How Much Does It Cost a Specialist Palliative Care Unit to Manage Constipation in Patients Receiving Opioid Therapy?

Article Outline

• Abstract
• Introduction
• Methods
• Results
  • Demographics
  • Treatment Pathways and Resources Required
• Discussion
• Conclusion
• References
• Copyright

Abstract 

The burden of constipation from the patient's perspective has been well described. The aim of this study was to evaluate the cost of managing constipation in patients taking opioids in a specialist palliative care inpatient unit. A retrospective review of the medical records of 58 patients (70 admissions) who died during a six-month period was undertaken to identify prescribing patterns for opioids and oral laxatives and tasks associated with managing constipation in these patients. A prospective time and motion study also was undertaken, whereby staff recorded the time and resources required to perform each task. These data were then applied to the actual frequency recorded in the retrospective review to calculate the direct cost of managing constipation in those 70 admissions during that six-month period. There was no discernable pattern in oral laxative prescribing. The mean cost of managing constipation was £29.81 (48.74 USD) per admission, with staff time accounting for 85% of the cost. The most time-consuming activity was staff discussion about bowel management, which occurred at least once daily for doctors and twice for nurses and involved up to eight members of staff at a time. The cost of managing constipation is skewed in that it costs £30 (49 USD) or less in 71% of admissions but exceeded £100 (163 USD) in 5%. In the latter group, earlier and/or more effective intervention for constipation could lead to clinical and economic benefits.

Key Words: Constipation, laxative, resource use, palliative care, opioid analgesic

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Introduction 

Opioid analgesics are widely used in the palliative care of patients with moderate to severe pain related to advanced cancer and other progressive diseases. Constipation as an adverse effect of opioid therapy is common, with 50% of all patients admitted to hospices citing constipation as a concern¹ and 95% of advanced cancer patients taking strong oral opioids requiring laxatives.² Current prevention and management of opioid-induced constipation rely on laxatives, most commonly a stimulant, an osmotic, or a combination of these agents.¹ A plethora of clinical guidelines are available, with broadly similar recommendations on the management of opioid-induced constipation.³, ⁴, ⁵, ⁶, ⁷ Although it is true that “assiduous treatment with laxatives is effective in the majority of patients,”⁸ the health care resources, especially in terms of staff time, which need to be devoted to the monitoring and management of bowel function of patients treated with opioids, may be significant.

There is growing interest in the potential use of newly developed, peripherally acting opioid antagonists as targeted therapies for opioid-induced constipation. Clinicians require information on the efficacy, safety, and adverse effect profiles of these products to help them make more informed decisions about the new therapies. Although cost-effectiveness is also an important factor in an environment of finite resources, there are very few data that assess cost. For example, a count of laxative prescriptions was included in a recent study of patterns of health care and associated costs in the palliative care of patients with advanced cancer;⁹ the management of constipation was not the focus of the study, however, and specific information about the resource implications of managing bowel function could not be obtained.

The aim of this study was to evaluate the burden of managing constipation within a specialist palliative care inpatient environment by:

The findings of this study contribute to the baseline data against which the cost of new therapies may be compared as they come into clinical practice.

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Methods 

This observational study was conducted in a single National Health Service (NHS), that is, publicly funded, specialist palliative care unit with 18 inpatient beds in the United Kingdom. Ethics approval for the project was given by the Milton Keynes Research Ethics Committee and management approval by the hospital's research and development department.

There were two components to this study. The retrospective component consisted of a review of the palliative care medical and nursing records of all adult patients who had had their first admission to the specialist palliative care unit between January 1, 2004, and December 31, 2006, and who died during the six-month period between July 1, 2006, and December 31, 2006. Patients were included in the study only if they were already taking opioid analgesics on admission or if opioid treatment was initiated during that admission. Additionally, they had to be constipated on admission and/or receive active treatment for constipation during the admission. Such active treatment comprised one or more of the following: oral laxative dose added, increased, or switched to another agent during admission; “as required” laxatives administered (not just prescribed); suppository or enema administered; and/or manual evacuation of the bowel performed during that period.

Data collected from the medical notes included demographic data, information on the opioid and laxative treatment pathways from admission to discharge, and the associated use of resources, which included the duration of inpatient stay and the use of investigations and procedures associated with constipation. Where patients were admitted to the unit more than once during the study period, a separate data set was recorded for each admission and multiple admissions for the same patient were linked via the patient's study identification code. The data were collected in an anonymized format on paper pro formas and then transferred to the computerized study database for analysis.

The prospective component of this study was a self-reported time and motion study carried out by the ward staff. The aim of this part of the study was to quantify the use of staff time and other resources associated with a range of tasks in the management of constipation. The tasks, first identified through the retrospective study, were discussed with ward staff. Descriptors for each task were explicitly written to standardize the start and endpoints of each task and then confirmed with the ward nurses. All members of the ward staff were invited to participate in this study, and individual informed consent was obtained. Consent was not sought from patients because no variation from normal clinical practice was required for the study, nor did they come into contact with any research staff. During the 11-week period of the prospective study, ward staff recorded the time they took to perform each of the identified tasks, including the administration of oral and rectal laxatives, administration of enemas, rectal examination, manual evacuation of the rectum, and patient care after bowel clearance. The information was recorded on data collection forms placed in locations convenient to the ward staff. These data were then entered into the computerized study database for analysis.

Using the time and motion (prospective) study, direct costs associated with each task in the management of constipation were calculated with respect to staff time and consumable items. The mean staff cost relating to each of these tasks was calculated using published NHS staff costs,¹⁰ taking into account the different numbers and grades of staff who participated in each task. The mean staff cost of each task was then applied to each occurrence of that task within the retrospective study database to work out the estimated cost of managing constipation during that study period. Drug costs were calculated by applying the basic net prices as stated in the British National Formulary (BNF)¹¹ to the drug use recorded in the retrospective study database, and the unit cost of consumable items associated with each task was obtained from staff within the service responsible for purchasing these items (personal communication). These costs were similarly applied to the retrospective study database.

Ideally, the staff cost for time spent discussing the management of constipation during nursing and medical ward handover meetings should have been calculated in a similar manner. However, the frequency and duration of these discussions could not be obtained from the retrospective data collection, nor was the requirement for patient care after bowel clearance reliably documented. These events had to be excluded from primary costing calculations. Instead, exploratory analyses were undertaken based on clinical opinion regarding the frequency and duration of these events (ward staff, personal communication).

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Results 

Three hundred ninety-seven patients known to the specialist palliative care service died during the period July to December 2006. Of these, the medical records of 33 (8%) were not available for review. Of the remaining 364 patients, 58 (15% of 397) met the inclusion criteria for this study. The rest were excluded for the following reasons: no inpatient admission during study period (219), not on opioids,¹² constipation not listed as a problem or not actively treated during inpatient stay (73), and documented Clostridium difficile infection that could affect the constipating effect of opioids.²

Demographics 

Of the 58 patients included in the study, 53.4% were female. The patients' median age at first admission was 70 years. All except one patient, who had end-stage emphysema, had a diagnosis of cancer, with primary sites in the colon n=3 (5%), other gastrointestinal sites n=12 (21%), lung n=12 (21%), breast n=8 (14%), prostate n=7 (12%), and other sites n=13 (22%). In the remaining two (3%), the site was unknown. Thirty-five patients (60%) had metastatic disease. None had bowel obstruction.

Among them, these 58 patients had a total of 70 admissions to the specialist palliative care unit. Forty-seven patients had one admission each, 10 had two each, and one patient was admitted on three occasions. In the rest of this article, the results of this study will be reported in terms of admissions, rather than patients.

Of the 70 admissions, 33 resulted in discharge from the unit. The mean lengths of stay was 19 days (median 17 days, range 1–55 days). There was no difference in mean or median lengths of stay between patients who were discharged and those who died in the unit.

Treatment Pathways and Resources Required 

In 64 of the 70 admissions, the patient was already receiving opioid analgesics on admission, although in 26 (41%), concurrent laxatives were not being taken. In the remaining six admissions, regular opioid medication was initiated during that inpatient stay.

Constipation was listed as a problem on admission in 35 (50%) admissions, but in 15 of these, the patient was not taking any laxative. The mean morphine equivalent total daily dose in patients who were constipated on admission and were taking a laxative was 194mg, as opposed to 182mg in those who were constipated but not taking laxatives, suggesting that, at least in this group of patients, there did not appear to be any association between the opioid dose and laxative prescribing in constipated patients admitted to the unit.

Patients were taking a variety of opioids and laxatives at the time of admission (see Fig. 1, Fig. 2). No change was made to the opioid prescription during 24 (34%) admissions, and no change was made in the laxative prescription in six (9%) admissions (Table 1). Suppositories were administered at least once in 31 (44%) admissions, with a mean of 1.2 administrations per admission. An enema was administered at least once in 12 (17%) admissions, with a mean of 0.2 enemas per admission. During 24 (34%) admissions, a rectal examination was undertaken; in 6% of admissions, a manual evacuation of the bowel was necessary. During 35 admissions, patients required a change of laxative or introduction of suppositories; in 16 of these, a further change was subsequently required.

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• Fig. 1 

  Opioids on admission. IR: immediate-release tablets or liquid; SR: slow-release tablets; Codeine: any codeine-containing formulation, including compound preparations; SC: subcutaneous injection or infusion.

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• Fig. 2 

  Laxatives prescribed on admission.

Table 1. Changes in Oral Laxatives

The range of tasks associated with the management of constipation and the staff time required to carry out these tasks are set out in Table 2. The consumable items used for the execution of tasks required for the management of constipation include gloves, aprons, lubricating jelly, wipes, incontinence pads, trays, tissues, medicine cups, and oral syringes. Using the time and resources actually required for carrying out each task in the prospective (time and motion) study, an estimation of the direct costs of managing constipation, according to the frequency recorded in the retrospective study database, was calculated (see Table 3 for breakdown of figures). The direct cost of managing constipation in this specialist palliative care inpatient unit, over the six-month study period, was estimated to be £2086.68 (3412 USD), with a mean cost per admission of £29.81 (48.74 USD) (95% confidence interval [CI] £21.36–£38.26). By contrast, the mean cost of opioid medications per admission was £43.21 (71 USD) (95% CI £21.81–£64.60).

Table 2. Range of Tasks Associated with Management of Constipation and Staff Time Required

Task	Sample Size	Mean Total Staff Time, Minutes:Seconds (Range, Minutes:Seconds)	Percentage of Total Meeting Time	Median Number of Staff Involved (Range)	Staff Grades Involved
Nurse discussion of bowel care at morning handover	3	7:19 (5:0–10:0)	20	8 (7–8)	Median: One ward manager Seven staff nurses
Nurse discussion of bowel care at afternoon handover	3	3:40 (1:0–7:11)	18	5 (3–6)	Median: One pharmacist Four staff nurses
Medical discussion of bowel care at handover	3	5.32 (4:05–7:0)	23	5 (4–6)	Median: One consultant Two trainee doctors One ward manager Two staff nurses
Rectal examination	10	10:24 (2:00–24:00)	NA	1 (1–2)	Total sample: Nurses grade 5, n=2 Nurses grade 6, n=8 Nurses grade 3, n=1 Student nurses, n=1
Administration of oral laxative (per dose)	10	3:01 (1:40–6:11)	NA	1 (1)	Total sample: Nurses grade 5, n=3 Nurses grade 6, n=6 Nurses grade 8, n=1
Administration of rectal suppository	10	7:46 or 22:00∗ (2 to 15minutes, or 2 minutes to 2 hours 30minutes)	NA	1 (1–2)	Total sample: Nurses grade 5, n=2 Nurses grade 6, n=8
Administration of enema	10	16:12 (5:00–30:00)	NA	1 (1–2)	Total sample: Nurses grade 5, n=5 Nurses grade 6, n=5 Student nurses, n=1
Patient care after bowel clearance	5	29:00 (7:00–50:00)	NA	2 (1–2)	Total sample: Nurses grade 6, n=4 Nurses grade 5, n=1 Nurses grade 3, n=1 Nurses grade 2, n=2
Manual evacuation of bowel	4	21:30 (5:00–50:00)	NA	1.5 (1–2)	Total sample: Nurses grade 6, n=4 Nurses grade 3, n=1 Nurses grade 2, n=1

NA = not applicable.

∗indicates an outlier.

Table 3. Summary of Costs Associated with Management of Constipation When Applied to Retrospective Database

Exchange rate applied: 1.635 USD=£1.

The overwhelming bulk of the cost of managing constipation in this group (85%) was for staff time. Only a relatively small proportion of the total related to drug expenditure (13%). The cost was highly skewed (Fig. 3). In almost three-quarters of admissions (71%, n=50), the estimated direct costs relating to the management of constipation was £30 (49 USD) or less, whereas in four (5%) admissions, the cost incurred exceeded £100 (163 USD) each. Discussion about bowel care during handover meetings was estimated to cost approximately £8394 (13,725 USD) in staff time during the six-month study period. The staff cost of caring for patients after bowel clearance was estimated to be approximately £579 (947 USD) (see Table 4 for breakdown of staff costs). Taking these additional exploratory analyses into account, the estimated total direct cost of managing constipation during the six-month study period was approximately £11,060 (18,083 USD).

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• Fig. 3 

  Estimated distribution of total costs associated with the management of constipation.

Table 4. Summary of Staff Costs by Task

Task	Mean Staff Cost per Occurrence (95% CI)	No. of Occurrences	Total Cost for Study Period
Primary analysis based on retrospective database
Laxative (oral) administration (per dose)	£0.88 (1.44 USD) (£0.70–£1.07)	1554	£1368 (2237 USD)
Administration of suppository	£2.70 (4.41 USD) (£1.84–£3.56)	85	£229 (374 USD)
Administration of enema	£5.40 (8.83 USD) (£3.45–£7.35)	15	£81 (132 USD)
PR examination	£2.99 (4.89 USD) (£1.80–£4.19)	23	£68 (111 USD)
Manual evacuation of bowel	£6.20 (10.14 USD) (£1.07–£11.33)	4	£26 (43 USD)
Exploratory analyses
Nurse discussion of bowel care at morning handover meeting	£22.90 (37.44 USD) (£13.38–£32.42)	184a	£4214 (6890 USD)
Nurse discussion of bowel care at afternoon handover meeting	£7.36 (12.03 USD) (−£1.23 to £15.94)	184a	£1354 (2214 USD)
Doctor discussion of bowel care at daily handover meeting	£15.36 (25.11 USD) (£10.54–£20.19)	184a	£2826 (4621 USD)
Patient care after bowel clearance	£8.27 (13.52 USD) (£4.40–£12.13)	Estimate 70b	£579 (947 USD)
Total staff costs	—		£10,744 (17,569 USD)

Exchange rate applied: 1.635 USD=£1.

PR = per rectum.

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Discussion 

The aim of this study was to evaluate the burden of managing constipation by describing its current treatment pathways in a specialist palliative care center and quantifying its resource implications. We found considerable variety in these treatment pathways, with a wide range of single-agent and combination of laxatives in use, and few discernable patterns by which laxative use could be characterized. This reflects the anecdotal view that prescribing for constipation in this patient group tends to be highly individualized and influenced by patient preference, as well as clinical opinion on optimum treatment strategies.

Forty-three percent of patients complaining of constipation and 41% of those taking opioids were not receiving laxative medication at the time of admission, suggesting that routine prophylactic coprescription of laxatives with opioids was not consistently occurring in the community and, for many patients, their constipation was not being effectively managed. This is also likely to be influenced by the varying tendencies of different opioids to constipate and individual variations in patients' bowel frequency and preferences. The similarity of the total daily morphine equivalent doses of those receiving (194mg) and not receiving a laxative (182mg) at admission suggests that decisions of whether to prescribe a laxative in the community are not just based on a dose-dependent estimation of the likely constipating effect of the opioid prescription. Moreover, opioid dosages in these patients can decrease, as well as increase, if other opioid-sparing interventions are used for pain management.

All except one of the patients not already receiving a laxative at admission were started on one or more during the admission. Constipation was a key part of the inclusion criteria for this study, so the prevalence of laxative use of 98% during their stay in a specialist palliative care unit is not surprising, but it does support Sykes's² earlier report that 87% of unselected patients with advanced cancer who were on strong opioids required a laxative.

Although 34% of admissions involved no change to the opioid prescription, only six (9%) involved no change in oral laxative prescription. This high proportion, together with the 44% of admissions requiring administration of suppositories, 17% requiring an enema, 34% involving at least one rectal examination, and 6% requiring a manual evacuation of the bowel, suggests a considerable burden of unresolved constipation among these patients.

Further evidence of the burden of managing constipation is derived from the prospective time and motion data, which shed light on the staff time and consumable items required to carry out a range of tasks related to constipation. The greatest burden and cost are associated with the staff time devoted to these tasks. The procedures that involved the greatest total staff time per episode were, as expected, manual evacuation of the bowel (mean 21.5minutes) and patient care after bowel clearance (mean 29minutes) principally because these procedures most often required two members of staff to attend to the patient. Patient care after bowel clearance represented the greater burden on staff time overall, in addition to taking longer time on average to complete, because it was also a more common activity than manual bowel evacuation, which was only required rarely as shown by the small number observed within the 11-week prospective study period. Similarly, administration of enemas, although only taking 16minutes on average, represents a significant burden on staff time because of the relative frequency with which this task is performed. Also, approximately 20% (18%–23%) of time in nursing and doctor handover meetings is spent discussing laxative prescribing and bowel function management. As these meetings are daily for medical staff and twice daily for nursing staff and involve up to eight staff, this represents a significant commitment of time.

The staff times recorded in this study were significantly lower than those reported by Duggan,¹² who based his estimates on an unpublished survey. Duggan assumes 34minutes for administration of enemas/suppositories and 60minutes for manual evacuation, both activities requiring two nurses. In contrast, the average task times for administration of enemas and suppositories reported by Frank et al.¹³ in a U.S. nursing home setting were markedly lower: 4.5minutes for enemas and 2.5minutes for suppositories. The reason for such wide variation in estimates of time is unclear, but it may relate to differences in the specification of the task being measured, for example, inclusion/exclusion of time associated with related activities, such as checking up on the patient after the procedure or assisting them to go to the bathroom. In our study, staff agreed to the specification of each task before data collection started, but a limitation of the self-reporting methodology is that under the pressure of clinical duties, the accuracy of data collection may suffer.

The data on administration of suppositories contained one particular apparent anomaly, with one episode recorded as taking 2.5hours, compared with the other nine episodes taking between two and 15minutes. The use of equipment recorded in this case suggests that this may have been an exceptionally complicated procedure, but the possibility cannot be excluded that this was an erroneous record and hence the mean time for suppository administration is reported, both including (22minutes) and excluding (seven minutes 46seconds) this case. Whether this result is a true reflection of the time taken in this case or is an error, the uncertainty around this result again highlights one of the limitations of a study design in which staff who are the subjects of a time and motion study undertake to self-report their own activity for research purposes, while continuing to focus on the requirements of the clinical care of their patients. However, it was decided that, on ethical grounds, accepting this limitation was preferable in this vulnerable group of patients and their relatives to the intrusion of involving a nonparticipant observer in recording data on the intimate procedures, which were the subject of this part of the study.

There are a number of other limitations to this study. It involved a relatively small selected population (15% of adult patients with advanced disease) who were admitted to a specialist palliative care unit receiving treatment with an opioid analgesic and with constipation either cited as a problem on admission or treated during the admission. However, the figure of 50% of patients citing constipation as a problem on admission in our study was consistent with that reported elsewhere for all patients admitted to hospices², ¹⁴ and lower than the 70% reported by Fallon and Hanks⁸ in a study of bowel function in patients with advanced cancer referred for palliative care, suggesting that our selected sample does not represent an overestimation of the burden of constipation among patients admitted for palliative care.

We recognize that, although we were trying to focus on opioid-induced constipation, we could only rely on the contemporaneous occurrence of regular opioid ingestion and constipation in patients to infer opioid-induced constipation. Other factors confound this inference in patients receiving palliative care for advanced disease, for example, diminished food and fluid intake, decreased mobility, and concurrent intake of other constipating medications.

The time taken to administer oral laxatives is only an estimate, as these drugs are given to patients together with the rest of their oral medications. It was not feasible to accurately separate the time spent administering each drug by direct recording. The estimate was derived from the total time taken to administer all of a patient's drugs at one medication round, apportioned in the ratio of the number of laxatives to the total number of drugs given to that patient. This method assumes that an equal amount of time is required to give each drug, which may not be a valid assumption: it is likely that more time is spent administering laxatives and analgesics, where discussion with the patient of the adequacy of pain relief and the need for “as required” dosing is more often required than with other classes of drugs. It is possible that the estimate of three minutes to administer each dose of laxative may be an underestimation of the staff time required. On the other hand, because discussions with patients often cover more than one topic, times recorded may be overestimates. However, it is interesting to note that the estimate for the time taken to administer oral medication reported in the Frank et al.¹³ study (4.5minutes) was only slightly higher than that reported in the present study.

A further limitation relates to our attempt to capture the costs of managing constipation. There are many additional indirect costs that could not be reliably documented. There is clearly an underpinning cost of the hospice bed, food, transport, and general care, but this would be complex to calculate, especially in retrospect, as patients are rarely admitted for the sole problem of constipation. The human cost to the patient and those close to him/her, in terms of discomfort, inconvenience, and time, is obvious but also not captured in this study. In the direct costs, we have only recorded the drugs, equipment, and staff time used for directly managing constipation, as well as an estimate of staff time spent in discussion. Other measures for alleviating constipation, for example, encouraging greater intake of fluids, increasing mobility, and dietary measures that patients often undertake for themselves, were not counted in the costs. The direct costs themselves must be regarded as an inevitable underestimate. For example, the drug costs used in this study are based on the figures published in the BNF. The actual cost to the NHS will be higher because of additional professional fees and overhead allowances, but we decided to use the BNF figures because they provide a means for comparison and are a widely quoted reference source for U.K. drug costs.

The economic analysis presented here is, to our knowledge, the first attempt to estimate the range of costs associated with the management of constipation in a specialist inpatient palliative care setting using micro-level data. The results of this study indicate that the overwhelming majority of costs associated with the management of constipation relate to staff time and that the most time-consuming activity over a six-month period was discussion of bowel care in nursing and doctor handover meetings. This suggests that although the overall cost associated with the management of constipation could be considered relatively modest, it remains a clinical preoccupation. Moreover, these costs are specific to the care setting in which this study took place, that is, a specialist palliative care unit within the NHS. The actual figures should not be extrapolated to a community-based population where the prevalence and severity of constipation, travel costs for staff, and so forth are likely to be different.

Costs at individual patient level indicate that a small proportion of patients incurred substantially larger costs than the average. It is this group of patients in whom earlier and/or more effective intervention for constipation could lead to the greatest economic benefits. A number of novel targeted therapies are currently in development for opioid-induced constipation. These new drugs are likely to be significantly more expensive than current laxative treatments but may provide greater efficacy by reversing the underlying cause of opioid-induced constipation. The additional costs of prescribing these new medications may be partially offset by reducing the time that nurses and doctors spend in activities associated with managing unresolved constipation. Finally, the considerable burden of constipation in terms of discomfort, distress, and pain as experienced by the patient must be acknowledged, even though this did not form part of the information we sought for the purposes of this study.

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Conclusion 

There is a wide variety of patterns in laxative prescribing for patients receiving palliative care for advanced disease, and changes in the choice and dose of these drugs were commonplace during admissions to this specialist palliative care unit. The burden of managing constipation in this group of patients derives more from the routine staff discussion, drug administration, and bowel care, which constitute proactive clinical management, than from the infrequently performed procedures, which although individually time-consuming, may be required in only the most difficult to manage patients.

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