The PAMINO-project: evaluating a primary care based educational program to improve the quality of life of palliative patients

ISRCTN	ISRCTN78021852
DOI	https://doi.org/10.1186/ISRCTN78021852
Protocol serial number	F-PAMINO 01
Sponsor	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Funder	Bundesministerium für Bildung und Forschung (ref: 01GK0601)

Submission date: 02/04/2007
Registration date: 04/04/2007
Last edited: 13/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thomas Rosemann
Scientific

University Hospital of Heidelberg
Department of General Practice and Health Services Research
Vosstr 2.
Heidelberg
69115
Germany

Phone	+49 (0)6221 565 213
Email	thomas.rosemann@med.uni-heidelberg.de

Study information

Primary study design	Interventional
Study design	(Prospective) two-armed controlled non-randomised evaluation study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	The PAMINO-project: evaluating a primary care based educational program to improve the quality of life of palliative patients
Study acronym	PAMINO - PAlliative Medical Initiative NOrth Baden
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	360
Key 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
Key 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
Date of first enrolment	01/05/2007
Date of final enrolment	31/05/2009

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital of Heidelberg

Heidelberg
69115
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2016		Yes	No
Protocol article	protocol	29/05/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/09/2016: Publication reference added.