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Adverse Effect of Other Antipsychotics and NeurolepticsNCT02604056

Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing

A study testing Audit + Feedback and Audit + Feedback + Educational Outreach in people with Adverse Effect of Other Antipsychotics and Neuroleptics, run by Women's College Hospital.

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

Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). Read more about this study

Who is it for?
Any age
What is being tested?
Audit + Feedback and Audit + Feedback + Educational Outreach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Sep 2015to Apr 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Nursing homes within pre-determined regions of Ontario that expressed an interest in the full intervention (the regions, or hubs, contain a wide variety of nursing home types within a reasonable travel distance [i.e., <100 km])
  • Nursing homes within the hubs in which the medical and administrative leads agree to and support the project

Who cannot join

  • Nursing homes with a previous or ongoing involvement in externally supported quality improvement initiatives focusing on antipsychotic medications
  • Nursing homes without any prescribers caring for at least 10 residents routinely
  • Nursing homes with fewer than 30 residents

About this study

Official title: Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes

Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). The 'standard' quality improvement supports represent 'usual care' as these are to be launched province-wide; a concurrent control arm with no exposure to a quality improvement intervention is not feasible.

Read the detailed description

The Ministry of Health and Long-Term Care and Ontario Medical Association have initiated a project aiming to improve appropriateness of prescribing in long-term care facilities (aka nursing homes) through integrated educational supports for nursing home prescribers, inter-professional care teams, as well as residents and family members. The first focus of the project is appropriate prescribing of antipsychotic medications. Working with Health Quality Ontario, the policy makers have determined that all prescribers will have the opportunity to review practice reports detailing their prescribing performance for this class of medication (aka audit and feedback).

The primary question of this pragmatic, cluster-randomized trial is: What is the effect of adding educational outreach compared to the 'usual' quality improvement supports (i.e. audit and feedback) on prescribing of antipsychotic medications in long-term care?

Secondary questions include the following:

  1. What is the effect of the intervention on acute care utilization (e.g., emergency room) rates? ii. What is the effect of the intervention on incidence of patient clinical outcomes and/or adverse effects associated with antipsychotic medications (e.g., falls, aggressive behaviours)? iii. What is the effect of the interventions on medications that might be used as alternatives to antipsychotic medications (e.g., benzodiazepines)? iv. What is the cost-benefit, focusing on prescribing outcomes?

Process evaluation questions include the following:

  1. How and why do the interventions work as observed?
  2. Was the intervention implemented as desired in nursing homes?
  3. What were the contextual factors associated with implementation?
  4. Do the interventions affect precursors of behaviour (e.g., motivation, capability)?
Being tested
Audit + Feedback, Audit + Feedback + Educational Outreach

What participants receive

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

  • Audit + FeedbackBehavioural

    Online Audit + Feedback practice reports detailing prescribing performance for this class of medication for each prescriber in the nursing home. (Details: http://www.hqontario.ca/Quality-Improvement/Practice-Reports/Primary-Care)

  • Audit + Feedback + Educational OutreachBehavioural

    The Educational Outreach program will be delivered by academic detailers, health professionals (often nurses or pharmacists) who have received specific intensive training to support prescribing providers in a particular environment, in this case long-term care homes, to make the best or appropriate clinical decisions as possible. It is defined as: "an innovative method of service-oriented educational outreach for front-line clinicians. It combines the interactive, one-on-one communication approach of industry detailers with the evidence-based, non-commercial information of academia." The Educational Outreach will be delivered in addition to online Audit + Feedback practice reports, which detail prescribing performance for this class of medication for each prescriber in the nursing home.

Study groups in NCT02604056
Study groupRoleWhat they receive
Audit + FeedbackActive comparator'Usual care' / standard quality improvement supports (including online Audit and Feedback reports for each prescriber in the home)
Receives: Behavioral: Audit + Feedback
Audit + Feedback + Educational OutreachExperimental'Active/full' intervention (featuring Educational Outreach offered to each prescriber and team members in the home)
Receives: Behavioral: Audit + Feedback; Behavioral: Audit + Feedback + Educational Outreach

What is being measured

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

  1. Antipsychotic dispensing

    Number of days with antipsychotic prescriptions in the last week (count, range 0 - 7)

    Measured: 6 months post-intervention

Secondary outcomes (12)

  1. Antipsychotic prescribing

    Any antipsychotic prescription during the past month (dichotomous)

    Measured: 3 and 6 months post-intervention

  2. Mean Antipsychotic dose

    Dose equivalent of antipsychotic dispensed in the past month (continuous)

    Measured: 3 and 6 months post-intervention

  3. Benzodiazepine (or sedative) prescribing

    Any prescription during the past month (dichotomous)

    Measured: 3 and 6 months post-intervention

  4. Anti-depressant prescribing

    Any prescription during the past month (dichotomous)

    Measured: 3 and 6 months post-intervention

  5. Acetaminophen prescribing

    Any prescription during the past month (dichotomous)

    Measured: 3 and 6 months post-intervention

  6. Difficulty in performing activities

    Activities of Daily Living long form scale (continuous variable, range 0-28)

    Measured: 3 and 6 months post-intervention

  7. Aggressive behaviour scale

    Extent of aggressive behaviour (continuous variable, range 0-12)

    Measured: 3 and 6 months post-intervention

  8. Pain

    Pain scale (continuous variable, range 0-3)

    Measured: 3 and 6 months post-intervention

  9. Depression

    Depression rating scale (continuous variable, range 0-14)

    Measured: 3 and 6 months post-intervention

  10. Falls

    Number of falls in the past month (count)

    Measured: 3 and 6 months post-intervention

  11. Emergency Room visits

    Number of ER visits during the previous 3 months (count)

    Measured: 3 months post-intervention

  12. Hospitalizations

    Number of hospital visits visit during the previous 3 months (count)

    Measured: 3 months post-intervention

Timeline

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

  1. First posted13 Nov 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02604056
Sponsor's protocol ID
MOHLTCAPDP
Status last verified
Mar 2018
First submitted
5 Nov 2015
Last updated
23 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Tadrous M, Fung K, Desveaux L, Gomes T, Taljaard M, Grimshaw JM, Bell CM, Ivers NM. Effect of Academic Detailing on Promoting Appropriate Prescribing of Antipsychotic Medication in Nursing Homes: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 May 1;3(5):e205724. doi: 10.1001/jamanetworkopen.2020.5724.

    PubMed 32453383

  • Desveaux L, Saragosa M, Rogers J, Bevan L, Loshak H, Moser A, Feldman S, Regier L, Jeffs L, Ivers NM. Improving the appropriateness of antipsychotic prescribing in nursing homes: a mixed-methods process evaluation of an academic detailing intervention. Implement Sci. 2017 May 26;12(1):71. doi: 10.1186/s13012-017-0602-z.

    PubMed 28549480

  • Desveaux L, Gomes T, Tadrous M, Jeffs L, Taljaard M, Rogers J, Bell CM, Ivers NM. Appropriate prescribing in nursing homes demonstration project (APDP) study protocol: pragmatic, cluster-randomized trial and mixed methods process evaluation of an Ontario policy-maker initiative to improve appropriate prescribing of antipsychotics. Implement Sci. 2016 Mar 29;11:45. doi: 10.1186/s13012-016-0410-x.

    PubMed 27026584

Questions about this trial

What is this clinical trial studying?

A study testing Audit + Feedback and Audit + Feedback + Educational Outreach in people with Adverse Effect of Other Antipsychotics and Neuroleptics, run by Women's College Hospital.

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 2 inclusion and 3 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Antipsychotic dispensing (time frame: 6 months post-intervention). 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 NCT02604056, 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 23 Mar 2018.

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