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Palliative patients cared for at home by PAMINO-trained and other GPs – health-related quality of life as measured by QLQ-C15-PAL and POS

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Palliative patients cared for at home by PAMINO-trained and other GPs – health-related quality of life as measured by QLQ-C15-PAL and POS
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  RESEARCH ARTICLE Open Access Palliative patients cared for at home byPAMINO-trained and other GPs  –  health-relatedquality of life as measured by QLQ-C15-PALand POS Katja Hermann * , Peter Engeser, Joachim Szecsenyi and Antje Miksch Abstract Background:  To maintain patients ’  quality of life is one of the major goals in palliative home care provided bygeneral practitioners (GPs). GPs need adequate training to care for palliative patients. The paper seeks to evaluatewhether a specific training in Germany (PAMINO) has any improving impact on the care of palliative patients andtheir health-related quality of life. Methods:  From September 2007 until June 2009, GPs and their palliative care patients with cancer participated in astudy to evaluate palliative courses for GPs offered by a regional palliative care initiative (PAMINO). For a period of six months at most or until death, patients were asked monthly to judge their quality of life on the Quality of LifeQuestionnaire Core 15 Palliative (QLQ-C15-PAL) of the European Organization for Research and Treatment of Cancer(EORTC) and on the Palliative Care Outcome Scale (POS). The  ‘ Overall quality of life ’  scale of the QLQ-C15-PAL takesvalues between 0 and 100 with higher values indicating a higher quality of life. The POS sum scale takes valuesbetween 0 and 40 with higher values indicating worse care outcomes. Patients cared for by PAMINO-trained GPsand patients cared for by other GPs (control group) are compared using t-tests for differences in group means. Results:  One hundred patients participated in the study; 96 patients filled out the questionnaires at least once. Onthe QLQ-C15-PAL, mean quality of life of the patient groups of PAMINO-trained and other GPs were 37.7 (SD=25.5)and 39.4 (SD=26.3) (p=.76), respectively. On the POS, respective mean values of 13.6 (SD=5.8) and 12.0 (SD=6.5)(p=.26) were given. Patients cared for by a PAMINO-trained GP did not report better quality of life and careoutcomes than patients cared for by other general practitioners. Conclusions:  Patients cared for by PAMINO-trained and other GPs in our study did not report differences in qualityof life. Quality of life and care outcomes of all patients were better than of palliative patients in institutional orspecialized care, emphasizing the ability of GPs to provide adequate care for these vulnerable patients. However,conclusions need to be drawn cautiously since the study had a small sample size. Trial registration:  Current Controlled Trials ISRCTN78021852 * Correspondence: katja.hermann@med.uni-heidelberg.deDepartment of General Practice and Health Services Research, UniversityHospital Heidelberg, Heidelberg, Germany © 2012 Hermann et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the srcinal work is properly cited. Hermann  et al. BMC Palliative Care  2012,  11 :13http://www.biomedcentral.com/1472-684X/11/13  Background To maintain patients ’  quality of life (QoL) is one of themajor goals in palliative care.For patients cared for at home, general practitioners(GPs) play an important role in providing the necessary medical support, since they are often the first and majorcontact person for patients and caregivers. They know private and familial circumstances and are long-termconfidants of the patients. They often accompany patients during the whole disease trajectory. For a ma- jority of patients, primary palliative care  –  as providedby GPs and home care nursing services  –  is sufficient,although adequate training should be given to care pro- viders [1-4]. In Germany, palliative care is obligatory during the med-ical curriculum only since 2009. Medical students hardly get into contact with palliative care issues. However, oncephysicians receive a board certification as a specialist, they might further train to get an additional qualification inpalliative medicine. This additional qualification is not aprerequisite for caring for palliative patients.In 2003, a regional initiative was founded in the federalstate of Baden-Wuerttemberg to improve outpatient pal-liative care (Palliativmedizinische Initiative Nordbaden,PAMINO) [5,6]. Within this initiative, a special focus islaid on general practitioners: vocational training coursesrequired for the additional qualification were developedand are offered by GPs for GPs. Additionally, participat-ing GPs organize themselves in a network with regularmeetings to provide collegial feedback and support [6].This study sought to evaluate if palliative patients of GPs trained in palliative care have a better health-relatedQoL. Methods From September 2007 until June 2009, GPs and theirpalliative care patients participated in a study to evaluatepalliative courses for GPs offered by a regional palliativecare initiative (PAMINO). For a period of six months oruntil death (if the patients died within the six-month ob-servation period), patients were asked monthly to judgetheir quality of life on the Quality of Life QuestionnaireCore 15 Palliative (QLQ-C15-PAL) of the EuropeanOrganization for Research and Treatment of Cancer(EORTC) [7] and on the Palliative Care Outcome Scale(POS) [8]. Within the study, no intervention or instruc-tion regarding care was given, but GPs carried out theirnormal duties. The study was conducted in accordancewith the Helsinki Declaration. The study protocol wasapproved by the ethics committee of the Medical Faculty Heidelberg (S-043/2007). The study was registered(ISRCTN78021852) and the study protocol was pub-lished [9]. Participants To be eligible for the study, GPs had to take care of pal-liative patients. The group of PAMINO-trained GPs(PG) had to have completed at least the 40-hours basictraining course in palliative care. There were no furtherrestrictions on GPs in the control group (CG); they should not have attended another palliative care training,but this was not an explicit exclusion criterion. GPs volunteered to participate in the study. All PAMINO-trained GPs and a random sample of other GPs from thesame region were invited to include patients in thestudy.Patients were eligible for inclusion in the study if they fulfilled the following criteria: (a) being in a palliativesituation with cancer, where the GP would not be sur-prised if they died within 6 months, and having no otherdisease with a lower life expectancy, (b) adult (at least18 years of age), (c) sufficient command of German tounderstand the study information and the questionnairesand (d) outpatient care by a GP who participated in thestudy as well. Patients and GPs had to give theirinformed and written consent to participate. Data collection Participating GPs informed eligible patients in theirpractice about the study. Patients were only included if they consented to participate. After inclusion in thestudy, GPs once a month gave patients a questionnairecontaining the QLQ-C15-PAL and the POS. Patientssent the questionnaires to the study centre in postage-paid return envelopes immediately after they filled themout. For study purposes (follow-up), patients were givena pseudonym number printed on the questionnaires toensure confidentiality. The study centre was not able toidentify patients personally; GPs were not informed of patients ’  individual answers.The Quality of Life Questionnaire Core 15 Palliative(QLQ-C15-PAL) [7] was developed as a core instrumentto measure QoL especially in cancer patients in palliativecare. It consists of 15 questions which are transformedinto two function scales ( ‘ Physical Functioning ’ ,  ‘ Emo-tional Functioning ’ ), seven symptom scales ( ‘ Fatigue ’ , ‘ Nausea/Vomiting ’ ,  ‘ Pain ’ ,  ‘ Dyspnoea ’ ,  ‘ Insomnia ’ ,  ‘ Appetiteloss ’ ,  ‘ Constipation ’ ) and an  ‘ Overall quality of life ’  scale.Patients should answer the questions according to theirexperiences during the previous week. Responses to 14questions are given on a four-point Likert scale with 1 ‘ Not at all ’ , 2  ‘ A little ’ , 3  ‘ Quite a bit ’ , and 4  ‘ Very much ’ ,the question to overall QoL allows answers between 1 ‘ Very poor ’  and 7  ‘ Excellent ’ . The QoL, function andsymptom scales take values between 0 and 100 withhigher values indicating a higher QoL, higher function-ing and higher symptom burden, respectively. Hermann  et al. BMC Palliative Care  2012,  11 :13 Page 2 of 7http://www.biomedcentral.com/1472-684X/11/13  The Palliative Care Outcome Scale (POS) [8] is usedto measure outcome in palliative care. It consists of 12questions covering the main components of palliativecare. Eight questions have a 5-point Likert-scale re-sponse from 0 (not at all) to 4 (overwhelming), twoquestions have 3 answer options (0-2-4), one question(main problems of the previous 3 days) is answered infree text and the last question asks patients if they needed help with filling out the questionnaire (0  –  no, 1 –  help from family or friend, 2  –  help from staff).Patients were asked to answer the questions accordingto their experiences during the previous 3 days. Al-though it is not a unidimensional scale [10], a sum scorewas used as well to describe outcome and to comparegroups next to single items [8,11] with higher scores in- dicating more severe problems.GPs recorded patients ’  medical problems as well, in-cluding the performance status (PS) of the Eastern Co-operative Oncology Group (ECOG) [12]. The ECOG PStakes values between 0 and 4 (0  –  fully active, able tocarry on all pre-disease performance without restriction,1  –  restricted in physically strenuous activity but ambu-latory and able to carry out work of a light or sedentary nature, 2  –  ambulatory and capable of all selfcare butunable to carry out any work activities, up and aboutmore than 50 % of waking hours, 3  –  capable of only limited selfcare, confined to bed or chair more than50 % of waking hours, 4  –  completely disabled, cannotcarry on any selfcare, totally confined to bed or chair). Data analysis Data from patients on QLQ-C15-PAL as well as the POSitem and sum scores are described as means (M) withstandard deviation (SD). The most recent data are consid-ered, i.e. the last available assessment from the patients be-fore either their death or the end of the 6-monthobservation period. Since both questionnaires shouldmeasure closely related constructs, ‘ Overall quality of life ’ fromtheQLQ-C15-PAL andthePOSsumscoreare corre-lated using Pearson ’ scorrelation coefficient.Patients cared for by PAMINO-trained GPs (PG)and patients cared for by other GPs (CG) are com-pared using chi-square test for frequencies and t-testsfor differences in group means. To confirm the resultsand to control for cluster effects in the practices aswell as for possible influences of patient and GP char-acteristics, we additionally conducted regression mod-els. For all tests, p<.05 is considered to be statistically significant. All statistical analyses are conducted usingSPSS 15.0 (SPSS Inc., Chicago, Ill.) and SAS 9.2 (SASInstitute Inc., Cary, NC).For sample size calculation, we assumed that every GPcared for 4 eligible patients who were willing to partici-pate in the study. To show a minimum mean differenceof 2.0 points in the sum score of the POS, with anassumed standard deviation of 0.6, power set to 80 %,and controlling for cluster effects, we needed to include360 patients from 90 practices. Results GP and patient sample There were 100 patients cared for by 45 GPs participat-ing in the study. Four patients did not fill out any ques-tionnaire in the study period; those patients wereexcluded from further analysis (Figure 1). Sixty-twopatients were cared for by 27 PAMINO-trained GPs; 34patients belonged to 18 other practices. There was oneGP with 3 patients in the control group who had a pal-liative care training other than PAMINO. GPs in bothgroups did not differ in respect to their demographicbackground and their years of experience (Table 1). Pa-tient characteristics are shown in Table 2. Patients werebetween 39 and 91 years old (M=69; SD=11.6); 38.5 %were female. The most common diagnoses were lung(n=13), colon (n=12) or breast (n=11) cancer, with 74patients having at least one comorbidity (e.g. hyperten-sion, diabetes). In the patient group cared for by PAMINO-trained GPs, 56 % of the patients had anECOG PS of 3 or 4. In the control group of patientscared for by other GPs 49 % of the patients had anECOG PS of 3 or 4. About 40 % of patients in bothgroups have had a hospital consultation within themonth prior to the study assessment; 7 patients were incontact with palliative care services (including physician,nursing, palliative care unit, and hospice). There wereno statistically significant differences between patientgroups.The QLQ-C15-PAL and the POS are both self-administered questionnaires measuring quality of life.More than half of the patients (PG: 52 %, CG: 63 %,p=.33) needed help from either family/friends or staff tofill out the questionnaires. ‘ Overall quality of life ’  and POS sum score Patients reported a mean quality of life on the QLQ-C15-PAL of 38.1 (SD=25.7, n=87) and on the POS of 13.0 (SD=6.1, n=83). Of 76 patients, both question-naires were available.  ‘ Overall quality of life ’  (QLQ-C15-PAL) and POS sum score correlated highly (r= − .59,p<.01).On the QLQ-C15-PAL, mean QoL of the patientgroups of PAMINO-trained and other GPs were 37.7(SD=25.5, n=54) and 39.4 (SD=26.3, n=33) (p=.76),respectively. On the POS, respective mean values of 13.6(SD=5.8, n=51) and 12.0 (SD=6.5, n=32) (p=.26)were given. Patients cared for by a PAMINO-trained GPdid not report better QoL and care outcomes thanpatients cared for by another GP. Hermann  et al. BMC Palliative Care  2012,  11 :13 Page 3 of 7http://www.biomedcentral.com/1472-684X/11/13  The results of the univariate analyses were confirmedin regression models using practice as cluster variableand group, ECOG PS, gender and age of the patient,and experience of the GP as independent variables.Due to missing values, the models were analyzed withn=81 and n=78 for  ‘ Overall quality of life ”  and thePOS sum score, respectively. Only the ECOG PS sig-nificantly influenced the two scales: Compared topatients with a ECOG PS of 4, patients with a ECOGPS of 0, 1 or 2 had a higher  ‘ Overall quality of life ’ ,and patients with a ECOG PS of 0 or 1 had a lowerPOS sum score. QLQ-C15-PAL function and symptom scales On the function scales, patients in both groups reporteda higher emotional functioning (M=46.9, SD=34.4,n=95) than physical functioning (M=30.1, SD=34.5,n=92). Additionally, physical functioning was skewedtowards the lower end of the scale (median=13.3). Themost prevalent symptoms were fatigue (M=74.4, SD=30.1, n=94), appetite loss (M=55.1, SD=40.3, n=95)and pain (M=51.1, SD=36.2, n=95). Patients in bothgroups did not differ in their perception of function andsymptoms (Table 3). POS item scores On the POS items, patients in both groups most oftenreported an  ‘ anxious family  ’  (M=2.4, SD=1.4, n=88)and not  ‘ feeling good ’  (M=1.9, SD=1.3, n=87). Therewere less problems with  ‘ waste of time ’  (M=0.3, SD=0.7, n=88) and  ‘ information given ’  (M=0.5, SD=1.1,n=87), where more than 80 % of the patients did not re-port any problems at all. Patients in the two groups didnot differ significantly in their perception of the variousaspects of care outcomes (Table 4). Discussion This study evaluated if there are differences within thehealth-related QoL of patients cared for by GPs whoparticipated in a palliative training course offered by GPs(PAMINO) compared to patients of other GPs. In ourstudy sample, patients did not report any differences intheir QoL and care as measured by QLQ-C15-PAL andPOS. The study suggests that PAMINO training makes 100 patients96 patientsDrop-out (n=4)4 patients did not return questionnaires96 patients with QLQ-C15-PAL88 patients with POS8 patients did not return POS, only QLQ-C15-PALFor 5 patients, a POS sum score could not be calculated9 patients did not answer QoL question87 patients with ’Overall quality of life’83 patients with POS sum score76 patients with both ’Overall quality of life’ and POS sum score Figure 1  Flowchart of study participants and available data. Hermann  et al. BMC Palliative Care  2012,  11 :13 Page 4 of 7http://www.biomedcentral.com/1472-684X/11/13  no noticeable difference to the quality of care forpatients between comparable groups of GPs.We tried to include as many GPs and patients as pos-sible, but did not reach our targeted sample size. GPs ei-ther did not care for enough eligible patients or did notparticipate due to time constraints. There were enoughpractices participating in the study (n=90), but only half of them included patients. Mostly, there were less eli-gible patients in the practices than expected: there werenot as many cancer patients as we assumed for our sam-ple size calculation. Therefore, this study has the charac-ter of a pilot study and conclusions need to be drawncautiously. Although our study is underpowered, itnevertheless describes the quality of life in palliativepatients cared for by GPs.Patients considered their QoL to be moderately high.Not surprisingly, QoL was much lower than in the gen-eral German population [13], but higher than in compar-able palliative care populations [14].Additionally, GPs in general delivered high-quality care in the patients ’  view. Compared to patients caredfor in nursing homes [11], they reported better care out-comes. The patients of the German POS validation study [8], who were mostly cared for in palliative care units inhospital, also reported worse care outcomes than ourstudy population.As was to be expected, both measures correlatedhighly showing the high interdependence of care out-comes and health-related quality of life as perceived by patients.Although our study failed to reveal statistical signifi-cant differences within the QoL of patients, it does notmean that the initiative had no impact at all. Unlikenon-participating doctors, GPs participating in this vol-untary training might gain valuable knowledge and skillsin caring for palliative patients, which are of increasingimportance in the future. Furthermore, we did notevaluate the training from the GPs ’  point of view, forwhich a longitudinal design with focussing on GPs per-ceptions and attitudes (asking GPs before and after thetraining) would have been more appropriate. Further-more, our study sample mostly consisted of middle-agedGPs with long years of experience. The way they care forpatients was perhaps not influenced by training but by learning on the job. These issues should be taken intoconsideration within further research.GPs had to include eligible patients from their practicein the study. Although there were inclusion criteria, therecruitment of patients was prone to a selection bias,since GPs decided whom they thought eligible. Patients Table 2 Patient characteristics of palliative patients all (n=96) PG (n=62) CG (n=34)female; n (%)  37 (38.5) 25 (40.3) 12 (35.3) male; n (%)  59 (61.5) 37 (59.7) 22 (64.7) age; M (SD) years  68.6 (11.6) 69.7 (11.2) 66.7 (12.2) living . . . ; n (%) . . .  alone  19 (19.8) 14 (22.6) 5 (14.7) . . .  with relatives  72 (75.0) 45 (72.6) 27 (79.4) . . .  in day care  3 (3.1) 2 (3.2) 1 (2.9) main cancer diagnosis site; n (%)lung  13 (13.5) 9 (14.5) 4 (11.8) colon  12 (12.5) 9 (14.5) 3 (8.8) breast  11 (11.5) 7 (11.3) 4 (11.8) stomach  8 (8.3) 4 (6.5) 4 (11.8) prostate  7 (7.3) 4 (6.5) 3 (8.8) other  45 (46.9) 29 (46.7) 16 (47.1) ECOG performance status; n (%)0 (fully active)  9 (9.4) 7 (11.3) 2 (5.9) 1 (restricted)  13 (13.5) 10 (16.1) 3 (8.8) 2 (ambulatory)  21 (21.9) 9 (14.5) 12 (35.3) 3 (limited ability)  16 (16.7) 9 (14.5) 7 (20.6) 4 (disabled)  33 (34.4) 24 (38.7) 9 (26.5) missing  4 (4.2) 3 (4.8) 1 (2.9) PG patient group cared for by PAMINO-trained general practitioners, CGcontrol group patients cared for by other general practitioners, M mean, SDstandard deviation, ECOG Eastern Cooperative Oncology Group. Table 1 Sample characteristics of GPs in PAMINO (PG)and control group (CG) PG (n=27) CG (n=18) Women (%) 9 (33.3) 3 (16.7)Men (%) 18 (66.7) 15 (83.3) Age ; mean yrs (SD) 53.5 (7.3) 54.5 (8.2) GP practice experience ; mean yrs (SD) 19.1 (8.1) 18.3 (7.4)single-handed practice (%) 13 (48.1) 8 (44.4)other (%) 14 (51.9) 10 (55.6) Practice location  (%)urban 5 (18.5) 5 (27.8)suburban 16 (59.3) 9 (50.0)rural 6 (22.2) 4 (22.2) No. of patients per quarter year  (%)up to 1000 patients 7 (25.9) 4 (22.2)1001 to 1500 patients 9 (33.3) 10 (55.6)more than 1500 patients 11 (40.7) 4 (22.2) Palliative care patients per year  (%)0-2 - 3 (16.7)3-5 11 (40.7) 4 (22.2)6-9 8 (29.6) 5 (27.8)10 and more 8 (29.6) 6 (33.3) Distance to the next palliative care unit ;median km (min-max)12.5 (1 – 60) 10 (0.5-80) Hermann  et al. BMC Palliative Care  2012,  11 :13 Page 5 of 7http://www.biomedcentral.com/1472-684X/11/13
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