Methods
Design
A clustered, two-armed RCT was performed, with the GP as cluster. The study ran from February 2009 until February 2011.
Ethical Considerations
The study was approved by the research ethics committee of the Radboud University Nijmegen Medical Center in accordance with the Medical Research Involving Human Subjects Acts (WMO). It also conforms to the Helsinki Declaration.
Participants
All GP practices in two regions of the comprehensive cancer centre of the Netherlands were invited by mail to participate. GPs were excluded if they were a consultant in a palliative care team. Participating GPs were stratified for working hours (part-time or full-time) and for degree of urbanization of their general practice (urban or rural) and they were randomly assigned to the intervention or control group by an independent statistician. To prevent contamination, GPs working together in the same practice were allocated to the same study group. Borland C software was used to randomly allocate GPs, as sequentially numbered containers, to the strata of one of both groups.
Intervention
The intervention, described in detail elsewhere,[27] consisted of three consecutive parts: 1. a five hour group training in early identification of those patients in their practice that can be considered as being palliative patients, by means of the RADPAC,[26] and in proactive care planning, 2. an individual coaching session by phone with a physician specialized in palliative care, per identified palliative patient for the GP and 3. two additional peer group sessions with the GPs in the intervention group a few months after start of the intervention, with a focus on patient – GP communication regarding the initiation of a palliative care trajectory. The GPs in the intervention group were invited to use the RADPAC indicators to screen the medical records of all persons in their practice to identify those patients with CHF, COPD or cancer who potentially could benefit from a palliative care approach. They were also asked to use this screening instrument whenever new data of any patient with one of these three diseases became available, in order to timely identify the change from a curative to a palliative trajectory. They were asked to consider and start structured anticipatory palliative care for every identified patient. The GPs discussed palliative care and the study with the patient, and provided him or her a brochure with information about palliative care, the content of the study and what participation would imply for the patient.
GPs in the control group were asked to provide care as usual. Although this usual care differs per GP, they all have easy access to a large number of palliative care standards (www.Oncoline.nl), and each physician and nurse in the Netherlands can consult a specialist in palliative care 24/7 by phone.[28]
Data Collection
At baseline, demographics and practice characteristics of each participating GP were collected, as well as their interest in palliative care (on a numeric rating scale (NRS) from 0, not interested at all to 10, extremely interested) and their confidence in providing palliative care by themselves (NRS from 0, not confident at all to 10, extremely confident).
If the patient was interested to participate, the GP asked him or her to sign an informed consent form, which was faxed to the researcher, together with a questionnaire with characteristics of the patient. The consulted palliative care specialists were asked to register each coaching session that they had with the GPs.
After 12 months, GPs that had not yet identified any patients for proactive palliative care were phoned by the research assistant and were asked in the form of an open question what the reason for non-inclusion was.
One year after start of the study, a questionnaire was sent to each GP in as well the intervention as the control group. They were asked to provide anonymous data, collected from the medical records of all patients that died in the past 12 months. This data included whether or not the patient died a sudden death, cause of death, age, gender, number and type of contacts with the GP out-of-hours service (by phone, consultation at the service, home visit) in the last three months before death, number and type of contacts with their own GP in the last month before death (phone calls and home visits during office hours and phone calls and home visits during out of office hours), place of death and number of hospital admissions in the last three months of life. Regarding out-of-hours contacts and contact with their own GP we chose a limited period of respectively one and three months before death, as we considered this a feasible period to check the electronic medical record, and as such contacts are most frequent near the end of life.
Statistical Analyses
The primary outcome measure was the number of contacts with the out-of-hours GP cooperative. We estimated that with 96 patients in each group, the study would have an 80 % power to detect a significance between the intervention and control group, which would be a 20 % reduction of out-of-hours contacts.[27]
Statistical analysis was performed with the use of SPSS software, version 20.0 and with SAS software, version 9.2. Descriptive statistics were used to calculate frequencies, means, and standard deviations of the study variables. Differences between GPs in baseline characteristics were assessed with the use of chi-square tests for categorical variables and Student's t-tests for continuous variables. To study differences, between deceased patients in both study groups, mixed effects models were used (SAS GLIMMIX), with the GP as a cluster. In this model, the type of disease the patient died of, the age of the GP, working hours, interest in palliative care, and estimation of the GP's own capacity were included in the model as possible confounders.
It appeared that only a portion of the deceased patients had actually been identified as in need of palliative care in the intervention group. Therefore we performed a post-hoc analysis. We also used the same model to study differences between those patients that had been identified as in need of palliative care by GPs in the intervention group, and all other deceased patients (in as well the control and the intervention group).
BMC Fam Pract. 2015;16(126) © 2015 BioMed Central, Ltd.
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