receiving RRT or conservative management was an important issue; however, no clinical or economic evidence was identified relating to this. The committee concluded that this could have an important benefit to patients as better coordination of care may mean they spend less of their time in hospital (many patients are already in hospital 3 or more days a week for dialysis but also require additional appointments related to concomitant conditions such as diabetes) and that could improve quality of life. The committee discussed what the resource use implications would be of people having a key worker to coordinate care including whether this would require a separate role or if this could be accommodated within an existing team member’s role, and who might be best placed to do it. The committee concluded there would be a resource use implication of having a key worker to coordinate care, whoever undertook the role. It was unclear if there would be any cost offsets to the NHS although it was conceivable that there could be if for example patients were seen in primary care for some appointments rather than secondary care, or if patient transport journeys were reduced. In addition, as described above there would be benefits to patients which may justify any additional cost.

The committee also discussed to what extent this role already existed and whether there would be a resource impact of recommending a key worker to coordinate care for people receiving RRT or conservative management. The committee concluded that it was not current practice in many areas and as such a recommendation may have a substantial resource impact.

Given the lack of clinical or cost effectiveness evidence and potential for a substantial resource impact the committee concluded they were not able to specifically recommend a key worker to coordinate care for people receiving RRT or conservative management. Although they noted that more general recommendations already exist about co-coordinating care in the NICE guidelines on Multimorbidity: clinical assessment and management NICE guideline [NG56] and Patient experience in adult NHS services: improving the experience of care for people using adult NHS services (CG138) and made a more general recommendation reflecting these given the importance of this issue for people undergoing RRT and conservative management.

Providing contact details of the lead healthcare professional responsible for care was not considered to have any resource use implications.

1.8.3. Other factors the committee took into account

A person may undergo a number of different transitions of care after starting renal replacement therapy. During these periods people often report not knowing who is responsible for their care or who to contact. This lead health professional is not responsible for coordinating care but should signpost to the most appropriate person to contact.

The committee emphasised the importance of the partnership between primary, secondary and social care. People undergoing renal replacement therapy or conservative management often have complex needs which are met by a number of different health professionals and services. The input of these professionals varies over time and depends on where the person is in the patient pathway. Good timely communication with the general practitioner is important so that the primary care team is fully aware of developments and ongoing management as this may have implications whilst managing other co-morbidities, poly-pharmacy as well as providing psycho-social support as necessary. It is important to involve the primary care team at all stages of the RRT pathway. Though the RRT pathway is secondary care/specialist led, primary care should remain in the loop to ensure optimal management of coexisting co-morbidities, effective medicines management, safe prescribing, help in promoting lifestyle changes, primary/secondary prevention of cardiovascular disease. Primary care health professionals can continue to provide holistic care, psychological support and sign post to specialists for problems relating to RRT and associated problems. Seamless transfer of care between primary and secondary care with effective sharing of information is likely to improve quality of care and improve the patient experience.

The committee highlighted the importance of the coordination of care for people who require end of life care

People often have to attend a number of different appointments for their renal condition and other conditions. The treatment burden for people on in-centre haemodialysis is particularly high. It is therefore important that treatment burden is discussed with each person, their families and carers and that strategies are adopted to minimise it.

The committee confirmed that the recommendations were applicable to children and young people. They highlighted the importance of good communication and coordination of care when a young person is transitioning to adult services. They were aware of NICE’s guidance on Transition from children’s to adults’ services for young people using health or social care services (NG43).

B.1. Clinical search literature search strategy

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual 2014, updated 2017

https://www.nice.org.uk/guidance/pmg20/resources/developing-nice-guidelines-the-manual-pdf-72286708700869

For more detailed information, please see the Methodology Review.

Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.

Table 8. Database date parameters and filters used

1. Line 81 (Medline) and line 75 (Embase) were added to the search strategy to reduce the number of items retrieved for observational studies as the overall results from the search were very large.
   This was checked to ensure that relevant studies were not excluded.

Medline (Ovid) search terms

Embase (Ovid) search terms

Cochrane Library (Wiley) search terms

HMIC (Ovid) search terms

B.2. Health Economics literature search strategy

Health economic evidence was identified by conducting a broad search relating to renal replacement therapy population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional searches were run on Medline and Embase for health economics.

Table 9. Database date parameters and filters used

Medline (Ovid) search terms

Embase (Ovid) search terms

NHS EED and HTA (CRD) search terms

E.1. Key worker vs usual care

Figure 2. Symptoms (KDQOL, symptom/problem, 0–100, higher is better, 12 weeks)

Figure 3. Functional measures (KDQOL, burden of kidney disease, 0–100, higher is better, 12 weeks)

Figure 4. Rate of readmission (by 12 weeks)

Figure 5. Rate of clinic visits (by 12 weeks)

Figure 6. Mental wellbeing (KDQOL, emotional wellbeing, 0–100, higher is better, 12 weeks)

Figure 7. Experience of care (KDQOL patient satisfaction, 0–100, higher is better, 12 weeks)

I.1. Excluded clinical studies

Table 11. Studies excluded from the clinical review

I.2. Excluded health economic studies

Studies that meet the review protocol population and interventions and economic study design criteria but have not been included in the review based on applicability and/or methodological quality are summarised below with reasons for exclusion.

Table 12. Studies excluded from the health economic review

J.1. Clinical and cost effectiveness of keyworkers

Research question: What is the clinical and cost effectiveness of having keyworkers present in the context of renal replacement therapy (RRT)?

Why this is important: The committee were unable to make a recommendation due to limited evidence and no evidence on the resource impact of a keyworker in this review. Recommendations regarding keyworkers are important to ensure people requiring RRT or conservative management are efficiently provided with the most clinical and cost effective treatment in regards to their care.

Criteria for selecting high-priority research recommendations