Inappropriate Prescribing, Polypharmacy
Conditions
Keywords
Deprescribing, Nursing Home, Potentially Inappropriate Medication
Brief summary
This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents
Detailed description
Nursing home residents are often prescribed inappropriate medication, drugs whose negative effects outweigh potential benefits or which are not useful anymore. Inappropriate medication have been linked with worse health outcomes, hospitalisations and death. Deprescribing, the structured process of withdrawing or tapering inappropriate medications, has been studied as a potential solution to this problem. In this study, nursing home residents living in institution which are already engaged in a deprescribing process will be randomly allocated to receive a medication review or usual care. The medication review will be performed by the nursing home pharmacist an its results will be discussed with the responsible physicians and nurses to create a deprescribing plan specifically tailored to the needs of the resident.
Interventions
OTHERIndividual Deprescribing Intervention
The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.
Sponsors
Anne Niquille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Take 5 or more prescribed drugs daily; * Reside in the Nursing Home since at least 4 months.
Exclusion criteria
* Physician judges that discussing deprescribing with them risks destabilising them.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Inappropriate Medication at Follow-up | 4 months | Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Drugs Prescribed as a Result of the Intervention | 4 months | This outcome was not analysed |
| Number of Chronic DDDs Prescribed to Participants | 4 months | Number of chronic DDDs prescribed to participants |
| Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up | 4 months | Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO. |
| Number of Chronic Drugs Prescribed to Participants | 4 months | Number of Chronic Drugs Prescribed to Participants |
| Health-related Quality of Life | 4 months | The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes * a visual analog scale, ranging from 0 to 100, 100 indicating the best health you can imagine and 0 the worst health you can imagine. Higher results indicate an higher quality of life. * 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life. |
| Number of Common Drug-related Complaints at Follow-up | 4 months | Number of common drug-related complaints at follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Falls in Participants That Fell at Least Once | 4 months | — |
| Number of Days Spent With Physical Restraints | 4 months | — |
| Number of Deaths | 4 months | Number of deaths |
| Number of Participants Hospitalized | 4 months | Number of participants hospitalized at any time during the study |
| Days Spent in Hospital | 4 months | Average number of days spent in hospital during the study period |
| Number of Falls Per Participant | 4 months | Average number of falls during the study period |
| Number of Participants Who Fell | 4 months | Number of participants who fell at least once during the study period |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Individual Deprescribing Intervention Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).
Individual Deprescribing Intervention: The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval. | 31 |
| Control Participants allocated to the control group will receive usual care. | 27 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death after initial data collection | 4 | 2 |
| Overall Study | Died before initial data collection | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Individual Deprescribing Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 87 years | 84 years | 87 years |
| Duration of stay in years | 3.1 years STANDARD_DEVIATION 2.3 | 3.6 years STANDARD_DEVIATION 3.6 | 3.4 years STANDARD_DEVIATION 2.9 |
| Number of chronic DDDs | 9.6 chronic DDD STANDARD_DEVIATION 3.5 | 9.3 chronic DDD STANDARD_DEVIATION 3.6 | 9.5 chronic DDD STANDARD_DEVIATION 4.1 |
| Number of chronic drugs | 12 drugs | 11 drugs | 11 drugs |
| Number of drugs prescribed | 15 drugs | 15 drugs | 15 drugs |
| Number of PIM DDDs | 3.6 PIM DDD STANDARD_DEVIATION 2.8 | 3.4 PIM DDD STANDARD_DEVIATION 2.1 | 3.5 PIM DDD STANDARD_DEVIATION 2.5 |
| Number of PIMs | 5 potentially inappropriate medications | 6 potentially inappropriate medications | 5 potentially inappropriate medications |
| Quality of life: EQ-5D-5L analog scale | 56.5 analog scale units STANDARD_DEVIATION 24.8 | 61.4 analog scale units STANDARD_DEVIATION 20.5 | 58.9 analog scale units STANDARD_DEVIATION 22.8 |
| Quality of life: EQ-5D-5L index | 0.46 index STANDARD_DEVIATION 0.34 | 0.50 index STANDARD_DEVIATION 0.33 | 0.48 index STANDARD_DEVIATION 0.34 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Switzerland | 31 participants | 27 participants | 58 participants |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 36 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 32 | 4 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 0 |
| serious Total, serious adverse events | 4 / 31 | 0 / 0 |
Outcome results
Primary
Number of Inappropriate Medication at Follow-up
Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Inappropriate Medication at Follow-up | 4.35 drugs | Standard Deviation 2.72 |
| Control | Number of Inappropriate Medication at Follow-up | 4.85 drugs | Standard Deviation 2.58 |
p-value: 0.72395% CI: [0.83, 1.138]Regression, Poisson
Secondary
Health-related Quality of Life
The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) tool was used to assess quality of life; this tool includes * a visual analog scale, ranging from 0 to 100, 100 indicating the best health you can imagine and 0 the worst health you can imagine. Higher results indicate an higher quality of life. * 5 questions, each with 5 possible answers. Using a valuation set, the answers to individual questions were transformed in a numeric index value for each participants, with a maximum of 1 and an infinitely low minimum. Higher values indicates higher perceived health-related quality of life.
Time frame: 4 months
Population: Data on this outcome were missing for some participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Individual Deprescribing Intervention | Health-related Quality of Life | EQ-5D-5L scale | 63.5 units on a scale | Standard Deviation 17.2 |
| Individual Deprescribing Intervention | Health-related Quality of Life | EQ-5D-l index | 0.51 units on a scale | Standard Deviation 0.31 |
| Control | Health-related Quality of Life | EQ-5D-5L scale | 65.4 units on a scale | Standard Deviation 22.4 |
| Control | Health-related Quality of Life | EQ-5D-l index | 0.61 units on a scale | Standard Deviation 0.33 |
Comparison: Analysis for the scale componentp-value: 0.76995% CI: [-10.6, 7.89]Regression, Linear
Comparison: Analysis for the index componentp-value: 0.07595% CI: [-0.202, 0.01]Regression, Linear
Secondary
Number of Chronic DDDs Prescribed to Participants
Number of chronic DDDs prescribed to participants
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Chronic DDDs Prescribed to Participants | 7.82 DDD | Standard Deviation 3.85 |
| Control | Number of Chronic DDDs Prescribed to Participants | 7.65 DDD | Standard Deviation 2.74 |
p-value: 0.85795% CI: [0.833, 1.246]Regression, Poisson
Secondary
Number of Chronic Drugs Prescribed to Participants
Number of Chronic Drugs Prescribed to Participants
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Chronic Drugs Prescribed to Participants | 9.68 drugs | Standard Deviation 3.59 |
| Control | Number of Chronic Drugs Prescribed to Participants | 9.67 drugs | Standard Deviation 3.1 |
p-value: 0.06495% CI: [0.834, 1.005]Regression, Poisson
Secondary
Number of Common Drug-related Complaints at Follow-up
Number of common drug-related complaints at follow-up
Time frame: 4 months
Population: Data on this outcome at follow-up were missing for some participants, because of death or hospitalisation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Common Drug-related Complaints at Follow-up | 2.35 Number of complaints | Standard Deviation 2.6 |
| Control | Number of Common Drug-related Complaints at Follow-up | 1.44 Number of complaints | Standard Deviation 1.26 |
p-value: 0.21295% CI: [0.886, 1.727]Mixed-effect regression, Poisson
Secondary
Number of New Drugs Prescribed as a Result of the Intervention
This outcome was not analysed
Time frame: 4 months
Population: This outcome was not analyzed, as the drugs newly prescribed as a result of the intervention could not be distinguished from the other drugs newly prescribed.
Secondary
Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up
Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up | 2.73 DDD | Standard Deviation 2.97 |
| Control | Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up | 3.10 DDD | Standard Deviation 1.99 |
p-value: 0.03395% CI: [0.594, 0.979]Regression, Poisson
Other Pre-specified
Days Spent in Hospital
Average number of days spent in hospital during the study period
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Days Spent in Hospital | 3.6 Number of days | Standard Deviation 15.8 |
| Control | Days Spent in Hospital | 0.6 Number of days | Standard Deviation 2.9 |
p-value: 0.366Wilcoxon (Mann-Whitney)
Other Pre-specified
Number of Days Spent With Physical Restraints
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Days Spent With Physical Restraints | 15.6 days | Standard Deviation 39.1 |
| Control | Number of Days Spent With Physical Restraints | 15.1 days | Standard Deviation 39.1 |
p-value: 0.911Wilcoxon (Mann-Whitney)
Other Pre-specified
Number of Deaths
Number of deaths
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Deprescribing Intervention | Number of Deaths | 4 Participants |
| Control | Number of Deaths | 2 Participants |
p-value: 0.675Fisher Exact
Other Pre-specified
Number of Falls in Participants That Fell at Least Once
Time frame: 4 months
Population: Only the participants who fell at least once were included in this analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Falls in Participants That Fell at Least Once | 1.6 Number of falls | Standard Deviation 1 |
| Control | Number of Falls in Participants That Fell at Least Once | 1.4 Number of falls | Standard Deviation 0.7 |
p-value: 0.958Fisher Exact
Other Pre-specified
Number of Falls Per Participant
Average number of falls during the study period
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individual Deprescribing Intervention | Number of Falls Per Participant | 0.45 falls | Standard Deviation 0.89 |
| Control | Number of Falls Per Participant | 0.48 falls | Standard Deviation 0.8 |
p-value: 0.738Wilcoxon (Mann-Whitney)
Other Pre-specified
Number of Participants Hospitalized
Number of participants hospitalized at any time during the study
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Deprescribing Intervention | Number of Participants Hospitalized | 3 Participants |
| Control | Number of Participants Hospitalized | 1 Participants |
p-value: 0.615Fisher Exact
Other Pre-specified
Number of Participants Who Fell
Number of participants who fell at least once during the study period
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Individual Deprescribing Intervention | Number of Participants Who Fell | 9 Participants |
| Control | Number of Participants Who Fell | 9 Participants |
p-value: 0.781Wilcoxon (Mann-Whitney)