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CancerPREPAREDNCT03393351

Implementation of Shared Decision-Making in Cancer Care

A study testing Shared decision-making program in people with Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Shared decision-making program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,131 participants
Where
3 sitesGermany
Study dates
5 Mar 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36)
  • admitted for inpatient or outpatient treatment at the participating clinics
  • age > 18 years
  • German-speaking

Who cannot join

  • severe cognitive impairment
  • Inclusion Criteria for participating health care professionals:
  • physician or nurse working at the participating clinics
  • Exclusion Criteria for participating health care professionals:
  • none

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic

    Hamburg

  • University Medical Center Hamburg-Eppendorf, Center for Surgical Sciences, Department of Gynecology

    Hamburg

  • University Medical Center Hamburg-Eppendorf, Head and Neurocenter, Department of Oral and Maxillofacial Surgery

    Hamburg

Other trials in Germany

About this study

Official title: Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial

This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.

Conditions
Cancer
Being tested
Shared decision-making program, Usual Care
Keywords
Shared Decision-Making, Decision Making, Patient Participation, Patient Centeredness, Health Services Research, Implementation Research, Oncology, Stepped Wedge Design, Mixed Methods
Medical subject headings
Neoplasms, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shared decision-making programOther

    The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components:

    1. shared decision-making trainings for health care professionals,
    2. individual coaching for physicians,
    3. patient activation strategy,
    4. provision of patient information material and decision aids,
    5. revision of the clinics quality management documents, and
    6. critical reflection of current organization of multidisciplinary team meetings.

    Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.

  • Usual CareOther

    No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.

Study groups in NCT03393351
Study groupRoleWhat they receive
Shared decision-making programExperimentalNot described
Receives: Other: Shared decision-making program
Usual careActive comparatorNot described
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in uptake of shared decision-making from the patients' perspective

    Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)

    Measured: All clinics: baseline, 8 months, 16 months, 24 months

Secondary outcomes (6)

  1. Change in uptake of shared decision-making from external observers' perspective

    Action to employ shared decision-making as measured by the German version of the Observer OPTION 5 scale using audio-recorded medical encounters. The Observer OPTION 5 scale measures the extent to which clinicians involve patients in decision-making. Each of the 5 items is assessed on a scale ranging from 0 to 4 with higher values indicating more involvement of patients in decision-making. A sum score is calculated (ranging from 0 to 20) and rescaled to be between 0 to 100, for ease of interpretation.

    Measured: All clinics: baseline, 8 months, 16 months, 24 months

  2. Acceptability of shared decision-making from the health care providers' perspective

    Perception that shared decision-making is agreeable, palatable, or satisfactory as measured by an adapted version of the acceptability survey developed by McColl et al.

    Measured: All clinics: baseline, 8 months, 16 months, 24 months

  3. Readiness for implementing change from the health care professionals' perspective

    As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure

    Measured: All clinics: baseline, 8 months, 16 months, 24 months

  4. Appropriateness of shared decision-making from the health care professionals' perspective

    Perceived fit, relevance, or compatibility of shared decision-making for the given practice setting as measured by an adapted version of the IcanSDM measure

    Measured: All clinics: baseline, 8 months, 16 months, 24 months

  5. Change in penetration of shared decision-making at the clinic level

    Integration of shared decision-making within a setting and its subsystems as measured by routine data from patient experience surveys of the clinics

    Measured: baseline, 3 years

  6. Change in penetration of shared decision-making in multidisciplinary team meetings

    Integration of shared decision-making within a setting and its subsystems as measured by an adapted version of the Metric for the Observation of Decision Making in Multidisciplinary Team Meetings (MDT-MODe)

    Measured: All clinics: baseline, 8 months, 16 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2018
  2. Study start5 Mar 2018
  3. Primary completion12 Sep 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
A stepped wedge design, a variant of the cluster randomized controlled trial feasible to evaluate interventions in routine implementation, will be used. Participating clinics will receive the multifaceted implementation program in a randomized sequence.
Masking
None (open label)
Enrolment
2,131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03393351
Sponsor's protocol ID
SCHO 1551/1-2
Acronym
PREPARED
Status last verified
Jun 2021
First submitted
19 Dec 2017
Last updated
4 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Scholl I, Hahlweg P, Lindig A, Bokemeyer C, Coym A, Hanken H, Muller V, Smeets R, Witzel I, Kriston L, Harter M. Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial. Implement Sci. 2018 Mar 27;13(1):51. doi: 10.1186/s13012-018-0740-y.

    PubMed 29580249

  • Hahlweg P, Lindig A, Frerichs W, Zill J, Hanken H, Muller V, Peters MC, Scholl I. Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial. BMC Health Serv Res. 2023 Aug 8;23(1):840. doi: 10.1186/s12913-023-09778-w.

    PubMed 37553560

  • Scholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Harter M, Kriston L. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4.

    PubMed 34965881

Questions about this trial

What is this clinical trial studying?

A study testing Shared decision-making program in people with Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in uptake of shared decision-making from the patients' perspective (time frame: All clinics: baseline, 8 months, 16 months, 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03393351, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.

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