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Department of Mental Health Sciences, Royal Free and University College Medical School, London
Edenhall Marie Curie Centre, London
St Joseph’s Hospice, Hackney, London
Department of Mental Health Sciences, Royal Free and University College Medical School, London, UK
Correspondence: Professor Michael King, Department of Mental Health Sciences, University College London, London NW3 2PF, UK. Tel: +(0)20 7830 2397; fax +(0)2 7830 2808; email: m.king{at}medsch.ucl.ac.uk
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODRESULTSDISCUSSIONACKNOWLEDGMENTSREFERENCES |
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Aims To evaluate the effectiveness of increased support for distressed, informal carers of patients receiving palliative care.
Method The sample was composed of 271 informal carers who scored over 5 on the 28-item General Health Questionnaire (GHQ–28). The intervention comprised six weekly visits by a trained advisor. Primary outcome was carer distress (GHQ–28) at 4-week, 9-week and 12-week follow-up. Secondary outcomes were carer strain and quality of life, satisfaction with care, and bereavement outcome.
Results Scores on the GHQ–28 fell below the threshold of 5/6 in a third of participants in each trial arm at any follow-up point. Mean scores in the intervention group were lower at all time points but these differences were not significant. No difference was observed in secondary outcomes. Carers receiving the intervention reported qualitative benefit.
Conclusions The intervention might have been too brief, and ongoing help might have had accruing benefits. Alternatively, informal carers of patients with cancer may already receive considerable input and the advisor’s help gave little additional advantage; or caring for a dying relative is extremely stressful and no amount of support is going to make it much better.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONACKNOWLEDGMENTSREFERENCES |
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We aimed to evaluate the effectiveness of an intervention to reduce symptoms of anxiety and depression and carer burden, improve quality of life and satisfaction with care, and reduce the intensity of grief reactions in distressed informal carers of patients with cancer. We predicted that a brief, carer-focused intervention, in addition to usual specialist palliative care, would be more effective at reducing distress than usual specialist palliative care alone.
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METHOD |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONACKNOWLEDGMENTSREFERENCES |
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Recruitment and randomisation
From January 2001 to April 2003 people providing informal care to patients
in all new referrals to six of the participating teams were screened for
psychological distress using the 28-item version of General Health
Questionnaire (GHQ–28; Goldberg,
1970). The seventh team joined the trial in June 2001. The
informal carer was identified by patients and palliative care teams as the
main person who provided unpaid practical and emotional support to the patient
on a regular basis and was in contact with the palliative care team.
Palliative care staff introduced the study at the earliest opportunity,
usually on second or third contact. The GHQ–28 was then completed
immediately or if the informal carer was not present for the palliative care
team visit, left for completion later. Carers returned questionnaires in
pre-paid envelopes to the research team. The research team was informed if the
carer declined to fill in the GHQ–28, if the patient was unlikely to
survive the time it would take to introduce the intervention, or if the
carer’s English skills would mean they could not gain full benefit from
the advisor visits. Informal carers who scored above the threshold of 5/6
(Goldberg & Williams, 1988)
on the GHQ–28 were approached to obtain informed consent and complete
baseline assessments, which included a measure of carer burden
(Robinson, 1983) and quality
of life (Weitzner et al,
1999). Patients’ physical performance status was assessed
using the criteria of the Eastern Cooperative Oncology Group (ECOG;
Oken et al, 1982). On
completion of the baseline assessments, participants were randomised using a
block randomisation design, stratified according to the seven participating
teams. Interviewers were masked to the block size of 12. Randomisation took
place at the trial centre under the supervision of the trial statistician
(R.B.).
Trial arms
Usual care
Specialist palliative care was provided by a team of clinical nurse
specialists, with specialist medical support and sometimes specialist social
work support, giving advice to patients at home, to their families and to
their primary healthcare teams. Patients were assisted with control of pain
and other physical symptoms as well as with social, psychological, emotional
and spiritual issues. Some people are referred for palliative care close to
death in the context of a rapidly changing clinical picture, whereas others
remain in contact with palliative care services for many months.
The carer advisor intervention
The intervention was developed by the research team. Two part-time carer
advisors with experience in community nursing and social work delivered the
intervention, which consisted of six visits over a 6-week period. The advisors
aimed to meet the carer alone, if necessary arranging meetings outside the
home or at the carer’s workplace, sometimes during evenings or weekends.
A comprehensive assessment of domains of need was made; past, present and
future issues were discussed and advice, information and emotional support
provided. The intervention was kept to giving advice and support rather than
taking action on behalf of carers; however, advice might go as far as (for
example) helping carers to calculate their benefit entitlements. In the event
of a patient’s death during the intervention period, the advisors
continued to offer visits, up to a total of six. Sometimes a telephone call
took the place of a visit. Telephone calls enabled flexibility in the
intervention and helped some carers to broach issues that were difficult to
discuss face-to-face. Such calls were discussed with the research team to
decide whether they were equivalent to a full intervention visit. The mean
number of advisor contacts was 5.0 (s.d.=2.0), and the mean number of contacts
up to the death of the patient was 3.6 (s.d.=2.6).
Both advisors undertook 1 month’s training, involving fieldwork in palliative care in the community, a hospice and a hospital setting. The advisors met weekly with the research team for debriefing, for advice on any issues that arose and to ensure that all domains of carer need were covered in the intervention. These domains were:
After 1 year, a further half-day in-service training session took place in which the delivery of the intervention was reviewed.
Study outcomes
Informal carers completed postal questionnaires at 4 weeks, 9 weeks and 12
weeks after randomisation (see Fig.
1). The first follow-up, part-way through the 6-week intervention,
was chosen to achieve at least one research assessment in most cases before
the patient died. When a patient died, the study participant was sent a
sympathy card and contacted again 4 months later for the final follow-up. A
patient’s death therefore necessarily ended the carer’s
participation in the subsequent follow-up assessments. Our primary outcome was
the proportion scoring above threshold (5/6) on the GHQ–28 at follow-up.
Secondary outcomes were GHQ–28 score, Carer Strain Index
(Robinson, 1983) and CareGiver
Quality of Life Index (Cancer) (Weitzner
et al, 1999) scores 4 weeks, 9 weeks and 12 weeks after
randomisation, and scores on Core Bereavement Items (CBI;
Burnett et al, 1997)
and satisfaction with care 4 months after the death of the patient. Brief,
semi-structured interviews at the final follow-up provided a qualitative
assessment of acceptability and helpfulness of the support provided by the
intervention.
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Power and statistical analysis
Power and sample size
All carers scored above the threshold 5/6 on the GHQ–28 at entry to
the trial. Prospective research in other settings
(Weich et al, 1997)
indicated that, given the stresses involved, 70% of the usual care group would
be likely to score above this threshold at follow-up. Thus our per protocol
power calculation indicated that in order to detect a drop to 50% caseness in
the experimental group at 90% power and the 5% level of significance, 124
carers would be required in each arm. To cover an expected 10% attrition from
the trial we needed to recruit 280 carers, a sample that would also provide
sufficient power for examination of GHQ–28 score as a continuous
measure.
Analysis
Treatment success was defined as any drop in GHQ–28 score to below
threshold, measured 4 weeks, 9 weeks or 12 weeks after randomisation. More
detailed analyses were performed on GHQ–28, Carer Strain Index and
quality of life scores from baseline, 4 weeks, 9 weeks and 12 weeks by a mixed
model approach using the random intercept random slope facility provided by
the generalised linear latent and mixed models (GLLAMM) procedure in Stata
release 8 (Rabe-Hesketh & Everitt,
2004). The model was built in the following order:
The most parsimonious model was selected, conditional on the inclusion of the main effect of the intervention. Group means on the CBI and satisfaction with care were compared in a one-way analysis of variance (ANOVA).
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RESULTS |
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Follow-up rates at 4, 9 and 12 weeks
As expected, a number of participants were lost through the death of the
patient. At 4 weeks 43 (16%) patients had died, by 9 weeks 85 (31%) had died
and by 12 weeks 109 (40%) had died. Refusal rates at each follow-up point
where the patient remained alive were 19% (43/228), 27% (50/186) and 24%
(39/162) respectively (Fig.
1).
Follow-up rates at 4 months after death
Two hundred and twenty-one patients had died by end of data collection at
the end of July 2003. Ninety-seven of 113 carers (86%) in the usual care arm
and 84 of 108 in the intervention arm (78%) participated in the 4-month
follow-up (82% overall).
Characteristics of the study group by trial arm
Four-fifths of trial participants were women, 86% were White and 64% were
spouses or partners of patients. Their mean age was 56.3 years (range
16–92) (Table 1). No
major difference occurred between the randomised groups at baseline on
demographic variables, GHQ–28 score or the patient’s physical
performance status assessed using the criteria of the ECOG
(Oken et al, 1982).
However, there was some imbalance in carer strain and quality of life. There
was no difference between trial arms in willingness of participants to
complete follow-up assessments or in the patients’ life expectancies;
median survival time from trial entry was 12 weeks
(Table 1).
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Primary outcome
Approximately a third of carers in each trial arm reduced their distress
enough to record a GHQ–28 score below the threshold of 5/6 at any
follow-up point (Table 2).
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Secondary outcomes
We examined GHQ–28 scores in more detail. The GLLAMM models assume
that data are missing at random. There was no difference in the follow-up
GHQ–28 scores of those attending and those not attending their next
follow-up assessment and the assumption is justified. Mean scores dropped by
the 4-week and 9-week follow-up assessments but increased again by 12 weeks
(Fig. 2,
Table 3). Although the
intervention group appears to experience greater improvement, the results of
GLLAMM did not reach significance for the interaction effects. The most
parsimonious model included significant values for time
(z=–4.70, P<0.001), which was curvilinear
(z=3.00, P<0.004); the treatment effect was not
significant (z=–1.10, P=0.272). Carer quality of life
deteriorated over time (Table
3) but there was no significant interaction between time and trial
arm on this outcome or carer strain; nor were differences found in bereavement
phenomenology or satisfaction with care 4 months after the patients’
death (Table 4).
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Carers’ views
The most valued aspect of the service was the additional emotional support,
with fewer carers reporting value from the added information, advice or
practical or financial help. One-fifth of respondents felt the allocation of
an advisor came too late in the patient’s illness and almost a third
thought more sessions with the advisor would have been helpful
(Table 5).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONACKNOWLEDGMENTSREFERENCES |
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Strengths and limitations
Recruitment to this trial demonstrates that large-scale randomised
controlled trials are possible in palliative care. Follow-up rates were
acceptable, with face-to-face contact after the death of the patient exceeding
80%. Sixty-one per cent of carers scored above threshold on the GHQ–28
and were eligible for the trial, which means that there is considerable
psychological morbidity in this population and that we were not simply dealing
with a distressed minority of carers in particularly difficult circumstances.
The carer advisor intervention arose from pilot work to identify carer
preference for support as well as from the research literature; it was
operationally defined, and was available in manual form to the advisors
(copies of the manual are available from the authors upon request); and the
intervention can be replicated. However, we cannot be certain that all
distressed carers were invited to participate. Service providers may influence
recruitment by ‘gate-keeping’, fearing that trials are intrusive
or inappropriate. Conversely, carers who are more engaged with services may be
more prepared to participate. Carers working away from the home or not living
with the patient were less accessible to the trial. These limitations will
affect its external validity. Finally, a major difficulty was management of
missing data (not completely at random;
Streiner, 2002) owing to death
of the patient. For ethical reasons our protocol excluded research contact
with participants in cases where the person cared for died before the 4-week,
9-week or 12-week follow-up. However, the death rate exceeded pre-trial
estimates, was the major source of attrition and inevitably reduced power.
Although palliative care referrals are increasingly made earlier in advanced
illness (Department of Health,
2000), in practice, community palliative care teams managed their
workloads in times of pressure by responding only to the most acute referrals,
sometimes when death was imminent. This meant that many carers were not
considered for this trial and 16% of those recruited experienced the death
during the first 4 weeks of the trial.
Interpretation
There are several possible reasons for our negative result. First, the
intervention might have been too brief. Qualitative data collected after the
death of the patient suggested that carers experienced some subjective benefit
from the advisor visits, but also a sense that the intervention was too brief.
Second, informal carers of patients with cancer might already have been
receiving considerable input from specialist palliative care services and the
care advisor’s extra help might have had little additional advantage;
for example, our intervention might have had greater impact in cases of
chronic cardiac failure where routine support for patients and carers is less
well developed. Third, caring for a dying relative is extremely stressful and
no amount of support is going to make it much better. Fourth, our intervention
might simply have been wrongly planned and thus unhelpful; however, our
qualitative results do not support this possibility. Fifth, our outcome
measures might have been insensitive to change or there was simply too much
variance in the trial to allow detection of important change. Finally, given
that nurses in the ‘treatment as usual’ group were aware of the
nature of the trial and the intervention under evaluation, they might have
tried harder to provide carer support. Given what we know about the workloads
for nurses in these teams, we believe the last possibility is unlikely.
Implications and challenges for health service research
National guidance published since the start of this trial acknowledges the
central role of families and carers in the informal care of cancer patients,
particularly in the palliative phase
(National Institute for Clinical
Excellence, 2004). Each domain of care addressed by our
intervention is referred to in the guidance, which contains a chapter
specifically devoted to carer issues. Transitory benefits are not unusual in
studies of brief service interventions and highlight a paradox in our concept
of the effectiveness of such interventions
(Bower et al, 2003):
when a medication is seen to be effective in treating a medical or
psychological condition, it is not regarded as ineffective if the condition
relapses on withdrawal of that drug; in psychological or supportive
interventions, however, loss of benefit when the intervention is withdrawn is
often interpreted as indicating that the intervention is ineffective.
Measuring change once the agent of change has been removed may be
inappropriate in supportive care, especially near the end of life in rapidly
progressive clinical and emotional circumstances. Our quantitative and
qualitative results suggest that the carer advisor intervention was too brief
and that ongoing help might have had accruing benefits. This would mirror the
policy direction of earlier referral for palliative care services and
contribute to more effective supportive care
(National Institute for Clinical
Excellence, 2004). Nevertheless, rigorous analysis of the
effectiveness of care for patients and carers in trials such as this provides
valuable evidence for service development in palliative and supportive care
and responds directly to the recommendations and requirements set out in the
NICE guidance (National Institute for
Clinical Excellence, 2004).
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ACKNOWLEDGMENTS |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONACKNOWLEDGMENTSREFERENCES |
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Received for publication March 8, 2006. Revision received June 28, 2006. Accepted for publication September 1, 2006.
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| Psychiatric Bulletin | Advances in Psychiatric Treatment | All RCPsych Journals |
