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 |
| Secondary identifying numbers | F-PAMINO 01 |
- 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
Not provided at time of registration
Contact information
Dr Thomas Rosemann
Scientific
Scientific
University Hospital of Heidelberg
Department of General Practice and Health Services Research
Vosstr 2.
Heidelberg
69115
Germany
| Phone | +49 (0)6221 565 213 |
|---|---|
| thomas.rosemann@med.uni-heidelberg.de |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use contact details to request a 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 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 360 |
| 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 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
69115
Germany
Sponsor information
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany)
Government
Government
Hannoversche Straße 28-30
Berlin
10115
Germany
| Phone | +49 (0)1888 57 0 |
|---|---|
| bmbf@bmbf.bund.de | |
| Website | http://www.bmbf.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Bundesministerium für Bildung und Forschung (ref: 01GK0601)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
Editorial Notes
13/09/2016: Publication reference added.
