Background
Intervention Bundle | Behavioral Activation | Medication Optimization and Deprescription |
---|---|---|
Interventionist | Trained social worker | Trained social worker and pharmacy team consisting of pharmacists and a geriatric psychiatrist |
Description | Behavioral psychotherapy that helps depressed and anxious patients through identifying and tracking enjoyable and meaningful activities guided by personal goals and priorities [43]. | |
Core active components | • Identify patient’s personalized rationale • Define patient’s values and assess goals • Schedule activities of interest • Monitor progress of activities | • Review patient’s medications • Identify the patient’s likely need for, and interest in, a medication adjustment • Suggest medication adjustments • Assess the response to that adjustment • Coordinate with hospital team to ensure medication changes introduced pre-operatively are maintained in-house • Ensure medication changes are reconciled during transitions of care |
Flexible components | • Selected behavioral activation activities: depending on patient needs and preferences • Timing: Pre-operative and post-operative phases • Format: 1:1 (patient-specific activities); group sessions (to share experiences with others and hear about other stories – peer-motivation) • Duration: 20–60 min • Frequency of sessions: 1–4 (pre-op); 2–12 (post-op) • Setting: In-person (first time –surgeon clinic/pre-op counseling class), telephone, and zoom (video) | • Suggest medication changes only if patient is comfortable • Timing: Pre-operative and post-operative phases (start as early as possible) • In-hospital care: Pharmacy team coordinates with in-hospital team to ensure continuity of care • Format: 1:1 session • Duration: 5 min • Frequency of sessions: 1–4 (pre); 2–12 (post) • Setting: In-person (first time); telephone; zoom (video) or in-person (for remaining sessions) |
Conceptual Framework
Methods
Study setting
Study design
Study partners and participants
Study partners
Study participants
Data collection
Purpose of Method | Phase | Participants | # | Findings |
---|---|---|---|---|
IAB workshop studios: To obtain different stakeholders’ perspectives and experiences: patient mental health needs, intervention objectives, and adaptations required for intervention content and delivery, as well as study delivery. | Pre-implementation | IAB study partners (Studios 1 and 3: patients and caregivers; Studio 2: all IAB members) | 3 | We identified barriers and facilitators to intervention implementation based on study partner perspectives and brainstormed adaptations to make. |
Weekly intervention refinement meetings: To identify pre-implementation adaptations necessary for successful PMH intervention bundle use among interventionists and patients. | Pre-implementation | Interventionists, social workers, pharmacists, psychiatrists, behavioral scientists, and research team members | 12 | We assessed progress in intervention bundle design We identified pre-implementation barriers to intervention delivery and brainstormed adaptations to make accordingly. |
Periodic intervention reflection meeting: To reflect upon interventionists’ experiences, to collect contextual data and triangulate data for a richer understanding [51]. | Post-implementation (mid-point) | Implementation scientists, interventionists, interventionist supervisor | 1 | We assessed study progress and interventionist experiences. We also identified barriers to intervention delivery and brainstormed adaptations to make accordingly. |
Weekly patient case review meetings: To review and discuss patient intervention sessions and to document adaptations and challenges to intervention implementation. | Post-implementation | Interventionists, social workers, pharmacists, psychiatrists, behavioral scientists, and research team members | 33 | We assessed study progress and intervention bundle use among patients. We also identified post-implementation barriers to intervention delivery and brainstormed adaptations to make accordingly. |
Audio-recordings of intervention sessions and collection of session documentation forms completed by interventionists: To capture data on progress towards MOD (adherence to medication changes, side effects) and BA (goals, values, activity scheduling and assessment) components; to also assess intervention fidelity through intervention delivery (delivering PMH intervention bundle consistently), intervention receipt (reflection of patients’ receipt and understanding of the PMH intervention bundle and their capacity to use skills taught), and intervention enactment (patients’ actual performance of MOD and BA skills and implementation of core intervention components) [52, 53]. | Post-implementation | Patients and interventionists | 226 | We assessed intervention fidelity to core components of MOD and BA and recorded any adaptations made during each session. |
Patient interviews and caregiver interviews: To assess perspectives on the intervention and study overall (see Appendix S1 for our semi-structured interview guide developed for the study [47]). | Post-implementation | Patients and caregivers from feasibility study | 19 | We identified patient suggestions for future improvement to study content and implementation (for adaptation evaluation only). |
Data analysis
IAB workshop studios and periodic intervention reflection meetings
Weekly intervention refinement meetings and weekly case review meetings
FRAME categories | Sub-categories | Example |
---|---|---|
Date of adaptation
| When was the change made? | 8/25/2021 |
Description of adaptation
| What has been changed? | BA session documentation forms were revised to be different for Sessions 1, 2–9, and 10. |
WHAT is adapted?
| Content: changes made to content itself, or that impact how aspects of the treatment are delivered Contextual: changes made to how the intervention is delivered, based on the study/research, target population, intervention format, intervention delivery mode, study setting, or study personnel Training and evaluation: changes made to how staff are trained or how the intervention is evaluated | Contextual: format |
What is the NATURE of the intervention adaptation?
| How did the intervention, study, or training and evaluation change? Tailoring/rewording/refining: a change to the intervention that leaves all of the major intervention principles and techniques intact Integrating intervention into another framework: another treatment approach is the starting point, but elements of the intervention are brought into the treatment Integrating another treatment into the intervention: the intervention is the starting point, but aspects of different therapeutic approaches or evidence-based practices are also used Removing/skipping elements: intervention baseline or standard treatment is based on the evidence-based practice, but particular elements are dropped Lengthening/extending (pacing/timing): a longer amount of time than prescribed by the manual is spent to complete the intervention or intervention sessions Adjusting the order of intervention components: intervention modules or concepts are presented in a different order than originally described in the manual Adding elements: additional distinct materials or areas of focus consistent with the fundamentals of the intervention are inserted Departing from intervention (drift): use of another intervention Loosening structure: the structure of intervention sessions is different from what is prescribed in the manual, but the core remains Repeating components: a module or intervention that is normally prescribed once during a protocol is done more than once Substituting components: a module or activity is replaced with something that is different in substance | Tailoring/rewording/refining |
Was the adaptation proactive or reactive?
| Proactive- Planned: Part of the plan to modify to maximize fit and implementation success Reactive- Unplanned: often in response to an obstacle, challenge, deviation from the plan | Proactive |
At what LEVEL of DELIVERY is the content level adaptation?
| For whom does the modification apply? Individual patient/practitioner level: individual roles that need to adapt Target intervention group level: group of individuals who participate in the intervention that need to adapt Clinic/unit-level: an entire unit or clinic that adapt Hospital level: the full organization that need to adapt System level: the healthcare system, county, or community that need to adapt | Target intervention group level |
HOW or on what basis was this change made?
|
Based on vision or values
Based on a framework
Based on knowledge and experience working with patients
Based on practical considerations
Based on financial incentives/payments
Based on feedback or suggestions
| Based on practical considerations |
WHY? What is the purpose of the adaptation?
| What is the intent or goal of the adaptation?
Increase reach, participation, access
Increase effectiveness
Increase adoption by more settings
Make intervention more aligned with organization goals
Increase implementation/ability of staff to deliver intervention successfully
| Increase implementation/ability of staff to deliver intervention successfully |
WHO suggested the decision to adapt?
| Who suggested the decision to adapt?
Interventionists
Pharmacists
Health IT administrator
Research team members
Patients
Caregivers
| Interventionists Research team members |
Patient and caregiver interviews
Intervention session audio-recordings and session documentation forms
Results
IAB study partners | N |
---|---|
Participant type | |
Clinicians | |
Anesthesiologist Social worker Pharmacist Psychiatrists Behavioral scientists Registered Nurse Surgeon | 1 (3.4%) 2 (6.9%) 1 (3.4%) 1 (3.4%) 1 (3.4%) 2 (6.9%) 1 (3.4%) |
Researchers | |
Implementation scientists Informatician Research coordinator Patient experience leader | 3 (10.3%) 1 (3.4%) 2 (6.9%) 1 (3.4%) |
Patients | |
Orthopedic patients Oncologic patients Cardiac patients | 3 (10.3%) 2 (6.9%) 2 (6.9%) |
Caregivers | |
Orthopedic caregivers Oncologic caregivers Cardiac caregivers | 2 (6.9%) 2 (6.9%) 2 (6.9%) |
Sex | |
Male Female | 13 (44.8%) 16 (55.2%) |
Race | |
White Black American Indian or Alaska Native Asian Native Hawaiian or Other Pacific Islander | 27 (93.1%) 1 (3.4%) 0 (0%) 1 (3.4%) 0 (0%) |
Ethnicity | |
Non-Hispanic or Latinx Hispanic or Latinx | 28 (96.6%) 1 (3.4%) |
Feasibility study participants
|
N
|
Participant type | |
Orthopedic patients Oncologic patients Cardiac patients Orthopedic caregivers Oncologic caregivers Cardiac caregivers | 8 (28.6%) 8 (28.6%) 7 (25%) 0 (0%) 4 (14.3%) 1 (3.6%) |
Sex* | |
Male Female | 8 (35%) 15 (65%) |
Race* | |
White Black American Indian or Alaska Native Asian Native Hawaiian or Other Pacific Islander Mixed | 19 (83%) 2 (8.7%) 0 (0%) 0 (0%) 0 (0%) 1 (4.3%) |
Ethnicity* | |
Non-Hispanic or Latinx Hispanic or Latinx Prefer not to answer | 19 (83%) 3 (13%) 1 (4.3%) |
Adaptation constructs | Adaptation elements | Pre-implementation | Post-implementation | Total |
---|---|---|---|---|
WHAT is adapted?
| Content: intervention elements | 9 | 13 | 22 |
Contextual: research, population, format, delivery mode, setting, and personnel | 6 | 15 | 21 | |
Training and evaluation: how staff are trained and how intervention is evaluated (e.g., outcomes) | 1 | 7 | 8 | |
What is the NATURE of the intervention adaptation?
| Tailoring/rewording/refining | 8 | 10 | 18 |
Integrating another treatment into the intervention | 0 | 1 | 1 | |
Removing/skipping elements | 1 | 3 | 4 | |
Lengthening/extending (pacing/timing) | 0 | 1 | 1 | |
Adjusting the order of intervention components | 2 | 2 | 4 | |
Adding elements | 6 | 13 | 19 | |
Loosening structure | 0 | 2 | 2 | |
Substituting components | 0 | 2 | 2 | |
Was the adaptation planned or reactive?
| Planned | 16 | 12 | 28 |
Reactive | 0 | 23 | 23 | |
At what LEVEL of DELIVERY is the content level adaptation?
| Individual patient or practitioner level | 10 | 26 | 36 |
Target intervention group level | 8 | 7 | 15 | |
HOW or on what basis was this change made?
| Based on vision or values | 3 | 7 | 10 |
Based on a framework | 4 | 1 | 5 | |
Based on knowledge and experience working with patients | 0 | 9 | 9 | |
Based on practical considerations | 8 | 18 | 26 | |
Based on financial incentives/payments | 0 | 0 | 0 | |
Based on feedback or suggestions | 0 | 1 | 1 | |
WHY? What is the purpose of the adaptation?
| Increase reach, participation, access | 3 | 12 | 15 |
Increase effectiveness | 6 | 4 | 10 | |
Make intervention more aligned with organization goals | 1 | 4 | 5 | |
Increase implementation/ability of staff to deliver intervention successfully | 6 | 15 | 21 |
Content adaptations
Pre-implementation adaptations
Post-implementation adaptations
Adaptations | Original protocol | What was adapted | When adaptation occurred | Planned or reactive | At what level of delivery | Intent of adaptation |
---|---|---|---|---|---|---|
Interventionists were renamed to “perioperative wellness partners” or “wellness partners” to use patient-friendly language that accurately and positively describes the clinician-patient relationship. | Originally, study personnel who were trained to deliver the intervention bundle to patients were called “interventionists.” | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To make intervention more aligned with organization goals |
Specific mental health-based needs, expectations, and goals were identified. | BA was not tailored specifically towards patient mental health needs. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase effectiveness |
Wellness partners served as liaisons for mental health support, referring patients to other resources, social work referrals, and financial aid when necessary. | Original protocols gave wellness partners more responsibility over social work and other resources. | Removing/skipping elements | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Medication optimization and deprescription was renamed to medication optimization (MO) and MO SOP was revised to focus on pre-operative psych medications and post-operative psych medication changes (including name, dose, units, frequency of sessions, start date and stop date, indication). | The pharmacotherapy component was originally called “medication optimization and deprescription.” The original SOP focused on all medications. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase effectiveness |
MO SOP was revised to assess potential for stopping muscle relaxants pre-operatively and reflect the difference between PRN/OTC and other prescribed medications. | The original MO SOP did not differentiate between specific medications that did not pertain to intervention bundle goals. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase effectiveness |
The first session of BA was focused on building trust and rapport and introducing the patient to the intervention and its core components (e.g., personalized rationale). Activity scheduling followed in the next sessions. | Previously, the first session of BA began therapy and goal-setting exercises immediately. | Adjusting the order of intervention components | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase effectiveness |
BA forms included simple activity planning. | BA documentation forms were originally more complex and harder to use. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Wellness partners made medication adjustments and assessed the responses to each adjustment. | Wellness partners originally did not need to check for side effects and responses to medication adjustments. | Adding elements | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase implementation/ability of staff to deliver intervention successfully |
Wellness partners coordinated with the hospital team to ensure that medication changes introduced pre-operatively were maintained in-house. | No check-ins were originally conducted to ensure continuity of care and medication use in-house. | Adding elements | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase effectiveness |
SOPs and documentation forms were revised to use simpler, layman terms for patients to understand. | SOPs originally had too much complex language that was hard for patients to understand. | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
BA SOP was revised to create tailored sessions (timing, frequency of sessions, referrals, resources, etc.). | The BA SOP originally was not tailored to each patient’s personal preference for timing, frequency of sessions, etc. | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
BA SOP was revised to include suggestions, referrals, and resources for sleep, pain, and alternate relaxation techniques during and after the intervention time period. | The BA SOP did not originally have additional suggestions and techniques. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To make intervention more aligned with organization goals |
MO SOP was revised to encourage patients to self-advocate and empower themselves to communicate with their prescribers to implement medication changes. | The MO SOP did not originally include guidelines to encourage self-advocacy. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase effectiveness |
BA was tailored for older surgical patients and their specific goals and activities pre-operatively and post-operatively (including surgery recovery goals from surgical team). | BA was originally not tailored for different types of surgeries and types of older patient (e.g., retired vs. semi-retired, family vs. no family). | Integrating intervention into another framework | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To make intervention more aligned with organization goals |
BA SOP was revised to include motivational interviewing techniques to encourage patients who have more resistance to changing their behavior. | The BA SOP did not originally use motivational interviewing techniques. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
BA documentation forms were reduced in detail and wellness partners were encouraged to reinforce activities in addition to suggesting new ones. Wellness partners were also encouraged to suggest flexible methods of activity documentation (e.g., journaling), and emphasized meeting the patient where they were, not forcing anything upon them. | Previously, wellness partners were encouraged to keep scheduling new activities and goals, without reinforcement. Furthermore, documentation forms were mandatory to the intervention bundle. | Loosening structure | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase effectiveness |
Intervention bundle was renamed to perioperative wellness program (emphasizing principles of BA, compassion and coordination) and MO across all intervention documents and research documents | The original intervention bundle was called the “perioperative mental health bundle.” | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase reach, participation, access |
The activity tracking form was modified to reflect the granularity as defined by the patient | The original activity tracking form was very detailed and required patients to track all their activities | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
MO SOP was revised to have the pharmacy team lead the MO component – review medications and optimize the targeted medications | Wellness partners originally reviewed medications and provided recommendations | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase effectiveness |
Screening procedure was revised to include a narrative showing that studies indicated BA was effective for anxiety, depression, and general well-being, followed by an explanation of the perioperative wellness program. | Previous screening procedures focused heavily on mental health screening, which was stigmatized by patients. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
Consent language was revised to include a description of what to expect from the perioperative wellness program, omitting language about anxiety and depression to avoid stigma. | Previous consent language was complex and vague, which meant that patients did not understand the intervention bundle prior to participation. | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
Both control and intervention groups in the future RCT will receive resources for mindfulness, relaxation, stress reduction, daily routines, sleep hygiene, activity rest cycle, brain training, and social activities. | Originally, the control group would only receive usual care. | Adding elements | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To make intervention more aligned with organization goals |
Contextual adaptations
Pre-implementation adaptations
Post-implementation adaptations
Adaptations | Original protocol | What was adapted | When adaptation occurred | Planned or reactive | At what level of delivery | Intent of adaptation |
---|---|---|---|---|---|---|
MO SOP was revised to involve patients in decision-making and to assign wellness partners with documentation responsibilities, including REDCap forms on medication changes. | The original MO SOP did not factor patients into the decisions that wellness partners made during sessions. | Adding elements | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase reach, participation, access |
Sessions were conducted in-person 1:1 informally at first and then over the phone/Zoom following the first session. | Sessions were conducted in accordance with patient preference. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase reach, participation, access |
Wellness partners used a medication management algorithm in addition to receiving supervision from pharmacists and a geriatric psychiatrist. | Wellness partners originally did MO themselves, in consultation with pharmacists and a geriatric psychiatrist. | Adding elements | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Target intervention group level | To increase implementation/ability of staff to deliver intervention successfully |
MO and BA sessions were scheduled to be biweekly or weekly for a total of 8–12 sessions. Additional sessions were added if necessary or if goals were not met. | Previously, there was no number of sessions or frequency set – wellness partners were expected to schedule them based on each patient’s individual preferences and availability. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase effectiveness |
BA session documentation forms were different for Sessions 1, 2, 3, 4–9, and 10. | Originally, forms were different for Sessions 1, 2, 3–9, and 10. | Tailoring/rewording/refining | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
2–4 BA sessions were conducted pre-operatively if possible, ideally starting 30 days prior to surgery and ending sessions 90 days after surgery. | Originally, there was no formal schedule or split between pre-operative and post-operative sessions. | Adjusting the order of intervention components | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase reach, participation, access |
Patients were contacted virtually up to 3 times for intervention sessions and follow-up before wellness partners reached out via mail. | Patients were contacted over email or by phone indefinitely. | Lengthening/extending (pacing/timing) | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
6 pharmacy students assisted wellness partners with MO (with supervision from pharmacists). | Originally, pharmacy students were not included in the study or intervention bundle. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase implementation/ability of staff to deliver intervention successfully |
MO SOP was revised to reflect medication data collection between first session and all other sessions. | The same type of medication data was originally collected at each session, causing some redundancy. | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase implementation/ability of staff to deliver intervention successfully |
MO SOP was revised to reflect the pharmacy team’s roles and responsibilities. | Originally, the pharmacy team’s roles and responsibilities did not extend to MO. | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase implementation/ability of staff to deliver intervention successfully |
BA and MO began in the same session. | Originally, BA began one session after MO. | Adjusting the order of intervention components | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Patients were reminded of their goals and about activities that made them feel good or mattered to them. They were also reminded that the goals of the study were to support overall surgical recovery, not just mental health. | Originally, BA SOP language emphasized mental health improvement and recovery, rather than overall surgical recovery. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Patients were offered opportunities to reach out to their wellness partners as needed within the 3-month intervention period, and were encouraged to check in monthly. | Originally, there was no guideline for patients to keep in touch with their wellness partners. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
Exclusion criteria were modified to exclude revisions to joint replacement surgery patients, patients with immediate suicidal ideation, and rescheduled surgical patients who have canceled or postponed surgeries within the past 3 months following enrollment into the study; inclusion criteria were modified to include patients 60 years of age and older. | The study originally included all joint replacement patients (primary and revisions), patients with suicidal ideation, and rescheduled surgical patients. The study originally excluded patients under 65 years of age. | Removing/skipping elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
Follow-up assessment surveys were optionally emailed to patients. | Follow-up assessment surveys were originally only administered via phone call. | Tailoring/rewording/refining | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
Employment status was collected during enrollment. | Originally, employment status was not collected. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase reach, participation, access |
Auto-generated calendars with follow-ups (throughout study and at end of study) were suggested for future RCT use. | Originally, wellness partners notified the research coordinator of patient progress via email. | Substituting components | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Data collection was revised to gather all medication lists from Epic and confirm them in each session to ensure in the future that the research coordinator is blinded. | The study team originally planned that data would be collected by the research coordinator, who would then know which patients were in each arm of the study. | Tailoring/rewording/refining | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase effectiveness |
Intervention sessions could be scheduled differently based on type of surgery -- orthopedic patients typically scheduled their surgeries 3 + months in advance and had more time for pre-operative sessions. In contrast, oncologic patients scheduled their surgeries about 2 weeks in advance, and cardiac patients scheduled their surgeries about 2–3 days in advance, leaving little room for pre-operative sessions. | Originally, there was no plan of scheduling sessions differently based on type of surgery. | Adjusting the order of intervention components | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase reach, participation, access |
Caregivers were not included in the intervention bundle. | Originally, caregiver involvement was optional and encouraged. | Removing/skipping elements | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase effectiveness |
Wellness partners were instructed to deliver the intervention bundle with elements of compassion and patient-sensitivity. | Originally, wellness partners did not intentionally incorporate elements of compassion into their sessions. | Adding elements | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To make intervention more aligned with organization goals |
Training and evaluation adaptations
Pre-implementation adaptations
Post-implementation adaptations
Adaptations | Original protocol | What was adapted | When adaptation occurred | Planned or reactive | At what level of delivery | Intent of adaptation |
---|---|---|---|---|---|---|
Wellness partners were trained based on previous work by Puspitasari et al. [33]. | Original protocol did not specify wellness partner training | Adding elements | Pre-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Wellness partners were retrained throughout the intervention implementation. | Original protocol did not utilize retraining sessions for wellness partners | Adding elements | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Pharmacy students were trained on how to support wellness partners during MO. | Original protocol did not train pharmacy students to aid in MO | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Data collection was simplified, including revision of suicide risk, alcohol consumption, opioid, falls, and medication questions. | The research coordinator used the Behavioral Activation for Depression Scale – Short Form (BADS-SF) and the Veterans RAND – 12 (VR-12) to measure target engagement and quality of life. | Loosening structure | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Data on hospital readmissions and follow-ups were collected. | Originally, data on hospital readmissions and follow-ups were not collected. | Adding elements | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase reach, participation, access |
Only 1-month and 3-month follow-ups were collected. | Originally, 1-month, 2-month, and 3-month follow-ups were collected. | Removing/skipping elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Target intervention group level | To increase reach, participation, access |
REDCap session documentation forms were revised to include a general emotional health question. | Originally, REDCap had a question that assumed that the patient had depression and anxiety and forced patients to provide ratings. | Adding elements | Post-implementation | Reactive: Unplanned often in response to an obstacle, challenge, deviation from the plan | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |
Future RCTs will use chart-based delirium detection tool (CHART-DEL) [55] to obtain delirium assessments. | The original protocol used in-person confusion assessment method (CAM) [56]. | Substituting components | Post-implementation | Planned: Part of the plan to modify to maximize fit and implementation success | Individual patient/practitioner level | To increase implementation/ability of staff to deliver intervention successfully |