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Pain Intervention for people with Dementia in nursing homes (PID): study protocol for a quasi-experimental nurse Intervention

Organizational Data

DRKS-ID:
DRKS00009726
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2017-01-10
Last update in DRKS:
2019-01-16
Registration type:
Retrospective

Acronym/abbreviation of the study

PID

URL of the study

https://www.zhaw.ch/no_cache/de/forschung/forschungsdatenbank/projektdetail/projektid/1312/

Brief summary in lay language

It is estimated that 19% to 83% of people with dementia suffer from pain that is inadequately treated in the last months of life. The aim of this study is to identify care needs of people with dementia suffering from pain living in a nursing home. Healthcare workers will be individually trained how to assess, intervene and evaluate acute and chronic pain. Outcome measures will be: pain events per shift and per week; degree of pain intensity per work shift, per week day; pain-free intervals.

Brief summary in scientific language

Background It is estimated that 19% to 83% of people with dementia suffer from pain that is inadequately treated in the last months of life. A large number of healthcare workers who care for these people in nursing homes lack appropriate expertise and may therefore not always recognise, assess and treat pain in those with dementia who have complex problems on time, properly and efficiently. The aim of this intervention trial is to identify care needs of people with dementia suffering from pain living in a nursing home. Methods/Design A quasi-experimental nurse-led intervention trial based on a convenience sample of four nursing homes in the Swiss Canton of Zurich examines the effects on dementia patients (n=411), the healthcare institution and the qualification level of the healthcare workers compared to historical controls, using an event analysis and a multilevel analysis. Healthcare workers will be individually trained how to assess, intervene and evaluate acute and chronic pain. There are three data-monitoring cycles (T0, T1, T2) and two intervention cycles (I1, I2) with a total study duration of 425 days. There is also a process evaluation based on Dobbins analyses that analyse in particular the potentials for change in clinical practice of change agents. Nursing homes can integrate the findings from the intervention trial into their internal quality control process. The potential for improvements that can be directly influenced by the nursing home itself will also be discussed.

Health condition or problem studied

Free text:
pain of people with dementia in nursing homes.
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
The intervention nurse is a nurse with a Master of Science in Nursing degree. The intervention consists of two parts: Intervention 1 – pain assessment Aim: to reinforce the systematic pain assessment of healthcare workers with the PAINAD Instrument which is used in German as BESD-instrument. Intervention 2 – pain management Aim: to reinforce the systemic pain management skills of healthcare workers including systematic documentation and information among nursing staff and general practitioners. Both interventions, 1 and 2, will be repeated in a second Intervention Phase. First Intervention phase: Day 50-98 Second Intervention phase: Day 208 - 256
Arm 2:
Comparison with RAI routine data from the nursing homes in the last three months before the study has been started.

Endpoints

Primary outcome:
Primary outcomes Pain is measured in all people with dementia by means of: • pain events per shift and per week; • degree of pain intensity per work shift, per week day; • pain-free intervals. Pain will be measured by the PAINAD scale (=BPSD in German) which is a standardised instrument for pain assessment. Hypotheses for primary outcomes Ha1: There is a 20% reduction in pain events over time before and after the intervention and between intervention and comparison groups among nursing home older people. Ha2: There is a 50% reduction in pain intensity over time before and after the intervention and between intervention and comparison groups among older people. Ha3: There is a 20% reduction in the duration of pain free intervals over time before and after the intervention and between intervention and comparison groups among older people. Furthermore the following hypotheses will be explored: • There is a difference in the behavioural problems score (NPI) before and after the intervention and between intervention and comparison groups among older people. • There is a difference in the psychopharmacological drug numbers / dosage before and after the intervention and between intervention and comparison groups among older people. • There is a difference in the numbers / dosage of painkillers before and after the intervention and between intervention and comparison groups among older people. • There is a difference in pain assessment over time before and after the intervention and between intervention and comparison groups among nursing home older people. • There is still a difference in pain assessment by healthcare workers on assistant level over time before and after the intervention • There is still a difference in pain assessment between healthcare workers on assistant level and registered nurses level over time before and after the intervention. Event history analyses The required number of events for a two-tailed test of individual coefficients within a Cox model with other covariates has been calculated based on the method of Hsieh and Lavori. Multilevel analyses (linear mixed models) The required number of cases for basic evaluations using multilevel models/linear mixed models have been determined by the approximation method with equal power and significance level as in the event analyses. Analysis will be done at the end of all data collection: T0 (day 1-49), T1 (day 159-207) and T2 (day 377-425). All dementia patients in the comparison group will be obtained from the Zurich Life And Death with Advanced Dementia (ZULIDAD) Study. The ZULIDAD data were collected from people with dementia (men and women), who are older than 70 years in one nursing home (n=150), in 2015. Data between intervention sites and comparison site are similar because the same assessment instruments were used, based on an older person assessment instrument, and include pain duration, pain intensity, behavioural problems, differences of psychopharmacological drugs, and differences of analgesics. The comparison can be made with data from the first day and from the 49th of each data collection phase (t0, t1, t2) and with a historical sample of pain duration and pain intensity from the last pain assessment documented in the older person Assessment Instrument Data (RAI) of each participant.
Secondary outcome:
Secondary outcome variables • frequency of behavioural problems (Neuropsychiatric Inventory NPI) • number / dosages of psychotropic drugs; • Number / dosages of analgesics. Tertiary outcome variables The documentation regarding the assessment of pain by nurses is always done in duplicate, by a health care worker on different education level. • changes in the assessment of pain by healthcare worker on healthcare assistant level and • changes between the two healthcare worker groups on healthcare assistant level and registered nurse level. Analysis will be done at the end of all data collection: T0 (day 1-49), T1 (day 159-207) and T2 (day 377-425).

Study Design

Purpose:
Other
Allocation:
Non-randomized controlled study
Control:
  • Historical
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Other
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Alters- und Pflegeheim Thurgau und Zürich

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-02-08
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
411
Final Sample Size:
231

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
All nurses are included in the study, trained and coached in the provision of interventions. The following inclusion criteria apply to nursing home employees (at assistant, secondary and tertiary level): • must be at least 18 years old; • must have been employed at least 12 months in the respective organisation; • must work for at least 30% of a working week; • be able to communicate in German.

Exclusion Criteria

No Entry

Addresses

Primary Sponsor

Zurich University of Applied Science
Prof. Dr. Andrea Koppitz
Technikumstrasse 81
8401 Winterthur
Switzerland
Telephone:
+41 58 934 64 94
Fax:
+41 58 935 64 94
Contact per E-Mail
URL:
http://www.zhaw.ch
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Zurich University of Applied Science
Prof. Dr. Andrea Kopitz
Technikumstrasse 81
8401 Winterthur
Switzerland
Telephone:
+41 58 934 64 94
Fax:
+41 58 9354 64 94
Contact per E-Mail
URL:
http://www.zhaw.ch

Contact for Public Queries

Zürcher Hochschule für angewandte Wissenschaften, Department Gesundheit, Institut für Pflege
Prof. Dr. Andrea Koppitz
Technikumstrasse 81
8401 Winterthur
Switzerland
Telephone:
0041589346494
Fax:
0041589356494
Contact per E-Mail
URL:
http://www.zhaw.ch

Principal Investigator

Zurich University of Applied Science
Prof. Dr. Andrea Kopitz
Technikumstrasse 81
8401 Winterthur
Switzerland
Telephone:
+41 58 934 64 94
Fax:
+41 58 9354 64 94
Contact per E-Mail
URL:
http://www.zhaw.ch

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

stv. Leiterin Sektion Nationale GesundheitspolitikProjektleiterin "Nationale Demenzstrategie"Eidgenössisches Departement des Inneren EDIBundesamt für Gesundheit BAG
Schwarzenburgstsse 161
3003 Bern
Switzerland
Telephone:
+41 58 463 88 21
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bag.admin.ch / www.nationaledemenzstrategie.ch

Private sponsorship (foundations, study societies, etc.)

Swiss Academy of Medical Science
Laupenstrasse 7
3001 Bern
Switzerland
Telephone:
+41 31 306 92 70
Fax:
No Entry
Contact per E-Mail
URL:
http://www.samw.ch/en

Ethics Committee

Address Ethics Committee

Kantonale Ethikkommission Zürich [Ethic comitee Canton of Zurich, Switzerland ]
Stampfenbachstrasse 121
CH-8090 Zürich
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.kek.zh.ch/internet/gesundheitsdirektion/kek/de/home.html

Vote of leading Ethics Committee

Date of ethics committee application:
2015-12-23
Ethics committee number:
KEK-ZH-Nr. 2016-0001 Unbedenklichkeit
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-01-06

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Koppitz A, Bosshard G, Blanc G, Hediger H, Payne S, Volken T. Pain Intervention for people with Dementia in nursing homes (PID): study protocol for a quasi-experimental nurse intervention. BMC Palliat Care. 2017;16(1):27.
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry