Trial Outcomes & Findings for Randomised, Controlled Trial of an Individual Deprescribing Intervention for Nursing Homes Residents (NCT NCT03655405)

Results Overview

Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

4 months

Results posted on

2021-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Control Participants allocated to the control group will receive usual care.
Overall Study STARTED	32	30
Overall Study COMPLETED	27	25
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control Participants allocated to the control group will receive usual care.
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

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.	Total n=58 Participants Total of all reporting groups
Age, Continuous	87 years n=31 Participants	84 years n=27 Participants	87 years n=58 Participants
Sex: Female, Male Female	16 Participants n=31 Participants	20 Participants n=27 Participants	36 Participants n=58 Participants
Sex: Female, Male Male	15 Participants n=31 Participants	7 Participants n=27 Participants	22 Participants n=58 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Switzerland	31 participants n=31 Participants	27 participants n=27 Participants	58 participants n=58 Participants
Duration of stay in years	3.1 years STANDARD_DEVIATION 2.3 • n=31 Participants	3.6 years STANDARD_DEVIATION 3.6 • n=27 Participants	3.4 years STANDARD_DEVIATION 2.9 • n=58 Participants
Number of drugs prescribed	15 drugs n=31 Participants	15 drugs n=27 Participants	15 drugs n=58 Participants
Number of chronic drugs	12 drugs n=31 Participants	11 drugs n=27 Participants	11 drugs n=58 Participants
Number of PIMs	5 potentially inappropriate medications n=31 Participants	6 potentially inappropriate medications n=27 Participants	5 potentially inappropriate medications n=58 Participants
Number of chronic DDDs	9.6 chronic DDD STANDARD_DEVIATION 3.5 • n=31 Participants	9.3 chronic DDD STANDARD_DEVIATION 3.6 • n=27 Participants	9.5 chronic DDD STANDARD_DEVIATION 4.1 • n=58 Participants
Number of PIM DDDs	3.6 PIM DDD STANDARD_DEVIATION 2.8 • n=31 Participants	3.4 PIM DDD STANDARD_DEVIATION 2.1 • n=27 Participants	3.5 PIM DDD STANDARD_DEVIATION 2.5 • n=58 Participants
Quality of life: EQ-5D-5L analog scale	56.5 analog scale units STANDARD_DEVIATION 24.8 • n=31 Participants	61.4 analog scale units STANDARD_DEVIATION 20.5 • n=27 Participants	58.9 analog scale units STANDARD_DEVIATION 22.8 • n=58 Participants
Quality of life: EQ-5D-5L index	0.46 index STANDARD_DEVIATION 0.34 • n=31 Participants	0.50 index STANDARD_DEVIATION 0.33 • n=27 Participants	0.48 index STANDARD_DEVIATION 0.34 • n=58 Participants

PRIMARY outcome

Timeframe: 4 months

Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Inappropriate Medication at Follow-up	4.35 drugs Standard Deviation 2.72	4.85 drugs Standard Deviation 2.58

SECONDARY outcome

Timeframe: 4 months

Appropriateness assessed using the French translation of STOPP v2; DDD defined by WHO.

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up	2.73 DDD Standard Deviation 2.97	3.10 DDD Standard Deviation 1.99

SECONDARY outcome

Timeframe: 4 months

Number of Chronic Drugs Prescribed to Participants

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Chronic Drugs Prescribed to Participants	9.68 drugs Standard Deviation 3.59	9.67 drugs Standard Deviation 3.10

SECONDARY outcome

Timeframe: 4 months

Number of chronic DDDs prescribed to participants

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Chronic DDDs Prescribed to Participants	7.82 DDD Standard Deviation 3.85	7.65 DDD Standard Deviation 2.74

SECONDARY outcome

Timeframe: 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.

This outcome was not analysed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Population: Data on this outcome were missing for some participants

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.

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=26 Participants 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.	Control n=25 Participants Participants allocated to the control group will receive usual care.
Health-related Quality of Life EQ-5D-5L scale	63.5 units on a scale Standard Deviation 17.2	65.4 units on a scale Standard Deviation 22.4
Health-related Quality of Life EQ-5D-l index	0.51 units on a scale Standard Deviation 0.31	0.61 units on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: 4 months

Population: Data on this outcome at follow-up were missing for some participants, because of death or hospitalisation.

Number of common drug-related complaints at follow-up

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=26 Participants 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.	Control n=25 Participants Participants allocated to the control group will receive usual care.
Number of Common Drug-related Complaints at Follow-up	2.35 Number of complaints Standard Deviation 2.60	1.44 Number of complaints Standard Deviation 1.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Number of deaths

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Deaths	4 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Number of participants hospitalized at any time during the study

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Participants Hospitalized	3 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Average number of days spent in hospital during the study period

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Days Spent in Hospital	3.6 Number of days Standard Deviation 15.8	0.6 Number of days Standard Deviation 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Average number of falls during the study period

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Falls Per Participant	0.45 falls Standard Deviation 0.89	0.48 falls Standard Deviation 0.80

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Number of participants who fell at least once during the study period

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Participants Who Fell	9 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Population: Only the participants who fell at least once were included in this analysis

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=9 Participants 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.	Control n=9 Participants Participants allocated to the control group will receive usual care.
Number of Falls in Participants That Fell at Least Once	1.6 Number of falls Standard Deviation 1.0	1.4 Number of falls Standard Deviation 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Individual Deprescribing Intervention n=31 Participants 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.	Control n=27 Participants Participants allocated to the control group will receive usual care.
Number of Days Spent With Physical Restraints	15.6 days Standard Deviation 39.1	15.1 days Standard Deviation 39.1

Adverse Events

0.911 0.911 Individual Deprescribing Intervention

Serious events: 4 serious events

Other events: 0 other events

Deaths: 5 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	0.911 0.911 Individual Deprescribing Intervention n=31 participants at risk 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.	Control Participants allocated to the control group will receive usual care.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.2% 1/31 • Number of events 3 • 4 months Adverse events were collected for the intervention group only.	— 0/0 • 4 months Adverse events were collected for the intervention group only.
Gastrointestinal disorders Hematemesis	3.2% 1/31 • Number of events 1 • 4 months Adverse events were collected for the intervention group only.	— 0/0 • 4 months Adverse events were collected for the intervention group only.
Musculoskeletal and connective tissue disorders Gout crisis	3.2% 1/31 • Number of events 1 • 4 months Adverse events were collected for the intervention group only.	— 0/0 • 4 months Adverse events were collected for the intervention group only.
Blood and lymphatic system disorders Oedema	3.2% 1/31 • Number of events 1 • 4 months Adverse events were collected for the intervention group only.	— 0/0 • 4 months Adverse events were collected for the intervention group only.

Other adverse events

Adverse event data not reported

Additional Information

Dr Anne Niquille

a. Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland

Phone: +41213144845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place