Condition category
Cancer
Date applied
02/04/2007
Date assigned
04/04/2007
Last edited
13/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pamino-bw.de/

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

GP practices

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2007

Overall trial end date

31/05/2009

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.bmbf.de

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

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17535418
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26767785

Publication citations

  1. Protocol

    Rosemann T, Hermann K, Miksch A, Engeser P, Szecsenyi J, The PAMINO-project: evaluating a primary care-based educational program to improve the quality of life of palliative patients., BMC Palliat Care, 2007, 6, 5, doi: 10.1186/1472-684X-6-5.

Additional files

Editorial Notes

13/09/2016: Publication reference added.