Contact information
Type
Scientific
Contact name
Dr Thomas Rosemann
ORCID ID
Contact details
University Hospital of Heidelberg
Department of General Practice and Health Services Research
Vosstr 2.
Heidelberg
69115
Germany
+49 (0)6221 565 213
thomas.rosemann@med.uni-heidelberg.de
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
F-PAMINO 01
Study information
Scientific title
The PAMINO-project: evaluating a primary care based educational program to improve the quality of life of palliative patients
Acronym
PAMINO - PAlliative Medical Initiative NOrth Baden
Study hypothesis
Patients of General Practitioners (GPs) who participated in the educational courses of the PAlliative Medical Initiative NOrth Baden (PAMINO) have a higher quality of life at the end of their life than patients of general practitioners who did not participate in palliative care training.
Ethics approval(s)
Ethics committee of the University of Heidelberg, March 2007, ref: 043/2007
Study design
(Prospective) two-armed controlled non-randomised evaluation study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
GP practice
Study type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Oncological diseases
Intervention
This study compares the outcomes between a multifaceted-based interdisciplinary training concept in palliative care in a primary care setting and usual palliative care for patients with malignant tumours. We will compare GPs who have already completed the PAMINO course.
PAMINO contains a curriculum consisting of a qualifying training course, which is based on the training course of the German Medical Association (Bundesärztekammer) and the German Association for Palliative Medicine, as well as of subsequent network meetings and quality circles. The interdisciplinary training course is held at the University of Heidelberg and covers issues of psychology of pain, legal aspects, dialogues of clarification with patients, ethics and attitudes, pain therapy (in theory and case studies), symptom control and specialised pain therapy (including practical applications), dying and the requirements of dying people, communication and burn-out, palliation in geriatrics, and palliative care.
Intervention type
Other
Primary outcome measure
As the primary outcome parameter, we observe the change of quality of life of patients in the intervention group (patients of general practitioners with PAMINO-training) compared to the control group (patients of general practitioners without PAMINO-training). Quality of life will be assessed by the German version of the Palliative care Outcome Scale (POS), and the Quality of Life Questionnaire Core-15 Palliative care (QLQ-C15-PAL) of the European Organisation for Research and Treatment of Cancer (EORTC).
All assessement tools (for patients, physicians, and family caregivers) are administered monthly from enrolment to either death of the patient or the end of the six-month observation period.
Secondary outcome measures
The training will have an effect on the following secondary outcomes:
1. A lower pain level as experienced by the patients and assessed by a Visual Analogue Scale (VAS)
2. Lower burden for family caregivers as assessed by the Burden Scale for Family Caregivers (BSFC)
3. Less utilisation of the health care system (primary and specialist care, nursing service) including emergency and hospital admittance
4. In a higher proportion of patients the favoured and actual site of death concur
The effects of the training on the following process indicators are observed:
1. Drug therapy, especially for pain, in adherence to the guidelines of the World Health Organisation (WHO)
2. Therapeutic elements of palliative medicine besides drug therapy
3. The existence of documents such as advance directives, do-not-resuscitate orders, and health care proxy, treatment plan
4. Prescription of pain medication
5. Realisation of substitution in case of unavailability of the treating family physician
6. Cooperation with nursing services
All assessement tools (for patients, physicians, and family caregivers) are administered monthly from enrolment to either death of the patient or the end of the six-month observation period.
Overall study start date
01/05/2007
Overall study end date
31/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. The GPs participating in the study include consecutively adult outpatients (at least 18 years of age) of whom they are the family physician
2. Patients need to be in a palliative situation with an oncological disease
3. They have to give their informed and written consent to participate
4. Estimated life expectancy is six months at most
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
360
Participant exclusion criteria
1. Patients with malignant tumours in a curative therapy situation or with an additional uncontrolled disease with a lower life expectancy than the tumour disease
2. Insufficient German language skills
Recruitment start date
01/05/2007
Recruitment end date
31/05/2009
Locations
Countries of recruitment
Germany
Study participating centre
University Hospital of Heidelberg
Heidelberg
69115
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Sponsor details
Hannoversche Straße 28-30
Berlin
10115
Germany
+49 (0)1888 57 0
bmbf@bmbf.bund.de
Sponsor type
Government
Website
ROR
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung (ref: 01GK0601)
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/05/2007 | Yes | No | |
| Results article | results | 15/01/2016 | Yes | No |