Condition category
Not Applicable
Date applied
25/08/2009
Date assigned
18/09/2009
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jürgen in der Schmitten

ORCID ID

Contact details

Abteilung für Allgemeinmedizin (Dpt. of General Practice)
Universitätsklinik (University Hospital)
Moorenstr. 5
Düsseldorf
40225
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GX9753

Study information

Scientific title

Controlled intervention study for the process- and system-oriented implementation of advance care planning in the nursing homes and further relevant care suppliers of a model region by means of qualifying n/h staff to facilitate ACP discussions, and a multi-faceted informational intervention (RESPEKT - Respekt für vorausverfügte Entscheidungen und Präferenzen für den Fall von Krankheit und Tod)

Acronym

RESPEKT

Study hypothesis

The prevalence of both meaningful and valid advance directives in nursing homes will increase significantly if nursing home staff trained as facilitators for advance care planning discussions provide thorough consultation.

Ethics approval

Ethics Committee of the University Hospital of Düsseldorf (Germany) approved on the 17th November 2008 (ref. 3116)

Study design

Longitudinal non-randomised non-blinded controlled interventional study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advance care planning process and results

Intervention

The core of the intervention is the training of altogether 16 nurses or social workers from the four nursing homes of a middle-sized town. The training consists of a week of intensive training (20 hours) and subsequently regular plenary sessions, and personal supervisions/coachings for at least one year, though with decreasing frequency. The training aims to teach the future facilitators to initiate discussion on advance care planning, to help residents or their proxies understand the choices to be made, and to develop, communicate, and document their personal preference. The training program is an adaptation of the US program Respecting Choices® (cf. http://www.respectingchoices.org/).

In the control group of 10 nursing homes in two other towns, there is no intervention (care as usual).

Recruitment for the controlled study was stopped on 30th June 2009 because the intervention began to strongly bias recruitment outcome in the intervention region. Follow up is ongoing.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Prevalence of written advance directives (authored by the resident or, if incapacitated, the legal proxy), in a three-step approach:
1. Presence of an advance directive (yes or no). If an advance directive is present, then the following step is evaluated:
2. Meaningfulness of the advance directive, i.e. it addresses the following scenarios typically relevant for nursing homes in Germany: cardiopulmonary resuscitation; hospital admission for life-sustaining treatment; long-term artificial feeding in dementia, both for the state of current decision-making capacity (if still given), and a possible future decision-making incapacity. If an advance directive is meaningful in that sense, then the following step is evaluated:
3. Validity of the advance directive, defined by a physician's written testimony that the signer (resident or proxy):
3.1. Has currently decision making capacity, and
3.2. Has understood and appreciated the implications of his or her decision

Primary outcomes measured on 30/06/2010.

Secondary outcome measures

1. Process quality:
1.1. Presence of a physician's order for emergency situations directed at the nursing staff, clarifying the issue of cardiopulmonary resuscitation (yes or no), of hospital admission, and of any urgent procedures aiming to prolong life.
1.2. Accessibility of advance directives/physician's order from within the nursing ward:
1.2.1. Rate of easily noticeable references to a given advance care planning in the paper or electronic file
1.2.2. Copy of advance directive and/or physician's order is prepared for the case of a transferral to hospital
1.3. Management of advance directives or physician orders' during residents' hospital stays
1.3.1. Copy of AD or physician order is in the hospital file
1.3.2. Treatment limitations stated in physicians' orders brought from the n/h are translated into corresponding written orders by hospital doctors
1.3.3. AD or physician's order is mentioned in discharge letter

2. Outcome quality:
2.1. Treatment:
2.1.1. Incidence of feeding tube insertions, days of artificial feeding, days of parenteral fluid application, as far as congruent with the expressed residents' preferences
2.1.2. Incidence and days of hospital treatments
2.1.3. Incidence of decubital ulcers
2.2. Course before dying:
2.2.1. Location of dying
2.2.2. Number of transferrals to hospital in the 30 (90) days before death
2.2.3. In-hospital (in-ICU) days in the 30 (90) days before death
2.2.4. Rate of index-treatments in the 30 (90) days before death (i.e., CPR, feeding tube insertions, days of artificial feeding, artificial ventilation, pace maker insertions, incidence of general surgery)
2.2.5. Incidence of decubital ulcers in the 30 (90) days before dying
2.3. Perception of the dying process from the perspective of third parties:
2.3.1. Judgment of the dying process from the nursing perspective
2.3.2. Judgment of the dying process from the relative perspective (after-bereavement interview)

3. Analysis of possible confounders:
3.1. Sex
3.2. Age
3.3. Nursing home
3.4. Facilitator

Secondary outcomes measured on 31/07/2010.

Overall trial start date

01/10/2008

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All residents of the enrolled nursing homes (adults of either sex)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

1080

Participant exclusion criteria

1. Life expectancy below four weeks according to medical or nursing judgment
2. Expected duration of stay in the nursing home below three months (short-term nursing care)
3. Unsurmountable language or communication barrier (resident and proxy)

Recruitment start date

01/10/2008

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Abteilung für Allgemeinmedizin (Dpt. of General Practice)
Düsseldorf
40225
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

Sponsor details

c/o Projektträger im DLR
Versorgungsnahe Forschung
Heinrich-Konen-Str. 1
Bonn
53227
Germany

Sponsor type

Government

Website

http://www.gesundheitsforschung-bmbf.de/de/167.php

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01 GX 0753)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

B. Braun Foundation (Germany) - providing small additional funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21261952

Publication citations

  1. Protocol

    In der Schmitten J, Rothärmel S, Mellert C, Rixen S, Hammes BJ, Briggs L, Wegscheider K, Marckmann G, A complex regional intervention to implement advance care planning in one town's nursing homes: Protocol of a controlled inter-regional study., BMC Health Serv Res, 2011, 11, 14, doi: 10.1186/1472-6963-11-14.

Additional files

Editorial Notes