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Completed

NCT Number: NCT02604056

Pragmatic Cluster Trial for Nursing Home Antipsychotic Prescribing

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

i. 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:

  • How and why do the interventions work as observed?
  • Was the intervention implemented as desired in nursing homes?
  • What were the contextual factors associated with implementation?
  • Do the interventions affect precursors of behaviour (e.g., motivation, capability)?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Audit + Feedback

Behavioral

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 Outreach

Behavioral

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.

Primary outcomes

  1. Antipsychotic dispensing

    Time frame: 6 months post-intervention

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

Secondary outcomes

  1. Antipsychotic prescribing

    Time frame: 3 and 6 months post-intervention

    Any antipsychotic prescription during the past month (dichotomous)

  2. Mean Antipsychotic dose

    Time frame: 3 and 6 months post-intervention

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

  3. Benzodiazepine (or sedative) prescribing

    Time frame: 3 and 6 months post-intervention

    Any prescription during the past month (dichotomous)

  4. Anti-depressant prescribing

    Time frame: 3 and 6 months post-intervention

    Any prescription during the past month (dichotomous)

  5. Acetaminophen prescribing

    Time frame: 3 and 6 months post-intervention

    Any prescription during the past month (dichotomous)

  6. Difficulty in performing activities

    Time frame: 3 and 6 months post-intervention

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

  7. Aggressive behaviour scale

    Time frame: 3 and 6 months post-intervention

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

  8. Pain

    Time frame: 3 and 6 months post-intervention

    Pain scale (continuous variable, range 0-3)

  9. Depression

    Time frame: 3 and 6 months post-intervention

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

  10. Falls

    Time frame: 3 and 6 months post-intervention

    Number of falls in the past month (count)

  11. Emergency Room visits

    Time frame: 3 months post-intervention

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

  12. Hospitalizations

    Time frame: 3 months post-intervention

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

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • Centre for Effective Practice
  • Health Quality Ontario
  • Ontario Medical Association
  • Ontario Ministry of Health and Long Term Care

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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